Advanced Breast Cancer: Learn about treatment options.

Generic Name: fentanyl (Buccal mucosa route, Oromucosal route, Sublingual route)

FEN-ta-nil

Sublingual route(Spray)

Sublingual fentanyl is contraindicated in patients who are not opioid-tolerant and in the management of acute or postoperative pain. The concomitant use of sublingual fentanyl with any CYP3A4 inhibitor may cause potentially fatal respiratory depression. Sublingual fentanyl has substantial differences in the pharmacokinetic profile compared with other fentanyl containing products. When prescribing or dispensing, do not substitute with other fentanyl containing products on a mcg per mcg basis. Sublingual fentanyl has an abuse liability similar to other opioid analgesics and is only available through the TIRF REMS access program .

Buccal mucosa route(Film;Lozenge/Troche;Tablet)

Due to the risk of fatal respiratory depression, immediate-release transmucosal fentanyl is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Keep out of reach of children. Use with CYP3A4 inhibitors may cause fatal respiratory depression. When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product. When dispensing, do not substitute with any other fentanyl products. Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program .

Sublingual route(Tablet)

Due to the risk of fatal respiratory depression, immediate-release transmucosal fentanyl is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Keep out of reach of children. Use with CYP3A4 inhibitors may cause fatal respiratory depression. When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products. When dispensing, do not substitute with any other fentanyl products. Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program .

Commonly used brand name(s)

In the U.S.

  • Abstral
  • Actiq
  • Fentora
  • Onsolis
  • Subsys

Available Dosage Forms:

  • Spray
  • Tablet
  • Lozenge/Troche
  • Film

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Fentora

Fentanyl is used to treat severe pain in cancer patients. It is used for breakthrough cancer pain, which are flares of pain that “break through” after a routine pain medicine has been used. Fentanyl belongs to the group of medicines called narcotic analgesics. It 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 or cause mental or physical dependence. However, people who have continuous pain should not let the fear of dependence keep them from using narcotics to relieve 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. Withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before the medicine is stopped completely. Talk to your doctor about the benefits of this medicine and how to prevent withdrawal side effects.

Slideshow: Are You at Risk of Prescription Drug Addiction?

This medicine is available only with your doctor's prescription. The Abstral®, Actiq®, Fentora®, Onsolis®, and Subsys® products are only available under a restricted distribution program. You will have to read and sign papers that explain how the medicine is used when you pick up your prescription.

Before Using Fentora

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 fentanyl in children younger than 18 years of age for the Abstral®, Fentora®, Onsolis®, and Subsys® brands, and in children younger than 16 years of age for the Actiq® brand. 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 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 fentanyl.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with 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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Boceprevir
  • Cobicistat
  • Lopinavir
  • Mifepristone
  • Naltrexone
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Tipranavir

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.

  • Abiraterone Acetate
  • Alefacept
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amiodarone
  • Amitriptyline
  • Amlodipine
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Amprenavir
  • Anileridine
  • Aprepitant
  • Atorvastatin
  • Baclofen
  • Bicalutamide
  • Bromazepam
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Cilostazol
  • Cimetidine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Cocaine
  • Codeine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Darunavir
  • Delavirdine
  • Desipramine
  • Desogestrel
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Diacetylmorphine
  • Diazepam
  • Dienogest
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Doxepin
  • Doxylamine
  • Drospirenone
  • Duloxetine
  • Eletriptan
  • Enzalutamide
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Estazolam
  • Estradiol
  • Eszopiclone
  • Ethchlorvynol
  • Ethinyl Estradiol
  • Ethylmorphine
  • Ethynodiol
  • Etonogestrel
  • Fluconazole
  • Flumazenil
  • Flunitrazepam
  • Fluoxetine
  • Flurazepam
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Fospropofol
  • Frovatriptan
  • Furazolidone
  • Ginkgo Biloba
  • Goldenseal
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Imatinib
  • Imipramine
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Isoniazid
  • Itraconazole
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Levomilnacipran
  • Levonorgestrel
  • Levorphanol
  • Linezolid
  • Lithium
  • Lomitapide
  • Lorazepam
  • Lorcaserin
  • Meclizine
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Mestranol
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Miconazole
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Mitotane
  • Moclobemide
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Naratriptan
  • Nefazodone
  • Nialamide
  • Nicardipine
  • Nicomorphine
  • Nifedipine
  • Nilotinib
  • Nitrazepam
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Nortriptyline
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Ospemifene
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Pargyline
  • Paroxetine
  • Pazopanib
  • Pentazocine
  • Pentobarbital
  • Phenelzine
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Piritramide
  • Posaconazole
  • Prazepam
  • Primidone
  • Procarbazine
  • Promethazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Ramelteon
  • Ranitidine
  • Ranolazine
  • Rasagiline
  • Regorafenib
  • Remifentanil
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rizatriptan
  • Secobarbital
  • Selegiline
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sumatriptan
  • Tapentadol
  • Telithromycin
  • Temazepam
  • Thiopental
  • Thioridazine
  • Ticagrelor
  • Tilidine
  • Tizanidine
  • Toloxatone
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Troleandomycin
  • Tryptophan
  • Valproic Acid
  • Venlafaxine
  • Verapamil
  • Voriconazole
  • Vortioxetine
  • Zaleplon
  • Zileuton
  • Zolmitriptan
  • Zolpidem
  • Zopiclone

