Frequently Asked Questions about FENTORA
Click on the following for answers to frequently asked questions about FENTORA.
About FENTORA
What is FENTORA?
FENTORA is used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.
FENTORA is a prescription medicine that contains the medicine fentanyl. FENTORA is a federally controlled substance (C-II) because it is a strong opioid pain medicine that can be abused by people who abuse medicines. Click here to learn more.
The SECURE program for FENTORA is designed to promote safe and appropriate use of the product.
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How does FENTORA work?
FENTORA should be placed above a rear molar tooth between the upper cheek and gum. You may feel a gentle bubbling sensation between your cheek and gum as the tablet dissolves. FENTORA is not meant to be chewed or swallowed.
About half of the fentanyl in FENTORA is absorbed through the lining of your mouth and into your bloodstream. The other portion gets swallowed and absorbed more slowly through your stomach and intestines, like the medicine in a pill.
As soon as the fentanyl enters the bloodstream, it is carried throughout your body. It travels to your central nervous system — the brain and spinal cord — where it works to relieve your pain.
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How is FENTORA different from the medicine I already take for my persistent pain?
The medicine you already take daily for your persistent pain is a strong around-the-clock opioid pain medicine that works throughout the day.
FENTORA is a treatment for breakthrough pain (an intense flare or spike that rises above persistent pain). You must continue to use your around-the-clock opioid medicine while you are using FENTORA.
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Who is an appropriate patient for FENTORA?
FENTORA is used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain. FENTORA is started only after you have been taking other opioid pain medicines and your body has gotten used to them (you are opioid tolerant). DO NOT USE FENTORA if you are not opioid tolerant.
Do Not Take FENTORA:
- if you are not regularly using other opioid pain medicines around-the-clock for your constant cancer pain.
- for the treatment of short-term pain from injuries, surgery, and headaches, including migraines.
- if you are allergic to anything in FENTORA. The active ingredient is fentanyl. See the Medication Guide [link] for a complete list of ingredients in FENTORA.
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Does FENTORA have a taste?
FENTORA contains no added flavors. You may sense a slight taste, or you may notice nothing at all.
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Is there sugar in FENTORA?
No. FENTORA is sugar-free.
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How is FENTORA packaged?
FENTORA comes in individually sealed child-resistant blister packs. Once removed from the blister pack, a FENTORA tablet must be taken immediately.
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How do I take FENTORA?
- Peel it.
- Keep tablets in blister packs until ready to use. Do not store in pillboxes
- Separate one of the blister units from its blister card by bending and tearing apart at the perforations
- Bend the blister unit along the line where indicated
- Peel back the foil on the blister pack to expose the tablet
- Do not push the tablet through the foil because this could damage the tablet
- Do not attempt to split the tablet
- Place it.
- Immediately place the FENTORA tablet in your mouth. Place it above a rear molar tooth between the upper cheek and gum
- Your doctor may instruct you to switch sides of the mouth with each new tablet used
- Do not bite, chew, or suck FENTORA tablets. If you do so, you will swallow more of the medicine before it can cross the lining of your mouth, and you may get less relief for your breakthrough cancer pain
- Feel it.
- Leave the FENTORA tablet in place until it dissolves. This may take about 14 to 25 minutes. As the tablet dissolves, you may feel a slight bubbling sensation between your cheek and gum
- If there is any tablet remaining after 30 minutes, swallow it with a glass of water
If you cannot take FENTORA this way, ask your doctor what to do.
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When do I take FENTORA?
Once your doctor has determined FENTORA is the right treatment for you, you should take FENTORA as soon as you start to feel a flare of breakthrough pain. Click here for more on the proper way to take a FENTORA tablet.
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How does my doctor find the right dose of FENTORA to relieve my breakthrough pain?
FENTORA comes in several dosage strengths. To start you on FENTORA, your doctor will likely prescribe you a low dosage strength. This initial dose may include more than 1 tablet (see Situation 1 below).
Next, your doctor may gradually increase the dosage strength of FENTORA to find the right dose for you. To help with this process, your doctor may instruct you to use several tablets at the same time (see Situation 1 below).
By following your doctor's instructions during this adjustment period, and telling the doctor how you’re feeling, you can help your doctor determine a correct dose. A pain journal can be a useful tool for remembering your experiences and talking with your doctor about them. Ask your doctor for details.
