Fentanyl Oral Transmucosal (patient information)

IMPORTANT WARNING

Fentanyl oral transmucosal may cause serious or life-threatening breathing difficulties, which can cause death, especially if not used properly. Fentanyl oral transmucosal should be used only for breakthrough (flare-up) cancer pain that occurs during treatment with a regularly scheduled narcotic (opiate) analgesic for chronic cancer pain. Fentanyl oral transmucosal should not be used to treat short-term pain, including pain from an injury or pain after an operation or medical or dental procedure. Fentanyl oral transmucosal should be used only for people who have already received regularly scheduled narcotic pain medication for at least a week and are narcotic-tolerant. If you are unsure if you are narcotic-tolerant, ask your doctor. Tell your doctor if you have or have ever had breathing difficulties, chronic obstructive pulmonary disease (COPD), or other lung disease. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications or those listed in the SPECIAL PRECAUTIONS section below: amiodarone (Cordarone, Pacerone); aprepitant (Emend); certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend); chloral hydrate; cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); cyclosporine (Neoral, Sandimmune); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E.E.S., E-Mycin, Erythrocin); general anesthetics; haloperidol (Haldol); hormonal contraceptives (birth control pills, rings, implants, injections, and patches); lovastatin (Advicor, Altocor, Mevacor); medications for anxiety, depression, or mental illness; medications to control cough, cold, or allergies;medications to control nausea or vomiting; medications to treat HIV/AIDS;muscle relaxants; other narcotic pain medications; nefazodone; phenobarbital; sedatives, sleeping pills, or tranquilizers; troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); or zafirlukast (Accolate). Alcohol will add to the drowsiness caused by fentanyl oral transmucosal. Talk to your doctor about drinking alcohol while using fentanyl oral transmucosal. If you have any of the following symptoms, stop using fentanyl oral transmucosal and call your doctor immediately: slow, shallow breathing; extreme drowsiness with slow breathing; difficulty thinking, talking, or walking normally; dizziness; confusion; extreme tiredness; fainting; difficulty awakening; or loss of consciousness.

Fentanyl oral transmucosal contains an amount of narcotic pain medication that can be harmful or fatal to a child. Keep fentanyl oral transmucosal out of the reach of children. Fentanyl oral transmucosal should not be used in children and adolescents younger than 16 years old. Fentanyl oral transmucosal must be stored in a locked storage space. Child-resistant cabinet locks, a temporary storage bottle, and a portable locking pouch (fanny pack) are available from the manufacturer. Ask your doctor to help you obtain these items. Never leave unused or partially used fentanyl oral transmucosal units where children or pets can get to them. Partially used fentanyl oral transmucosal medication units contain enough medication to be harmful or fatal to a child or other adults who have not been prescribed fentanyl. To keep this medication away from children and pets, used or unused medication units must be placed in a child-resistant storage bottle available from the manufacturer until it can be completely destroyed in the sink or toilet, as described below. Carefully read all the child safety warnings contained in the manufacturer's information for the patient.

Talk to your doctor about the risks using this medication.

Why this medication is prescribed

Fentanyl oral transmucosal is used to treat breakthrough pain (flare ups) that is uncontrolled by a regularly prescribed narcotic pain medication in people with chronic cancer pain. Fentanyl oral transmucosal is in a class of medications called narcotic (opioid) analgesics. It works to treat pain by changing the way the brain and nervous system respond to pain.

How this medication should be used

Fentanyl oral transmucosal comes as a solid dosage unit on a handle to place in the mouth between the cheek and gum. Let this medication dissolve over 15 minutes by sucking on the unit and moving it to each side of the mouth. Pain relief should begin to occur in about 15 minutes after using the medication unit. Finishing the medication too quickly or over a longer period of time will cause less pain relief. Do not eat or drink anything while using fentanyl oral transmucosal. Fentanyl oral transmucosal should be used in addition to a regularly prescribed cancer pain medication as directed by your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use fentanyl oral transmucosal exactly as directed. Do not use more of it or use it more often than prescribed by your doctor.

Do not bite or chew fentanyl oral transmucosal.

