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DATE 2016-12-01

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DATE 2016-12-28
FROM From: "Pharmacy Times"
SUBJECT Subject: [Hangout-NYLXS] Xtampza(R) ER (oxycodone) Product Bulletin
From hangout-bounces-at-nylxs.com Wed Dec 28 23:12:59 2016
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Subject: [Hangout-NYLXS] Xtampza(R) ER (oxycodone) Product Bulletin
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If you can't read this email. Please view online [ http://eventsolutions.biz/xtampza/pharmacist.html ]

Pharmacies shoulder a heavy burden for the responsible distribution of opioids - 4.3 million Americans abuse prescription pain relievers by using them nonmedically 1, 64% of abusers are given or buy pain relievers from friends or relatives 2, and 21% of abusers obtain pain relievers through a prescription from one doctor 2

- Xtampza ® ER is an abuse-deterrent, extended-release oxycodone featuring DETERx ® microsphere technology

- PK clinical studies of Xtampza ER have shown that manipulation - including crushing, chewing, and snorting - had little to no effect on PK profile, although abuse by these routes is still possible

- Xtampza ER does not contain this common boxed warning language 3:

BOXED WARNING

Instruct patients to swallow whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dole of oxycodone

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING BELOW

The use of any opioid may result in serious, life-threatening, or fatal respiratory depression, even when used as recommended

- DETERx technology is engineered for manipulation resistance

- However, abuse of Xtampza ER by injection, by the nasal route of administration, and by the oral route is still possible

Xtampza ER is the exclusive extended release oxycodone for United Healthcare's commercial members beginning January 1, 2017.

1 US Department of Health and Human Services. Results from the 2014 National Survey on Drug Use and Health: Summary of National Findings. http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf. Published September 2015. Accessed October 20, 2016.

2 US Department of Health and Human Services. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.pdf. Published September 2014. Accessed October 20, 2016.

3 Xtampza ER [package insert]. Canton, MA: Collegium Pharmaceutical, Inc.; 2016.

DOWNLOAD BULLETIN [ http://www.xtampzaer.com/hcp/assets/pdfs/pharmacist_product_bulletin.pdf ]

LEARN MORE

For more information, visit XtampzaER.com

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AT THE LINKS BELOW

Important Safety Information [ http://www.xtampzaer.com ]
Full Prescribing Information [ http://www.xtampzaer.com/pdf/xtampza-pi.pdf ]

INDICATIONS AND USAGE:

Xtampza ER (oxycodone) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Xtampza ER for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Xtampza ER is not indicated as an as-needed (prn) analgesic.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse

Xtampza ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression, especially during initiation of Xtampza ER or following a dose increase.

Accidental Ingestion

Accidental ingestion of even 1 dose of Xtampza ER, especially by children, can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 3A4 Interaction

The concomitant use of Xtampza ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Xtampza ER and any CYP3A4 inhibitor or inducer.

CONTRAINDICATIONS:

Xtampza ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, known or suspected gastrointestinal obstruction, including paralytic ileus, and hypersensitivity (eg, anaphylaxis) to oxycodone.

WARNINGS AND PRECAUTIONS:

Addiction, Abuse, and Misuse

Xtampza ER contains oxycodone, a Schedule II controlled substance. As an opioid, Xtampza ER exposes users to the risks of addiction, abuse, and misuse. As extendedrelease products such as Xtampza ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Xtampza ER during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

Concomitant use of Xtampza ER with a CYP3A4 inhibitor, such as macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), and protease inhibitors (eg, ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Xtampza ER is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in Xtampza ER–treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions. When using Xtampza ER with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in Xtampza ER–treated patients, monitor patients closely at frequent intervals and consider dosage reduction of Xtampza ER until stable drug effects are achieved.

Concomitant use of Xtampza ER with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to oxycodone. When using Xtampza ER with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur.

Risks Due to Interactions with Central Nervous System Depressants

Hypotension, profound sedation, respiratory depression, coma, and death may result if Xtampza ER is used concomitantly with other central nervous system (CNS) depressants (eg, benzodiazepines and other sedative-hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids). If coadministration is required, start with one-third to one-half the usual dose of Xtampza ER; monitor patients for signs of respiratory depression, sedation and hypotension; and consider using a lower dose of the concomitant CNS depressant. Use an alternative analgesic for patients who require a dose of Xtampza ER less than 9 mg.

Risk of Life-Threatening Respiratory Depression in Elderly, Cachectic, and Debilitated Patients

Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients, as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor such patients closely, particularly when initiating and titrating Xtampza ER and when Xtampza ER is given concomitantly with other drugs that depress respiration. Use an alternative analgesic for patients who require a dose of Xtampza ER less than 9 mg.

Risk of Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease

The use of Xtampza ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Xtampza ER–treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, are at increased risk of decreased respiratory drive, including apnea, even at recommended dosages of Xtampza ER.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often after more than 1 month of use. Presentation of adrenal insufficiency may include nonspecific symptoms and signs, including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

Severe Hypotension

Xtampza ER may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (eg, phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dosage of Xtampza ER. In patients with circulatory shock, Xtampza ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Xtampza ER in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

In patients who may be susceptible to the intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors), Xtampza ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Xtampza ER.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Xtampza ER in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions

Xtampza ER is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus.

The oxycodone in Xtampza ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Risks of Use in Patients with Seizure Disorders

The oxycodone in Xtampza ER may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during Xtampza ER therapy.

Withdrawal

Avoid the use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including Xtampza ER. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing Xtampza ER, gradually taper the dosage. Do not abruptly discontinue Xtampza ER.

Risks of Driving and Operating Machinery

Xtampza ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Xtampza ER and know how they will react to the medication.

Laboratory Monitoring

Not every urine drug test for "opioids" or "opiates" detects oxycodone reliably, especially those designed for in-office use. Further, many laboratories will report urine drug concentrations below a specified "cut-off" value as "negative." Therefore, if urine testing for oxycodone is considered in the clinical management of an individual patient, ensure that the sensitivity and specificity of the assay is appropriate, and consider the limitations of the testing used when interpreting results.

ADMINISTRATION WITH FOOD:

Instruct patients to always take Xtampza ER capsules with food and with approximately the same amount of food in order to ensure consistent plasma levels are achieved. For patients who have difficulty swallowing, Xtampza ER can also be taken by sprinkling the capsule contents on soft foods, into a cup and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

ADVERSE REACTIONS:

The most common adverse reactions (>5%) reported by patients in the Phase 3 clinical trial were nausea, headache, constipation, somnolence, pruritus, vomiting, and dizziness.

Xtampza ER and DETERx are registered trademarks of Collegium Pharmaceutical, Inc.

®2016 Collegium Pharmaceutical, Inc. All rights reserved. PP-DT-US-0007 11/16.

Collegium Pharmaceutical, Inc. 780 Dedham Street, Suite 800. Canton, MA, 02021, USA.


Pharmacy Times : Practical Information for Today's Pharmacist | 666 Plainsboro Road | Building 300

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If you can't read this email. [1]Please view online

[header.gif]
Pharmacies shoulder a heavy burden for the responsible distribution of
opioids -
4.3 million Americans abuse prescription pain relievers by using them
nonmedically^1, 64% of abusers are given or buy pain relievers from
friends or
relatives^2, and 21% of abusers obtain pain relievers through a
prescription from one doctor^2
* Xtampza^? ER is an abuse-deterrent, extended-release oxycodone
featuring DETERx^? microsphere technology
* PK clinical studies of Xtampza ER have shown that manipulation -
including crushing, chewing, and snorting - had little to no effect
on PK profile, although abuse by these routes is still possible
* Xtampza ER does not contain this common boxed warning language^3:

[PT_Xtanpza_boxedwarning%20X.PNG]

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION, INCLUDING BOXED
WARNING BELOW
The use of any opioid may result in serious, life-threatening, or fatal
respiratory depression, even when used as recommended

* DETERx technology is engineered for manipulation resistance
* However, abuse of Xtampza ER by injection, by the nasal route of
administration, and by the oral route is still possible

Xtampza ER is the exclusive extended release oxycodone for United
Healthcare's commercial members beginning January 1, 2017.

^1 US Department of Health and Human Services. Results from the 2014
National Survey on Drug Use and Health: Summary of National Findings.
http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FR
R1-2014.pdf. Published September 2015. Accessed October 20, 2016.
^2 US Department of Health and Human Services. Results from the 2013
National Survey on Drug Use and Health: Summary of National Findings.
http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013
/Web/NSDUHresults2013.pdf. Published September 2014. Accessed October
20, 2016.
^3 Xtampza ER [package insert]. Canton, MA: Collegium Pharmaceutical,
Inc.; 2016.

[2][PT_Xtanpza_downloadbutton3.png]

LEARN MORE
For more information, visit XtampzaER.com

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING
INFORMATION, INCLUDING BOXED WARNING AT THE LINKS BELOW

[3]Important Safety Information | [4]Full Prescribing Information



INDICATIONS AND USAGE:
Xtampza ER (oxycodone) is indicated for the management of pain severe
enough to require daily, around-the-clock, long-term opioid treatment
and for which alternative treatment options are inadequate.

Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even
at recommended doses, and because of the greater risks of overdose and
death with extended-release opioid formulations, reserve Xtampza ER for
use in patients for whom alternative treatment options (eg, non-opioid
analgesics or immediate-release opioids) are ineffective, not
tolerated, or would be otherwise inadequate to provide sufficient
management of pain.

Xtampza ER is not indicated as an as-needed (prn) analgesic.
IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME;
AND CYTOCHROME
P450 3A4 INTERACTION
Addiction, Abuse, and Misuse
Xtampza ER exposes patients and other users to the risks of opioid
addiction, abuse, and misuse, which can lead to overdose and death.
Assess each patient's risk prior to prescribing Xtampza ER and monitor
all patients regularly for the development of these behaviors or
conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of Xtampza ER. Monitor for respiratory depression, especially
during initiation of Xtampza ER or following a dose increase.
Accidental Ingestion
Accidental ingestion of even 1 dose of Xtampza ER, especially by
children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Xtampza ER during pregnancy can result in neonatal
opioid withdrawal syndrome, which may be life-threatening if not
recognized and treated, and requires management according to protocols
developed by neonatology experts. If opioid use is required for a
prolonged period in a pregnant woman, advise the patient of the risk of
neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
Cytochrome P450 3A4 Interaction
The concomitant use of Xtampza ER with all cytochrome P450 3A4
inhibitors may result in an increase in oxycodone plasma
concentrations, which could increase or prolong adverse drug effects
and may cause potentially fatal respiratory depression. In addition,
discontinuation of a concomitantly used cytochrome P450 3A4 inducer may
result in an increase in oxycodone plasma concentration. Monitor
patients receiving Xtampza ER and any CYP3A4 inhibitor or inducer.
CONTRAINDICATIONS:
Xtampza ER is contraindicated in patients with significant respiratory
depression, acute or severe bronchial asthma in an unmonitored setting
or in the absence of resuscitative equipment, known or suspected
gastrointestinal obstruction, including paralytic ileus, and
hypersensitivity (eg, anaphylaxis) to oxycodone.
WARNINGS AND PRECAUTIONS:
Addiction, Abuse, and Misuse
Xtampza ER contains oxycodone, a Schedule II controlled substance. As
an opioid, Xtampza ER exposes users to the risks of addiction, abuse,
and misuse. As extendedrelease products such as Xtampza ER deliver the
opioid over an extended period of time, there is a greater risk for
overdose and death due to the larger amount of oxycodone present.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been
reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may
lead to respiratory arrest and death. Management of respiratory
depression may include close observation, supportive measures, and use
of opioid antagonists, depending on the patient's clinical status.
Carbon dioxide (CO2) retention from opioid-induced respiratory
depression can exacerbate the sedating effects of opioids.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Xtampza ER during pregnancy can result in withdrawal
in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid
withdrawal syndrome in adults, may be life-threatening if not
recognized and treated, and requires management according to protocols
developed by neonatology experts. Observe newborns for signs of
neonatal opioid withdrawal syndrome and manage accordingly. Advise
pregnant women using opioids for a prolonged period of the risk of
neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4
Inhibitors and Inducers
Concomitant use of Xtampza ER with a CYP3A4 inhibitor, such as
macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg,
ketoconazole), and protease inhibitors (eg, ritonavir), may increase
plasma concentrations of oxycodone and prolong opioid adverse
reactions, which may cause potentially fatal respiratory depression,
particularly when an inhibitor is added after a stable dose of Xtampza
ER is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as
rifampin, carbamazepine, and phenytoin, in Xtampza ER-treated patients
may increase oxycodone plasma concentrations and prolong opioid adverse
reactions. When using Xtampza ER with CYP3A4 inhibitors or
discontinuing CYP3A4 inducers in Xtampza ER-treated patients, monitor
patients closely at frequent intervals and consider dosage reduction of
Xtampza ER until stable drug effects are achieved.

Concomitant use of Xtampza ER with CYP3A4 inducers or discontinuation
of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations,
decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in
a patient who had developed physical dependence to oxycodone. When
using Xtampza ER with CYP3A4 inducers or discontinuing CYP3A4
inhibitors, monitor patients closely at frequent intervals and consider
increasing the opioid dosage if needed to maintain adequate analgesia
or if symptoms of opioid withdrawal occur.
Risks Due to Interactions with Central Nervous System Depressants
Hypotension, profound sedation, respiratory depression, coma, and death
may result if Xtampza ER is used concomitantly with other central
nervous system (CNS) depressants (eg, benzodiazepines and other
sedative-hypnotics, anxiolytics, tranquilizers, muscle relaxants,
general anesthetics, antipsychotics, and other opioids). If
coadministration is required, start with one-third to one-half the
usual dose of Xtampza ER; monitor patients for signs of respiratory
depression, sedation and hypotension; and consider using a lower dose
of the concomitant CNS depressant. Use an alternative analgesic for
patients who require a dose of Xtampza ER less than 9 mg.
Risk of Life-Threatening Respiratory Depression in Elderly, Cachectic,
and Debilitated Patients
Life-threatening respiratory depression is more likely to occur in
elderly, cachectic, or debilitated patients, as they may have altered
pharmacokinetics or altered clearance compared to younger, healthier
patients. Monitor such patients closely, particularly when initiating
and titrating Xtampza ER and when Xtampza ER is given concomitantly
with other drugs that depress respiration. Use an alternative analgesic
for patients who require a dose of Xtampza ER less than 9 mg.
Risk of Life-Threatening Respiratory Depression in Patients with
Chronic Pulmonary Disease
The use of Xtampza ER in patients with acute or severe bronchial asthma
in an unmonitored setting or in the absence of resuscitative equipment
is contraindicated.

Xtampza ER-treated patients with significant chronic obstructive
pulmonary disease or cor pulmonale, and those with a substantially
decreased respiratory reserve, hypoxia, hypercapnia, or preexisting
respiratory depression, are at increased risk of decreased respiratory
drive, including apnea, even at recommended dosages of Xtampza ER.
Adrenal Insufficiency
Cases of adrenal insufficiency have been reported with opioid use, more
often after more than 1 month of use. Presentation of adrenal
insufficiency may include nonspecific symptoms and signs, including
nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood
pressure. If adrenal insufficiency is suspected, confirm the diagnosis
with diagnostic testing as soon as possible. If adrenal insufficiency
is diagnosed, treat with physiologic replacement doses of
corticosteroids. Wean the patient off of the opioid to allow adrenal
function to recover and continue corticosteroid treatment until adrenal
function recovers. Other opioids may be tried as some cases reported
use of a different opioid without recurrence of adrenal insufficiency.
The information available does not identify any particular opioids as
being more likely to be associated with adrenal insufficiency.
Severe Hypotension
Xtampza ER may cause severe hypotension, including orthostatic
hypotension and syncope in ambulatory patients. There is an increased
risk in patients whose ability to maintain blood pressure has already
been compromised by a reduced blood volume or concurrent administration
of certain CNS depressant drugs (eg, phenothiazines or general
anesthetics). Monitor these patients for signs of hypotension after
initiating or titrating the dosage of Xtampza ER. In patients with
circulatory shock, Xtampza ER may cause vasodilation that can further
reduce cardiac output and blood pressure. Avoid the use of Xtampza ER
in patients with circulatory shock.
Risks of Use in Patients with Increased Intracranial Pressure, Brain
Tumors, Head Injury, or Impaired Consciousness
In patients who may be susceptible to the intracranial effects of CO2
retention (eg, those with evidence of increased intracranial pressure
or brain tumors), Xtampza ER may reduce respiratory drive, and the
resultant CO2 retention can further increase intracranial pressure.
Monitor such patients for signs of sedation and respiratory depression,
particularly when initiating therapy with Xtampza ER.

Opioids may also obscure the clinical course in a patient with a head
injury. Avoid the use of Xtampza ER in patients with impaired
consciousness or coma.
Risks of Use in Patients with Gastrointestinal Conditions
Xtampza ER is contraindicated in patients with gastrointestinal
obstruction, including paralytic ileus.

The oxycodone in Xtampza ER may cause spasm of the sphincter of Oddi.
Opioids may cause increases in the serum amylase. Monitor patients with
biliary tract disease, including acute pancreatitis, for worsening
symptoms.
Risks of Use in Patients with Seizure Disorders
The oxycodone in Xtampza ER may increase the frequency of seizures in
patients with seizure disorders and may increase the risk of seizures
in other clinical settings associated with seizures. Monitor patients
with a history of seizure disorders for worsened seizure control during
Xtampza ER therapy.
Withdrawal
Avoid the use of mixed agonist/antagonist (eg, pentazocine, nalbuphine,
and butorphanol) or partial agonist (eg, buprenorphine) analgesics in
patients who have received or are receiving a course of therapy with a
full opioid agonist analgesic, including Xtampza ER. In these patients,
mixed agonist/antagonist and partial agonist analgesics may reduce the
analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing Xtampza ER, gradually taper the dosage. Do not
abruptly discontinue Xtampza ER.
Risks of Driving and Operating Machinery
Xtampza ER may impair the mental or physical abilities needed to
perform potentially hazardous activities such as driving a car or
operating machinery. Warn patients not to drive or operate dangerous
machinery unless they are tolerant to the effects of Xtampza ER and
know how they will react to the medication.
Laboratory Monitoring
Not every urine drug test for "opioids" or "opiates" detects oxycodone
reliably, especially those designed for in-office use. Further, many
laboratories will report urine drug concentrations below a specified
"cut-off" value as "negative." Therefore, if urine testing for
oxycodone is considered in the clinical management of an individual
patient, ensure that the sensitivity and specificity of the assay is
appropriate, and consider the limitations of the testing used when
interpreting results.
ADMINISTRATION WITH FOOD:
Instruct patients to always take Xtampza ER capsules with food and with
approximately the same amount of food in order to ensure consistent
plasma levels are achieved. For patients who have difficulty
swallowing, Xtampza ER can also be taken by sprinkling the capsule
contents on soft foods, into a cup and then directly into the mouth, or
through a gastrostomy or nasogastric feeding tube.
ADVERSE REACTIONS:
The most common adverse reactions (>5%) reported by patients in the
Phase 3 clinical trial were nausea, headache, constipation, somnolence,
pruritus, vomiting, and dizziness.


Xtampza ER and DETERx are registered trademarks of Collegium
Pharmaceutical, Inc.

? 2016 Collegium Pharmaceutical, Inc. All rights reserved.
PP-DT-US-0007 11/16.

Collegium Pharmaceutical, Inc. 780 Dedham Street, Suite 800. Canton,
MA, 02021, USA.


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Plainsboro Road | Building 300
Plainsboro, NJ 08536 | P: 609.716.7777 | F: 609.257.0701 |
[5]www.PharmacyTimes.com | [6]Terms & Conditions


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References

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2. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTAzOQ/index.html
3. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0MA/index.html
4. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0MQ/index.html
5. http://www.pharmacytimes.com/?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=Xtampza%5FCustom%5FeBlast2%5F12%2D28%2D16
6. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0Mg/index.html
7. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0Mw/index.html
8. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0NA/index.html
9. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0NQ/index.html
10. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0Ng/index.html

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If you can't read this email. Please view online [ http://eventsolutions.biz/xtampza/pharmacist.html ]

Pharmacies shoulder a heavy burden for the responsible distribution of opioids - 4.3 million Americans abuse prescription pain relievers by using them nonmedically 1, 64% of abusers are given or buy pain relievers from friends or relatives 2, and 21% of abusers obtain pain relievers through a prescription from one doctor 2

- Xtampza ® ER is an abuse-deterrent, extended-release oxycodone featuring DETERx ® microsphere technology

- PK clinical studies of Xtampza ER have shown that manipulation - including crushing, chewing, and snorting - had little to no effect on PK profile, although abuse by these routes is still possible

- Xtampza ER does not contain this common boxed warning language 3:

BOXED WARNING

Instruct patients to swallow whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dole of oxycodone

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING BELOW

The use of any opioid may result in serious, life-threatening, or fatal respiratory depression, even when used as recommended

- DETERx technology is engineered for manipulation resistance

- However, abuse of Xtampza ER by injection, by the nasal route of administration, and by the oral route is still possible

Xtampza ER is the exclusive extended release oxycodone for United Healthcare's commercial members beginning January 1, 2017.

