Fentanyl

IMPORTANT WARNING:

Fentanyl may be habit forming, especially with prolonged use. Use fentanyl exactly as directed. Do not use a larger dose of fentanyl, use the medication more often, or use it for a longer period of time than prescribed by your doctor. While using fentanyl, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had mental problems such as depression, schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), or hallucinations (seeing things or hearing voices that do not exist). There is a greater risk that you will overuse fentanyl if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Fentanyl may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take fentanyl. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Fentanyl should only be prescribed by doctors who are experienced in treating pain in cancer patients. It should be used only to treat breakthrough cancer pain (sudden episodes of pain that occur despite around-the-clock treatment with pain medication) in cancer patients at least 18 years of age (or at least 16 years of age if using Actiq brand lozenges) who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. This medication should not be used to treat pain other than chronic cancer pain, especially short-term pain such as migraines or other headaches, pain from an injury, or pain after a medical or dental procedure. Fentanyl may cause serious breathing problems or death if it is used by people who are not being treated with other narcotic medications or who are not tolerant to narcotic medications.

Fentanyl may cause serious harm or death if used accidentally by a child or by an adult who has not been prescribed the medication. Even partially used fentanyl may contain enough medication to cause serious harm or death to children or other adults. Keep fentanyl out of reach of children, and if you are using the lozenges, ask your doctor how to obtain a kit from the manufacturer containing child safety locks and other supplies to prevent children from getting the medication. Dispose of partially used lozenges according to the manufacturer's directions immediately after you remove them from your mouth. If fentanyl is used by a child or an adult who has not been prescribed the medication, try to remove the medication from the person's mouth and get emergency medical help.

Taking certain medications with fentanyl may increase the risk that you will develop serious or life-threatening breathing problems, sedation, or coma. Tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use fentanyl with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Fentanyl comes as two different transmucosal products and several other types of products. The medication in each product is absorbed differently by the body, so one product cannot be substituted for any other fentanyl product. If you are switching from one product to another, your doctor will prescribe a dose that is best for you.

A program has been set up for each fentanyl product to decrease the risk of using the medication. Your doctor will need to enroll in the program in order to prescribe fentanyl and you will need to have your prescription filled at a pharmacy that is enrolled in the program. As part of the program, your doctor will talk with you about the risks and benefits of using fentanyl and about how to safely use, store, and dispose of the medication. After you talk with your doctor, you will sign a form acknowledging that you understand the risks of using fentanyl and that you will follow your doctor's instructions to use the medication safely. Your doctor will give you more information about the program and how to get your medication and will answer any questions you have about the program and your treatment with fentanyl.

Tell your doctor if you are pregnant or plan to become pregnant. If you use fentanyl regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fentanyl and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/drugs/drugsafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using this medication.

WHY is this medicine prescribed?

Fentanyl is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients at least 18 years of age (or at least 16 years of age if using Actiq brand lozenges) who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) analgesics. It works by changing the way the brain and nervous system respond to pain.

Fentanyl should be used along with your other pain medication(s). Do not stop taking your other pain medication(s) when you begin your treatment with fentanyl. If you stop taking your other pain medication(s) you will need to stop using fentanyl.

Are there OTHER USES for this medicine?

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Fentanyl comes as a lozenge on a handle, a sublingual (underneath the tongue) tablet, and a buccal (between the gum and cheek) tablet to dissolve in the mouth. Fentanyl is used as needed to treat breakthrough pain but not more often than four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Your doctor will probably start you on a low dose of fentanyl and gradually increase your dose until you find the dose that will relieve your breakthrough pain. If you still have pain after using one lozenge or tablet, your doctor may tell you to use a second lozenge or tablet. You may use the second lozenge (Actiq) 15 minutes after you finish the first lozenge, or use the second tablet (Fentora) 30 minutes after you started using the first tablet. After you treat an episode of pain using 1 or 2 doses of fentanyl as directed, you must wait at least 4 hours after using fentanyl lozenge or tablet before treating another episode of breakthrough cancer pain. Talk to your doctor about how well the medication is working and whether you are experiencing any side effects so that your doctor can decide whether your dose should be adjusted. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with oxycodone. Do not take more of it or take it more often than prescribed by your doctor.

Do not use fentanyl more than four times a day. Call your doctor if you experience more than four episodes of breakthrough pain per day or if you have new pain or an increased sensitivity to pain during your treatment with fentanyl. Your doctor may need to adjust the dose of your other pain medication(s) to better control your pain.

Do not stop using fentanyl without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop using fentanyl, you may experience unpleasant withdrawal symptoms.

