Fentora

Generic Name: fentanyl (buccal) (FEN ta nil (BUK al))
Brand Names: Fentora, Onsolis

What is Fentora?

Fentora (fentanyl) is a narcotic (opioid) pain medicine.

Fentora is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Fentanyl 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.

Fentora may also be used for purposes not listed in this medication guide.

Important information about Fentora

Fentora 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 Fentora 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.

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Fentora 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 Fentora 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 Fentora, 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 Fentora buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Fentora may be habit-forming and should be used only by the person it was prescribed for. Never share Fentora 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.

Before using Fentora

Do not use Fentora 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 Fentora 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 Fentora, 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.

Fentora may be habit-forming and should be used only by the person it was prescribed for. Never share Fentora 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 Fentora 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 this medicine. Fentora may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while you are using Fentora.

See also: Fentora pregnancy and breastfeeding warnings (in more detail)

How should I use Fentora?

Fentora 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.

Use Fentora exactly as prescribed. Never use Fentora in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

If you switch from using Actiq (fentanyl oral transmucosal devices) to using Fentora (fentanyl buccal tablets) or Onsolis (fentanyl buccal soluble film), you will not use the same dose. Fentora and Onsolis are given at lower doses than Actiq. Fentanyl dosage must also be adjusted if switching between Fentora and Onsolis.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use only dry fingers when handling Fentora tablets. Use only 1 tablet at a time. Do not swallow the tablet whole. Allow the tablet to dissolve in your mouth without breaking, chewing, or sucking on it.

If you feel dizzy, nauseated, or very sleepy while the Fentora tablet is still in your mouth, spit the medicine out into a sink or toilet and rinse your mouth with water to remove all remaining pieces of the tablet. Call your doctor for instructions.

If your pain does not completely go away, use a second tablet only if your doctor has approved it.

Wait at least 4 hours to treat a new pain episode with Fentora tablets.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine.

Do not stop using Fentora suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Fentora. Keep this medicine out of the reach of children or pets. The amount of fentanyl in each buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Store Fentora at room temperature away from moisture and heat. Do not freeze. Keep the medicine its original package until you are ready to take your dose. Keep track of the amount of medicine used from each new bottle. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not use a Fentora tablet that has been left out of the blister pack for more than a few minutes. Flush the tablet down a toilet. Throw away any other unused tablets or by removing them from the blister pack and flushing them down a toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

What happens if I miss a dose?

Since Fentora is used on an as needed basis, you are not likely to miss a dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Fentora overdose can be fatal.

Overdose symptoms may include extreme weakness or dizziness, pinpoint pupils, cold and clammy skin, weak pulse, fainting, slow breathing (breathing may stop).

What should I avoid while using Fentora?

Do not use Fentora with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Fentora may impair your thinking or reactions. Avoid driving or operating machinery until you know how Fentora will affect you. Do not drink alcohol. It can increase drowsiness or breathing problems caused by Fentora.

Grapefruit and grapefruit juice may interact with Fentora and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Fentora side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Fentora: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Fentora and call your doctor at once if you have a serious side effect such as:

• weak or shallow breathing;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious Fentora side effects may include:

• nausea, vomiting, constipation;

• dizziness, drowsiness;

• headache;

• feeling weak or tired;

• swelling in your hands or feet; or

• pain or mouth sores where the medicine was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Fentora side effects (in more detail)

What other drugs will affect Fentora?

Do not take Fentora with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

• dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• St. John's wort;

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

• antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

• an antidepressant such as nefazodone;

• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with Fentora. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Fentora.