IMPORTANT RISK INFORMATION

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.

ADVERSE REACTIONS

• 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. 

TIRF REMS

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.

Description	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.
Dosage Strength	600 mcg
Compares To	ACTIQ®
Identification Code	Imprinted with 9206 and 600 mcg
Rating	AB

ORDER INFORMATION

NDC #	Package Size	Case Quantity
0406-9206-30	30's	6

For additional information on Oral Transmucosal Fentanyl Citrate, CII 600 mcg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.