Recommended Topic Related To:

Fentora

"Patients with a type of cancer known as primary mediastinal B-cell lymphoma who received infusions of chemotherapy, but who did not have radiation therapy to an area of the thorax known as the mediastinum, had excellent outcomes, according to "...

Fentora

FENTORA®
(fentanyl) Buccal Tablets

WARNING

RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

RESPIRATORY DEPRESSION

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. [see CONTRAINDICATIONS]

FENTORA must be kept out of reach of children. [see PATIENT INFORMATION and HOW SUPPLIED/Storage and Handling]

The concomitant use of FENTORA with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see DRUG INTERACTIONS].

MEDICATION ERRORS

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. [see DOSAGE AND ADMINISTRATION]
  • When dispensing, do not substitute a FENTORA prescription for other fentanyl products.

ABUSE POTENTIAL

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. [see WARNINGS AND PRECAUTIONS] Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.

DRUG DESCRIPTION

FENTORA (fentanyl buccal tablet) is a potent opioid analgesic, intended for buccal mucosal administration.

FENTORA is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa.

FENTORA employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa.

Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula:

FENTORA® (fentanyl buccal) Structural Formula Illustration

All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 microgram strength tablet contains 100 micrograms of fentanyl free base.

Inactive Ingredients: Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.

What are the possible side effects of fentanyl buccal (Fentora, Onsolis)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious side effects may include:

  • nausea, vomiting,...

Read All Potential Side Effects and See Pictures of Fentora »

What are the precautions when taking fentanyl buccal tablet (Fentora)?

Before taking fentanyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating...

Read All Potential Precautions of Fentora »

Last reviewed on RxList: 3/12/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Fentora - User Reviews

Fentora User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Fentora sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.


NIH talks about Ebola on WebMD