A:
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 or street drugs.
Read more.
The Risk Minimization Action Plan for
FENTORA is designed to promote safe and appropriate use of the product.
Read more.
A: FENTORA uses OraVescent® Technology to quickly
distribute medicine to your body and give you relief. The tablet should be placed
above a rear molar tooth between your cheek and gum, as it’s not meant to be chewed
or swallowed. You may feel a gentle bubbling sensation between your cheek and gum
as the tablet dissolves.
Some patients may start to feel relief as early as 15 minutes.
Learn more.
A: The medicine you already take daily for your persistent pain
is an around-the-clock
opioid pain medicine that works throughout the day.
FENTORA is a treatment for breakthrough cancer 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.
Learn more.
A: That’s only something you and your healthcare professional can decide.
FENTORA is used to treat breakthrough pain in adults, 18 years of age and older with cancer,
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
for a complete list of ingredients in FENTORA
A: FENTORA contains no added flavors. You may sense a
slight taste, or you may notice nothing at all.
A: No. FENTORA is sugar free.
A: FENTORA comes in individually sealed child-resistant
blister packs. Once removed from the blister pack, a FENTORA tablet must
be taken immediately.
A: Follow these 3 easy steps:
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1. Peel from blister card.
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2. Place it in your mouth.
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3. Feel it dissolve and work quickly.
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Read more about how to properly take
FENTORA.
A: Once your healthcare professional has determined FENTORA is the right
treatment for you, you should take FENTORA as soon as you start to feel
a flare of breakthrough cancer pain. Read more.
A: To start you on FENTORA, your healthcare professional will likely prescribe
a low-dosage strength. Read more.
Your healthcare professional may gradually increase the dosage strength of FENTORA to find
the right dose for you. To help with this process, your healthcare professional may instruct you
to use several tablets at the same time. Read
more.
By following your healthcare professional's instructions during this adjustment period, and telling
the healthcare professional how you’re feeling, you can help your healthcare professional determine a correct dose.
A daily pain journal can be a useful tool for remembering your experiences and talking
with your healthcare professional about them. Ask your healthcare professional for details.
Once your healthcare professional finds the dose of FENTORA that is right for you, you should
use only 1 FENTORA tablet
per breakthrough pain flare. Read more.
A: Some people may start to feel relief as early as 15 minutes.
If a flare or episode of breakthrough cancer pain is not relieved within 30 minutes,
your healthcare professional may instruct you to take
ONLY 1 additional dose. (Do not take more than 2 doses.)
You must wait at least 4 more hours before taking FENTORA for another flare of
breakthrough cancer pain.
See the special instructions for taking an additional
dose in the Medication Guide.
A: On some occasions, a single dose of FENTORA may not
control your breakthrough cancer pain because some flares of pain may be more severe. If
your pain is not relieved within 30 minutes,
your healthcare professional may instruct you to take ONLY 1 additional dose.
(Do not take more than 2 doses.)
You must wait at least 4 more hours
before taking FENTORA for another flare of breakthrough pain.
Read more.
A: 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.
Read more about taking FENTORA.
A: Yes. If you have difficulty producing saliva, please talk with
your healthcare professional. You may drink some water before taking FENTORA, but you should
not eat or drink anything while taking FENTORA.
Read more about taking FENTORA.
A: You must continue
to 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 healthcare professional
before making an adjustment to any of your other medicines.
Always discuss any questions about your medicine with your healthcare professional.
Read more about taking FENTORA.
A: When starting FENTORA, discontinue use of Actiq®/OTFC
(oral transmucosal fentanyl citrate). Dispose of all remaining units properly.
Your healthcare professional will prescribe a starting dose of FENTORA that is different
from other fentanyl containing medicines you may have been taking. Do not substitute
FENTORA for other fentanyl medicines, including Actiq®,
without talking with your healthcare professional.
A: All medicines have benefits and risks. The most common side
effects of FENTORA are nausea, vomiting, dizziness, sleepiness, headache,
and constipation. These are not all the possible side effects of FENTORA.
For a complete list, ask your healthcare professional.
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 healthcare professional about changes in your diet and
the use of laxatives and stool softeners to prevent or treat constipation while taking FENTORA.
Call your healthcare professional for medical advice about side effects. You may report side effects
to the FDA at 1-800-FDA-1088.
Read more about potentially serious side effects.
A:
FENTORA can cause serious breathing problems, including slow, shallow breathing that
can become life threatening, especially if FENTORA is used the wrong way.
Call your healthcare professional, or get emergency medical help right away, if you or the person taking the medication is:
- Having trouble breathing
- Having extreme drowsiness, with slowed breathing
- Having slow, shallow breathing (little chest movement while breathing)
- Feeling faint, very dizzy, confused, or have unusual symptoms
The above symptoms may lead to serious problems or death if not treated right away.
Read more about potentially serious side effects.
A: Tell your healthcare professional about all medical and mental health issues,
especially if you or the person you’re caring for has:
- 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 health issues including major depression or hallucinating (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 healthcare professional if you or the person you’re caring for is:
- Pregnant or planning to become pregnant. FENTORA may harm your unborn baby
- Breast-feeding. Fentanyl passes through breast milk and may cause serious harm to
your baby. Therefore, you should not use FENTORA while breast-feeding
Tell your doctor about all the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal and dietary supplements.
Read more about using FENTORA safely.
A: Do not start any new prescription medicine, non-prescription
medicine, vitamins, or herbal supplements while using FENTORA until you
have talked with your healthcare professional.
Your healthcare professional will tell you if it is safe to take other
medicines while you are using FENTORA.
Read more about taking FENTORA safely.
A:
Do not drink alcohol while using FENTORA.
Drinking alcohol can produce dangerous side effects, resulting in serious injury
or death. Read more about taking FENTORA
safely.
A: You should not take FENTORA if you:
- Are not regularly using other opioid pain medicines for your persistent cancer pain
- Only have short-term pain from injuries, surgery, and headaches, including 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
Read more about taking FENTORA
safely.
A:
Keep FENTORA in a safe and secure place away from children and 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.
Read more about properly storing FENTORA.
A: 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, or information on how to return
unused tablets, call Cephalon at 1-800-896-5855.
Read more about how to properly dispose
of FENTORA.
A: Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Call 911 or emergency help immediately.
A: 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.
Read more about using FENTORA safely.
A: When taken under a healthcare professional’s supervision, FENTORA can
be a safe and effective pain-management tool. However, 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 healthcare professional about the risk of addiction.
A: 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 pre-authorizations 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.
Read more about the different ways you
can pay for FENTORA.
A: For patients with no prescription drug coverage, or limited
financial resources, the CephalonCares® 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.
Read more about patient-assistance
programs.