Generic name: FENTANYL CITRATE 200ug
Dosage form: buccal soluble film
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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.
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.
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.
Administration of Onsolis
Use the tongue to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of Onsolis. Open the Onsolis package immediately prior to product use. Place the entire Onsolis film near the tip of a dry finger with the pink side facing up and hold in place. Place the pink side of the Onsolis film against the inside of the cheek. Press and hold the Onsolis film in place for 5 seconds. The Onsolis film should stay in place on its own after this period. Liquids may be consumed after 5 minutes.
An Onsolis film, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when used as directed [see Clinical Pharmacology – Pharmacokinetics (12.3)].
The Onsolis film should not be cut or torn prior to use.
The Onsolis film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or finger(s) and eating food should be avoided until the film has dissolved.