"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Onsolis Patient Information Including Side Effects
Brand Names: Fentora, Onsolis
Generic Name: fentanyl (buccal) (Pronunciation: FEN ta nil (BUK al))
- What is fentanyl buccal (Onsolis)?
- What are the possible side effects of fentanyl buccal (Onsolis)?
- What is the most important information I should know about fentanyl buccal (Onsolis)?
- What should I discuss with my healthcare provider before using fentanyl buccal (Onsolis)?
- How should I use fentanyl buccal (Onsolis)?
- What happens if I miss a dose (Onsolis)?
- What happens if I overdose (Onsolis)?
- What should I avoid while using fentanyl buccal (Onsolis)?
- What other drugs will affect fentanyl buccal (Onsolis)?
- Where can I get more information?
What is fentanyl buccal (Onsolis)?
Fentanyl is a narcotic (opioid) pain medicine.
Fentanyl buccal is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Fentanyl buccal 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.
Fentanyl buccal may also be used for purposes not listed in this medication guide.
What are the possible side effects of fentanyl buccal (Onsolis)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using fentanyl 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 side effects may include:
- nausea, vomiting, constipation;
- dizziness, drowsiness;
- 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.
Read the Onsolis (fentanyl buccal soluble film) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about fentanyl buccal (Onsolis)?
Fentanyl buccal 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 fentanyl 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.
Fentanyl buccal tablets are 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 fentanyl buccal 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 fentanyl buccal, 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 fentanyl buccal tablet 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 fentanyl 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.
Additional Onsolis Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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