1 US Department of Health and Human Services. Results from the 2014 National Survey on Drug Use and Health: Summary of National Findings. http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf. Published September 2015. Accessed October 20, 2016.

2 US Department of Health and Human Services. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.pdf. Published September 2014. Accessed October 20, 2016.

3 Xtampza ER [package insert]. Canton, MA: Collegium Pharmaceutical, Inc.; 2016.

DOWNLOAD BULLETIN [ http://www.xtampzaer.com/hcp/assets/pdfs/pharmacist_product_bulletin.pdf ]

LEARN MORE

For more information, visit XtampzaER.com

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AT THE LINKS BELOW

Important Safety Information [ http://www.xtampzaer.com ]
Full Prescribing Information [ http://www.xtampzaer.com/pdf/xtampza-pi.pdf ]

INDICATIONS AND USAGE:

Xtampza ER (oxycodone) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Xtampza ER for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Xtampza ER is not indicated as an as-needed (prn) analgesic.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse

Xtampza ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression, especially during initiation of Xtampza ER or following a dose increase.

Accidental Ingestion

Accidental ingestion of even 1 dose of Xtampza ER, especially by children, can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 3A4 Interaction

The concomitant use of Xtampza ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Xtampza ER and any CYP3A4 inhibitor or inducer.

CONTRAINDICATIONS:

Xtampza ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, known or suspected gastrointestinal obstruction, including paralytic ileus, and hypersensitivity (eg, anaphylaxis) to oxycodone.

WARNINGS AND PRECAUTIONS:

Addiction, Abuse, and Misuse

Xtampza ER contains oxycodone, a Schedule II controlled substance. As an opioid, Xtampza ER exposes users to the risks of addiction, abuse, and misuse. As extendedrelease products such as Xtampza ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Xtampza ER during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

Concomitant use of Xtampza ER with a CYP3A4 inhibitor, such as macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), and protease inhibitors (eg, ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Xtampza ER is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in Xtampza ER–treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions. When using Xtampza ER with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in Xtampza ER–treated patients, monitor patients closely at frequent intervals and consider dosage reduction of Xtampza ER until stable drug effects are achieved.

Concomitant use of Xtampza ER with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to oxycodone. When using Xtampza ER with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur.

Risks Due to Interactions with Central Nervous System Depressants

Hypotension, profound sedation, respiratory depression, coma, and death may result if Xtampza ER is used concomitantly with other central nervous system (CNS) depressants (eg, benzodiazepines and other sedative-hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids). If coadministration is required, start with one-third to one-half the usual dose of Xtampza ER; monitor patients for signs of respiratory depression, sedation and hypotension; and consider using a lower dose of the concomitant CNS depressant. Use an alternative analgesic for patients who require a dose of Xtampza ER less than 9 mg.

Risk of Life-Threatening Respiratory Depression in Elderly, Cachectic, and Debilitated Patients

Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients, as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor such patients closely, particularly when initiating and titrating Xtampza ER and when Xtampza ER is given concomitantly with other drugs that depress respiration. Use an alternative analgesic for patients who require a dose of Xtampza ER less than 9 mg.

Risk of Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease

The use of Xtampza ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Xtampza ER–treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, are at increased risk of decreased respiratory drive, including apnea, even at recommended dosages of Xtampza ER.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often after more than 1 month of use. Presentation of adrenal insufficiency may include nonspecific symptoms and signs, including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

Severe Hypotension

Xtampza ER may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (eg, phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dosage of Xtampza ER. In patients with circulatory shock, Xtampza ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Xtampza ER in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

In patients who may be susceptible to the intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors), Xtampza ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Xtampza ER.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Xtampza ER in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions

Xtampza ER is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus.

The oxycodone in Xtampza ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Risks of Use in Patients with Seizure Disorders

The oxycodone in Xtampza ER may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during Xtampza ER therapy.

Withdrawal

Avoid the use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including Xtampza ER. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing Xtampza ER, gradually taper the dosage. Do not abruptly discontinue Xtampza ER.

Risks of Driving and Operating Machinery

Xtampza ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Xtampza ER and know how they will react to the medication.

Laboratory Monitoring

Not every urine drug test for "opioids" or "opiates" detects oxycodone reliably, especially those designed for in-office use. Further, many laboratories will report urine drug concentrations below a specified "cut-off" value as "negative." Therefore, if urine testing for oxycodone is considered in the clinical management of an individual patient, ensure that the sensitivity and specificity of the assay is appropriate, and consider the limitations of the testing used when interpreting results.

ADMINISTRATION WITH FOOD:

Instruct patients to always take Xtampza ER capsules with food and with approximately the same amount of food in order to ensure consistent plasma levels are achieved. For patients who have difficulty swallowing, Xtampza ER can also be taken by sprinkling the capsule contents on soft foods, into a cup and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

ADVERSE REACTIONS:

The most common adverse reactions (>5%) reported by patients in the Phase 3 clinical trial were nausea, headache, constipation, somnolence, pruritus, vomiting, and dizziness.

Xtampza ER and DETERx are registered trademarks of Collegium Pharmaceutical, Inc.

®2016 Collegium Pharmaceutical, Inc. All rights reserved. PP-DT-US-0007 11/16.

Collegium Pharmaceutical, Inc. 780 Dedham Street, Suite 800. Canton, MA, 02021, USA.


Pharmacy Times : Practical Information for Today's Pharmacist | 666 Plainsboro Road | Building 300

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[header.gif]
Pharmacies shoulder a heavy burden for the responsible distribution of
opioids -
4.3 million Americans abuse prescription pain relievers by using them
nonmedically^1, 64% of abusers are given or buy pain relievers from
friends or
relatives^2, and 21% of abusers obtain pain relievers through a
prescription from one doctor^2
* Xtampza^? ER is an abuse-deterrent, extended-release oxycodone
featuring DETERx^? microsphere technology
* PK clinical studies of Xtampza ER have shown that manipulation -
including crushing, chewing, and snorting - had little to no effect
on PK profile, although abuse by these routes is still possible
* Xtampza ER does not contain this common boxed warning language^3:

[PT_Xtanpza_boxedwarning%20X.PNG]

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION, INCLUDING BOXED
WARNING BELOW
The use of any opioid may result in serious, life-threatening, or fatal
respiratory depression, even when used as recommended

* DETERx technology is engineered for manipulation resistance
* However, abuse of Xtampza ER by injection, by the nasal route of
administration, and by the oral route is still possible

Xtampza ER is the exclusive extended release oxycodone for United
Healthcare's commercial members beginning January 1, 2017.