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.

  • Azithromycin
  • Clotrimazole
  • Dirithromycin
  • Econazole
  • Josamycin
  • Mepartricin
  • Miokamycin
  • Nevirapine
  • Perampanel
  • Rokitamycin
  • Roxithromycin
  • Spiramycin

Interactions with Food/Tobacco/Alcohol

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, history of—Physical or mental dependence may be more likely to develop.
  • Bradyarrhythmia (slow heart rhythm)—Use with caution. May make this condition worse.
  • Brain tumor, history of or
  • Breathing problems (eg, asthma, wheezing) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Head injury, history of—May cause side effects to become worse.
  • Diabetes—Use the Actiq® brand with caution. There are 2 grams of sugar in each unit.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of fentanyl

This section provides information on the proper use of a number of products that contain fentanyl. It may not be specific to Fentora. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

The Abstral®, Actiq®, Fentora®, Onsolis®, and Subsys® products are only available under a restricted distribution program. You will have to read and sign papers that explain how the medicine is used when you pick up your prescription.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

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

Keep the medicine in the original blister package. Open the package right before use.

Abstral® tablets:

  • Place the tablet under the tongue until it dissolves. Do not chew, suck, or swallow the tablet.
  • Do not eat or drink anything until the tablet has dissolved. If your mouth is dry, use water to rinse the mouth before you place the tablet under the tongue.

Actiq® lozenges:

  • Place the lozenge in the mouth between the cheek and lower gum. Using the handle, move the lozenge from one side to the other every now and then.
  • Suck the medicine for 15 minutes and do not chew it.

Fentora® buccal tablets:

  • Peel the blister back to remove the tablet. Do not push the tablet through the blister as this may damage the tablet.
  • Place the tablet between the upper cheek and gum, above a back molar, until it dissolves. Do not chew, suck, or swallow the tablet.
  • If the tablet does not dissolve completely after 30 minutes, you may swallow it with a glass of water.

Onsolis® buccal film:

  • Use your tongue to wet the side of your cheek or rinse your mouth with water in the area where you will place the film.
  • Do not cut or tear the film. Hold the film on a clean, dry finger with the pink side facing up.
  • Press the film against your cheek and hold it there for 5 seconds.
  • Leave the film in place until it dissolves and do not touch or move the film. Do not chew or swallow the film.
  • If you must use more than one film, place the second 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.

Subsys® sublingual spray:

  • Carefully spray the medicine under your tongue.
  • Hold the medicine under your tongue for 30 to 60 seconds. Do not rinse your mouth and do not spit out any medicine.

