Frequently asked questions about FENTORA

What is FENTORA?
How does FENTORA work?
How is FENTORA different from the medicine I already take for my persistent pain?
Who should not take FENTORA?
What should I tell my doctor before starting FENTORA?
When do I take FENTORA?
When can I expect FENTORA to work?
Does FENTORA have a taste?
Is there sugar in FENTORA?
How is FENTORA packaged?
How do I take FENTORA?
How does my doctor find the right dose of FENTORA to relieve my breakthrough pain?
What if I still have pain after taking a single dose of FENTORA?
When can I treat another breakthrough pain flare with FENTORA?
Can I bite, chew, suck, or swallow FENTORA?
Can I take FENTORA if I have a dry mouth?
While taking FENTORA, can I take my around-the-clock pain medicine?
What are the possible or reasonably likely side effects of FENTORA?
When should I call emergency help?
Can I use medicines (other than my pain medicine) and herbal products while taking FENTORA?
Can I drink alcoholic beverages while taking FENTORA?
How should I store FENTORA?
How should I dispose of unopened FENTORA tablets when they are no longer needed?
What happens if someone else takes my FENTORA?
Are opioid pain medicines addictive?
Will my insurance or Medicaid cover the cost of FENTORA?

What is FENTORA?

FENTORA is a prescription medicine that contains the medicine fentanyl. FENTORA is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse medicines.

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.

The SECURE program for FENTORA is designed to promote safe and appropriate use of the product. Click here to learn more about how you can stay SECURE with FENTORA.

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 should not be sucked, 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.

How is FENTORA different from the medicine I already take for my persistent pain?

The medicine you already take for your persistent pain is a strong around-the-clock opioid pain medicine that works for 8 hours or more.

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.

Who should not take FENTORA?

Do not take FENTORA if you

Are not regularly using other opioid pain medicines around the clock for your persistent cancer pain
Only have short-term pain from injuries, surgery, or headaches/migraines
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
Have not been prescribed FENTORA

What should I tell my doctor before starting FENTORA?

Tell your doctor about all medical and mental problems, especially the ones listed below.

Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
A head injury or brain problem
Liver or kidney problems
Seizures (convulsions or fits)
Slow heart rate or other heart problems
Low blood pressure
Mental problems including major depression or hallucinations (seeing or hearing things that are not there)
A past or present drinking problem or alcoholism, or a family history of this problem
A past or present drug abuse or addiction problem, or a family history of this problem

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

When do I take FENTORA?

Once your doctor has determined that you are an appropriate patient for FENTORA, you should take FENTORA as soon as you start to feel a flare of breakthrough pain. Click here to learn more about the proper way to take a FENTORA tablet.

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.

Does FENTORA have a taste?

FENTORA contains no added flavors. You may sense a slight taste, or you may notice nothing at all.

Is there sugar in FENTORA?

No. FENTORA is sugar-free.

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.

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 pain 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.

How does my doctor find the right dose of FENTORA to relieve my breakthrough pain?

FENTORA comes in multiple 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 multiple 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. Click here to download your own Daily Pain Journal.

Once you are on a regular dose of FENTORA, you should generally use only 1 FENTORA tablet per breakthrough pain flare.

What if I still have pain after taking a single dose of FENTORA?

If your pain is not relieved within 30 minutes, your doctor may instruct you to take only 1 additional dose of the same strength from that flare. Please note, no more than 2 doses should be used per breakthrough pain flare (see Situation 2 below).

When can I treat another breakthrough pain flare with FENTORA?

Follow the instructions that you received from your doctor or pharmacist about how often to take FENTORA.

Wait at least 4 hours before treating another breakthrough pain flare, and treat no more than 6 flares in a single day.

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.

If you have accidentally swallowed a FENTORA tablet, 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.

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.

While taking FENTORA, can I take my around-the-clock pain medicine?

You must take your around-the-clock 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.

What are the possible or reasonably 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. 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.

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 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 problems

These are not all the possible side effects of FENTORA. For a complete list, ask your doctor.

Talk with your doctor about any unusual side effects or side effects that do not go away.

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.

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

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.

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.

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.

To dispose of unused FENTORA, remove FENTORA tablets from blister packages and flush down the toilet. Do not flush the FENTORA blister packages or cartons down the toilet.

If you need help with disposal of FENTORA, call Cephalon Medical Services at 1-800-896-5855.

What happens if someone else takes my FENTORA?

Call 911 or call emergency help immediately.

Are opioid pain medicines addictive?

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.

There is a chance you could get addicted to 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 problems. 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.

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.

For patients with limited or no insurance, or limited financial resources, Cephalon offers a FENTORA Patient Assistance Program. If you would like to know whether you qualify, call the FENTORA Reimbursement Program at 1-877-4FENTORA (1-877-433-6867).

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.