To use fentanyl lozenges (Actiq), follow these steps:

1. Check the blister package and the handle of the lozenge to make sure the lozenge contains the dose of medication you have been prescribed.
2. Use scissors to cut open the blister package and remove the lozenge. Do not open the blister package until you are ready to use the medication.
3. Place the lozenge in your mouth, between your cheek and gum. Actively suck on the lozenge, but do not chew, crush, or bite it. Move the lozenge around in your mouth, from one side to the other, using the handle. Twirl the handle often.
4. Do not eat or drink anything while the lozenge is in your mouth.
5. Finish the lozenge in about 15 minutes.
6. If you begin to feel dizzy, very sleepy, or nauseated before you have finished the lozenge, remove it from your mouth. Dispose of it immediately as described below or put it in the temporary storage bottle for later disposal.
7. If you finish the entire lozenge, throw the handle away in a garbage can that is out of the reach of children. If you did not finish the entire lozenge, hold the handle under hot running water to dissolve all the medication, and then throw the handle away in a garbage can that is out of the reach of children and pets.

To use fentanyl sublingual and buccal tablets, follow these steps:

1. Separate one blister unit from the blister card by tearing along the perforations. Peel back the foil to open the blister unit. Do not try to push the tablet through the foil. Do not open the blister unit until you are ready to use the tablet.
2. Place the tablet in your mouth above one of your upper back teeth between your cheek and your gum or under your tongue as far back as you can.
3. Leave the tablet in place until it dissolves completely. It may take 14 to 25 minutes for the tablet to dissolve. Do not split, chew, bite, or suck the tablet; do not swallow the tablet whole.
4. If any of the tablet is left in your mouth after 30 minutes, swallow it with a drink of water.
5. If you begin to feel dizzy, very sleepy, or nauseated before the tablet dissolves, rinse your mouth with water and spit the remaining pieces of tablet into the sink or toilet. Flush the toilet or rinse the sink to wash away the tablet pieces.

What SPECIAL PRECAUTIONS should I follow?

Before using fentanyl,

• tell your doctor and pharmacist if you are allergic to fentanyl, any other medications, or any of the ingredients in fentanyl tablets or lozenges. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).

• The following nonprescription or herbal products may interact with fentanyl: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using fentanyl. Do not start these medications while using fentanyl without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use fentanyl.

• tell your doctor if you have or have ever had seizures; slowed heartbeat or other heart problems; low blood pressure; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); problems urinating; diabetes; or pancreas, gallbladder, thyroid, kidney or liver disease.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are using fentanyl. Fentanyl can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using fentanyl.

• you should know that fentanyl may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that fentanyl may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using fentanyl. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• if you have diabetes, you should know that each fentanyl lozenge (Actiq) contains about 2 grams of sugar.

• if you will be using the lozenges (Actiq), talk to your dentist about the best way to care for your teeth during your treatment. The lozenges contain sugar and may cause tooth decay and other dental problems.

• you should know that fentanyl may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medication.

What should I do IF I FORGET to take a dose?

This medication is usually used as needed according to directions.

What SIDE EFFECTS can this medicine cause?

Fentanyl may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• headache
• stomach pain
• gas
• heartburn
• weight loss
• difficulty urinating
• changes in vision
• anxiety
• depression
• unusual thinking
• unusual dreams
• difficulty falling asleep or staying asleep
• dry mouth
• sudden reddening of the face, neck, or upper chest
• uncontrollable shaking of a part of the body
• back pain
• pain, sores, or irritation in the mouth in the area where you placed the medication
• swelling of the hands, arms, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• changes in heartbeat
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination,or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• seizures
• rash; hives; itching; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat
• changes in heartbeat
• chest pain
• extreme drowsiness

Fentanyl may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the packaging it came in, tightly closed, and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store fentanyl in a safe place so that no one else can use it accidentally or on purpose. Use the child-resistant locks and other supplies provided by the manufacturer to keep children away from the lozenges. Keep track of how much fentanyl is left so you will know if any is missing. Store fentanyl at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze fentanyl.

You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program.. If you do not have a take-back program nearby or one that you can access promptly, then flush the fentanyl down the toilet so that others will not take it. Dispose of unneeded lozenges by removing each lozenge from the blister package, holding the lozenge over the toilet, and cutting off the medicine end with wire cutters so that it falls into the toilet. Throw away the remaining handles in a place that is out of the reach of children and pets, and flush the toilet twice when it contains up to five lozenges. Dispose of unneeded tablets by removing them from the packaging and flushing them down the toilet. Throw the remaining fentanyl packaging or cartons into a trash container; do not flush these items down the toilet. Call your pharmacist or the manufacturer if you have questions or need help disposing of unneeded medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, remove the fentanyl from the victim's mouth and call local emergency services at 911.

While using fentanyl, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to tell recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• excessive drowsiness or sleepiness
• slow or shallow breathing
• difficulty breathing
• cold, clammy skin
• narrowing or widening of the pupils (black circles in the middle of the eyes)
• unable to respond or wake up
• slowed heartbeat
• unusual snoring

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication, even if he or she has the same symptoms that you have. Selling or giving away this medication may cause severe harm or death to others and is against the law.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.