^1 US Department of Health and Human Services. Results from the 2014
National Survey on Drug Use and Health: Summary of National Findings.
http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FR
R1-2014.pdf. Published September 2015. Accessed October 20, 2016.
^2 US Department of Health and Human Services. Results from the 2013
National Survey on Drug Use and Health: Summary of National Findings.
http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013
/Web/NSDUHresults2013.pdf. Published September 2014. Accessed October
20, 2016.
^3 Xtampza ER [package insert]. Canton, MA: Collegium Pharmaceutical,
Inc.; 2016.

[2][PT_Xtanpza_downloadbutton3.png]

LEARN MORE
For more information, visit XtampzaER.com

PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING
INFORMATION, INCLUDING BOXED WARNING AT THE LINKS BELOW

[3]Important Safety Information | [4]Full Prescribing Information



INDICATIONS AND USAGE:
Xtampza ER (oxycodone) is indicated for the management of pain severe
enough to require daily, around-the-clock, long-term opioid treatment
and for which alternative treatment options are inadequate.

Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even
at recommended doses, and because of the greater risks of overdose and
death with extended-release opioid formulations, reserve Xtampza ER for
use in patients for whom alternative treatment options (eg, non-opioid
analgesics or immediate-release opioids) are ineffective, not
tolerated, or would be otherwise inadequate to provide sufficient
management of pain.

Xtampza ER is not indicated as an as-needed (prn) analgesic.
IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME;
AND CYTOCHROME
P450 3A4 INTERACTION
Addiction, Abuse, and Misuse
Xtampza ER exposes patients and other users to the risks of opioid
addiction, abuse, and misuse, which can lead to overdose and death.
Assess each patient's risk prior to prescribing Xtampza ER and monitor
all patients regularly for the development of these behaviors or
conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of Xtampza ER. Monitor for respiratory depression, especially
during initiation of Xtampza ER or following a dose increase.
Accidental Ingestion
Accidental ingestion of even 1 dose of Xtampza ER, especially by
children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Xtampza ER during pregnancy can result in neonatal
opioid withdrawal syndrome, which may be life-threatening if not
recognized and treated, and requires management according to protocols
developed by neonatology experts. If opioid use is required for a
prolonged period in a pregnant woman, advise the patient of the risk of
neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
Cytochrome P450 3A4 Interaction
The concomitant use of Xtampza ER with all cytochrome P450 3A4
inhibitors may result in an increase in oxycodone plasma
concentrations, which could increase or prolong adverse drug effects
and may cause potentially fatal respiratory depression. In addition,
discontinuation of a concomitantly used cytochrome P450 3A4 inducer may
result in an increase in oxycodone plasma concentration. Monitor
patients receiving Xtampza ER and any CYP3A4 inhibitor or inducer.
CONTRAINDICATIONS:
Xtampza ER is contraindicated in patients with significant respiratory
depression, acute or severe bronchial asthma in an unmonitored setting
or in the absence of resuscitative equipment, known or suspected
gastrointestinal obstruction, including paralytic ileus, and
hypersensitivity (eg, anaphylaxis) to oxycodone.
WARNINGS AND PRECAUTIONS:
Addiction, Abuse, and Misuse
Xtampza ER contains oxycodone, a Schedule II controlled substance. As
an opioid, Xtampza ER exposes users to the risks of addiction, abuse,
and misuse. As extendedrelease products such as Xtampza ER deliver the
opioid over an extended period of time, there is a greater risk for
overdose and death due to the larger amount of oxycodone present.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been
reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may
lead to respiratory arrest and death. Management of respiratory
depression may include close observation, supportive measures, and use
of opioid antagonists, depending on the patient's clinical status.
Carbon dioxide (CO2) retention from opioid-induced respiratory
depression can exacerbate the sedating effects of opioids.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Xtampza ER during pregnancy can result in withdrawal
in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid
withdrawal syndrome in adults, may be life-threatening if not
recognized and treated, and requires management according to protocols
developed by neonatology experts. Observe newborns for signs of
neonatal opioid withdrawal syndrome and manage accordingly. Advise
pregnant women using opioids for a prolonged period of the risk of
neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4
Inhibitors and Inducers
Concomitant use of Xtampza ER with a CYP3A4 inhibitor, such as
macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg,
ketoconazole), and protease inhibitors (eg, ritonavir), may increase
plasma concentrations of oxycodone and prolong opioid adverse
reactions, which may cause potentially fatal respiratory depression,
particularly when an inhibitor is added after a stable dose of Xtampza
ER is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as
rifampin, carbamazepine, and phenytoin, in Xtampza ER-treated patients
may increase oxycodone plasma concentrations and prolong opioid adverse
reactions. When using Xtampza ER with CYP3A4 inhibitors or
discontinuing CYP3A4 inducers in Xtampza ER-treated patients, monitor
patients closely at frequent intervals and consider dosage reduction of
Xtampza ER until stable drug effects are achieved.

Concomitant use of Xtampza ER with CYP3A4 inducers or discontinuation
of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations,
decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in
a patient who had developed physical dependence to oxycodone. When
using Xtampza ER with CYP3A4 inducers or discontinuing CYP3A4
inhibitors, monitor patients closely at frequent intervals and consider
increasing the opioid dosage if needed to maintain adequate analgesia
or if symptoms of opioid withdrawal occur.
Risks Due to Interactions with Central Nervous System Depressants
Hypotension, profound sedation, respiratory depression, coma, and death
may result if Xtampza ER is used concomitantly with other central
nervous system (CNS) depressants (eg, benzodiazepines and other
sedative-hypnotics, anxiolytics, tranquilizers, muscle relaxants,
general anesthetics, antipsychotics, and other opioids). If
coadministration is required, start with one-third to one-half the
usual dose of Xtampza ER; monitor patients for signs of respiratory
depression, sedation and hypotension; and consider using a lower dose
of the concomitant CNS depressant. Use an alternative analgesic for
patients who require a dose of Xtampza ER less than 9 mg.
Risk of Life-Threatening Respiratory Depression in Elderly, Cachectic,
and Debilitated Patients
Life-threatening respiratory depression is more likely to occur in
elderly, cachectic, or debilitated patients, as they may have altered
pharmacokinetics or altered clearance compared to younger, healthier
patients. Monitor such patients closely, particularly when initiating
and titrating Xtampza ER and when Xtampza ER is given concomitantly
with other drugs that depress respiration. Use an alternative analgesic
for patients who require a dose of Xtampza ER less than 9 mg.
Risk of Life-Threatening Respiratory Depression in Patients with
Chronic Pulmonary Disease
The use of Xtampza ER in patients with acute or severe bronchial asthma
in an unmonitored setting or in the absence of resuscitative equipment
is contraindicated.

