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 information page to apply for and download your card.*

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

    *Eligibility required. 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 1-888-884-2566 Monday-Friday, 8AM-9PM EST for assistance.

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; 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.

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

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

Addiction, Abuse, and Misuse

Life-threatening Respiratory Depression

Neonatal Opioid Withdrawal Syndrome

Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

Risk of Life-threatening Respiratory Depression in Patients With Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

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.

Patients With Chronic Pulmonary Disease:

Xtampza ER -treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Xtampza ER.

Elderly, Cachectic, or 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.

Alternatively, consider the use of non-opioid analgesics in these patients. Use an alternative analgesic for patients who require a dose of Xtampza ER less than 9 mg.

Adrenal Insufficiency

Severe Hypotension

Risks of Use in Patients With Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

Risks of Use in Patients With Gastrointestinal Conditions

Risk of Use in Patients With Seizure Disorders

Withdrawal

Risks of Driving and Operating Machinery

Laboratory Monitoring

ADMINISTRATION WITH FOOD:

ADVERSE REACTIONS:

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