Your doctor will probably start you on a low dose of fentanyl oral transmucosal and gradually increase your dose to find the dose that will relieve your breakthrough pain. If pain is not relieved, your doctor may allow you to use a second medication unit during the same episode of breakthrough pain. Do not use a second fentanyl oral transmucosal unit unless your doctor tells you that you may. A second dose may be used 15 minutes after the previous dose has been completed (a total of at least 30 minutes from the time the previous dose was started). Call your doctor if two doses of fentanyl oral transmucosal do not control your breakthrough pain; do not use more than two doses in a single pain episode. Keep a record of fentanyl oral transmucosal use over several episodes of breakthrough pain, and tell the doctor how well this medication is relieving your pain. When you and your doctor find a dose that controls your pain, call your doctor if you need to use fentanyl oral transmucosal more than four times a day.

Fentanyl oral transmucosal is used on an as-needed basis to control breakthrough pain. It may take some time to find the appropriate dose and frequency of use for fentanyl oral transmucosal. Do not stop taking your regularly prescribed narcotic pain medication while using fentanyl oral transmucosal.

Fentanyl oral transmucosal may be habit-forming. Do not use a larger dose of fentanyl oral transmucosal, use it more often, or use it for a longer period of time than prescribed by your doctor. Tell your doctor if you or your family drink or have ever drunk large amounts of alcohol, have overused narcotic pain medications, have used street drugs, or have or have ever had depression or mental illness. Call your doctor if you begin to use more medication than you have been prescribed, or if you begin "craving" this medication.

If you suddenly stop using fentanyl oral transmucosal while taking doses on a regular basis, you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, tearing from your eyes, runny nose, yawning, sweating, chills, feeling that your hair stands on end, muscle aches, large pupils (black circles in the center of the eyes), irritability, anxiety, backache, pain in the joints, weakness, stomach cramps, difficulty falling asleep or staying asleep, upset stomach, loss of appetite, vomiting, diarrhea, fast heartbeat or rapid breathing.

To use fentanyl oral transmucosal:

1. Check the blister package and the handle of the fentanyl oral transmucosal unit to make sure the unit contains the dose of medication you have been prescribed.
2. Use scissors to cut open the blister package containing fentanyl oral transmucosal, and remove the medication unit. Do not use the medication unit if the blister package has been damaged or opened before you are ready to use it, or if the medication is expired. If the medication is expired or damaged, call your pharmacist.
3. Place fentanyl oral transmucosal in your mouth, between your cheek and lower gum, and actively suck on the medication unit. Move the unit around in your mouth, from one side to the other, using the handle. Twirl the handle often.
4. Finish the fentanyl oral transmucosal in about 15 minutes.
5. If you begin to feel dizzy or sick to your stomach before you have finished the medication, 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 are not finishing the entire medication unit each time you use it, call your doctor, to see if future doses may need to be decreased.

Follow these directions to dispose of fentanyl oral transmucosal:

1. If the medication is completely used (dissolved), throw the handle away in a place that is out of the reach of children or pets.
2. If the handle is not totally clean and there is some medication remaining, place the handle under hot running water until the medication is gone. Then throw away the handle as previously directed.
3. If the handle is not totally clean and you cannot immediately dissolve the medication as described in Step 2, put the medication unit in the temporary storage bottle you received from the manufacturer. Push the medication unit into the opening on top of the storage bottle until it falls completely into the bottle.
4. Empty the temporary storage bottle of any handles and partially used medication units at least once a day, following the steps above.
5. Do not flush entire unused medication units, handles, or blister packages down the toilet.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and ask them any questions you may have about the safe use of fentanyl oral transmucosal.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special Precautions

Before using fentanyl oral transmucosal:

