Are you a Healthcare Professional or Patient/Caregiver?

Healthcare Professional Patient/Caregiver

How should I take Xtampza ER?

Xtampza ER is taken twice daily and MUST be taken with food

It is important to take each Xtampza ER dose with approximately the same amount of food to make sure the medicine is consistently absorbed

Take your prescribed dose every 12 hours, at the same time every day

What are some risks I should be aware of when taking an opioid?

Long-acting opioid medications can put you at risk for overdose if they are not taken correctly.

Signs and symptoms of drug overdose include the following:

  • Feeling high (euphoria)
  • Slowed breathing rate
  • Drowsiness
  • Confusion
  • Poor coordination
  • Nausea (severe)
  • Constipation (severe)

Talk with your doctor if you are concerned:

  • Common side effects may be expected with your medication
  • Let your doctor know if the dosage you are taking does not control your pain
  • Do not stop taking Xtampza ER without talking to your doctor

For further information about Xtampza ER, please see full Prescribing Information and Medication Guide.

Always take each dose of Xtampza ER exactly as your doctor prescribed—no more and no less

INDICATIONS AND USAGE

Xtampza® ER (oxycodone) is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed by your healthcare provider, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not for use to treat pain that is not around-the-clock.
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IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, and MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT 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 prescribing Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

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

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 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.

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.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Important Safety Information about Xtampza ER

Do not take Xtampza ER if you have:

Before taking Xtampza ER, tell your healthcare provider if you have a history of:

Tell your healthcare provider if you are:

When taking Xtampza ER:

While taking Xtampza ER, DO NOT:

The possible side effects of Xtampza ER are:

Get emergency medical help if you have:

These are not all the possible side effects of XTAMPZA ER. Call your doctor for medical advice about side effects.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

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