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Xtampza ER

A prescription medication that can help relieve your pain for 12 hours after each dose.

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Eligible patients may pay as little as $35* for each prescription

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See Program Terms, Conditions, and Eligibility Criteria.

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Eligibility required. See Program Terms, Conditions, and Eligibility Criteria.

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.

Program Terms, Conditions, and Eligibility Criteria

Offer is valid for commercially insured patients only. Most eligible commercially insured patients will pay as little as $35 (maximum benefit amount of $100) for each fill of Xtampza® ER (oxycodone) capsules. Any remaining out-of-pocket expense will be the patient’s responsibility. This offer is valid in the United States. Some restrictions may apply. Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, Tricare or other federal or state health programs (such as medical assistance programs). Cash Discount Cards and other non-insurance plans are not valid as primary under this offer. If the patient is eligible for drug benefits under any such program, the patient cannot use this offer. By using this offer, the patient certifies that he or she will comply with any terms of his or her health insurance contract requiring notification to his or her payer of the existence and/or value of this offer. This offer is not valid for cash paying patients. Offer not valid for patients under 18 years of age. Program not valid in Massachusetts.

Patient Instructions: To redeem this offer, you must have a valid prescription for Xtampza® ER and follow the dosage instructions provided by your healthcare provider with a valid Prescriber ID# (e.g. NPI or DEA). This offer may not be redeemed for cash. Patients with questions about the Xtampza® ER savings offer should call 1‑844‑247‑4753.

Program expires 06/30/2019.

This offer is not transferable and is limited to one offer per person. Not valid if reproduced. Void where prohibited by law. Program managed by ConnectiveRx on behalf of Collegium Pharmaceutical. The parties reserve the right to rescind, revoke or amend this offer without notice at any time.

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