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Precautions and Warnings With Fentanyl Buccal Soluble Film

You may not be able to safely use fentanyl buccal soluble film if you have certain medical conditions, such as low blood pressure, lung disease, or kidney problems. Other precautions and warnings with fentanyl buccal soluble film include the danger of becoming addicted to the medication, the safety of using it when pregnant or breastfeeding, and potential drug interactions.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to using fentanyl buccal soluble film (Onsolis™) if you have:
  • A history of drug or alcohol dependence or abuse
  • Liver disease, such as cirrhosis, liver failure, or hepatitis
  • Kidney disease, such as kidney failure (renal failure)
  • A history of breathing problems, asthma, chronic obstructive pulmonary disease (COPD), or any other lung disease
  • A head injury, brain tumor, or increased pressure around the brain
  • A history of seizures
  • A slow heart rate or other heart problems
  • Low blood pressure (hypotension)
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
Make sure to tell your healthcare provider about any medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Fentanyl Buccal Soluble Film Precautions and Warnings

Some warnings and precautions to be aware of prior to using fentanyl buccal soluble film include the following:
  • This medication should only be used in people who are already taking other opioid narcotics and are tolerant to their effects, which means the body has gotten used to the opioid. People who are not opioid tolerant may experience life-threatening breathing problems, or even death, from using this medication.
  • Because it has a high risk for abuse and overdose, this medication is only available through a special program called the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program. You, your healthcare provider, and your pharmacy must be enrolled in the program before you can receive this medication. Your healthcare provider and pharmacy will help you enroll in the program. For inpatient use (such as within a hospital), only the pharmacy (not the prescriber or the patient) needs to be enrolled. 
  • Do not substitute fentanyl buccal soluble film for other medications that contain fentanyl. Doing this could result in an overdose, as the doses used in these medications are not the same. Other products that contain fentanyl include but are not limited to:
  • Fentanyl buccal soluble film can be dangerous, and may even cause death, if taken by a child. Keep this medication out of the reach of children at all times (see Onsolis Storage and Disposal for more information).
  • Do not share this medication with anyone, even if they seem to have the same symptoms as you. Sharing fentanyl buccal soluble film is against the law and may cause serious problems, including death, in people for whom it was not prescribed.
  • Do not drink alcohol while using this medication. Consuming alcohol with fentanyl buccal soluble film could increase your risk for serious side effects, including extreme drowsiness, confusion, memory loss, or difficulty breathing.
  • Fentanyl buccal soluble film is a narcotic opioid medication with a high abuse potential (see Onsolis Abuse). Do not use the drug more frequently or at a higher dose than prescribed. Store it in a safe place to prevent theft. If you think you may be developing a problem with abusing fentanyl buccal soluble film, please seek help from a healthcare provider.
  • Like other narcotics, fentanyl buccal soluble film can cause physical dependence. This means you might experience uncomfortable withdrawal symptoms if you suddenly stop using it. If you no longer need to use this pain medicine, ask your healthcare provider how to slowly stop treatment to reduce your chance of experiencing withdrawal symptoms (see Onsolis Withdrawal for more information).
  • Like all opioids, fentanyl buccal soluble film can cause life-threatening breathing problems (called "respiratory depression"). People who have respiratory depression may take slow and shallow breaths, or deep breaths separated by long pauses. Certain people may have an increased risk for respiratory depression with this pain medication, including:
    • Older adults
    • People who already have breathing difficulties
    • People who are not tolerant to opioids
    • People who are taking certain other medications.
  • This medication may be particularly dangerous for people with head injuries or high intracranial pressure (pressure around the brain). It should only be used with extreme caution in these people.
  • Fentanyl buccal soluble film can cause a slow heart rate (bradycardia) and should be used with caution in people who already have a very slow heart rate.
  • Do not drive or operate heavy machinery until you know how fentanyl buccal soluble film will affect you. This medication can make you extremely drowsy. Your reflexes and reaction times may be significantly altered, even if you feel fine.
  • This medication comes with a guide that explains in detail the correct way to use it. Make sure to read this guide each time you get your prescription filled, as new information may be available.
  • Fentanyl buccal soluble film passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Onsolis and Breastfeeding).
  • Fentanyl buccal soluble film is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Onsolis and Pregnancy).
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Fentanyl Buccal Soluble Film Information

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