Start Saving Today with the Xtampza® ER Co-pay Card!
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 is not valid in Massachusettsor in any other state or jurisdiction where prohibited or restricted by law.
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# (eg, 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.
Pharmacist: When you apply this offer, you are certifying that you have not submitted a claim for reimbursement under any federal, state, or other governmental programs for this prescription. Participation in this program must comply with all applicable laws and regulations as a pharmacy provider.
Pharmacist instructions for a patient with an Eligible Third Party Payer: Submit the claim to the primary Third Party Payer first, then submit the balance due to Change Healthcare as a Secondary Payer COB [coordination of benefits] with patient responsibility amount and a valid Other Coverage Code (eg, 8). Most eligible commercially insured patients will pay as little as $35 (maximum benefit amount of $100) for Xtampza® ER capsules. Reimbursement will be received from Change Healthcare. Valid Other Coverage Code required. For any questions regarding Change Healthcare online processing, please call the Help Desk at 1-800-422-5604.
Program expires 06/30/2020.
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.
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 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
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
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