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FENTORA® (fentanyl buccal tablet) [C-II]
IMPORTANT SAFETY INFORMATION FOR PATIENTS AND CAREGIVERS—SEPTEMBER 2007
Last updated: September 17, 2007
Patients and caregivers must be aware of important safety information about FENTORA® (fentanyl buccal tablet) [C-II]. Before taking FENTORA, they should understand who should use the medicine, who should not, and how it should be taken. Reports of death have occurred with FENTORA when the medicine was not used appropriately.
FENTORA is a prescription opioid medicine. FENTORA is used to treat breakthrough pain in adults with cancer (18 years and older) who are regularly using opioid medicines for their constant (around-the-clock) cancer pain. Breakthrough pain is a component of chronic pain. Flares of breakthrough pain can come on quickly; they can happen even if the around-the-clock pain is well managed.
FENTORA can cause breathing problems which can lead to death:
- Do NOT use FENTORA unless you are regularly using other opioid pain medicines and your body is used to these medicines.
- Do NOT use FENTORA for short-term pain from surgery or injuries or for headache or migraine.
Do NOT take FENTORA more often than prescribed:
- Once you and your doctor have found the dose of FENTORA that works for you, use only one tablet per breakthrough pain episode. If your breakthrough pain is not relieved within 30 minutes, you may take only one more dose of medicine.
- Wait at least four hours before taking FENTORA for another episode of breakthrough pain.
- Talk to a doctor or nurse if you have more than four breakthrough pain episodes per day. The dose of the around-the-clock medicine may need to be adjusted.
If you are taking ACTIQ® (oral transmucosal fentanyl citrate) [C-II] and your doctor decides to change your medicine to FENTORA, DO NOT continue taking ACTIQ once you start taking FENTORA.
- FENTORA is not a generic version of ACTIQ.
Do NOT share this medicine with anyone. Like all opioids, it can be abused by people who abuse prescription medicines or street drugs.
IMPORTANT: Keep FENTORA in a safe place away from children. 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.
Carefully read the Medication Guide that comes with each prescription of FENTORA and talk with your doctor if you have any questions. For more information, you can contact Cephalon Medical Services (1-800-895-5855) or go www.fentora.com.
FENTORA Medication Guide Approved 6-22-07
Updated October 8, 2007 |
