FENTORA Safety

Using FENTORA Safely

Do not take FENTORA:

  • If you are not regularly using other opioid pain medicines around the clock for your constant cancer pain
  • For the treatment of short-term pain from injuries, surgery, and headaches, including migraines
  • If you are allergic to anything in FENTORA. The active ingredient in FENTORA is fentanyl. The other ingredients are mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate

Do not let anyone else take the FENTORA that has been prescribed for you.

As with all prescription medications, some precautions should be taken with FENTORA. Tell your healthcare professional about all medical and mental health issues, especially if you or the person you’re caring for has:

  • Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
  • A head injury or brain problem
  • Liver or kidney problems
  • Seizures (convulsions or fits)
  • Slow heart rate or other heart problems
  • Low blood pressure
  • Mental health issues including major depression or hallucinations (seeing or hearing things that are not there)
  • A past or present drinking problem or alcoholism, or family history
  • A past or present drug abuse or addiction problem, or family history

Tell your healthcare professional if you or the person you’re caring for is:

  • Pregnant or planning to become pregnant. FENTORA may harm your unborn baby
  • Breast-feeding. Fentanyl passes through breast milk and may cause serious harm to your baby. Therefore, you should not use FENTORA while breast-feeding
  • Using medicines (other than your pain medicine) and herbal products while taking FENTORA
    • Do not start any new prescription medicine, non-prescription medicine, vitamins, or herbal supplements while using FENTORA until you have talked with your healthcare professional. Your healthcare professional will tell you if it is safe to take other medicines while you are using FENTORA

Tell your healthcare professional about all the medicines you take, including: prescription and non-prescription medicines, vitamins, and dietary supplements.

Avoid alcohol

Do not drink alcohol while using FENTORA. Drinking alcohol can produce dangerous side effects, resulting in serious injury or death.

Storing FENTORA

Keep FENTORA in a safe and secure place away from children and anyone for whom it has not been prescribed. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes FENTORA, get emergency help right away.

FENTORA is supplied in single sealed, child-resistant blister packages. Keep tablets in their blister packages until you are ready to take FENTORA. Do not store FENTORA in pillboxes. Once a blister is opened, the tablet must be taken immediately.

Store FENTORA at room temperature, 59°F to 86°F (15°C-30°C), until ready to use.

Always keep FENTORA in a secure place to protect from theft.

Disposing of FENTORA tablets

Dispose of any unopened FENTORA tablets remaining from a prescription as soon as they are no longer needed.

If you need help with disposal of FENTORA, or information on how to return unused tablets, call Cephalon at 1-800-896-5855.

IMPORTANT:

Do not use FENTORA unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.

Keep FENTORA in a safe place away from children.

Get emergency help right away if:

  • a child takes FENTORA. FENTORA can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed FENTORA uses it
  • an adult who is not already taking opioids around-the-clock, uses FENTORA.

These are medical emergencies that can cause death. If possible, try to remove FENTORA from the mouth.

Read this Medication Guide completely before you start using FENTORA, and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Share this important information with members of your household and other caregivers.

FENTORA is used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.

The most important information you should know about FENTORA is:

FENTORA can cause life-threatening breathing problems which can lead to death.

  1. Do not use FENTORA if you are not opioid tolerant.
  2. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using FENTORA. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  3. Use FENTORA exactly as prescribed by your healthcare provider.
    • You must not use more than 2 doses of FENTORA for each episode of breakthrough cancer pain.
    • You must wait at least 4 hours before treating a new episode of breakthrough pain with FENTORA. See the Medication Guide section “How should I use FENTORA?” and the Patient Instructions for Use at the end of this Medication Guide for detailed information about how to use FENTORA the right way.
  4. Do not switch from FENTORA to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of FENTORA is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of FENTORA that may be different than other fentanyl containing medicines you may have been taking.