Why is this medication 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 should this medicine 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:

• 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.
• 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.
• 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.
• Finish the fentanyl oral transmucosal in about 15 minutes.
• 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:

• If the medication is completely used (dissolved), throw the handle away in a place that is out of the reach of children or pets.
• 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.
• 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.
• Empty the temporary storage bottle of any handles and partially used medication units at least once a day, following the steps above.
• 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.

What storage conditions are needed for this medicine?  

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

What other information should I know?  

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.

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