Xtampza ER-treated patients with significant chronic obstructive
pulmonary disease or cor pulmonale, and those with a substantially
decreased respiratory reserve, hypoxia, hypercapnia, or preexisting
respiratory depression, are at increased risk of decreased respiratory
drive, including apnea, even at recommended dosages of Xtampza ER.
Adrenal Insufficiency
Cases of adrenal insufficiency have been reported with opioid use, more
often after more than 1 month of use. Presentation of adrenal
insufficiency may include nonspecific symptoms and signs, including
nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood
pressure. If adrenal insufficiency is suspected, confirm the diagnosis
with diagnostic testing as soon as possible. If adrenal insufficiency
is diagnosed, treat with physiologic replacement doses of
corticosteroids. Wean the patient off of the opioid to allow adrenal
function to recover and continue corticosteroid treatment until adrenal
function recovers. Other opioids may be tried as some cases reported
use of a different opioid without recurrence of adrenal insufficiency.
The information available does not identify any particular opioids as
being more likely to be associated with adrenal insufficiency.
Severe Hypotension
Xtampza ER may cause severe hypotension, including orthostatic
hypotension and syncope in ambulatory patients. There is an increased
risk in patients whose ability to maintain blood pressure has already
been compromised by a reduced blood volume or concurrent administration
of certain CNS depressant drugs (eg, phenothiazines or general
anesthetics). Monitor these patients for signs of hypotension after
initiating or titrating the dosage of Xtampza ER. In patients with
circulatory shock, Xtampza ER may cause vasodilation that can further
reduce cardiac output and blood pressure. Avoid the use of Xtampza ER
in patients with circulatory shock.
Risks of Use in Patients with Increased Intracranial Pressure, Brain
Tumors, Head Injury, or Impaired Consciousness
In patients who may be susceptible to the intracranial effects of CO2
retention (eg, those with evidence of increased intracranial pressure
or brain tumors), Xtampza ER may reduce respiratory drive, and the
resultant CO2 retention can further increase intracranial pressure.
Monitor such patients for signs of sedation and respiratory depression,
particularly when initiating therapy with Xtampza ER.

Opioids may also obscure the clinical course in a patient with a head
injury. Avoid the use of Xtampza ER in patients with impaired
consciousness or coma.
Risks of Use in Patients with Gastrointestinal Conditions
Xtampza ER is contraindicated in patients with gastrointestinal
obstruction, including paralytic ileus.

The oxycodone in Xtampza ER may cause spasm of the sphincter of Oddi.
Opioids may cause increases in the serum amylase. Monitor patients with
biliary tract disease, including acute pancreatitis, for worsening
symptoms.
Risks of Use in Patients with Seizure Disorders
The oxycodone in Xtampza ER may increase the frequency of seizures in
patients with seizure disorders and may increase the risk of seizures
in other clinical settings associated with seizures. Monitor patients
with a history of seizure disorders for worsened seizure control during
Xtampza ER therapy.
Withdrawal
Avoid the use of mixed agonist/antagonist (eg, pentazocine, nalbuphine,
and butorphanol) or partial agonist (eg, buprenorphine) analgesics in
patients who have received or are receiving a course of therapy with a
full opioid agonist analgesic, including Xtampza ER. In these patients,
mixed agonist/antagonist and partial agonist analgesics may reduce the
analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing Xtampza ER, gradually taper the dosage. Do not
abruptly discontinue Xtampza ER.
Risks of Driving and Operating Machinery
Xtampza ER may impair the mental or physical abilities needed to
perform potentially hazardous activities such as driving a car or
operating machinery. Warn patients not to drive or operate dangerous
machinery unless they are tolerant to the effects of Xtampza ER and
know how they will react to the medication.
Laboratory Monitoring
Not every urine drug test for "opioids" or "opiates" detects oxycodone
reliably, especially those designed for in-office use. Further, many
laboratories will report urine drug concentrations below a specified
"cut-off" value as "negative." Therefore, if urine testing for
oxycodone is considered in the clinical management of an individual
patient, ensure that the sensitivity and specificity of the assay is
appropriate, and consider the limitations of the testing used when
interpreting results.
ADMINISTRATION WITH FOOD:
Instruct patients to always take Xtampza ER capsules with food and with
approximately the same amount of food in order to ensure consistent
plasma levels are achieved. For patients who have difficulty
swallowing, Xtampza ER can also be taken by sprinkling the capsule
contents on soft foods, into a cup and then directly into the mouth, or
through a gastrostomy or nasogastric feeding tube.
ADVERSE REACTIONS:
The most common adverse reactions (>5%) reported by patients in the
Phase 3 clinical trial were nausea, headache, constipation, somnolence,
pruritus, vomiting, and dizziness.


Xtampza ER and DETERx are registered trademarks of Collegium
Pharmaceutical, Inc.

? 2016 Collegium Pharmaceutical, Inc. All rights reserved.
PP-DT-US-0007 11/16.

Collegium Pharmaceutical, Inc. 780 Dedham Street, Suite 800. Canton,
MA, 02021, USA.


Pharmacy Times: Practical Information for Today's Pharmacist | 666
Plainsboro Road | Building 300
Plainsboro, NJ 08536 | P: 609.716.7777 | F: 609.257.0701 |
[5]www.PharmacyTimes.com | [6]Terms & Conditions


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References

1. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTAzOA/index.html
2. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTAzOQ/index.html
3. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0MA/index.html
4. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0MQ/index.html
5. http://www.pharmacytimes.com/?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=Xtampza%5FCustom%5FeBlast2%5F12%2D28%2D16
6. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0Mg/index.html
7. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0Mw/index.html
8. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0NA/index.html
9. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0NQ/index.html
10. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTA0Ng/index.html

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_______________________________________________
hangout mailing list
hangout-at-nylxs.com
http://www.nylxs.com/
--===============0683963320==--

