Xtampza ER

Xtampza ER is used to manage severe and persistent pain in adults that requires an extended treatment period with a daily opioid pain medicine when other pain medicines do not treat your pain well enough, or you cannot tolerate them. It is a long-acting (extended-release) opioid pain medication that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Xtampza ER is not for "as-needed" use.

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics to balance benefits against risks of addiction and misuse. Prescribers must complete REMS-compliant education, counsel patients on safe use and disposal, ensure patients read Medication Guides, and consider patient-prescriber agreements to enhance safety.

Xtampza ER (oxycodone) is a full mu-opioid receptor agonist providing analgesia with no ceiling effect, meaning doses are limited only by adverse effects like respiratory and CNS depression. Its precise analgesic mechanism is unknown, but CNS opioid receptors throughout the brain and spinal cord are believed to be involved.

An oxycodone extended-release product first gained FDA approval on October 26, 1998. Xtampza ER capsules were approved on April 26, 2016. All oxycodone formulations are Schedule II controlled substances.

Get emergency help or call 911 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 or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

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 a narrowing of the stomach or intestines
• An allergy to oxycodone, Xtampza ER, or any of the ingredients in your oxycodone preparation.

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, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• Noticing your pain is getting worse. If your pain gets worse after you take Xtampza ER, do not take more Xtampza ER without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking oxycodone.
• Pregnant or planning to become pregnant. Using oxycodone for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• Breastfeeding. Xtampza ER passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
• Living in a household where there are small children or someone who has abused street or prescription drugs.
• 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.

Common Side Effects

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.

Serious Side Effects

Get emergency medical help or call 911 right away 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
• Mental changes such as confusion.

These are not all the possible side effects of Xtampza ER. Call your healthcare provider 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

When taking Xtampza ER, do not change your dose. Take it 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.
• Xtampza ER MUST be taken with food.
• Swallow Xtampza ER capsules whole. Do not snort or inject Xtampza ER because this may cause you to overdose and die.
• If you cannot swallow Xtampza ER capsules, refer to the Instructions for Use in the Medication Guide.
• 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.
• Always take Xtampza ER capsules with approximately the same amount of food to ensure enough medicine is absorbed.
• Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

Comments

• 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.

How do I Dispose of Xtampza ER?

Dispose of expired, unwanted, or unused Xtampza ER capsules by promptly flushing them 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 lightheaded.
• 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An Xtampza ER overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend that you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Xtampza ER can interact dangerously with many medications, potentially causing serious side effects or death. Always inform your doctor of all medications you take, including:

• Other opioids, pain medicines, or prescription cough medicines
• Sedatives, such as Xanax, Valium, Ativan, Klonopin, or Restoril
• Sleeping pills, muscle relaxants, or tranquilizers
• Mental health medications for depression, anxiety, or other conditions
• Neurological medications for Parkinson's disease, migraines, or seizures
• Antibiotics, antifungals, or HIV/hepatitis C treatments
• Heart or blood pressure medications
• Cold, allergy, or asthma medications
• Nausea, motion sickness, or bladder medications

Some medications affect how Xtampza ER (oxycodone) is processed in the body, potentially raising levels to dangerous concentrations. This list is not complete; always check with your doctor or pharmacist before starting or stopping any medication, including over-the-counter products, vitamins, and herbal supplements.

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Xtampza ER is a drug of abuse, and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Store at room temperature, around 25°C (77°F).

Because of the risks associated with accidental ingestion, misuse, and abuse, Xtampza ER should be stored securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Leaving Xtampza ER unsecured can pose a deadly risk to others in the home.

Active Ingredient: oxycodone

Inactive ingredients: myristic acid, yellow wax, carnuba wax, PEG-32 stearate, magnesium stearate, silicon dioxide, hypromellose unspecified, titanium dioxide, water.

Other inactive ingredients in specific capsules:

• 9 mg capsules also contain ferric oxide yellow
• 13.5 mg capsules also contain ferric oxide red
• 18 mg capsules also contain ferric oxide yellow
• 27 mg capsules also contain ferrosoferric oxide
• 36 mg capsules also contain ferric oxide red.

Xtampza ER extended-release capsules are manufactured by Patheon Pharmaceuticals, 2110 Galbraith Road, Cincinnati, OH 45237, www.collegiumpharma.com, or call 855-331-5615.