Fentora (generic: fentanyl) is a prescription medication used to manage breakthrough pain in adults with cancer who are already taking other opioid pain medications around the clock for pain. Fentora belongs to a group of drugs called opioid narcotic analgesics which help to relieve pain by binding to certain opoid receptors in the body.
Fentora is a prescrition medication used to manage breakthrough pain in adults with cancer who are already taking other opioid pain medicines around-the-clock for cancer pain.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Fentora can cause serious side effects, including:
- Serious breathing problems that can become life-threatening. See “Drug Precautions”.
- Call your doctor or get emergency medical help right away if you:
- have trouble breathing
- have drowsiness combined with slow breathing
- have slow, shallow breathing (little chest movement with breathing)
- feel faint, very dizzy, confused, or have unusual symptoms
If you experience these symptoms, it can be a sign that your dose it too high, or that you have taken too much Fentora. This 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 doctor.
- Decreased blood pressure which can make you feel dizzy or lightheaded.
- Physical dependence (your body has become used to medicines). Do not stop using Fentora or taking any other opioid without talking to your healthcare provider. You could experience 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. If you have previously been addicted to or abused other medicines, or alcohol, or if you have a history of mental health problems, the likelihood of your abuse of Fentora is higher.
- Pain, irritation, or sores on your gum or the inside of your cheek where the medication is applied. Tell your doctor if this is a problem for you.
The most common side effects of Fentora are:
- low red blood cell count
- swelling of the arms, hands, legs and feet
Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Fentora and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Fentora.
These are not all the possible side effects of Fentora. For more information, ask your doctor or pharmacist.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening side effects when taken with Fentora, particularly medicines that make you sleepy. Especially tell your doctor if you take:
- barbiturates such as phenobarbital (Luminal)
- buprenorphine (Buprenex, Subutex, in Suboxone)
- butorphanol (Stadol)
- carbamazepine (Carbatrol, Epitol, Tegretol)
- efavirenz (in Atripla, Sustiva)
- isocarboxazid (Marplan)
- medications for mental illness and nausea
- modafinil (Provigil)
- muscle relaxants
- nalbuphine (Nubain)
- nalmefene (Revex)
- naloxone (Narcan)
- nevirapine (Viramune)
- oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone
- oxcarbazepine (Trileptal)
- pentazocine (Talwin)
- phenelzine (Nardil)
- phenytoin (Dilantin, Phenytek)
- pioglitazone (Actos, in Actoplus Met, in Duetact)
- rifabutin (Mycobutin)
- rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
- selegiline (Eldepryl, Emsam, Zelapar)
- sleeping pills
- St. John's Wort
- tranylcypromine (Parnate)
This is not a complete list of Fentora drug interactions. Ask your doctor or pharmacist for more information.
Fentora can cause life-threatening breathing problems which can lead to death.
Do not use Fentora if you are not opioid tolerant (already taking scheduled, around-the-clock opiods and your body is used to them).
Do not switch from Fentora to other medicines that contain fentanyl without talking with your doctor.
Do not use Fentora for short-term pain that you would expect to go away in a few days, such as:
- pain after surgery
- headache or migraine
- dental pain
Never give Fentora to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.
- Fentora is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.
- Prevent theft, misuse or abuse. Keep Fentora in a safe place to protect it from being stolen. Fentora can be a target for people who abuse (narcotic) medicines or street drugs.
- Selling or giving away this medicine is against the law.
Do not use Fentora if you are allergic to any of the ingredients in Fentora. See "Forms of Medication".
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Fentora affects you. Fentora can make you sleepy. Ask your healthcare provider when it is okay to do these activities.
Do not drink alcohol while using Fentora. It can increase your chance of getting dangerous side effects.
Grapefruit and grapefruit juice may interact with Fentora and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before using Fentora, tell your doctor about all of your medical conditions. Especially tell your doctor if you have:
- trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
- head injury or brain problem (including seizures)
- liver, kidney, or heart problems
- low blood pressure
- depression, schizophrenia or hallucinations (seeing or hearing things that are not there) or other mental problems
- a drinking problem (past or present), or a family history of drinking problems (alcoholism)
- a drug abuse problem (past or present) or addiction problem, or a family history of a drug abuse problem or addiction problem
- any other medical conditions
Tell your doctor if you are pregnant or breastfeeding.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or plan to become pregnant. Fentora may cause serious harm to your unborn baby.
