IMPORTANT RISK INFORMATION
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION
ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with oral transmucosal fentanyl citrate, including following use in opioid nontolerant patients and improper dosing. The substitution of oral transmucosal fentanyl citrate for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, oral transmucosal fentanyl citrate is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.
Death has been reported in children who have accidentally ingested oral transmucosal fentanyl citrate. Oral transmucosal fentanyl citrate must be kept out of reach of children.
The concomitant use of oral transmucosal fentanyl citrate 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 oral transmucosal fentanyl citrate 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 oral transmucosal fentanyl citrate.
- When dispensing, do not substitute an oral transmucosal fentanyl citrate prescription for other fentanyl products.
ABUSE POTENTIALBecause of the risk for misuse, abuse, addiction, and overdose, oral transmucosal fentanyl citrate 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.
Oral transmucosal fentanyl citrate contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Oral transmucosal fentanyl citrate can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oral transmucosal fentanyl citrate in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
- Oral transmucosal fentanyl citrate is contraindicated in:
- Opioid non-tolerant patients.
- Management of acute or postoperative pain including headache/migraines and dental pain.
- Intolerance or hypersensitivity to fentanyl or components of oral transmucosal fentanyl citrate.
WARNINGS AND PRECAUTIONS
- DO NOT convert a patient to oral transmucosal fentanyl citrate from any other fentanyl product on a mcg per mcg basis as oral transmucosal fentanyl citrate and other fentanyl products are not equivalent on a microgram per microgram basis.
- The substitution of oral transmucosal fentanyl citrate for any other fentanyl product may result in a fatal overdose.
- Full and partially consumed oral transmucosal fentanyl citrate units contain medicine that can be fatal to a child. Ensure proper storage and disposal. Interim safe storage container available.
- Clinically significant respiratory and CNS depression can occur.
- There are no safe conversion directions available for patients on any other fentanyl products.
- The concomitant use of oral transmucosal fentanyl citrate with other CNS depressants, including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages, or use with potent cytochrome P450 3A4 inhibitors may produce increased depressant effects (e.g., respiratory depression, hypotension, and profound sedation).
- The use of fentanyl may impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
- Caution use of oral transmucosal fentanyl citrate in patients with chronic obstructive pulmonary disease or pre-existing medical conditions because it may predispose them to respiratory depression.
- Administer oral transmucosal fentanyl citrate with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.
- Titrate oral transmucosal fentanyl citrate cautiously in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression and in patients susceptible to intracranial effects of CO2 retention.
- Caution use of oral transmucosal fentanyl citrate in patients with bradyarrhythmias.
- Oral transmucosal fentanyl citrate is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
- Serious adverse events may include respiratory depression, apnea, respiratory arrest, bradycardia, circulatory depression, tachycardia, anaphylactic reactions, hypotension or hypertension, and shock.
- Most common adverse reactions include nausea, dizziness, somnolence, vomiting, asthenia, headache, dyspnea, constipation, confusion, and anxiety.
USE IN SPECIFIC POPULATIONS
- Safety and effectiveness in pediatric patients below 16 years of age have not been established.
- Breast feeding: Fentanyl is excreted in human milk and is not recommended in nursing women.
- Elderly patient may have increased sensitivity to oral transmucosal fentanyl citrate. Caution should be exercised in titrating these patients to provide adequate efficacy while minimizing risk.
Because of the risk for misuse, abuse, addiction, and overdose, oral transmucosal fentanyl citrate is available only through a restricted program called the TIRF REMS Access program. Under the TIRF REMS Access program, outpatients, healthcare professionals who prescribe for outpatient use, pharmacies and distributors must enroll in the program. For inpatient administration (e.g. hospitals, hospices and long term care facilities that prescribe for inpatient use) of oral transmucosal fentanyl citrate, patient and prescriber enrollment is not required.
Each dosage unit has a white to off-white color. The product code and dosage strength of each unit is marked on the solid drug matrix and handle tag.
Imprinted with 9204 and 400 mcg
For additional information on Oral Transmucosal Fentanyl Citrate, CII 400 mcg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
ACTIQ is a registered trademark of Anesta Corporation