Onsolis Soluble FilmGeneric Name: Fentanyl
Onsolis Soluble Film is only for breakthrough pain caused by cancer in certain patients who are already using and are tolerant to around-the-clock narcotic pain medicine. Onsolis Soluble Film may cause severe, sometimes life-threatening, breathing problems in patients who are not already using other narcotic medicines. Do not use Onsolis Soluble Film for short-term pain (including headache, migraine, or dental pain) or for pain that occurs after surgery. Keep Onsolis Soluble Film out of the reach of children. Onsolis Soluble Film can be harmful, and even fatal, to a child.
Onsolis Soluble Film is used for:
Managing breakthrough pain in certain cancer patients who are already using and are tolerant to around-the-clock narcotic pain medicines.
Onsolis Soluble Film is a narcotic (opioid) analgesic. It works in the brain to decrease pain.
Do NOT use Onsolis Soluble Film if:
- you are allergic to any ingredient in Onsolis Soluble Film or to any similar medicine (eg, sufentanil)
- you have not been taking other narcotic pain medicines (eg, morphine, codeine) on a regular schedule
- you have mild or short-term pain, including dental pain or pain from injuries, surgery, headache, or migraine
- you have diarrhea caused by food poisoning
- you are taking sibutramine or sodium oxybate (GHB)
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Onsolis Soluble Film:
Some medical conditions may interact with Onsolis Soluble Film. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of mental or mood problems (eg, depression, hallucinations) or suicidal thoughts or actions
- if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or a recent head injury
- if you or a family member has a history of alcohol, narcotic, or other substance abuse or dependence
- if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, diabetes, heart problems (eg, slow or irregular heartbeat, ventricle problems), low blood pressure, liver or kidney problems, inflammation in the mouth, an enlarged prostate, stomach or bowel problems (eg, recent stomach surgery, inflammatory bowel disease, chronic constipation, severe diarrhea), an underactive thyroid, or seizures
- if you have been very ill, have a fever, or have had a recent surgery
Some MEDICINES MAY INTERACT with Onsolis Soluble Film. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiodarone, antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam, midazolam), calcium channel blockers (eg, diltiazem, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolides (eg, erythromycin, clarithromycin), MAOIs (eg, phenelzine), nefazodone, nelfinavir, phenothiazines (eg, chlorpromazine), skeletal muscle relaxants (eg, cyclobenzaprine), sodium oxybate (GHB), or troleandomycin because they may increase the risk of Onsolis Soluble Film's side effects, including serious breathing problems, severe lightheadedness or dizziness, or severe drowsiness
- Serotonin reuptake blockers (eg, fluoxetine) or sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma may occur
- Mixed agonist/antagonist analgesics (eg, pentazocine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease Onsolis Soluble Film's effectiveness and withdrawal symptoms may occur
- Rifampin because it may decrease Onsolis Soluble Film's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Onsolis Soluble Film may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine
How to use Onsolis Soluble Film:
Use Onsolis Soluble Film as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Onsolis Soluble Film comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Onsolis Soluble Film refilled.
- Do not substitute Onsolis Soluble Film for any other fentanyl product.
- Do not use Onsolis Soluble Film if the foil pack is damaged in any way.
- Do not chew or swallow the film whole. Do not try to cut or tear the film in half.
- Do not remove the film from the foil package until you are ready to take Onsolis Soluble Film. Make sure that your hands are dry when you open the foil package.
- Using scissors, cut along the arrows of the foil package. Separate the layers of the foil package and remove the film. Take the film right away after opening the foil package. Do not store the removed film for future use.
- Moisten the inside of your cheek. Place the film inside your mouth with the pink side against the inside of your moistened cheek. With your finger, press and hold the film against your cheek for 5 seconds. Leave the film in place and allow it to dissolve.
- Onsolis Soluble Film usually takes 15 to 30 minutes to dissolve. Do not touch or move the film while it dissolves. You may drink liquids after 5 minutes. Do not eat any food until after the film dissolves.
- If your doctor tells you to use more than one film at the same time, place a film on either side of the mouth. Do not place the films on top of each other.
- Single doses of Onsolis Soluble Film should be separated by at least 2 hours.
- Check with your doctor before including grapefruit or grapefruit juice in your diet while you use Onsolis Soluble Film.
- If Onsolis Soluble Film is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Onsolis Soluble Film properly.
- If you miss a dose of Onsolis Soluble Film and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Onsolis Soluble Film.
Important safety information:
- Onsolis Soluble Film may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Onsolis Soluble Film with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Onsolis Soluble Film; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Onsolis Soluble Film may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Constipation is a common side effect of Onsolis Soluble Film. Talk with your doctor about dietary changes or using laxatives or stool softeners to prevent or treat constipation while you use Onsolis Soluble Film.
- Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop taking Onsolis Soluble Film without checking with your doctor.
- Tell your doctor or dentist that you take Onsolis Soluble Film before you receive any medical or dental care, emergency care, or surgery.
- Contact your doctor if your pain is not relieved or if it worsens after you use Onsolis Soluble Film. Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider how your pain is responding to Onsolis Soluble Film so that your dose can be adjusted if needed.
- If Onsolis Soluble Film is no longer needed, dispose of it as soon as possible. If you have questions about how to dispose of Onsolis Soluble Film properly, check with your doctor or other health care provider.
- Diabetes patients - Onsolis Soluble Film may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Use Onsolis Soluble Film with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, stomach pain, constipation, and vomiting.
- Onsolis Soluble Film can be harmful, even fatal, if used in CHILDREN. Keep Onsolis Soluble Film out of the reach of children.
- Use Onsolis Soluble Film with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Onsolis Soluble Film may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Onsolis Soluble Film while you are pregnant. Onsolis Soluble Film is found in breast milk. Do not breast-feed while taking Onsolis Soluble Film.
When used for long periods of time or at high doses, Onsolis Soluble Film may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Onsolis Soluble Film stops working well. Do not take more than prescribed.
When used for longer than a few weeks or at high doses, some people develop a need to continue taking Onsolis Soluble Film. This is known as DEPENDENCE or addiction.
If you suddenly stop taking Onsolis Soluble Film, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
Possible side effects of Onsolis Soluble Film:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; mouth pain or irritation; nausea; numbness or tingling at the site where the film is used; stomach pain; vomiting; weakness or tiredness; weight loss.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes (eg, depression); mouth sores, ulcers, bleeding, or inflammation; numbness or tingling in the hands, legs, or feet; severe drowsiness; severe dry eyes, mouth, or skin; severe or persistent dizziness; shortness of breath; slowed breathing; swelling of the hands, feet, or ankles; trouble sleeping; unusual bruising or bleeding; unusual or severe weakness or tiredness; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; pinpoint pupils; severe drowsiness or dizziness; slow or shallow breathing; very slow or weak heartbeat.Proper storage of Onsolis Soluble Film:
Store Onsolis Soluble Film between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original package, away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Do not use if the foil pouch has been opened. Keep Onsolis Soluble Film out of the reach of children and away from pets.
- If you have any questions about Onsolis Soluble Film, please talk with your doctor, pharmacist, or other health care provider.
- Onsolis Soluble Film is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Onsolis Soluble Film. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.