IMPORTANT SAFETY INFORMATION
The information listed below is not a complete list. Please read the full Medication Guide completely
before you start using FENTORA® (fentanyl buccal tablet) CII,
and each time you get a new prescription. This information does not take the place
of talking with your healthcare provider about your medical condition or your treatment.
Share this important information with members of your household and other caregivers.
Do not use FENTORA unless you are regularly using another opioid pain medicine around-the-clock
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 IMMEDIATELY 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.
What important information should I know about FENTORA?
FENTORA can cause life-threatening breathing problems.
- Use FENTORA exactly as prescribed by your healthcare provider
- - DO NOT use more than 2 doses of FENTORA for each episode of breakthrough
- - Wait at least 4 hours before treating a new episode of breakthrough cancer pain
- Do not switch from FENTORA to other medicines that contain fentanyl or
change your FENTORA dose without talking with your healthcare provider
Never give FENTORA to anyone else, even if they have the same symptoms
you have. It may harm them or even cause death and is against the law. Keep FENTORA
in a safe place
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 about the benefits
and risks of FENTORA, agree to all of the instructions, and sign the Patient-Prescriber
Who should not use FENTORA?
Do not use FENTORA:
- If you are not opioid tolerant. Opioid tolerant means that you are already taking
other opioid pain medicines around-the-clock for your cancer pain, and your body
is used to these medicines
- For short-term pain that you would expect to go away in a few days, such as pain
after surgery, headaches or migraine, and/or dental pain
- If you are allergic to any of the ingredients in FENTORA
What should I tell my healthcare provider before using FENTORA?
Tell your healthcare provider about all the medicines you take, including
prescription medicines, vitamins, and herbal supplements. Some medicines may cause
serious or life-threatening side effects when taken with FENTORA.
- Do not take any medicine while using FENTORA until you have talked to
your healthcare provider. Your healthcare provider will tell you if it is okay to
take other medicines while you are using FENTORA
- Be very careful about taking other medicines that may make you sleepy, such as other
pain medicines, antidepressant medicines, sleeping pills, anti-anxiety medicines,
antihistamines, or tranquilizers
What should I avoid while using FENTORA?
- Do not drive, operate heavy machinery, or do other dangerous activities until
you and your healthcare provider know how FENTORA affects you
- Do not drink alcohol while using FENTORA. It can increase the chance
of dangerous side effects
What are possible side effects of FENTORA?
FENTORA can cause serious side effects, including:
- Breathing problems that can become life-threatening.
Stop taking FENTORA and call your healthcare provider or get emergency medical
help IMMEDIATELY if you:
- Have trouble breathing
- Have drowsiness with slowed breathing
- Have slow, shallow breathing (little chest movement with breathing)
- Feel faint, very dizzy, confused, or have unusual symptoms
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.
- Decreased blood pressure. This can make you feel dizzy or lightheaded when
you stand up.
- Physical dependence. Do not stop taking FENTORA or taking any other opioid
without talking to your healthcare provider. You could become sick with uncomfortable
withdrawal symptoms because your body has become used to these medicines. Physical
dependency is not the same as drug addiction.
- A chance of abuse or addiction. This chance is higher if you are or have
been addicted to or abused other medicines, street drugs, or alcohol, or have a
history of mental health problems.
- Pain, irritation, or sores at the application site (on your gum, on the inside
of your cheek, or under your tongue).
The most common side effects of FENTORA are:
- Low red blood cell count
- Swelling of the arms, hands, legs and feet
Constipation is a very common side effect of opioid pain medicines including FENTORA
and is unlikely to go away without treatment. Talk to your healthcare provider about
prevention or treatment of constipation while taking FENTORA.
Talk to your healthcare provider if you have any side effects.
These are not all the possible side effects of FENTORA. For more information,
ask your healthcare provider or pharmacist or call 1-800-896-5855.
You are encouraged to report side effects of prescription drugs to the FDA. Visit
www.FDA.gov/medwatch, call 1-800-FDA-1088, or fax to 1-800-FDA-0178.
This information does not take the place of talking with your doctor for medical
advice about your condition or treatment.
Please see the Medication Guide
located at the end of the Full Prescribing