  1. 2016-12-01 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] FYI for Brooklynites and others
  2. 2016-12-01 Ruben Safir <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] Fwd: Patrolling the Dark Net,
  3. 2016-12-03 Asher Elbein <aelbein-at-gmail.com> Subject: [Hangout-NYLXS] [dinosaur] Regarding Art Theft
  4. 2016-12-03 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] [dinosaur] Regarding Art Theft
  5. 2016-12-03 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Witner Labs
  6. 2016-12-03 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] the city for the people and by the people
  7. 2016-12-03 IEEE Engineering in Medicine and Biology Society <noreply-at-embs.org> Subject: [Hangout-NYLXS] HIMSS17 Early Bird Registration Deadline is
  8. 2016-12-04 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Nice lecture on Quantum Mechanics
  9. 2016-12-05 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Fwd: Tomorrow's Webinar - No Downtime Data
  10. 2016-12-05 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] http://www.lazarus-ide.org/
  11. 2016-12-05 Ruben Safir <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] Fwd: [LIU Comp Sci] Nice possible project for NYLXS
  12. 2016-12-05 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Oh Look a real website
  13. 2016-12-05 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] information access, copyright wars and DRM
  14. 2016-12-05 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] More retarded news from the city that wants to push
  15. 2016-12-06 ruben safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] png data format
  16. 2016-12-06 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] png data format
  17. 2016-12-05 From: "Rijksmuseum" <rijksstudio-at-news.rijksmuseum.nl> Subject: [Hangout-NYLXS] Glorious food in Rijksstudio
  18. 2016-12-06 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] [Learn] png data format
  19. 2016-12-06 Christopher League <league-at-contrapunctus.net> Re: [Hangout-NYLXS] [Learn] png data format
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  22. 2016-12-06 Christopher League <league-at-contrapunctus.net> Re: [Hangout-NYLXS] [Learn] png data format
  23. 2016-12-06 John Bowler <john.cunningham.bowler-at-gmail.com> Re: [Hangout-NYLXS] [png-mng-implement] 4 byte length storage
  24. 2016-12-06 John Bowler <john.cunningham.bowler-at-gmail.com> Re: [Hangout-NYLXS] [png-mng-implement] 4 byte length storage
  25. 2016-12-06 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] [png-mng-implement] 4 byte length storage
  26. 2016-12-06 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] [Learn] png data format
  27. 2016-12-06 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] [Learn] png data format
  28. 2016-12-06 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Fwd: Re: [luny-talk] Humble Bundle O'Reilly UNIX
  29. 2016-12-06 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Every face is tracked. Every footfall was
  30. 2016-12-06 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] JT's words
  31. 2016-12-06 James E Keenan <jkeen-at-verizon.net> Subject: [Hangout-NYLXS] The ny.pm talks I'd like to hear
  32. 2016-12-07 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Islam s fine
  33. 2016-12-09 Ruben Safir <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] Fwd: Kindly Share the Free Journal
  34. 2016-12-09 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] good Shabbos All
  35. 2016-12-10 ruben safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Michael Kingsley and the Fascist in Office
  36. 2016-12-10 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] slow Vietnam like creep into Syrian civil war
  37. 2016-12-10 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] C++ returning lvalue references and pointers and
  38. 2016-12-10 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] a real live dinosaur tail found in the flesh
  39. 2016-12-10 Ruben Safir <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] Movie of the Week
  40. 2016-12-10 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] Michael Kingsley and the Fascist in Office
  41. 2016-12-11 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] I knew as soon as I learned about dark matter that
  42. 2016-12-11 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] islam is your friend
  43. 2016-12-11 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] islam is your friend
  44. 2016-12-12 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] islam is your friendII
  45. 2016-12-12 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] islam is your friend III
  46. 2016-12-12 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] islam is your friend IV
  47. 2016-12-12 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] islam is your friend V
  48. 2016-12-12 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] islam is your friend VI
  49. 2016-12-12 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] islam is your friend VI
  50. 2016-12-12 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] islam is your friend VII
  51. 2016-12-12 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] islam is your friend VI
  52. 2016-12-11 Rick Tanner <leaf-at-real-time.com> Subject: [Hangout-NYLXS] [crossfire] Crossfire wiki offline for maintenance
  53. 2016-12-12 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout-NYLXS] [Perlweekly] #281 - The holidays are upon us!
  54. 2016-12-12 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] islam is your friend VI
  55. 2016-12-12 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] islam is your friend VI
  56. 2016-12-12 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Minoan history
  57. 2016-12-13 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Death of the Sea Saw
  58. 2016-12-12 Nawaz Nazeer Ahamed <nawaz.nazeer.ahamed-at-oracle.com> Subject: [Hangout-NYLXS] MySQL Community Server 5.6.35 has been released
  59. 2016-12-13 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] C++ Threads Workshop
  60. 2016-12-13 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Summer Jobs
  61. 2016-12-14 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] islam is your friend VI
  62. 2016-12-14 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Fwd: Re: [dinosaur] Ceratopsid (Centrosaurinae:
  63. 2016-12-13 From: "Ruben.Safir" <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] goldfinch
  64. 2016-12-14 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Apollo Moon Shot Photography
  65. 2016-12-14 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Subject: [Hangout-NYLXS] For Ruben ( + those in NYC Metro ) : Holiday Social
  66. 2016-12-14 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] islam is your friend VI
  67. 2016-12-14 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] islam is your friend VI
  68. 2016-12-14 Elfen Magix <elfen_magix-at-yahoo.com> Re: [Hangout-NYLXS] Apollo Moon Shot Photography
  69. 2016-12-15 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] islam is your friend VI
  70. 2016-12-15 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Your Santa Imam is here
  71. 2016-12-15 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] islam is your friend VI
  72. 2016-12-15 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] islam is your friend VI
  73. 2016-12-15 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Barak and Jerry Show
  74. 2016-12-15 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] Michael Kingsley and the Fascist in Office
  75. 2016-12-15 From: "American Museum of Natural History" <mat-at-amnh.org> Subject: [Hangout-NYLXS] Join the MAT Program Class of 2017
  76. 2016-12-16 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] this story is 5 years late on drug prices
  77. 2016-12-16 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Attacks at Cornel
  78. 2016-12-17 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  79. 2016-12-17 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  80. 2016-12-17 Ruben Safir <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] Movie of the Week! Hello BOB!!
  81. 2016-12-17 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] anyone want to see Star Wars tonight?
  82. 2016-12-18 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  83. 2016-12-16 From: "APhA's Pharmacy Today" <PTdaily-at-aphanet.org> Subject: [Hangout-NYLXS] December 16,
  84. 2016-12-18 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  85. 2016-12-18 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  86. 2016-12-18 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  87. 2016-12-18 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  88. 2016-12-18 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  89. 2016-12-18 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  90. 2016-12-18 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Look C++ is a functional programming language
  91. 2016-12-18 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  92. 2016-12-18 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  93. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  94. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  95. 2016-12-19 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] New Distros to try
  96. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] New Distros to try
  97. 2016-12-19 mayer ilovitz <pmamayeri-at-gmail.com> Re: [Hangout-NYLXS] New Distros to try
  98. 2016-12-19 ruben <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] New Distros to try
  99. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] New Distros to try
  100. 2016-12-19 ruben <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] another offbeat distro
  101. 2016-12-19 ruben <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] New Distros to try
  102. 2016-12-19 ruben <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] systemd critique et al
  103. 2016-12-19 ruben <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] New Distros to try
  104. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] New Distros to try
  105. 2016-12-19 From: "Ruben.Safir" <ruben.safir-at-my.liu.edu> Re: [Hangout-NYLXS] New Distros to try
