Drug Database - Fentora

Generic Name: fentanyl (buccal) (FEN-ta-nil) (BUK-al)

Brand Names: Fentora®

Classification: Narcotic Pain Medicine

Issue Date: 2007

Fentora treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief. Fentora may also be used for purposes other than those listed here.

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.

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

• isocarboxazid (Marplan)
• phenelzine (Nardil)
• rasagiline (Azilect)
• selegiline (Eldepryl, Emsam)
• tranylcypromine (Parnate)

within the past 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
• a history of drug or alcohol addiction

FDA pregnancy category C. It is not known whether Fentora is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. Do not use Fentora without telling your doctor if you are breast-feeding a baby.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each Fentora 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. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Use Fentora exactly as it was prescribed for you. Do not use the medication in larger amounts or use it for longer than recommended by your doctor. Using too much Fentora can be very harmful or fatal. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If you switch from using Actiq (fentanyl oral transmucosal devices) to using Fentora (fentanyl buccal tablets), you will not use the same fentanyl dose. Fentora is given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms.

To use Fentora tablets:

• Keep the tablet in its blister pack until you are ready to take the medicine. Separate a single blister from the rest of the pack by tearing along the dotted lines. Bend the blister unit on the fold line and peel the foil backing off. Do not push a tablet through the foil or you may damage the tablet.


• Tip the blister unit and drop the Fentora tablet into the palm of your hand. Using dry fingers, place the tablet between your upper gum and your cheek, near your back teeth. The tablet will begin to dissolve right away. You may feel a slight bubbling while the tablet dissolves.


• Do not break, chew, or swallow the tablet whole. Allow it to dissolve in your mouth without chewing. This should take about 14 to 25 minutes.


• If any pieces of the Fentora tablet remain in your mouth after 30 minutes, drink a glass of water to wash them down.

You may use a second Fentora tablet 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine.

If you feel dizzy, nauseated, or very sleepy while the 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. Call your doctor if your pain does not improve, or if it gets worse after using Fentora.

You may have withdrawal symptoms when you stop using Fentora after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Store this medication at room temperature, away from heat and moisture. Do not allow the tablets to freeze. Keep this medicine out of the reach of children or pets. The amount of fentanyl in each Fentora tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Keep track of how many tablets have been used from each new package of this medicine. Fentora is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

If you end up not using a tablet that has been removed from the blister pack, flush the tablet down a toilet. Do not use a Fentora tablet that has been left out of the blister pack for more than a few minutes.

Throw away any other unused tablets by removing them from the blister pack and flushing them down a toilet.

Fentora can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which 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. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Since Fentora tablets are taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Stop using Fentora and call your doctor AT ONCE if you have any of these SERIOUS side effects:

• weak, shallow breathing
• severe weakness, drowsiness, or confusion
• cold, clammy skin
• feeling light-headed or fainting

Less serious Fentora side effects may include:

• nausea, vomiting, stomach pain, constipation
• dizziness, drowsiness, headache
• swelling
• pain or mouth sores where the tablet 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.

Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Fentora. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicine.

Before using this medication, tell your doctor if you are using any of the following drugs:

• aprepitant (Emend)
• diltiazem (Cardizem, Cartia, Dilacor, Tiazac)
• verapamil (Calan, Covera, Isoptin, Verelan)
• an antibiotic such as clarithromycin (Biaxin) or erythromycin (E-Mycin Ery-Tab, E.E.S.)
• antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral)
• HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept)

This list is not complete and there may be other drugs that can interact with Fentora. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.