Onsolis buccal soluble film contains fentanyl, a narcotic (opioid) pain medicine.

Onsolis is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Onsolis is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Onsolis may also be used for purposes not listed in this medication guide.

Onsolis is available only under special programs called Fentora REMS or the FOCUS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Do not use Onsolis unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Onsolis is used to treat "breakthrough" cancer pain. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Do not use Onsolis if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using Onsolis, tell your doctor if you have a breathing disorder, a head injury or brain tumor, seizures, mental illness, a heart rhythm disorder, low blood pressure, liver or kidney disease, or a history of drug or alcohol addiction.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each Onsolis buccal film can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens. Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share Onsolis with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Use Onsolis exactly as prescribed. Never use fentanyl in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Use the tongue to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of Onsolis. Open the package immediately prior to use. Place the entire Onsolis film near the tip of a dry finger with the pink side facing up and hold in place. Place the pink side of the Onsolis film against the inside of the cheek. Press and hold the film in place for 5 seconds. The Onsolis film should stay in place on its own after this period.

Onsolis film should not be cut or torn before using.

The Onsolis film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or fingers and eating food should be avoided until the film has dissolved. You may drink liquids after 5 minutes.

If your doctor tells you to use more than one Onsolis film at the same time for your breakthrough cancer pain, do not put the films on top of each other. Onsolis films may be placed on either side of your mouth.

If you switch from using Actiq (fentanyl oral transmucosal devices) to using Fentora (fentanyl buccal tablets) or Onsolis (fentanyl buccal soluble film), you will not use the same dose. Fentora and Onsolis are given at lower doses than Actiq. Fentanyl dosage must also be adjusted if switching between Onsolis and Fentora.

If you feel dizzy, nauseated, or very sleepy while the film is still in your mouth, spit the medicine out into a sink or toilet and rinse your mouth with water to remove all remaining pieces of the film. Call your doctor for instructions.

If your pain does not completely go away, use a second film only if your doctor has approved it.

Wait at least 2 hours to treat a new pain episode with Onsolis film.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine.

Do not stop using Onsolis suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Onsolis. Keep this medicine out of the reach of children or pets. The amount of fentanyl in each Onsolis film can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Store Onsolis at room temperature away from moisture and heat. Do not freeze. Keep the medicine its original package until you are ready to take your dose. Keep track of the amount of medicine used from each new bottle. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Throw away unused Onsolis films by removing them from the foil packaging and flushing them down a toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety

Do not use Onsolis unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, and others), hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant. Do not use Onsolis if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take Onsolis, tell your doctor if you have any of these other conditions:

• a breathing disorder such as chronic obstructive pulmonary disease (COPD);

• a history of head injury or brain tumor;

• a heart rhythm disorder;

• seizures or epilepsy;

• mental illness such as depression, hallucinations;

• low blood pressure;

• liver or kidney disease; or

• a history of drug or alcohol addiction.

Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share Onsolis with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether Onsolis will harm an unborn baby. Fentanyl may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using Onsolis. Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while you are using Onsolis.

Since Onsolis is used on an as needed basis, you are not likely to miss a dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal.

Overdose symptoms may include extreme weakness or dizziness, pinpoint pupils, cold and clammy skin, weak pulse, fainting, slow breathing (breathing may stop).

Do not use Onsolis with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Onsolis may impair your thinking or reactions. Avoid driving or operating machinery until you know how Onsolis will affect you. Do not drink alcohol. It can increase drowsiness or breathing problems caused by Onsolis.

Grapefruit and grapefruit juice may interact with Onsolis and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction to Onsolis: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Onsolis and call your doctor at once if you have a serious side effect such as:

• weak or shallow breathing;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious Onsolis side effects may include:

• nausea, vomiting, constipation;

• dizziness, drowsiness;

• headache;

• feeling weak or tired;

• swelling in your hands or feet; or

• pain or mouth sores where the medicine was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not take Onsolis with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

• dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• St. John's wort;

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

• antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

• an antidepressant such as nefazodone;

• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with Onsolis. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.