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

What is Fentora?

Fentora (fentanyl) is an opioid pain medication. An opioid is sometimes called a narcotic.

Fentora is used to treat "breakthrough" cancer pain that is not controlled by other medicines. It is taken together with other non-fentanyl narcotic pain medicine that is used around the clock.

Fentora is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.

Fentora is available only under a special program called the TIRF REMS Program. You must be registered in the program and understand the risks and benefits of taking this medication.

Important information

Fentora can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Fentanyl may be habit-forming, even at regular doses. 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.

MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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Fentora is available only under a special program called the TIRF REMS Program. You must be registered in the program and understand the risks and benefits of taking this medication.

You should not use Fentora unless you are already using an around-the-clock opioid medicine and are tolerant to it. Ask your doctor if you are not sure you are opioid-tolerant.

Some medicines can cause unwanted or dangerous effects when used with Fentora. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Fentora.

If you switch from using Actiq (fentanyl oral transmucosal "lollipop" device) to using Fentora (fentanyl buccal tablets), you will not use the same fentanyl dose. Fentora is given at lower doses than Actiq. Using too much Fentora can cause a fatal overdose.

Before using Fentora

You should not use Fentora if you are allergic to fentanyl. You should not use Fentora unless you are already using an around-the-clock opioid medicine and are tolerant to it. Ask your doctor if you are not sure you are opioid-tolerant.

To make sure Fentora is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • a history of head injury, brain tumor, or seizures;

  • slow heartbeats or other 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 is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

FDA pregnancy category C. It is not known whether Fentora will harm an unborn baby. Fentanyl may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

See also: Pregnancy and breastfeeding warnings (in more detail)

Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while you are using Fentora.

Tell your doctor if there are children living in the home where you will store this medicine. Keep out of the reach of children. The amount of fentanyl in each Fentora tablet can be fatal to a child.

How should I use Fentora?

If you switch from using Actiq (fentanyl oral transmucosal devices) to using Fentora (fentanyl buccal tablets), you will not use the same dose. Fentora is given at lower doses than Actiq. Using too much Fentora can cause a fatal overdose.

Fentanyl may be habit-forming, even at regular doses. Never share Fentora with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Fentora to any other pserson is against the law.

Follow all directions on your prescription label. Fentanyl can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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 medicine to dissolve in your mouth without breaking, chewing, or sucking on it.

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.

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

Wait at least 4 hours after taking a Fentora tablet to treat a new pain episode.

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 this medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine in its original package until you are ready to take your dose. Do not use a buccal tablet that has been left out of the blister pack for more than a few minutes. Flush the tablet 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.

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 the amount of medicine used from each carton. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Carefully follow disposal instructions when this medicine is no longer needed. Throw away any unused Fentora tablets 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 this medicine is used around the clock, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Fentora will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Fentora.

Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products while using this medicine.

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:

  • slow heart rate, weak or shallow breathing, severe drowsiness;

  • confusion;

  • a light-headed feeling, like you might pass out;

  • pale skin, rapid heart rate, trouble concentrating; or

  • if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin.

Common Fentora side effects may include:

  • nausea, vomiting, constipation;

  • mild dizziness, feeling weak or tired;

  • headache;

  • 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: Side effects (in more detail)

What other drugs will affect Fentora?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Fentora with a sleeping pill, other pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not take this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Many other medicines can increase the risk of serious breathing problems when used with Fentora. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Fentora, especially:

  • an antibiotic--clarithromycin, erythromycin, rifampin, telithromycin;

  • antifungal medication--fluconazole, itraconazole, ketoconazole, and others;

  • heart medication--diltiazem, verapamil, and others; or

  • HIV/AIDS medication--ritonavir, saquinavir, and others.

This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Fentora.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fentora only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 7.02. Revision Date: 2014-01-13, 5:23:35 PM.

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