Fentanyl, Transmucosal

What are other names for this medicine?

Type of medicine: narcotic analgesic (painkiller)

Generic and brand names: fentanyl, transmucosal; Actiq; Fentora

What is this medicine used for?

This medicine is used to treat breakthrough pain in adults with cancer. This medicine is prescribed only for people who take other narcotic pain medicines on a regular schedule. You must not take this medicine if your body is not used to narcotic pain medicines.

It comes in the form of a lozenge on a handle, or as a tablet that dissolves between your teeth and cheek.

What should my healthcare provider know before I take this medicine?

Before using this medicine, tell your healthcare provider if you have:

• an allergic reaction to any medicine
• a head injury or brain tumor
• breathing problems or a lung disease such as asthma or COPD
• dental disease
• diabetes (The lozenge form of this medicine contains sugar.)
• heart disease
• intestinal disease or severe diarrhea or constipation
• kidney or liver disease
• mental problems such as depression or hallucinations (seeing or hearing things that are not there)
• pancreatitis or biliary tract disease
• problems with drug or alcohol abuse
• seizures
• thyroid problems

Tell your provider if you have taken never narcotic pain medicines before. This medicine is to be used only by those who have taken narcotic painkillers before.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Use this medicine exactly as your healthcare provider prescribes. Using too much of this medicine can be dangerous. Your healthcare provider will adjust your dosage until the lowest effective dosage is determined. Do not stop taking this medicine without your healthcare provider's approval. You may have to gradually reduce your dosage.

Check the label on the medicine for directions about your specific dose. Read the instructions that come in the package with the medicine. The lozenge and tablet forms are absorbed in different ways by your body, so you cannot just switch one form for the other.

Keep the medicine in the sealed child-proof package until you are ready to use it. This medicine is very strong and may be fatal to children.

Carefully open the blister package right before you use it.

If you have the lozenge, place the medicine in your mouth between your cheek and gum and gently suck. You may move the medicine from one side of your mouth to the other while it dissolves. Twirl the handle often. Do not chew, break, or crush the lozenge. Let the medicine dissolve over a 15-minute period. Do not swallow any of the white plastic.

If you have the tablet, place the tablet toward the back your mouth between the upper cheek and gum. Let it dissolve slowly over 15 to 25 minutes. Do not chew, break, or crush the tablet. If there are small pieces of the tablet remaining after 30 minutes, you may swallow them with a glass of water.

Do not eat or drink anything while the medicine is dissolving.

If you have breakthrough pain more than 4 times a day, talk with your healthcare provider. You may need to have your pain medicine(s) adjusted to better control your pain.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: trouble breathing or shallow breathing, tiredness, extreme drowsiness, lightheadedness, dizziness, confusion, trouble thinking, trouble talking or walking.

What should I watch out for?

This drug is only for people who have taken narcotic painkillers before. It is a controlled substance. It is illegal for you to give it to anyone else. Only healthcare providers experienced with this drug should prescribe it. This is a very strong medicine used only to control cancer pain.

This medicine may be habit-forming. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine will increase the chances of side effects. Contact your healthcare provider if your pain does not improve in a few days or if it gets worse.

This medicine may cause serious or life-threatening breathing problems, especially during the first few days. If you have any trouble breathing, contact your healthcare provider right away. If you are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help.

This medicine is very strong and may be fatal to children. Be very careful to keep this medicine out of reach of children. Never leave unused or partly used medicine where children or pets can get to it. Keep this medicine out of the reach of children and discard properly. See the disposal instructions that come in the medicine package.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicine unless your healthcare provider approves.

Your mouth may get dry. Drinking plenty of water, chewing sugarless gum, or sucking on hard sugarless candy may help to relieve dry mouth symptoms.

The lozenge form of this medicine contains sugar. It may increase the risk of dental cavities with frequent use. Have regular dental check-ups.

This medicine may make you constipated. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing).

