Fentora

The oral transmucosal or buccal form of fentanyl is used to treat breakthrough cancer pain. Breakthrough episodes of cancer pain are the flares of pain which a€śbreaks througha€ť the medication used to control the persistent pain. Oral transmucosal or buccal 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 doctor will take this into consideration when deciding on the amount of oral transmucosal or buccal fentanyl you should receive.

This medicine is available only with your doctor`s prescription. Buccal fentanyl film is available only under a restricted distribution program called FOCUSA® Program .

This product is available in the following dosage forms:

• Tablet


• Lozenge/Troche


• Film

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of buccal fentanyl in children below 18 years of age, or oral transmucosal fentanyl in children below 16 years of age. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oral transmucosal or buccal fentanyl in the elderly. However, elderly patients may be more sensitive to the effects of narcotic analgesics than younger adults and are more likely to have age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving oral transmucosal or buccal fentanyl.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Adinazolam


• Alfentanil


• Alprazolam


• Alprenolol


• Amiodarone


• Amlodipine


• Amobarbital


• Amprenavir


• Anileridine


• Aprepitant


• Aprobarbital


• Atenolol


• Bepridil


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromazepam


• Brotizolam


• Bucindolol


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Carteolol


• Carvedilol


• Celiprolol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Clarithromycin


• Clobazam


• Clonazepam


• Clorazepate


• Clorgyline


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Diltiazem


• Erythromycin


• Esmolol


• Estazolam


• Ethchlorvynol


• Felodipine


• Fentanyl


• Fluconazole


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Fosamprenavir


• Fospropofol


• Furazolidone


• Halazepam


• Hydrocodone


• Hydromorphone


• Iproniazid


• Isocarboxazid


• Isradipine


• Itraconazole


• Ketazolam


• Ketoconazole


• Labetalol


• Levobunolol


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Mepindolol


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Metipranolol


• Metoprolol


• Midazolam


• Moclobemide


• Morphine


• Morphine Sulfate Liposome


• Nadolol


• Nalbuphine


• Nebivolol


• Nefazodone


• Nelfinavir


• Nialamide


• Nicardipine


• Nifedipine


• Nimodipine


• Nisoldipine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxprenolol


• Oxycodone


• Oxymorphone


• Pargyline


• Pazopanib


• Penbutolol


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Pindolol


• Prazepam


• Procarbazine


• Prochlorperazine


• Promazine


• Promethazine


• Propoxyphene


• Propranolol


• Quazepam


• Rasagiline


• Remifentanil


• Ritonavir


• Secobarbital


• Selegiline


• Sibutramine


• Sodium Oxybate


• Sotalol


• Sufentanil


• Talinolol


• Tapentadol


• Temazepam


• Tertatolol


• Thiethylperazine


• Thiopental


• Thioridazine


• Timolol


• Toloxatone


• Tranylcypromine


• Triazolam


• Trifluoperazine


• Troleandomycin


• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Azithromycin


• Carbamazepine


• Clotrimazole


• Dirithromycin


• Econazole


• Indinavir


• Josamycin


• Lopinavir


• Mepartricin


• Miconazole


• Miokamycin


• Nevirapine


• Phenytoin


• Rifampin


• Rokitamycin


• Roxithromycin


• Saquinavir


• Spiramycin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol


• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or


• Drug dependence, especially narcotic abuse or dependence, history ofa€”Dependence may be more likely to develop.

• Diabetesa€”Use with caution. Oral transmucosal fentanyl contains sugar .

• Emphysema or other chronic lung disease or


• Head injuriesa€”Use with caution. Some of the side effects of oral transmucosal or buccal fentanyl can cause serious problems in patients who have these medical problems .

• Hypotension (low blood pressure) or


• Mental illness or


• Seizures, history of or


• Slow heartbeat or other heart problemsa€”Oral transmucosal or buccal fentanyl can make these conditions worse.

• Kidney disease or


• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use

Oral transmucosal or buccal fentanyl comes with patient instructions. If you are switching from the oral transmucosal form of fentanyl to buccal form, make sure you read the patient instructions carefully. These forms are very different.

It is very important that you understand the requirements of the FOCUSA® program, and become familiar with the FOCUSA® educational materials and Medication Guide. Ask your doctor or pharmacist before starting buccal fentanyl film treatment .

How to use oral 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 .

How to use buccal fentanyl:

• Keep the medication in sealed pouch until ready to use.


• Remove the tablet from the blister unit just before product use. Do not push the tablet through the blister as this may cause damage to the tablet .


• Do not store the tablet after removing it from the blister package . It should be used immediately.


• Place the medicine in your mouth between the upper cheek and gum, above a back molar.


• Allow the tablet to dissolve. It usually takes around 14 to 25 minutes for the tablet to dissolve completely.


• Do not suck, chew, or swallow the tablet . If the tablet did not dissolve completely after 30 minutes, you may swallow it with a glass of water .

To use the buccal fentanyl film:

• The foil package should be opened with scissors immediately prior to product use.


• Separate the layers of the foil package and remove the film. Do not cut or tear the film.


• Use your tongue to wet the side of your cheek, or rinse your mouth with water to wet the area in your mouth where you will place the film.


• Hold the film in place on your clean, dry finger with the pink side facing up.


• Press the film against your cheek. Hold it there for 5 seconds.


• Leave the film in place until it dissolves. It usually dissolves within 15 to 30 minutes after you apply it. Do not touch or move the film while it dissolves.


• If your doctor tells you to use more than one film, place the new film on the other side of your mouth .


