Onsolis

ONSOLIS- fentanyl citrate film, soluble
Meda Pharmaceuticals Inc.

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

RESPIRATORY DEPRESSION
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 (4)] 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)].

MEDICATION ERRORS
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.

ABUSE POTENTIAL 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.

1 INDICATIONS AND USAGE

Onsolis (fentanyl buccal soluble film) is an opioid analgesic indicated only 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. Patients considered opioid tolerant are those who are taking at least: 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while taking ONSOLIS.

This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression could occur in patients not taking chronic opiates. For this reason, Onsolis is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.

Onsolis is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Limitations of Use:

As a part of the TIRF REMS Access program, Onsolis may be dispensed only to outpatients enrolled in the program [see Warnings and Precautions (5.10)]. For inpatient administration of Onsolis (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.

2 DOSAGE AND ADMINISTRATION

Healthcare professionals who prescribe Onsolis on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of Onsolis [see Warnings and Precautions (5.10)].

As with all opioids, the safety of patients using such products is dependent on healthcare professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

2.1 Dose Titration

The goal of dose titration is to find the individual patient’s effective and tolerable dose. The dose of Onsolis is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and MUST be determined by dose titration.

Starting Dose: Individually titrate Onsolis to a dose that provides adequate analgesia with tolerable side effects. All patients MUST begin treatment using one 200 mcg Onsolis film. Due to differences in pharmacokinetic properties and individual variability, patients switching from another oral transmucosal fentanyl product must be started on no greater than 200 mcg of Onsolis. When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to Onsolis as Onsolis is not equivalent on a mcg per mcg basis with any other fentanyl product. Onsolis is NOT a generic version of any other oral transmucosal fentanyl product.

From the initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia.

If adequate pain relief is not achieved after one 200 mcg Onsolis film, titrate using multiples of the 200 mcg Onsolis film (for doses of 400, 600, or 800 mcg). Increase the dose by 200 mcg in each subsequent episode until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Do not use more than four of the 200 mcg Onsolis films simultaneously. When multiple 200 mcg Onsolis films are used, they should not be placed on top of each other and may be placed on both sides of the mouth.

If adequate pain relief is not achieved after 800 mcg Onsolis (i.e., four 200 mcg Onsolis films), and the patient has tolerated the 800 mcg dose, treat the next episode by using one 1200 mcg Onsolis film. Doses above 1200 mcg Onsolis should not be used.

Once adequate pain relief is achieved with a dose between 200 and 800 mcg Onsolis, the patient should use or safely dispose of all remaining 200 mcg Onsolis films [see Disposal of Onsolis (16.2)]. Patients who require 1200 mcg Onsolis, should dispose of all remaining unused 200 mcg Onsolis films [see Disposal of Onsolis (16.2)]. The patient should then get a prescription for Onsolis films of the dose determined by titration (i.e., 200, 400, 600, 800, or 1200 mcg) to treat subsequent episodes.

Single doses should be separated by at least 2 hours. Onsolis should only be used once per breakthrough cancer pain episode, i.e., Onsolis should not be redosed within an episode.

During any episode of breakthrough cancer pain, if adequate pain relief is not achieved after Onsolis, the patient may use a rescue medication (after 30 minutes) as directed by their healthcare provider.

Onsolis Dose Titration Flowchart
(click image for full-size original)

2.2 Dosage Adjustment

During maintenance treatment, if the prescribed dose no longer adequately manages the breakthrough cancer pain episode for several consecutive episodes, increase the dose of Onsolis as described in Dose Titration (2.1). Once a successful dose has been found, each episode is treated with a single film. Onsolis should be limited to four or fewer doses per day. Consider increasing the dose of the around-the-clock opioid medicine used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.

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