  106. 2016-12-19 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout-NYLXS] [Perlweekly] #282 - The White Camels are roaming
  107. 2016-12-19 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] New Distros to try: Please explain what the
  108. 2016-12-19 mayer ilovitz <pmamayeri-at-gmail.com> Re: [Hangout-NYLXS] New Distros to try: Please explain what the
  109. 2016-12-19 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] the issues with SystemD: why are they doing
  110. 2016-12-19 mayer ilovitz <pmamayeri-at-gmail.com> Re: [Hangout-NYLXS] the issues with SystemD: why are they doing
  111. 2016-12-19 ISOC-NY announcements <announce-at-lists.isoc-ny.org> Subject: [Hangout-NYLXS] [isoc-ny] JOB: Telecommunications Policy Specialist
  112. 2016-12-19 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  113. 2016-12-19 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  114. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] the issues with SystemD: why are they doing
  115. 2016-12-19 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] NYLXS Textbook Section
  116. 2016-12-19 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] NYLXS Textbook Section
  117. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] New Distros to try: Please explain what the
  118. 2016-12-19 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] New Distros to try: Please explain what the
  119. 2016-12-19 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] NYLXS Textbook Section
  120. 2016-12-19 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] Workshops -at- ACM/SPEC ICPE 2017 - Call for
  121. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] wow - just got an email from Ruth
  122. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] This Mayor is an IDIOT
  123. 2016-12-20 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  124. 2016-12-20 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  125. 2016-12-20 mayer ilovitz <pmamayeri-at-gmail.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  126. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  127. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  128. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Ocean Parkway Protest!!
  129. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] The ever growing police state
  130. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Serious danger to state sovereignty and your right
  131. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] F'ing Mouse Pad
  132. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  133. 2016-12-20 IEEE Engineering in Medicine and Biology Society <noreply-at-embs.org> Subject: [Hangout-NYLXS] BHI'17 Registration Now Open!
  134. 2016-12-20 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] Serious danger to state sovereignty and your
  135. 2016-12-20 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  136. 2016-12-20 einker <eminker-at-gmail.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  137. 2016-12-20 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  138. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] Serious danger to state sovereignty and your
  139. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  140. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] The fascinating case of Bernie Goetz
  141. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  142. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] The fascinating case of Bernie Goetz
  143. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  144. 2016-12-21 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] The fascinating case of Bernie Goetz
  145. 2016-12-21 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] Serious danger to state sovereignty and your
  146. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Thank god he is dead
  147. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Brooklyn Principal Shot to Death While Looking for
  148. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Marla Hanson recalls her nightmare
  149. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Official crime numbers in Kings County
  150. 2016-12-21 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] I'm sure it's a coincidence, part n+1
  151. 2016-12-21 ruben <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] LIU Brooklyn Campus Safety
  152. 2016-12-21 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] LIU Brooklyn Campus Safety
  153. 2016-12-21 Rick Moen <rick-at-linuxmafia.com> Subject: [Hangout-NYLXS] What California gets for Christmas
  154. 2016-12-21 From: "Amy at NTEN" <amy-at-nten.org> Subject: [Hangout-NYLXS] NTEN Connect: The Best NPTech Stories of 2016,
  155. 2016-12-21 IEEE Engineering in Medicine and Biology Society <noreply-at-embs.org> Subject: [Hangout-NYLXS] 2017 ISBI Call for Abstracts- Submission Deadline
  156. 2016-12-21 einker <eminker-at-gmail.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  157. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  158. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Marnchester by the Sea
  159. 2016-12-21 mayer ilovitz <pmamayeri-at-gmail.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  160. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  161. 2016-12-21 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] What California gets for Christmas
  162. 2016-12-21 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  163. 2016-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT
  164. 2016-12-22 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] the sorry state of this country and its bizarre
  165. 2016-12-22 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] What California gets for Christmas: Yeah but
  166. 2016-12-22 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] sorry state this country,
  167. 2016-12-22 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] This Mayor is an IDIOT | | Yeah,
  168. 2016-12-22 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] sorry state this country,
  169. 2016-12-22 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] Shelter Cove- which one ? There are two- one in
  170. 2016-12-22 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] Shelter Cove- which one ? There are two- one in
  171. 2016-12-22 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] And be aware you were an unexcused no-show
  172. 2016-12-22 Ruben Safir <ruben.safir-at-my.liu.edu> Re: [Hangout-NYLXS] And be aware you were an unexcused no-show
  173. 2016-12-22 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] And be aware you were an unexcused no-show
  174. 2016-12-22 Ruben Safir <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] And be aware you were an unexcused no-show
  175. 2016-12-22 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout-NYLXS] We were talking about how you could transport
  176. 2016-12-23 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] And be aware you were an unexcused no-show
  177. 2016-12-23 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] Shelter Cove- which one ? There are two- one in
  178. 2016-12-23 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] This Mayor is an IDIOT | | Yeah,
  179. 2016-12-23 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] sorry state this country,
  180. 2016-12-23 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] What California gets for Christmas: Yeah but
  181. 2016-12-23 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Homeless have taken over 34th street
  182. 2016-12-23 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] the sorry state of this country and its bizarre
  183. 2016-12-23 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] the sorry state of this country and its bizarre
  184. 2016-12-23 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] HOPL (History of Programming Languages)
  185. 2016-12-23 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout-NYLXS] Tiny Compiler in many languages at
  186. 2016-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Chag Simaach
  187. 2016-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] jobs
  188. 2016-12-25 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Sanders and Socialism
  189. 2016-12-25 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Free Speach
  190. 2016-12-25 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Google and C++
  191. 2016-12-25 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Conflicts of Interest
  192. 2016-12-25 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] Syria wished you a Merry Christmas
  193. 2016-12-25 Rick Moen <rick-at-linuxmafia.com> Subject: [Hangout-NYLXS] Light even in the darkness
  194. 2016-12-25 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] Syria wished you a Merry Christmas
  195. 2016-12-26 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout-NYLXS] [Perlweekly] #283 - Merry Christmas & Happy Hanukkah
  196. 2016-12-26 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout-NYLXS] [Perlweekly] #283 - Merry Christmas & Happy Hanukkah
  197. 2016-12-27 From: "Ruben.Safir" <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] Israel band, Iran Good
  198. 2016-12-27 mrbrklyn <mrbrklyn-at-panix.com> Subject: [Hangout-NYLXS] Israel band, Iran Good
  199. 2016-12-27 mrbrklyn <mrbrklyn-at-panix.com> Subject: [Hangout-NYLXS] International criminals, every jew
  200. 2016-12-27 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout-NYLXS] she's gone
  201. 2016-12-27 Rick Moen <rick-at-linuxmafia.com> Re: [Hangout-NYLXS] International criminals, every jew
  202. 2016-12-28 mrbrklyn <mrbrklyn-at-panix.com> Re: [Hangout-NYLXS] International criminals, every jew
  203. 2016-12-28 mrbrklyn <mrbrklyn-at-panix.com> Subject: [Hangout-NYLXS] can't find the damn ball anywhere here
  204. 2016-12-28 From: "Pharmacy Times" <enews-at-pharmacytimes.com> Subject: [Hangout-NYLXS] Xtampza(R) ER (oxycodone) Product Bulletin
  205. 2016-12-29 From: "Ruben.Safir" <ruben.safir-at-my.liu.edu> Subject: [Hangout-NYLXS] Police State gets one step closer

NYLXS are Do'ers and the first step of Doing is Joining! Join NYLXS and make a difference in your community today!