Fentanyl Buccal (Transmucosal)

Conditions Treated

Buccal fentanyl is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) analgesics. It works by changing the way the brain and nervous system respond to pain.

Possible Side Effects

What Side Effects Can This Cause?

Buccal fentanyl may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• nausea
• stomach pain
• vomiting
• constipation
• diarrhea
• gas
• heartburn
• loss of appetite
• weight loss
• difficulty urinating
• weakness
• headache
• changes in vision
• anxiety
• depression
• hallucinations (seeing things or hearing voices that do not exist)
• unusual thinking
• unusual dreams
• difficulty falling asleep or staying asleep
• dry mouth
• sweating
• flushing
• uncontrollable shaking of a part of the body
• back pain
• chest pain
• pain, sores, or irritation in the mouth in the area where you placed the buccal tablet
• rash
• itching
• swelling of the hands, arms, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• slow, shallow breathing
• extreme drowsiness
• dizziness
• confusion
• fainting
• heartbeat that is slower or faster than normal
• seizures

Buccal fentanyl may cause other side effects. Call your doctor if you have any unusual problems while using this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Buccal fentanyl comes as a lozenge on a handle (Actiq) and a tablet (Fentora) to dissolve in the mouth. Fentanyl buccal lozenges and tablets are used as needed to treat breakthrough pain, but not more often than four times a day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Your doctor will probably start you on a low dose of fentanyl buccal lozenges or tablets and gradually increase your dose until you find the dose that will relieve your breakthrough pain. When you start using buccal fentanyl and are still trying to reach the correct dose, if you still have pain after using one buccal lozenge or tablet, your doctor may tell you to use a second lozenge or tablet. You may use the second lozenge 15 minutes after you finish the first lozenge, or use the second tablet 30 minutes after you started using the first tablet. Do not use a second lozenge or tablet to treat the same episode of pain unless your doctor tells you that you should. Talk to your doctor about how well the medication is working and whether you are experiencing any side effects so that your doctor can decide whether your dose should be adjusted. Do not use fentanyl buccal lozenges or tablets more than four times a day. Call your doctor if you experience more than four episodes of breakthrough pain per day. Your doctor may need to adjust the dose of your other pain medication to better control your pain. Fentanyl buccal lozenges and tablets should be used along with your other pain medication(s). Do not stop taking your other pain medication(s) when you begin your treatment with fentanyl buccal lozenges or tablets. Buccal fentanyl may be habit-forming. Do not use a larger dose of buccal fentanyl, use the medication more often, or use it for a longer period of time than prescribed by your doctor. Do not stop using fentanyl buccal lozenges or tablets without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using fentanyl buccal lozenges or tablets, you may experience unpleasant withdrawal symptoms. To use fentanyl buccal lozenges, follow these steps:

Check the blister package and the handle of the lozenge to make sure the lozenge contains the dose of medication you have been prescribed.

Use scissors to cut open the blister package, and remove the lozenge. Do not open the blister package until you are ready to use the medication.

Place the lozenge in your mouth, between your cheek and gum. Actively suck on the lozenge, but do not chew or bite it. Move the lozenge around in your mouth, from one side to the other, using the handle. Twirl the handle often.

Do not eat or drink anything while the lozenge is in your mouth.

Finish the lozenge in about 15 minutes.

If you begin to feel dizzy, very sleepy, or nauseated before you have finished the lozenge, remove it from your mouth. Dispose of it immediately as described below or put it in the temporary storage bottle for later disposal.

If you finish the entire lozenge, throw the handle away in a garbage can that is out of the reach of children. If you did not finish the entire lozenge, hold the handle under hot running water to dissolve all the medication, and then throw the handle away in a garbage can that is out of the reach of children and pets.

To use fentanyl buccal tablets, follow these steps:

Separate one blister unit from the blister card by tearing along the perforations. Peel back the foil to open the blister unit. Do not try to push the tablet through the foil. Do not open the blister unit until you are ready to use the tablet.

Place the tablet in your mouth between one of your upper back teeth and your gum.

Leave the tablet in place until it dissolves completely. You may notice a gentle bubbling feeling between your cheek and gum as the tablet dissolves. It may take 14 to 25 minutes for the tablet to dissolve. Do not split, chew, bite, or suck the tablet.

If any of the tablet is left in your mouth after 30 minutes, swallow it with a drink of water.

If you begin to feel dizzy, very sleepy, or nauseated before the tablet dissolves, rinse your mouth with water and spit the remaining pieces of tablet into the sink or toilet. Flush the toilet or rinse the sink to wash away the tablet pieces.

What Dietary Instructions Should I Follow

Avoid eating grapefruit and drinking grapefruit juice while using this medication.

Are There Any Special Instructions

Before using fentanyl buccal lozenges or tablets, tell your doctor and pharmacist if you are allergic to fentanyl or any other medications. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following medications: antihistamines; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); carbamazepine (Carbatrol, Epitol, Tegretol); medications for mental illness and nausea; muscle relaxants; other pain medications; nalbuphine (Nubain); naloxone (Narcan); nalmefene (Revex); pentazocine (Talwin); phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; and tranquilizers. Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor what herbal products you are taking, especially St. John's wort. tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol or uses or has ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have or have ever had a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; seizures; slowed heartbeat or other heart problems; low blood pressure; mental problems such as depression or hallucinations (seeing things or hearing voices that do not exist); lung disease such as asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); or kidney or liver disease. if you are having surgery, including dental surgery, tell the doctor or dentist that you are using buccal fentanyl. you should know that buccal fentanyl may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you. do not drink alcohol while you are using buccal fentanyl. Alcohol increases the chance that you will experience serious side effects of the medication. you should know that buccal fentanyl may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using buccal fentanyl. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. if you have diabetes, you should know that each fentanyl buccal lozenge contains about 2 grams of sugar. if you will be using the lozenges, talk to your dentist about the best way to care for your teeth during your treatment. The lozenges contain sugar and may cause tooth decay and other dental problems. you should know that buccal fentanyl may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.