WARNING: ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM
USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
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
Xtampza ER and monitor all patients regularly for the
development of these behaviors or
Opioid Analgesic Risk Evaluation and Mitigation Strategy
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 REMS
for these products. Under the requirements of the REMS, drug companies with approved
opioid analgesic products must make REMS-compliant education programs available to
healthcare providers. Healthcare providers are strongly encouraged to
- complete a REMS-compliant education program,
- counsel patients and/or their caregivers, with every prescription, on safe use,
serious risks, storage, and disposal of these products,
- emphasize to patients and their caregivers the importance of reading the Medication
Guide every time it is provided by their pharmacist, and
- consider other tools to improve patient, household, and community safety.
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 of even one 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
fatal respiratory depression. In addition, discontinuation of a concomitantly used
P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor
Xtampza ER and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines or Other
Concomitant use of opioids with benzodiazepines or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory depression, coma, and
- Reserve concomitant prescribing of
Xtampza ER and benzodiazepines or other CNS depressants
for use in patients for whom
alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.