ONSOLIS® is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS® may be dispensed only to patients enrolled in the TIRF REMS Access program.
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of ONSOLIS for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, ONSOLIS is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients. [see Contraindications]
ONSOLIS must be kept out of reach of children. [See Patient Counseling Information (17.1) and How Supplied/Storage and Handling(16.1)]
The concomitant use of ONSOLIS with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see Drug Interactions (7)].
Substantial differences exist in the pharmacokinetic profile of ONSOLIS 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 ONSOLIS. (2.1)
- When dispensing, do not substitute an ONSOLIS prescription for other fentanyl products.
ONSOLIS contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ONSOLIS can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ONSOLIS 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, ONSOLIS 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 (5.10)].
Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.
INDICATIONS AND USAGE
ONSOLIS® is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Limitations of Use: ONSOLIS® may be dispensed only to patients enrolled in the TIRF REMS Access Program.
- Opioid non-tolerant patients.
- Acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.
- Intolerance or hypersensitivity to fentanyl or components of ONSOLIS®.
WARNINGS AND PRECAUTIONS
- Clinically significant respiratory and CNS depression can occur. Monitor patients accordingly.
- ONSOLIS® films contain medicine that can be fatal to a child. Ensure proper storage and disposal.
- Use with other CNS depressants or CYP3A4 inhibitors may increase depressant effects including hypoventilation, hypotension, and profound sedation. Consider dosage adjustments if warranted.
- ONSOLIS® may impair ability for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
- Titrate ONSOLIS® cautiously in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to hypoventilation and in patients susceptible to intracranial effects of CO2 retention.
Most common adverse reactions (frequency ≥10%): nausea, vomiting, dizziness, dehydration, dyspnea, and somnolence.
To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences at 1-800-469-0261, option 2 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch