
What is Onsolis?
The buccal film that is soluble in Onsolis contains the drug fentanyl. It is one of the narcotic (opioid) painkillers. The drug Onsolis can be used for treating "breakthrough" cancer pain that cannot be controlled by other drugs. Onsolis is administered in conjunction with other non-fentanyl pain medications that are used all the time. The medication is not intended to treat pain that's not related to cancer, like general back pain or headaches. Onsolis is also employed for other purposes that are not covered in this guide to medication.
Warnings
Onsolis can only be purchased through specific programmes known as Fentora REMS or CUS. You have to be enrolled in the programme and acknowledge in the documents that you have read and understand the risks and benefits of this drug. Don't use Onsolis unless you're taking an opioid pain medication or if your body seems already tolerant of it. Consult your physician to determine if you're opioid-tolerant. The drug Onsolis can be used for treating "breakthrough" cancer pain. It is not meant to treat pain not related to cancer, like general back pain or headaches.
Don't take Onsolis if your previous use was an MAO inhibitor, such as furazolidone (Furoxone) or isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam, Zelapar), as well as tranylcypromine (Parnate) within the last 14 days. Before taking Onsolis, inform your doctor whether you suffer from a breathing disorder, brain tumour, injury to the head, seizures, mental illness, heart rhythm disorder, low blood pressure, kidney or liver problems, or a background of alcohol or drug dependence.
Make sure this medication is out of the reach of pets and children. There is a significant amount of fentanyl present in every Onsolis buccal film, which may prove fatal for the pet or child who has a mishap and swallows the drug. Get medical attention immediately when this occurs. Fentanyl can cause dependence and should only be used by the individual for whom it was prescribed. Do not give Onsolis to someone else, particularly someone who has a history of drug dependence or abuse. Place the medication in a location where others can't access it.
Similar/related drugs
Tramadol, Duloxetine, Oxycodone, Cymbalta, Percocet, Fentanyl, and Actiq
Before taking Onsolis
Don't use Onsolis unless you are taking an opioid pain medication and your body is already tolerant of it. Opioid medications consist of morphine (Kadian, MS Contin, and many others) and hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Consult your physician when you're not certain you're tolerant of opioids. Don't take Onsolis if you've previously taken an MAO inhibitor, such as furazolidone (Furoxone) or isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), and selegiline (Eldepryl, Emsam, Zelapar), as well as tranylcypromine (Parnate), in the past 14 days. A drug interaction that is dangerous could result in severe adverse and unwanted side effects.
To make sure that you can safely take Onsolis, consult your physician if you have any of these health conditions:
- A breathing disorder, such as chronic obstructive pulmonary disorder (COPD);
- A history of head trauma or a brain tumour
- A heart rhythm disorder
- Seizures or epilepsy;
- Mental illness, such as hallucinations or depression;
- Low blood pressure
- Kidney disease, liver failure, or
- A history of addiction to drugs or alcohol dependence.
Fentanyl can cause dependence and should only be taken by the person prescribed for it. Do not use Onsolis with anyone else or anyone with a history of dependence or abuse. Place the medication in a location where other people can't access it.
FDA classification of pregnancy C It isn't known whether the drug will cause harm to an unborn baby. Fentanyl could trigger withdrawal symptoms or addiction for a baby when the mother is taking the drug during pregnancy. Consult your physician if you are expecting or planning for pregnancy while taking Onsolis. Fentanyl could also cause withdrawal and addiction symptoms in nursing infants. Do not breastfeed during the time you take Onsolis.
How to take Onsolis?
Utilize Onsolis strictly as directed by your doctor. Never take fentanyl in higher quantities or for a longer period than your doctor has recommended. Follow the instructions on the label of your prescription. Inform your doctor if the medication isn't working or reducing the discomfort.
Make use of the tongue to moisten the inside of the cheek, or rinse your mouth with water to moisten the area that will be used for placing onsolis. The package should be opened before you use it. Put the entire Onsolis film close to the edge of your dry finger, with its pink face upwards, and then hold the film in the desired position. The pink side of the Onsolis film on the cheek's inside holds the film in place for five minutes. The Onsolis film will remain in place by itself following this time. Onsolis film shouldn't be ripped or cut prior to making use of it.
Onsolis film Onsolis film will disintegrate within 15–30 minutes following application. The film shouldn't be handled with fingers or the tongue, and eating food is not recommended until the film has completely disintegrated. It is possible to drink liquids within five minutes. If your doctor advises you to utilise multiple Onsolis films at a time for the treatment of your cancer that is causing you breakthrough pain, don't put the films over one another. Onsolis films can be placed on either side of your mouth. If you decide to switch from Actiq (a fentanyl transmucosal oral device) to Fentora (fentanyl buccal tablets) or Onsolis (fentanyl buccal soluble film), you will not receive the same dosage. Fentora and Onsolis are available at lower dosages than Actiq. Fentanyl dosage should also be adjusted when changing to onsolis as well as fentora.
