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Frequently asked questions

  • What is Xtampza ER?

    Xtampza ER is a prescription pain medicine that contains an opioid. It is used to manage pain severe enough to require daily, around-the-clock treatment.

    “ER” stands for “extended release.” Extended-release opioids work for a long period of time because the medicine is released slowly in your body.

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

  • How should I take Xtampza ER?

    Xtampza ER is taken twice daily and MUST be taken with food every 12 hours, at the same time every day. It is important to take each Xtampza ER dose with approximately the same amount of food to make sure the medicine is consistently absorbed.

    Call your doctor 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.

  • What if I dislike or have difficulty swallowing pills?

    Xtampza ER can be taken in several ways that do not involve swallowing pills or capsules:

    • Sprinkled on soft foods
    • Sprinkled in a cup and then directly into mouth
    • Taken through feeding tubes

    Click here for specific instructions on how you can take Xtampza ER.

    If you have difficulty swallowing Xtampza ER capsules or have a preference about how to take your medication, let your doctor know and ask him/her about your options.

    Xtampza ER MUST be taken with food.

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

  • What should I avoid while taking Xtampza ER?

    While taking Xtampza ER, do not drive or operate heavy machinery until you know how Xtampza ER affects you. Xtampza ER can make you sleepy, dizzy, or lightheaded.

    Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Xtampza ER may cause you to overdose and die.

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

  • Who should not take Xtampza ER?

    Do not take Xtampza ER if you have severe asthma, trouble breathing, or other lung problems; if you have a bowel blockage, or have narrowing of the stomach or intestines; or if you have hypersensitivity to oxycodone.

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

  • What should I tell my doctor before taking Xtampza ER?

    Before taking Xtampza ER, tell your healthcare provider if you have a history of head injury, seizures, problems with the liver, kidney, or thyroid, problems urinating, pancreas or gallbladder problems, abuse of street or prescription drugs, alcohol addiction, or mental health problems.

    Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of Xtampza ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider if you are breastfeeding, as it is not recommended during treatment with Xtampza ER and may harm your baby. Tell your healthcare provider if you are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Xtampza ER with certain other medicines can cause serious side effects that could lead to death.

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

  • How can I save on my Xtampza ER prescription?

    If you’re eligible, you may be able to start saving on your prescription with an Xtampza ER Co-pay Card. If you don’t have one yet, visit the Co-pay Card information page to apply for and download your card.*

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

    *See Program Terms, Conditions, and Eligibility Criteria.

  • Are there any resources available to help me while taking Xtampza ER?

    Our Pharmacy Locator Specialists are here to help you find the nearest pharmacies stocking Xtampza ER.

    Call 1-888-884-2655 Monday-Friday, 8AM-9PM ET for assistance.

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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