Two options for FENTORA administration: between the upper cheek and gum
(buccal cavity) and beneath the tongue (sublingual cavity)1
Your doctor will determine an appropriate dose using buccal administration, after
FENTORA can be used buccally or sublingually.
When starting treatment, FENTORA should always be placed in the buccal cavity,
above the rear molar, between the upper cheek and gum. Switch sides of your mouth
for each dose.
Once your doctor determines your maintenance dose, you may have the option of taking
FENTORA sublingually. Place the tablet under your tongue and let it dissolve.
For more information on how to take FENTORA
, talk to your doctor and click
to see the Medication Guide.
IMPORTANT SAFETY INFORMATION
Do not use FENTORA® (fentanyl buccal tablet) CII unless you are regularly using another opioid pain medicine around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines (this means you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.
Keep FENTORA in a safe place away from children.
Get emergency help right away if:
- a child takes FENTORA. FENTORA can cause an overdose and death in any child who takes it.
- an adult who has not been prescribed FENTORA uses it.
- an adult who is not already taking opioids around-the-clock, uses FENTORA.
These are medical emergencies that can cause death. If possible, try to remove FENTORA from the mouth.
Important information about FENTORA:
- Get emergency help right away if you take too much FENTORA (overdose). When you first start taking FENTORA, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur.
- Taking FENTORA with other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death.
- Never give anyone else your FENTORA. They could die from taking it. Store FENTORA away from children and in a safe place to prevent stealing or abuse. Selling or giving away FENTORA is against the law.
- If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using FENTORA. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
- FENTORA is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive FENTORA, you must:
- - talk to your healthcare provider
- - understand the benefits and risks of FENTORA
- - agree to all of the instructions
- - sign the Patient-Prescriber Agreement form
- FENTORA is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your FENTORA prescription filled.
- Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressant medicines, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers.
- Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Do not take FENTORA if:
- You are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for at least one week or longer for your cancer pain, and your body is used to these medicines.
- You have severe asthma, trouble breathing, or other lung problems.
- You have a bowel blockage or have narrowing of the stomach or intestines.
- You are allergic to any of the ingredients in FENTORA. See the Medication Guide for a complete list of ingredients in FENTORA.
- You have short-term pain that you would expect to go away in a few days, such as: pain after surgery, headache or migraine, dental pain
Before taking FENTORA, tell your healthcare provider if you have a history of: troubled breathing or lung problems such as asthma, wheezing, or shortness of breath; head injury, seizures; slow heart rate or other heart problems; low blood pressure; mental problems [including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)]; problems urinating; liver, kidney, thyroid problems; pancreas or gallbladder problems; abuse of street or prescription drugs, alcohol addiction, or mental health problems
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of FENTORA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. FENTORA passes into breast milk and may harm your baby.
- taking prescription over-the-counter medicines, vitamins, or herbal supplements. Taking FENTORA with certain other medicines can cause serious side effects that could lead to death.
When taking FENTORA:
- DO NOT Drive or operate heavy machinery, until you know how FENTORA affects you. FENTORA can make you sleepy, dizzy, or lightheaded.
- DO NOT Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with FENTORA may cause you to overdose and die.
- DO NOT Switch from FENTORA to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of FENTORA is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of FENTORA that may be different than other fentanyl containing medicines you may have been taking.
Possible side effects of FENTORA:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, low red blood cell count, swelling of the arms, hands, legs and feet. Call your healthcare provider if you have any of these symptoms and they are severe.
- decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
- pain, irritation, or sores at the application site (on your gum, on the inside of your cheek, or under your tongue). Tell your healthcare provider if this is a problem for you.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
- These symptoms can be a sign that you have taken too much FENTORA or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more FENTORA until you have talked to your healthcare provider.
These are not all the possible side effects of FENTORA. Call your doctor for medical advice about side effects. You may report side effects to FDA at
For more information go to dailymed.nlm.nih.gov
Please read the Medication Guide
located at the end of the Full Prescribing
Information for FENTORA.
References: 1. Fentora [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2016. 2. Portenoy RK, Taylor D, Messina J, Tremmel L. A randomized, placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer. Clin J Pain. 2006;22(9):805-811.