• tell your doctor and pharmacist if you are allergic to fentanyl, other narcotic pain medications, any other medications, or any of the ingredients in fentanyl oral transmucosal. Ask your pharmacist for a list of the ingredients.
• 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: buprenorphine (Buprenex, Subutex, Suboxone); butorphanol (Stadol); carbamazepine (Carbatrol, Epitol, Tegretol); dexamethasone (Decadron, Dexpak); griseofulvin (Fulvicin, Grifulvin, Gris-PEG); nalbuphine (Nubain); naloxone (Narcan);pentazocine (Talwin); phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate). Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Carbex, Eldepryl), 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 have or have ever had any of the conditions listed in the IMPORTANT WARNING section or a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; loss of consciousness; seizures; slowed heart beat; prostate problems or any other condition that causes difficulty urinating; or kidney or liver disease.
• do not use fentanyl oral transmucosal if you are pregnant or plan to become pregnant. If you become pregnant while using fentanyl oral transmucosal, call your doctor. Do not breast-feed while using fentanyl oral transmucosal.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fentanyl oral transmucosal.
• you should know that fentanyl oral transmucosal may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that fentanyl oral transmucosal 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 this medication. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

Special dietary instructions

Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medication.

What to do if you forget a dose

This medication is usually used as needed. If your doctor has told you to use fentanyl oral transmucosal regularly, and you have forgotten to use a dose, use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Fentanyl oral transmucosal may cause side effects, especially during the beginning of treatment. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• upset stomach
• vomiting
• constipation
• difficulty urinating
• weakness
• headache
• dizziness
• changes in vision
• anxiety
• nervousness
• depression
• elevated mood
• seeing or hearing voices that do not really exist (hallucinating)
• difficulty falling asleep or staying asleep
• decreased alertness
• dry mouth
• dental cavities
• loss of teeth
• gum disease
• sweating
• shaking hands you cannot control
• abnormal muscle contractions

Fentanyl oral transmucosal contains sugar. Dry mouth is associated with the use of narcotic medications and may also add to the risk of dental cavities or tooth decay when using this medication. You should see your dentist regularly to ensure proper dental care while using fentanyl oral transmucosal.

Severe Side Effects

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• heart beat that is slower or faster than normal
• fainting
• seizures
• hives
• rash
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

Fentanyl oral transmucosal 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/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the blister package it came in, tightly closed, and out of reach of children. Store fentanyl oral transmucosal in a place that is secured with the child-resistant lock provided by the manufacturer. You may keep a small supply of fentanyl oral transmucosal in the portable locking pouch (fanny pack) provided by the manufacturer so that it is nearby for your immediate use. Keep this pouch secured with its lock and out of the reach and sight of children. Store fentanyl oral transmucosal at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate or freeze fentanyl oral transmucosal, or store it inside a car.

If you are no longer using fentanyl oral transmucosal, if you have changed to a different dose unit, or if you have unused fentanyl oral transmucosal in your home, follow these steps to dispose of the medication as soon as possible:

Remove all unneeded fentanyl oral transmucosal from the locked storage space. Using scissors, remove one fentanyl oral transmucosal unit from its blister package. Hold it by its handle over the toilet bowl. Using wire-cutting pliers, cut the medicine end off the unit so that it falls into the toilet bowl. Throw away the empty medication unit handle in a place that is out of the reach of children. Repeat Steps 1- 4 for each fentanyl oral transmucosal unit. Flush the toilet twice after 5 medication units have been cut and dropped into the toilet bowl. Do not flush more than 5 medication units at a time. If you need help disposing of fentanyl oral transmucosal that is no longer needed, call your pharmacist or your local Drug Enforcement Administration (DEA) office.

Store fentanyl oral transmucosal in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many medication units are left so you will know if any are missing.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

If an overdose is suspected, the medication unit should be removed from the person's mouth immediately and disposed of properly. If the person is asleep, call their name and shake their arm or shoulder to keep them awake. Contact the numbers listed above for emergency care. Once the emergency situation is taken care of, call the doctor to find out if future doses of fentanyl oral transmucosal should be at a lower dose.

Symptoms of overdose may include:

• drowsiness
• itching, especially around the nose and eyes
• dizziness
• upset stomach
• vomiting
• slowed breathing or stopped breathing

Other information

Keep all appointments with your doctor.

Fentanyl oral transmucosal contains narcotic pain medication. Do not let anyone else use your medication. Selling or giving away this medication is against the law.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

Brand names

• Actiq