• Do not eat any food until the film dissolves. You may drink water or other liquids after 5 minutes.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take 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 the medicine.

• For cancer pain:
  
  
  
  • For buccal dosage form (film):
    
    
    
    • Adultsa€”At first, one 200 microgram (mcg) film during an episode of breakthrough cancer pain. Your doctor may increase your dose as needed. However, patients should not use this medicine for more than four 200 mcg film per episode of breakthrough pain a day.
    
    
    • Childrena€”Use and dose must be determined by the doctor .
    
    
    
    
  
  
  • For buccal dosage form (tablets):
    
    
    
    • Adultsa€”At first, 100 micrograms (mcg) during an episode of breakthrough cancer pain. Dosing may be repeated if pain is not relieved by a single dose . Redosing may start 30 minutes after taking this medicine and the same dosage strength should be used. Your doctor may increase your dose as needed. Patients should not use more than 4 tablets per episode of breakthrough pain. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their doctor to determine if a dosage adjustment is warranted.
    
    
    • Childrena€”Use and dose must be determined by the doctor .
    
    
    
    
  
  
  • For oral transmucosal dosage form (lozenge):
    
    
    
    • Adultsa€”At first, 200 micrograms (mcg) during an episode of breakthrough cancer pain. 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 doctors to determine if a dosage adjustment is warranted.
    
    
    • Childrena€”Use and dose must be determined by the doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not use if the foil pouch has been opened. A temporary storage bottle is provided as part of the ActiqA® 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.

Dispose of any unopened buccal fentanyl tablets that are no longer needed. To dispose, remove the buccal fentanyl tablets from the blister packages and flush down the toilet. Do not flush the blister packages or cartons down the toilet. If additional assistance is required, call 1-800-896-5855.

To dispose any unneeded buccal fentanyl film: remove the film from its foil package and flush down the toilet. Do not flush the foil packages or cartons down the toilet. If additional assistance is required, call 1-800-526-3840.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure that this medicine is working properly and to check you for any problems or unwanted effects that may be caused by this medicine.

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

Do not use buccal fentanyl film if you need pain medicine for just a short time, such as during a headache or migraine attack, or when recovering from surgery or an injury.

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 allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

Oral transmucosal or buccal 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 doctor 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 doctor 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 oral transmucosal or buccal 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 doctor . You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects.

Using too much oral transmucosal or buccal fentanyl, or taking too much of another narcotic while using oral transmucosal or buccal 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 the 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.

Check with your dentist at regular times while using fentanyl. This medicine contains sugar and may increase your chance for tooth decay or other trouble with your teeth or gums.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose . Call your doctor for instructions.

Do not use buccal fentanyl if you have taken a monoamine oxidase (MAOI) inhibitor (e.g., isocarboxazid [MarplanA®], phenelzine [NardilA®], selegiline [EldeprylA®], or tranylcypromine [ParnateA®]) in the past 2 weeks.

Do not take other medicines unless they have been discussed with your doctor . This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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 immediately if any of the following side effects occur:

More common

• Black, tarry, stools


• Blurred vision


• Chest pain


• Confusion


• Convulsions


• Cough


• Decreased urine


• Difficult or labored breathing


• Dizziness


• Dry mouth


• Fainting


• Fever or chills


• Increased thirst


• Irregular heartbeat


• Lightheadedness


• Loss of appetite


• Lower back or side pain


• Mood changes


• Muscle pain or cramps


• Nausea or vomiting


• Nervousness


• Numbness or tingling in the hands, feet, or lips


• Painful or difficult urination


• Pale skin


• Pounding in the ears


• Rapid breathing


• Shortness of breath


• Sneezing


• Sore throat


• Sunken eyes


• Swelling of the hands, ankles, feet, or lower legs


• Tightness in the chest


• Troubled breathing with exertion


• Ulcers, sores, or white spots in the mouth


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Wheezing


• Wrinkled skin

Less common

• Abdominal or stomach pain


• Change in walking and balance


• Clumsiness or unsteadiness


• Decreased awareness or responsiveness


• Decreased frequency of urination


• Headache


• Muscle twitching or jerking


• Pounding in the ears


• Rhythmic movement of the muscles


• Seeing, hearing, or feeling things that are not there


• Seizures


• Severe constipation


• Severe sleepiness


• Shakiness in the legs, arms, hands, or feet


• Slow or fast heartbeat


• Thinking abnormalities


• Trembling or shaking of the hands or feet

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Extremely shallow or slow breathing

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain


• Diarrhea


• Difficulty having a bowel movement (stool)


• Difficulty in moving


• Discouragement


• Feeling sad or empty


• Irritability


• Lack or loss of strength


• Loss of interest or pleasure


• Muscle stiffness


• Pain in the joints


• Sleepiness or unusual drowsiness


• Sleeplessness


• Tiredness


• Trouble concentrating


• Trouble sleeping


• Unable to sleep


• Weight loss

Less common

• Changes in vision


• Excessive muscle tone


• Feeling of constant movement of self or surroundings


• Feeling of warmth or heat


• Flushing or redness of the skin, especially on the face and neck


• Irritation, pain, or sores at the site of application


• Itching skin


• Muscle tension or tightness


• Rash


• Sensation of spinning


• Sweating

Incidence not known

• Tooth pain


• Trouble with gums


• Trouble with teeth

After you stop using this medicine, it may still produce some side effects that need attention . During this period of time, check with your doctor immediately if you notice the following side effects:

• Restlessness


• Speech disorder


• Stomach cramps


• Weakness

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.