What is fentanyl buccal?
Fentanyl is a narcotic (opioid) pain medicine.
Fentanyl buccal is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Fentanyl buccal is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.
Fentanyl buccal may also be used for purposes not listed in this medication guide.
What is the most important information I should know about fentanyl buccal?
Fentanyl buccal is available only under special programs called Fentora REMS or the FOCUS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.
Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.
Fentanyl buccal tablets are used to treat "breakthrough" cancer pain. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.
Do not use fentanyl buccal if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.
Before using fentanyl buccal, tell your doctor if you have a breathing disorder, a head injury or brain tumor, seizures, mental illness, a heart rhythm disorder, low blood pressure, liver or kidney disease, or a history of drug or alcohol addiction.
Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.
Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
What should I discuss with my healthcare provider before using fentanyl buccal?
Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, and others), hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant.
Do not use fentanyl if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
To make sure you can safely take fentanyl buccal, tell your doctor if you have any of these other conditions:
a breathing disorder such as chronic obstructive pulmonary disease (COPD);
a history of head injury or brain tumor;
a heart rhythm disorder;
seizures or epilepsy;
mental illness such as depression, hallucinations;
low blood pressure;
liver or kidney disease; or
a history of drug or alcohol addiction.
Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl buccal with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether fentanyl buccal will harm an unborn baby. Fentanyl may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using fentanyl buccal.
Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while you are using fentanyl buccal.