Tell your doctor if you are breastfeeding or plan to breastfeed. Fentora is excreted in human breast milk. It can cause serious harm to your baby. You should not take Fentora while breastfeeding.
Before you can begin to use Fentora:
- Your doctor will explain the TIRF REMS Access program to you.
- You will sign the TIRF REMS Access program Patient-Prescriber Agreement form.
- Fentora is only available at pharmacies that are part of the TIRF REMS Access program. Ask your doctor to let you know the pharmacy closest to your home where you can have your Fentora prescription filled.
- Use Fentora exactly as prescribed. Never use Fentora more often than prescribed.
- Your doctor will change the dose until you and your doctor find the right dose for you.
- See the detailed Patient Instructions for Use in the Medication Guide that comes with Fentora for information about how to use Fentora the right way.
- Use Fentora tablets whole. Do not split, suck, chew, or swallow Fentora tablets. You will get less relief for your breakthrough cancer pain.
- Wait 30 minutes after using Fentora. If there is any of the Fentora tablet left in your mouth, you may drink a glass of water to help you swallow the left over medicine.
- You must not use more than 2 doses of Fentora for each episode of breakthrough cancer pain.
- Use 1 dose of Fentora for an episode of breakthrough cancer pain.
- If your breakthrough cancer pain does not get better 30 minutes after taking the first dose of Fentora, you can use only 1 more dose of Fentora as instructed by your healthcare provider.
- If your breakthrough pain does not get better after the second dose of Fentora, call your doctor for instructions. Do not use another dose of Fentora at this time.
- Wait at least 4 hours before treating a new episode of breakthrough cancer pain with Fentora.
- If you only need to take 1 dose of Fentora for an episode of breakthrough pain, you must wait 4 hours from the time of that dose to take a dose of Fentora for a new episode of breakthrough pain.
- If you need to use 2 doses of Fentora for an episode of breakthrough pain, you must wait 4 hours after the second dose to take a dose of Fentora for anew episode of breakthrough pain.
It is important for you to keep taking your around-the-clock opioid pain medicine while using Fentora. Talk to your doctor if your dose of Fentora does not relieve your breakthrough cancer pain. Your doctor will decide if your dose of Fentora needs to be changed. Talk to your doctor if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock opioid pain medicine may need to be adjusted.
If you begin to feel dizzy, sick to your stomach, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away. Rinse the sink or flush the toilet to dispose of any remaining tablet pieces.
Take Fentora exactly as prescribed. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you based on medicines you are already taking, medical conditions you have, and your body's response to this medicine.
For people who are not taking Actiq (a fentanyl lozenge) the Fentora starting dose for breakthrough pain is 100 mcg. In people who are switching from Actiq, the Fentora starting dose will be based on the current Actiq dosage, which usually ranges from Fentora 100 mcg to 400 mcg.
If after 30 minutes your pain is not relieved, you may take one more Fentora dose. After a maximum of two doses, you must wait at least four hours before using Fentora again. Do not take more than two doses each time you have a breakthrough pain episode.
If you use too much Fentora or overdose, you or your caregiver should call for emergency medical help or have someone take you to the nearest hospital emergency room.
Fentora tablets are available in 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths.
Active Ingredient: fentanyl citrate
Inactive Ingredients: mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.
Fentora comes in individually sealed, child-resistant blister packages. The amount of fentanyl contained in Fentora can cause death to a child. Keep Fentora out of the reach of children.
Store Fentora at room temperature, away from excess moisture. Do not freeze. Do not use if the blister package has been tampered with.
Dispose of any 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 Fentora blister packages or cartons down the toilet. If you need additional assistance with disposal of Fentora, call Cephalon, Inc., at 1-800-896-5855.
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with Fentora, including following use in opioid non-tolerant patients and improper dosing.The substitution of Fentora for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, Fentora is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.
Fentora must be kept out of reach of children.
The concomitant use of Fentora with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
Substantial differences exist in the pharmacokinetic profile of Fentora compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to Fentora.
- When dispensing, do not substitute a Fentora prescription for other fentanyl products.
Fentora contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Fentora can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Fentora in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Because of the risk for misuse, abuse, addiction, and overdose, Fentora is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.