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| DATE | 2016-12-28 |
| FROM | From: "Pharmacy Times"
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| SUBJECT | Subject: [Hangout-NYLXS] Xtampza(R) ER (oxycodone) Product Bulletin
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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
Plainsboro, NJ 08536 | P: 609.716.7777 | F: 609.257.0701 | www.PharmacyTimes.com [ http://www.pharmacytimes.com?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=Xtampza%5FCustom%5FeBlast2%5F12%2D28%2D16 ] | Terms & Conditions [ http://www.pharmacytimes.com/terms_condition?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=Xtampza%5FCustom%5FeBlast2%5F12%2D28%2D16 ]
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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.
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
If you no longer wish to receive email communications from Collegium,
please [7]click here
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2. http://mjh-pharmacytimes.informz.net/z/cjUucD9taT01ODA1MzQxJnA9MSZ1PTgxMjI2NjM4OCZsaT0zOTk5OTAzOQ/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
Plainsboro, NJ 08536 | P: 609.716.7777 | F: 609.257.0701 | www.PharmacyTimes.com [ http://www.pharmacytimes.com?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=Xtampza%5FCustom%5FeBlast2%5F12%2D28%2D16 ] | Terms & Conditions [ http://www.pharmacytimes.com/terms_condition?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=Xtampza%5FCustom%5FeBlast2%5F12%2D28%2D16 ]
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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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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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