A strategy applicable to all extended‑release and long‑acting opioids to help manage the known serious risk of abuse, misuse, and diversion.
The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended‑release or long‑acting opioids. You can obtain a copy of the REMS by clicking here.
Pursuant to requirements of the ER/LA Opioid Analgesic REMS, a consortium of manufacturers of opioid drug products provides physicians with access to the measures described below to ensure that the benefits of the products, including Xtampza ER, outweigh the risks of adverse outcomes, such as addiction, unintentional overdose, and death.
Continuing education (CE): REMS‑compliant training is available to healthcare professionals who prescribe ER opioids. The accredited CE courses focus on the safe prescribing of ER opioids, patient selection and monitoring, and how to recognize opioid misuse, abuse, addiction, and overdose.
Patient counseling: In addition to the Xtampza® ER Medication Guide, you can download the REMS Patient Counseling Document, which explains how to use, store, and dispose of opioids. You can distribute these materials to your patients to ensure they understand how to safely use opioids.
24/7 call center: Contact the REMS call center at 1‑800‑503‑0784. The call center is available to healthcare professionals to answer FAQs and to provide information about program materials and services. Trained call center representatives can also direct questions or concerns to the appropriate outlet.
XTAMPZA® ER (oxycodone) is indicated for the
management of severe and persistent pain that requires an extended treatment period with
a daily opioid analgesic and for which alternative treatment options are inadequate.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER
Addiction, Abuse, and Misuse
Because the use of 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 reassess 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, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of XTAMPZA ER are essential.
Accidental ingestion of even one dose of XTAMPZA ER, especially by children, can result in a fatal overdose of oxycodone.
Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of XTAMPZA ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Neonatal Opioid Withdrawal Syndrome (NOWS)
If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.
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. Regularly evaluate patients receiving XTAMPZA ER and any CYP3A4 inhibitor or inducer.
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and
misuse, the Food and
Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for
Under the requirements of the REMS, drug companies with approved opioid analgesic products must
REMS-compliant education programs available to healthcare providers. Healthcare providers are
encouraged to do all of the following:
To obtain further information on the REMS and a list of accredited REMS CME/CE, call
1-800-503-0784, or log on to www.opioidanalgesicrems.com. The FDA Blueprint can be found at
See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other
serious risks, accompanying this piece or at XTAMPZAER.com/PI.
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