Fentora Warnings and Precautions
Before taking Fentora, make sure to inform your healthcare provider of any health issues you may have, such as low blood pressure, kidney disease, or a history of drug or alcohol abuse. Also, it is important to know that this medication can be lethal in the case of an overdose. Warnings and precautions with Fentora also apply to women who are pregnant or breastfeeding.
What Should I Tell My Healthcare Provider?Talk with your healthcare provider prior to taking Fentora® (fentanyl buccal tablets) 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)
- Ever had breathing problems, asthma, chronic obstructive pulmonary disease (COPD), or any other lung disease
- A head injury, brain tumor, or increased pressure around the brain
- Ever had a seizure
- 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:
- Pregnant or thinking of becoming pregnant.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Specific Precautions and Warnings With FentoraSome warnings and precautions to be aware of prior to taking this pain medicine include the following:
- This medication should only be used in people who are already taking scheduled, around-the-clock opioids 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 death, from even small Fentora doses.
- Do not substitute Fentora for other medications that contain fentanyl. Substituting Fentora for another fentanyl product 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:
- 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.
- The amount of fentanyl in one Fentora tablet is enough to cause serious problems, including death, if taken by a child. Store this medication in a safe place, away from children (see Fentora Storage and Disposal for more information).
- Some people may experience mouth pain, irritation, or sores at the application site (the area of the mouth where the Fentora tablet is placed). These problems are more likely to occur when the medication is first started. Talk to your healthcare provider if you get any mouth irritation or sores while using this medication.
- Normally, you should not place more than one Fentora tablet in your mouth at a time, unless your healthcare provider is trying to find the best dose to treat your pain. Once an effective dose is established, use only one tablet at a time, and no more than two (30 minutes apart) for each breakthrough pain episode.
- Do not drink alcohol while using this medication. Consuming alcohol with Fentora could increase your risk for serious side effects, including extreme drowsiness, confusion, memory loss, or difficulty breathing.
- Fentora may cause serious problems, including death, if used in people for whom the medication was not prescribed. Do not share this medication with someone else, even if they seem to have the same symptoms as you.
- Fentora is a narcotic opioid medication with a significant potential for abuse (see Fentora Abuse). Do not take 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 Fentora abuse, please seek help from a healthcare provider.
- Like other narcotics, Fentora can cause physical dependence. This means that you might experience uncomfortable withdrawal symptoms if you suddenly stop taking the medication. If you no longer need to use Fentora, ask your healthcare provider how to slowly stop taking it, to reduce your chance of experiencing withdrawal symptoms (see Fentora Withdrawal for more information).
- Fentora can cause potentially life-threatening slow and irregular breathing (known medically as respiratory depression). Certain people have an increased risk for respiratory depression with Fentora, 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. It should only be used with extreme caution in such circumstances.
- Fentora 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 Fentora affects you. Fentora can make you extremely drowsy. Your reflexes and reaction times may be significantly altered, even if you feel fine.
- Fentora comes with a medication guide that describes the correct way to use it. Make sure to read this medication guide each time you get your prescription filled, as new information may be available.
- Fentora may interact with a number of other medications (see Fentora Drug Interactions for more information).
- Fentora passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Fentora and Breastfeeding).
- Fentora 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 Fentora and Pregnancy).