In the U.S.—

• Analgesic

Fentanyl (FEN-ta-nil) belongs to the group of medicines called narcotic analgesics (nar-KOT-ik an-al-GEE-ziks). Narcotic analgesics are used to relieve pain. The transmucosal form of fentanyl is used to treat breakthrough cancer pain. Breakthrough episodes of cancer pain are the flares of pain which “breakthrough” the medication used to control the persistent pain. Transmucosal fentanyl is only used in patients who are already taking narcotic analgesics.

Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your health care professional will take this into consideration when deciding on the amount of transmucosal fentanyl you should receive.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Transmucosal (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For transmucosal fentanyl, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fentanyl, including the stick-on patch. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although studies on birth defects with fentanyl have not been done in pregnant women, it has not been reported to cause birth defects.

Breast-feeding—Fentanyl passes into breast milk. Nursing babies whose mothers are using this medicine regularly may receive enough of it to cause unwanted effects such as drowsiness or breathing problems. A mother who wishes to breast-feed and who needs treatment for continuing pain should discuss the risks and benefits of different pain treatments with her health care professional.

Children—Studies with transmucosal fentanyl have been done only in adult patients, and there is no specific information comparing use of transmucosal fentanyl in children with use in other age groups. It contains a medicine in an amount which can be fatal to a child. Patients and their caregivers should keep transmucosal fentanyl out of the reach of children and discard open units properly.

Older adults—Elderly people may be especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects during treatment. Your health care professional will take this into consideration when deciding on the amount of transmucosal fentanyl you should receive.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using transmucosal fentanyl, it is especially important that your health care professional know if you are taking any other dosage form of fentanyl (e.g., injection, patch) or nonprescription (over-the-counter [OTC] medicine) or any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicines that cause drowsiness), including other narcotics or
• Erythromycin (e.g., E-Mycin) or
• Itraconazole (e.g., Diflucan) or
• Ketoconazole (e.g., Nizoral) or
• Ritonavir (e.g., Norvir)—These medicines may add to the effects of transmucosal fentanyl. This may increase the chance of serious side effects.

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking transmucosal fentanyl while you are taking or within 2 weeks of taking MAO inhibitors may cause an increased chance of serious side effects

• Alcohol abuse or history of or
• Drug dependence, especially narcotic abuse or dependence, history of or
• Kidney disease or
• Liver disease—The chance of side effects may be increased
• Emphysema or other chronic lung disease or
• Head injuries—Some of the side effects of transmucosal fentanyl can cause serious problems in people who have these medical problems

• Slow heartbeat—Transmucosal fentanyl can make this condition worse

Transmucosal fentanyl contains a medicine in an amount which can be fatal to a child. Patients and their caregivers should keep transmucosal fentanyl out of the reach of children and discard open units properly.

Transmucosal fentanyl comes with patient instructions. Read them carefully before using the product.

How to use transmucosal fentanyl:
• Keep medication in sealed pouch until ready to use.
• The foil package should be opened with scissors immediately prior to product use.
• Place the medicine in mouth between the cheek and lower gum, occasionally moving the medicine from one side to the other using the handle.
• The medicine should be sucked, not chewed.
• Suck the medicine over a 15-minute period.

Dosing—

The dose of transmucosal fentanyl will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of transmucosal fentanyl. If your dose is different, do not change it unless your doctor tells you to do so.

The number of units that you use will depend on the strength of the medicine. Also, the number of doses you use each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using transmucosal fentanyl.

• For oral transmucosal dosage form :
  • For cancer pain:
    • Adults—The initial dose to treat episodes of breakthrough cancer pain in patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain is 200 micrograms.Redosing may start 15 minutes after the previous dose has been completed (30 minutes after the start of the previous dose). Patients should not use more than 2 units per episode of breakthrough pain. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted.
    • Children—Use and dose must be determined by the doctor.

Missed dose—

If your medical doctor has ordered you to use this medicine according to a regular schedule and you miss a dose, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
• Do not use if the foil pouch has been opened.
• A temporary storage bottle is provided as part of the Actiq ^® Welcome Kit. This container is to be used by patients or their caregivers in the event that a partially consumed unit cannot be disposed of promptly. If additional assistance is required, refer to 1-800-615-0187.

Transmucosal fentanyl contains a medicine in an amount which can be fatal to a child. Patients and their caregivers should keep transmucosal fentanyl out of the reach of children and discard open units properly.

Check with your health care professional at regular times while using fentanyl. Be sure to report any side effects.

Transmucosal fentanyl comes with patient instructions. Read them carefully before using the product.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your health care professional before taking any of the other medicines listed above while you are using this medicine.

Transmucosal fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your health care professional if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using narcotics for a long time can cause severe constipation. To prevent this, your health care professional may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using transmucosal fentanyl.

If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your health care professional. You may be directed to reduce gradually the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects.

Using too much transmucosal fentanyl, or taking too much of another narcotic while using transmucosal fentanyl, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin; low blood pressure; pinpoint pupils of eyes; and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Dizziness, feeling faint, lightheadedness, unusual tiredness or weakness;  shortness of breath 
  
  

• Less common
  • Anxiety;  confusion;  decrease in urine volume;  decreased frequency of urination;  drowsiness;  false sense of well-being;  nervousness;  seeing, hearing, or feeling things that are not there 
  
  

• Symptoms of overdose
  • Cold, clammy skin;  convulsions (seizures) ;  feeling faint;  pinpoint pupils of the eyes;  severe dizziness, drowsiness, nervousness, restlessness, or weakness;  slow or troubled breathing 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  dry mouth;  nausea and/or vomiting 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Diarrhea;  nausea and/or vomiting;  restlessness or irritability ;  speech disorder;  stomach cramps;  trouble in sleeping;  weakness 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.