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):
      • Adults—At first, one 200 microgram (mcg) film for each pain episode. Your doctor may adjust your dose as needed. However, the maximum number of pain episodes that can be treated each day is 4.
      • Children—Use and dose must be determined by your doctor.
    • For buccal dosage form (tablets):
      • Adults—At first, 100 micrograms (mcg) for each pain episode. If instructed by your doctor, this dose may be repeated after waiting 30 minutes between doses. Your doctor may adjust your dose as needed. However, the maximum number of pain episodes that can be treated each day is 4.
      • Children—Use and dose must be determined by your doctor.
    • For transmucosal dosage form (lozenges):
      • Adults—At first, 200 micrograms (mcg) for each pain episode. If instructed by your doctor, this dose may be repeated after waiting 15 minutes between doses. Your doctor may adjust your dose as needed. However, the maximum number of units that can be used each day is 4.
      • Children—Use and dose must be determined by your doctor.
    • For sublingual dosage form (spray):
      • Adults—At first, 100 micrograms (mcg) or 1 spray for each pain episode. If instructed by your doctor, this dose may be repeated once after waiting 30 minutes. Additional pain episodes may be treated after a minimum of 4 hours.
      • Children—Use and dose must be determined by your doctor.
    • For sublingual dosage form (tablets):
      • Adults—At first, 100 micrograms (mcg) for each pain episode. If instructed by your doctor, this dose may be repeated after waiting 30 minutes between doses. Your doctor may adjust your dose as needed. However, the maximum number of pain episodes that can be treated each day is 4.
      • Children—Use and dose must be determined by your doctor.

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.

Abstral® tablets: Dispose of any unopened tablets that are not needed. Remove the tablets from the blister package and flush them down the toilet. Do not flush the blister package or carton down the toilet. If you have questions, call 1-888-227-8725.

Actiq® lozenges: Place used handles in the temporary storage bottle from the Actiq® Child Safety Kit and empty the bottle each day. To dispose of the lozenge end of the handle, hold it over the toilet and cut it off with wire-cutting pliers. Flush the toilet twice. Throw the handle away in a place that is out of the reach of children. Use the same process to dispose of any unopened lozenges, but only flush 5 lozenges at a time. Do not flush the entire lozenge unit, the handle, or the blister package down the toilet. If you have questions, call 1-800-896-5855.

Fentora® tablets: Dispose of any unopened tablets that are not needed. Remove the tablets from the blister package and flush them down the toilet. Do not flush the blister package or carton down the toilet. If you have questions, call 1-800-896-5855.

Onsolis® film: Dispose of any unopened film that is not needed. Remove the film from the foil package and flush it down the toilet. Do not flush the foil package or carton down the toilet. If you have questions, call 1-800-526-3840.

Subsys® spray: Place the used spray unit into a disposal bag. Seal the disposal bag and throw it into a trash container that is out of the reach of children. For the unopened spray units, use the disposal bottle to empty the liquid from each unit. Place the disposal bottle in a bag and seal it. Throw the bag into a trash container that is out of the reach of children. If you have questions, call 1-877-978-2797.

Precautions While Using Fentora

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Fentanyl is a medicine that can harm or cause death to a child. Patients and caregivers should keep this medicine out of the reach of children. Carefully dispose of any partially used units or unused medicine properly.

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 this medicine for minor aches and pains (eg, headaches, migraines) or after surgery or injuries.

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 medicines listed above while you are using this medicine.

Fentanyl may cause some people to become drowsy, confused, or dizzy. 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. Check with your doctor if you have confusion or drowsiness that is severe enough to interfere with your daily activities.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may tell you to take laxatives, drink fluids, or increase the amount of fiber in your diet. Follow the directions carefully. Constipation that continues can lead to more serious problems.

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

Using too much fentanyl, or taking too much of another narcotic with 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 each minute) and drowsiness that is so severe you are not able to answer when spoken to, or if asleep, cannot be awakened.

The Actiq® product contains sugar and may increase your chance for tooth decay. Schedule regular dentist visits if you are using Actiq®.

Do not use this medicine if you have taken a monoamine oxidase (MAOI) inhibitor (eg, isocarboxazid phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate®) 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 (eg, St. John's wort) or vitamin supplements.

Fentora 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
  • 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
  • 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 with 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
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • 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.

See also: Side effects (in more detail)

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