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Generic Name: fentanyl (buccal) (FEN tan il BUK al /sub LIN gwal)
Brand Names: Fentora

What is Fentora?

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

Fentora buccal tablets are placed inside the mouth between the upper cheek and gum or on the floor of your mouth, under your tongue and left in place until the tablet dissolves.

Fentora buccal tablets are used to treat "breakthrough" cancer pain that is not controlled by other medicines. This medicine is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.

Important information

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

Fentanyl 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 this medicine with another person.

Some medicines can interact with fentanyl and worsen the effects on your breathing. Tell your doctor about all medicines you use.

You should not use Fentora unless you are already using an around-the-clock opioid medicine and are tolerant to it. Do not use this medicine to replace any other form of fentanyl (injection, skin patch, "lollipop" device).

If you switch to Fentora after using another form of fentanyl, you may not use the same dose.

Keep out of the reach of children. The amount of fentanyl in this medicine can be fatal to a child.

Before taking this medicine

You should not use Fentora if you are allergic to fentanyl. Do 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 interact with fentanyl and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

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

  • mouth sores or ulcers;

  • any type of breathing problem or lung disease;

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

  • low blood pressure, slow heartbeats or other heart rhythm disorder;

  • mental illness such as depression, schizophrenia, or hallucinations;

  • liver or kidney disease; or

  • a personal or family history of drug or alcohol addiction.

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

If you use Fentora while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Fentora may also cause drowsiness, breathing problems, or withdrawal symptoms in a nursing infant. Do not breast-feed while you are using this medicine.

How should I use Fentora?

Use Fentora exactly as prescribed by your doctor. Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. Never use 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.

If you have been using another form of fentanyl (injection, skin patch, "lollipop" device), your Fentora buccal dose may be different.

Use only one tablet at a time. Allow the whole tablet to dissolve in your mouth without breaking, chewing, or sucking on it. You can place a Fentora tablet in your mouth above a rear molar tooth between the upper cheek and gum. Switch sides of your mouth for each dose. You may also place the tablet on the floor of your mouth, under your tongue. First lift your tongue, then place the tablet under your tongue, and then lower your tongue over the tablet. Leave the tablet in place until it dissolves. A Fentora tablet generally takes between 14 to 25 minutes to dissolve. After 30 minutes, if there is any Fentora left in your mouth, you may drink a glass of water to help you swallow the left over medicine.

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 go away completely, use a second Fentora tablet only if your doctor has approved it. Wait at least 4 hours before treating 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 treat more than 4 pain episodes per day with this medicine.

Do not stop using Fentora suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Never crush or break a Fentora tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of fentanyl and similar prescription drugs.

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 Fentora tablet that has been left out of the blister pack for more than a few minutes. Flush the tablet down a toilet.

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.

Keep Fentora 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.

Carefully follow disposal instructions when this medicine is no longer needed. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, throw away any unused Fentora buccal tablets by removing them from the blister pack and flushing them down a toilet.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Since Fentora is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use 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 fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme weakness or drowsiness, weak pulse, cold and clammy skin, pinpoint pupils, and slow breathing (breathing may stop).

What should I avoid while using Fentora?

This medicine 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 fentanyl.

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

Fentora side effects

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

Call your doctor at once if you have:

  • slow heart rate, weak or shallow breathing, sighing, severe drowsiness, feeling like you might pass out;

  • confusion, extreme fear, unusual thoughts or behavior;

  • pale skin, feeling short of breath, rapid heart rate, trouble concentrating;

  • infertility, missed menstrual periods, impotence, sexual problems, loss of interest in sex;

  • low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

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

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Fentora side effects may include:

  • constipation, nausea, vomiting;

  • dizziness, drowsiness, pale skin, feeling weak or tired;

  • headache, dehydration (thirst, dry mouth, little or no urinating); or

  • swelling in your hands or feet.

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?

Some medicines can cause unwanted or dangerous effects when used with fentanyl. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Using 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 a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, seizures, high blood pressure, heart rhythm disorders, or viral infections such as hepatitis or HIV.

You should not take Fentora 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.

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. Tell your doctor about all your medications and any you start or stop using during treatment with Fentora.

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 1996-2016 Cerner Multum, Inc. Version: 5.04. Revision Date: 2016-03-28, 10:27:09 AM.