New Content Directory South Carolina: Actiq

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

FEN-ta-nil SIT-rate

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 .

Commonly used brand name(s)

In the U.S.

Actiq

Fentora

Onsolis

Available Dosage Forms:

Tablet

Lozenge/Troche

Film

Therapeutic Class: Analgesic

Chemical Class: Fentanyl

Uses For Actiq

Fentanyl belongs to the group of medicines called narcotic analgesics, which are medicines used to relieve pain. 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 “breaks through” 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 FOCUS® Program.

Before Using Actiq

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

	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.

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.

Adinazolam

Alfentanil

Alprazolam

Amiodarone

Amobarbital

Amprenavir

Anileridine

Aprepitant

Aprobarbital

Bromazepam

Brotizolam

Buprenorphine

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Citalopram

Clarithromycin

Clobazam

Clonazepam

Clorazepate

Clorgyline

Codeine

Crizotinib

Dantrolene

Dezocine

Diazepam

Diltiazem

Erythromycin

Estazolam

Ethchlorvynol

Fentanyl

Fluconazole

Flunitrazepam

Fluphenazine

Flurazepam

Fosamprenavir

Fospropofol

Furazolidone

Halazepam

Hydrocodone

Hydromorphone

Imatinib

Iproniazid

Isocarboxazid

Itraconazole

Ketazolam

Ketoconazole

Levorphanol

Linezolid

Lopinavir

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Moclobemide

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nefazodone

Nelfinavir

Nialamide

Nicardipine

Nifedipine

Nitrazepam

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pargyline

Paroxetine

Pazopanib

Pentazocine

Pentobarbital

Perphenazine

Phenelzine

Phenobarbital

Prazepam

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propoxyphene

Quazepam

Ranolazine

Rasagiline

Remifentanil

Ritonavir

Secobarbital

Selegiline

Sertraline

Sibutramine

Sodium Oxybate

Sufentanil

Tapentadol

Temazepam

Thiethylperazine

Thiopental

Thioridazine

Toloxatone

Tranylcypromine

Triazolam

Trifluoperazine

Troleandomycin

Vemurafenib

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

Mepartricin

Miconazole

Miokamycin

Nevirapine

Phenytoin

Rifampin

Rokitamycin

Roxithromycin

Saquinavir

Spiramycin

Voriconazole

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

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 Actiq. Please read with care.

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 FOCUS® program, and become familiar with the FOCUS® 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):
  - Adults—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.
  - Children—Use and dose must be determined by the doctor.
- For buccal dosage form (tablets):
  - Adults—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.
  - Children—Use and dose must be determined by the doctor.
- For oral transmucosal dosage form (lozenge):
  - Adults—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.
  - Children—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 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.

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 While Using Actiq

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 [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [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 or vitamin supplements.

Actiq 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.

See also: Actiq side effects (in more detail)

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More Actiq resources

Actiq Side Effects (in more detail)
Actiq Use in Pregnancy & Breastfeeding
Actiq Drug Interactions
Actiq Support Group
10 Reviews for Actiq - Add your own review/rating

Actiq Prescribing Information (FDA)

Actiq Lozenge MedFacts Consumer Leaflet (Wolters Kluwer)

Actiq Consumer Overview

Abstral Consumer Overview

Abstral MedFacts Consumer Leaflet (Wolters Kluwer)

Duragesic Prescribing Information (FDA)

Duragesic Patch MedFacts Consumer Leaflet (Wolters Kluwer)

Duragesic Consumer Overview

Fentanyl MedFacts Consumer Leaflet (Wolters Kluwer)

Fentanyl Citrate Monograph (AHFS DI)

Fentora Consumer Overview

Fentora Prescribing Information (FDA)

Fentora MedFacts Consumer Leaflet (Wolters Kluwer)

Ionsys Prescribing Information (FDA)

Ionsys Consumer Overview

Lazanda Spray MedFacts Consumer Leaflet (Wolters Kluwer)

Lazanda Consumer Overview

Onsolis Prescribing Information (FDA)

Onsolis Soluble Film MedFacts Consumer Leaflet (Wolters Kluwer)

Onsolis Consumer Overview

Sublimaze Prescribing Information (FDA)

Subsys Consumer Overview

Compare Actiq with other medications

Breakthrough Pain
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New Content Directory South Carolina

Friday, October 7, 2016

Actiq