Once your doctor finds the dose of FENTORA that is right for you, you should use only 1 FENTORA tablet per breakthrough pain flare.
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When can I expect FENTORA to work?
Some patients may start to feel relief as early as 15 minutes.
If a flare or episode of breakthrough pain is not relieved within 30 minutes, your doctor may instruct you to take an additional dose. See the special instructions for taking an additional dose in the Medication Guide or by clicking here.
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What if I still have pain after taking a single dose of FENTORA?
Once you have found an effective dose, a single dose of FENTORA may not always control your breakthrough pain because some flares of pain may be more severe. No more than 2 doses should be used per breakthrough pain flare (see Situation 2 below). If your pain is not relieved within 30 minutes, your doctor may instruct you to take only 1 additional dose of the same strength for that flare. You must wait at least 4 hours before taking FENTORA for another flare of breakthrough pain.
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Can I bite, chew, suck, or swallow FENTORA?
No. Do not bite, chew, or suck on a FENTORA tablet. Do not swallow tablets whole. If you do so, you will swallow more of the medicine before it can cross the lining of your mouth, and you may get less relief for your breakthrough cancer pain.
Talk with your doctor. He or she may allow you to take another FENTORA tablet, but you can only take that tablet 30 minutes after having started the one you swallowed.
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Can I take FENTORA if I have a dry mouth?
Yes. If you have difficulty producing saliva, please talk with your doctor. You may drink some water before taking FENTORA, but you should not eat or drink anything while taking FENTORA.
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While taking FENTORA, can I take my around-the-clock opioid pain medicine?
You must take your around-the-clock opioid pain medicine as long as you are taking FENTORA. Do not stop taking your around-the-clock opioid pain medicine. Talk with your doctor before making an adjustment to any of your other medicines.
Always discuss any questions about your medicine with your doctor.
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What do I do if I am currently on Actiq®?
When starting FENTORA, discontinue use of Actiq/OTFC (oral transmucosal fentanyl citrate). Dispose of all remaining units properly.
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Side Effects and FENTORA
What are the possible or likely side effects of FENTORA?
FENTORA may cause side effects. The most common side effects of FENTORA are nausea, vomiting, dizziness, sleepiness, headache, and constipation.
Constipation (not often enough or hard bowel movements) is a very common side effect of opioid pain medicines and may happen with FENTORA. Constipation is unlikely to go away without treatment. Talk with your doctor about changes in your diet and the use of special medicines to prevent or treat constipation while taking FENTORA.
- FENTORA can cause pain or sores at the application site (on your gum or inside your cheek). Tell your doctor if this is a problem for you
- FENTORA can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down
- FENTORA can cause physical dependence. Do not stop taking FENTORA or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction
- There is a chance of abuse or addiction with FENTORA. The chance is higher if you are or have been addicted to or abused other medications, street drugs, or alcohol, or if you have a history of mental health issues
These are not all the possible side effects of FENTORA. For a complete list, ask your doctor.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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When should I call emergency help?
FENTORA can cause serious side effects — including slow, shallow breathing that can become life-threatening — especially if FENTORA is used the wrong way.
Call your doctor or get emergency medical help right away if you
- Have trouble breathing
- Have slow, shallow breathing (little chest movement while breathing)
- Have extreme drowsiness, with slowed breathing
- Feel faint, very dizzy, confused, or have unusual symptoms
These can be symptoms that you have taken too much (overdose) FENTORA or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.
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Safe Use, Storage and Disposal
What should I tell my doctor before starting FENTORA?
Tell your doctor about all medical and mental health issues, especially the ones listed below.
- Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
- A head injury or brain problem
- Seizures (convulsions or fits)
- Liver or kidney problems
- Slow heart rate or other heart problems
- Low blood pressure
- Mental health issues including major depression or hallucinations (seeing or hearing things that are not there)
- A past or present drinking problem or alcoholism, or family history
- A past or present drug abuse or addiction problem, or family history
Tell your doctor if you are
- Pregnant or planning to become pregnant. FENTORA may harm your unborn baby
- Breast-feeding. Fentanyl passes through breast milk, and it may cause serious harm to your baby. Therefore, you should not use FENTORA while breast-feeding
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Can I use medicines (other than my pain medicine) and herbal products while taking FENTORA?