Serious (report these to your healthcare provider right away): Fast or slow heartbeat; cold, clammy skin; blue lips, fingernails, or skin; slow or trouble breathing; hallucinations (seeing or hearing things that are not there); seizures; feeling faint; pinpoint pupils of the eyes; severe confusion, drowsiness, nervousness, restlessness, or weakness.

Other: Dizziness, nausea, vomiting, blurred vision, headache, flushing, sweating, constipation, trouble urinating, dry mouth, mouth sores, mouth pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), triazolam (Halcion), temazepam (Restoril), flurazepam (Dalmane), and oxazepam
• antidepressants such as sertraline (Zoloft), fluoxetine (Prozac), citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil), nefazodone, venlafaxine (Effexor), fluvoxamine, amitriptyline, nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), desipramine (Norpramin), and doxepin (Sinequan)
• antifungals such as fluconazole (Diflucan), itraconazole (Diflucan), and ketoconazole (Nizoral)
• antihistamines or medicine for hay fever, allergies, or colds such as diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), brompheniramine (Dimetane), and hydroxyzine (Atarax, Vistaril)
• anti-HIV medicines such as ritonavir (Norvir), saquinavir (Invirase), nelfinavir (Viracept), amprenavir (Agenerase), fosamprenavir (Lexiva), and indinavir (Crixivan)
• antinausea medicines such as aprepitant (Emend), prochlorperazine (Compazine), and promethazine (Phenergan)
• antipsychotic medicines such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine, thioridazine, haloperidol (Haldol), clozapine (Clozaril), risperidone (Risperdal), olanzapine (Zyprexa), and trifluoperazine (Stelazine)
• antiseizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), primidone (Mysoline), fosphenytoin (Cerebyx), ethotoin (Peganone), gabapentin (Neurontin), felbamate (Felbatol), lamotrigine (Lamictal), levetiracetam (Keppra), topiramate (Topamax), oxcarbazepine (Trileptal), tiagabine (Gabitril), and valproic acid (Depakote, Depakene, Depacon)
• barbiturates such as phenobarbital, butabarbital (Butisol), and pentobarbital (Nembutal)
• heart medicines such as amiodarone (Cordarone; Pacerone), diltiazem (Cardizem, Dilacor, Tiamate, Tiazac), quinidine (quinidine sulfate, quinidine gluconate), and verapamil (Calan, Covera, Isoptin)
• herbs with sedative effects such as kava, gotu kola, valerian, and St. John's wort
• antibiotics such as clarithromycin (Biaxin), azithromycin (Zithromax), rifampin (Rifadin), and erythromycin (Ery-Tabs, E.E.S., E-Mycin)
• MAO inhibitors such as phenelzine (Nardil), procarbazine (Matulane), selegiline (Eldepryl), and tranylcypromine (Parnate) (Do not take an MAO inhibitor and this medicine within 14 days of each other.)
• medicines that block or may partially block the effect of other narcotics such as naltrexone (ReVia), buprenorphine (Buprenex, Subutex), butorphanol (Stadol), nalbuphine (Nubain), and pentazocine (Talwin)
• muscle relaxants such as cyclobenzaprine (Flexeril), baclofen (Lioresal), carisoprodol (Soma), tizanidine (Zanaflex), methocarbamol (Robaxin), and dantrium sodium (Dantrium)
• other pain medicines such as codeine, hydrocodone (Vicodin, Lortab), oxycodone (Percocet, Tylox, OxyContin), morphine (MS Contin, Oramorph SR, Kadian, MSIR), propoxyphene (Darvocet N-100), pentazocine (Talwin) methadone (Dolophine), hydromorphone (Dilaudid), meperidine (Demerol), and fentanyl patch (Duragesic)
• sibutramine (Meridia)
• sleeping pills such as zolpidem (Ambien), zaleplon (Sonata), and chloral hydrate

Do not drink alcohol while you are taking this medicine.

The effects of this medicine may be increased if you take it with grapefruit or grapefruit juice. Talk with your healthcare provider about this.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Keep the medicine in the sealed child-proof pouch or blister card until you are ready to use it. Store it at room temperature. Protect from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.