FENTORA Safety

FENTORA Safety

Cephalon provides training and educational materials for healthcare professionals and pharmacies as part of the FENTORA Risk Minimization Action Plan.

In addition, Cephalon has prepared a Medication Guide that summarizes important information you need to know about FENTORA. If you would like more information, talk with your healthcare professional or pharmacist, or call Cephalon Medical Information 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.