• For Healthcare Professionals

Here, you’ll find support and helpful information, including tips to prepare for your next appointment, a tool to locate pharmacies stocking Xtampza® ER, links to pain support organizations, and answers to common questions about Xtampza ER.

Talking with your doctor

You are the only one who can tell your doctor how your treatment is working for you. Remember to talk to your doctor about any questions or concerns you might have, so you can both be sure that your current treatment plan is meeting your needs.

4 tips to prepare for your next appointment:

Keep Track

Keep a journal of your pain, symptoms, activities, and any side effects you are experiencing. Bring the journal to your appointment so you can discuss what you’ve recorded.

Bring Support

Bring along a family member or friend for support. Your companion can help with providing information to your doctor or taking notes during your appointment.

Ask Questions

Write down any questions you might have about your pain, current treatment, or side effects.

Take Notes

Remember to take notes during your appointment so you can keep track of any directions or important information your doctor gives you.

Finding a pharmacy

If your nearest pharmacy doesn’t carry Xtampza ER, we can help!

Speak with a specialist to find the nearest pharmacies stocking Xtampza ER.

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

Finding support

Suffering from any chronic condition can feel very isolating. Connecting with others who also live with chronic pain can be helpful in understanding your pain and how to manage it.

Below, you'll find organizations dedicated to educating and supporting those living with pain. Visit their sites to find support groups in your area as well as other helpful information.

Frequently Asked Questions about Xtampza ER

Xtampza ER is a prescription pain medicine and an abuse-deterrent, oral formulation of oxycodone. It’s used to manage pain severe enough to require daily, around-the-clock treatment when alternative treatments are inadequate.

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

Xtampza ER is designed with DETERx® technology. This technology may help reduce problems like misuse, diversion, or abuse.

  • Misuse is when a medicine is used incorrectly (this can be on purpose or not)
  • Diversion is when a prescription medication is transferred to a person for whom it was not prescribed
  • Abuse is when a medicine is used for a nonmedical purpose

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 because it helps the body properly absorb the medication.

Call your doctor if the dosage you are taking does not control your pain. Do not stop taking Xtampza ER or change your dose without talking to your doctor.

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

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

  • Sprinkled on soft foods
  • Sprinkled in a cup of liquid and then swallowed
  • Taken through a feeding tube

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

Xtampza ER MUST be taken with food.

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

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 light-headed.

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 the Medication Guide.

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.

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

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

  • head injury, seizures
  • liver, kidney, thyroid problems
  • 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
  • breastfeeding. Not recommended during treatment with Xtampza ER. It may harm your baby
  • 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 the Medication Guide.

Xtampza ER was developed with abuse-deterrent technology to help address some of the issues relating to opioid use. However, abuse of Xtampza ER is still possible, and like all opioid medications, Xtampza ER carries risks of addiction, misuse, and diversion. Talk to your doctor about your role in responsible pain management and how you can help keep your Xtampza ER prescriptions, and those around you, safe.

Remember to:

  • Take Xtampza ER exactly as your doctor has prescribed and do not share with others
  • Store all your medications safely and securely (such as in a locked box or cabinet)
  • Discard unused medications properly and do not save them if they are no longer needed

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

If you’re eligible,* you may be able to save with an Xtampza ER Co-pay Card.

*For eligible commercially insured patients. Maximum savings limit applies; patient out-of-pocket expense may vary.
Please see Program Terms, Conditions, and Eligibility Criteria.

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

You can call 888-884-2655, Monday - Friday, 8 AM-9 PM ET, for assistance..

You can connect with others and find resources on chronic pain management through our list of chronic pain organizations. These organizations offer support and education to people living with pain and their family and friends.

ISI arrow
ISI arrow

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

IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA ER

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 information about Xtampza ER:

  • Get emergency help right away if you take too much Xtampza ER (overdose). When you first start taking Xtampza ER, when your dose is changed, or if you take too much (overdose), serious life‑threatening breathing problems that can lead to death may occur
  • Taking Xtampza ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death
  • Never give anyone else your Xtampza ER. They could die from taking it. Selling or giving away Xtampza ER is against the law
  • Store Xtampza ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home

Do not take Xtampza ER if you have:

  • severe asthma, trouble breathing, or other lung problems
  • a bowel blockage, or have narrowing of the stomach or intestines

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

  • head injury, seizures
  • liver, kidney, thyroid problems
  • 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
  • breastfeeding. Not recommended during treatment with Xtampza ER. It may harm your baby
  • 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

When taking Xtampza ER:

  • Do not change your dose. Take Xtampza ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed
  • Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time
  • If you cannot swallow Xtampza ER capsules, see the detailed Instructions for Use in the Medication Guide
  • Always take Xtampza ER capsules with approximately the same amount of food to ensure enough medicine is absorbed
  • Swallow Xtampza ER whole. Do not snort, or inject Xtampza ER because this may cause you to overdose and die
  • The contents of the Xtampza ER capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube
  • Call your healthcare provider if the dose you are taking does not control your pain
  • Do not stop taking Xtampza ER without talking to your healthcare provider
  • Dispose of expired, unwanted or unused Xtampza ER by promptly flushing down the toilet, if a drug take‑back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines

IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA ER

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.

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 light‑headed
  • 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

The possible side effects of Xtampza ER are:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light‑headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion

These are not all the possible side effects of Xtampza ER. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1‑800‑FDA‑1088. For more information, go to dailymed.nlm.nih.gov.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, or speak to your healthcare provider if you have questions about Xtampza ER.

Are you a Healthcare Professional or Patient/Caregiver?

Healthcare Professional Patient/Caregiver