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 if you have or have ever had depression or another mental illness. 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 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.
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.
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 (Abstral, Fentora) 30 minutes after you started using the first tablet. Do not use a second lozenge or tablet to treat the same episode of pain unless your doctor tells you that you should. If you are using fentanyl film (Onsolis), you should not use a second dose to treat the same episode of pain. After you treat an episode of pain using 1 or 2 doses of fentanyl as directed, you must wait at least 2 hours after using fentanyl (Abstral or Onsolis) or 4 hours after using fentanyl (Actiq or Fentora) before treating another episode of breakthrough cancer pain.
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 if you are taking any of the following medications: amiodarone (Nexterone, Pacerone); certain antibiotics such as clarithromycin (Biaxin, in PrevPac), erythromycin (Erythocin), telithromycin (Ketek), and troleandomycin (TAO) (not available in the US); certain antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); aprepitant (Emend); benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); cimetidine (Tagamet); diltiazem (Cardizem, Taztia, Tiazac, others); certain medications for human immunodeficiency virus (HIV) such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); medications for mental illness and nausea; muscle relaxants; nefazodone; sedatives; sleeping pills; tranquilizers; or verapamil (Calan, Covera, Verelan). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use fentanyl with any of these 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 four 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.
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 ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using this medication.
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 comes as a lozenge on a handle (Actiq), a sublingual (underneath the tongue) tablet (Abstral), a film (Onsolis), and a buccal (between the gum and cheek) tablet (Fentora) 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 30 minutes after using fentanyl films (Onsolis), your doctor may tell you to use another pain medication to relieve that pain, and may increase your dose of fentanyl films (Onsolis) to treat your next episode of 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.
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. Your doctor may need to adjust the dose of your other pain medication(s) to better control your pain.
Swallow the buccal tablet whole; do not split, chew, or crush. Also do not chew or bite the lozenge on a handle; only suck on this medication as directed.
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:
To use fentanyl buccal tablets (Fentora), follow these steps:
To use fentanyl sublingual tablets (Abstral), follow these steps:
To use fentanyl films (Onsolis), follow these steps:
This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.
Before using fentanyl,
Do not eat grapefruit or drink grapefruit juice while using this medication.
This medication is usually used as needed according to directions.
Fentanyl may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
If you experience any of these symptoms, stop using fentanyl and call your doctor immediately or get emergency medical treatment:
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 ( Web Site) or by phone (1-800-332-1088).
Keep this medication in the packaging it came in, tightly closed, and out of reach of children. 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 or films 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. Web Site
In case of overdose, remove the fentanyl from the victim's mouth and call local emergency services at 911.
While using fentanyl, you may be told to always have a rescue medication called naloxone 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. You will probably be unable to treat yourself if you experience an opiate overdose. You should make sure that your family members, caregivers, or the people who spend time with you know how to tell if you are experiencing 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 someone sees that you are experiencing symptoms of an overdose, he or she should give you your 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:
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.