If you are feeling sick, dizzy, or sleepy when the film remains inside your mouth, take the medicine into the toilet or sink and wash the mouth thoroughly with clean water to eliminate all pieces remaining of the film. Consult your physician for further instructions. If the pain doesn't disappear completely, try another film only if your physician has endorsed the procedure. Make sure you wait at least 2 hours to treat a painful episode using the Onsolis film. Contact your physician if you experience pain or discomfort that has a breakthrough more than four times in a day while taking this medication.
Don't stop taking Onsolis immediately after prolonged use, or you may experience painful withdrawal signs. Discuss with your physician how you can prevent withdrawal symptoms once you stop taking Onsolis. Make sure that this medicine is kept away from pets or children. Fentanyl is a poison that is present in every Onsolis film and can cause fatality to a pet or a child who accidentally inhales or swallows the film. Get medical attention immediately in the event of this. Keep Onsolis in a cool, dry place free of heat and moisture. Don't put it in the freezer. Keep the medicine in its original container until you're ready. Make a note of the quantity of medicine that you take from each bottle. Fentanyl is a substance of abuse, and you must be aware of any person who is using the medicine in a way that is not legal or without having a prescription.
Get rid of any unneeded Onsolis films by taking the aluminium packaging off before flushing them down the toilet. Disposing of medicines through flushing is recommended to minimise the chance of accidental overdoses that can cause death. This suggestion is for the smallest amount of drugs. The FDA, in conjunction with the manufacturer, has found this to be the best disposal method and presents the lowest risk to the health of people.
What happens if I miss the dose?
Because Onsolis is prescribed on a need-to-know basis, you're likely not to skip the dose. Don't take additional medicine to replace the missed dose.
What happens if I overdose?
For medical emergencies, seek emergency treatment, contact emergency medical attention, or call the Poison Help Line at 1-800-222-1222. An overdose of fentanyl can lead to death.
The signs of an overdose could include extreme dizziness or weakness, sharp pupils, cold and clammy skin, a weak pulse, weak breathing, and fainting (breathing might be stopped).
What should be avoided?
Don't use Onsolis in conjunction with other painkillers such as tranquilisers, sedatives, sleeping medications, relaxers for muscles, or other drugs that cause you to sleep or cause breathing to slow down. There are risks of adverse side effects. Onsolis could affect your reactions or thinking. Avoid operating machinery or driving until you understand how Onsolis can affect your thinking and reactions. Avoid drinking alcohol. It can cause increased drowsiness and breathing problems that are caused by onsolis.
Grapefruit juice and grapefruit may be in contact with Onsolis and could cause harmful adverse effects. Consider discussing the consumption of products made from grapefruit with your doctor.
Side effects of Onsolis
Contact a medical professional immediately. If you notice any of the following signs or warnings of an allergic reaction, such as hives, trouble breathing, or swelling of your lips, face, and tongue,
Stop taking Onsolis and consult your physician immediately if you experience an adverse reaction that is serious, like:
- Breathing that is shallow or weak;
- Pale skin and feeling lightheaded or short of breath; fast heart rate; difficulty concentrating or
- Experiencing extreme thirst or heat, feeling very thirsty or hot, not being able to urinate, excessive sweating, and dry and hot skin.
Less severe onsolis adverse effects could include:
- Nausea, vomiting, constipation;
- Dizziness, drowsiness;
- Headache;
- Fatigue or feeling weak;
- Swelling in your feet, hands, or feet;
- Sores or pain in the mouth in the area where the medicine was dispensed
This isn't a complete list of all the side effects. Other side effects could occur. Consult your physician to seek medical advice on the effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.
Interaction with other drug
Do not consume Onsolis along with any other pain medication, such as tranquillizers, sedatives, sleep drugs, muscle relaxers, or any other medication that may cause you to feel sleepy or reduce your breathing. Risky side effects could result.
Discuss with your doctor all other medicines you are taking, particularly:
- Dexamethasone (Cortastat, Dexasone, Solurex, dexpak);
- Imatinib (Gleevec);
- Isoniazid (for treatment of tuberculosis);
- John's Wort;
- An antibiotic like clarithromycin (Biaxin) or erythromycin (E.E.S., eryped, Ery-Tab, Erythrocin, Pediazole) or the drugs rifabutin (Mycobutin) and rifampin (Rifadin, Rifater, Rifamate) or rifapentine (Priftin) as well as telithromycin (Ketek);
- Antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
- An antidepressant, such as nefazodone
- Blood pressure or heart medication like the medication diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), as well as the drugs nifedipine (Nifedical, Procardia), quinidine (Quin-G), and verapamil (Calan, Covera, Isoptin, Verelan), and other medications;
- HIV medications such as atazanavir (Reyataz), delavirdine (Rescriptor), and Efavirenz (Sustiva, Atripla), Etravirine (Intelence), Nelfinavir (Viracept), Nevirapine (Viramune), or Saquinavir (Invirase), or the drug ritonavir (Norvir, Kaletra); or
- Seizure medications like carbamazepine (Carbatrol, Equetro, Tegretol) or felbamate (Felbatol), oxycarbazepine (Trileptal), phenytoin (Dilantin), and primidone (Mysoline).
This list isn't complete, and other medications could interfere with Onsolis. Inform your doctor about the medications you are taking. This includes prescriptions, over-the-counter vitamins, herbal products, and vitamin products. Do not begin any new medication without first talking to your physician.