Do not start any new prescription medicine, nonprescription medicine, vitamins, or herbal supplements while using FENTORA until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are using FENTORA.
Tell your doctor about all the medicines you take, including:
- Prescription and nonprescription medicines
- Vitamins
- Herbal supplements
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Can I drink alcoholic beverages while taking FENTORA?
No. You should avoid alcoholic beverages while using FENTORA. Drinking alcohol can produce dangerous side effects, resulting in serious injury or death.
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Who should not take FENTORA?
- Patients who are not regularly using other opioid pain medicines for your persistent cancer pain
- Patients who only have short-term pain from injuries, surgery, or headaches/migraines
- Patients who are allergic to anything in FENTORA. The active ingredient in FENTORA is fentanyl. The other ingredients are mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate
- Patients who do not let anyone else take the FENTORA that has been prescribed for you
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How should I store FENTORA?
Keep FENTORA in a safe place away from children and from anyone for whom it has not been prescribed. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes FENTORA, get emergency help right away.
FENTORA is supplied in single sealed child-resistant blister packages. Keep tablets in their blister packages until you are ready to take FENTORA. Do not store FENTORA in pillboxes. Once a blister is opened, the tablet must be taken immediately.
Store FENTORA at room temperature, 59°F to 86°F (15°C-30°C) until ready to use.
Always keep FENTORA in a secure place to protect from theft.
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How should I dispose of unopened FENTORA tablets when they are no longer needed?
Dispose of any unopened FENTORA tablets remaining from a prescription as soon as they are no longer needed.
If you need help with disposal of FENTORA, or information on how to return unused tablets, call Cephalon at 1-800-896-5855.
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What happens if someone else takes my FENTORA?
Call 9-1-1 or call emergency help immediately.
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What is addiction?
Addiction is a chronic disease that is characterized by one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving of a medicine. Addiction does not often occur when you take medicine under your doctor's supervision.
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Are opioid pain medicines addictive?
There is a chance you could get addicted to opioid pain medication including FENTORA. The chance is higher if you are or were ever addicted to other medicines, street drugs, or alcohol, or if you abused them. The chance is also higher if you have a history of mental health issues. Talk with your doctor about the risk of addiction.
You can develop "physical dependence" on an opioid. This means that stopping the opioid suddenly makes you feel sick because your body has become used to it. Physical dependence is not the same as addiction.
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Additional Information
Will my insurance or Medicaid cover the cost of FENTORA?
FENTORA is eligible for Medicaid reimbursement in all 50 states; however, coverage may vary from state to state.
If you have questions about whether FENTORA is covered under your insurance plan, you can call the FENTORA Reimbursement Program toll-free at 1-877-4FENTORA (1-877-433-6867). Reimbursement specialists can answer your questions about insurance coverage, reimbursement, and limitations. They can help you and your physician with preauthorizations and denied claims.
Cephalon does not formally conduct appeals for callers. The responsibility for obtaining prior authorization and seeking appeals ultimately must rest with patients and providers.
While Cephalon provides tools and services that may facilitate the reimbursement process, third-party payment for FENTORA is affected by several factors – not all of which can be resolved by the FENTORA Reimbursement Program staff. As a result, Cephalon cannot guarantee success in obtaining insurance authorizations or payments.
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What if I don't have insurance?
For patients with no prescription drug coverage, or limited financial resources, the CephalonCaresSM Foundation can help patients get the Cephalon medicines they need. For more information, call 1-877-CEPH-881 (1-877-237-4881) or visit Cephaloncares.com.
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IMPORTANT:
- DO NOT USE FENTORA unless you are regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is used to these medicines.
- Keep FENTORA in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes FENTORA, get emergency help right away.
Read the Medication Guide that comes with FENTORA before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. Share this important information with members of your household.
The most important information you should know about FENTORA is:
- FENTORA can cause life-threatening breathing problems which can lead to death:
- If you are not regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is not used to these medicines. This means that you are not opioid tolerant
- If you do not use it exactly as prescribed by your doctor
- Your doctor will prescribe a starting dose of FENTORA that is different than other fentanyl containing medicines you may have been taking. Do not substitute FENTORA for other fentanyl medicines, including Actiq®, without talking with your doctor.