OnsolisTM is a new short-acting dosage-form of fentanyl supplied as a soluble film. It consists of a small, dissolvable, polymer film formulated with fentanyl for application to the buccal mucosa (inner lining of the cheek). The film is about the size of a dime and it completely dissolves within 15-30 minutes after administration. It is indicated for treating episodes of severe breakthrough pain in patients who are already being treated with routine opioids.
OnsolisTM joins a couple of close cousins already on the market for management of severe breakthrough pain: the fentanyl lozenge (Actiq) and the fentanyl buccal tablet (Fentora). OnsolisTM is not a generic version of these products and it should not be substituted for any other fentanyl product. Substantial differences exist in how OnsolisTM is absorbed compared to other oral transmucosal fentanyl products. Substitution of OnsolisTM for any other oral transmucosal fentanyl product may result in fatal overdose.
OnsolisTM is available in 5 strengths: 200mcg, 400mcg, 600mcg, 800mcg, and 1200mcg. Strict initial dose titration guidelines are provided in the manufacturer's package insert in order to achieve an effective dose while minimizing the risk for toxicity. All patients must begin treatment using 1 OnsolisTM 200mcg film. The effective dose of OnsolisTM is not predictable from the daily maintenance dose of opioid that the patient is using to manage persistent pain and must be determined by titration. If adequate relief is not achieved after 1 OnsolisTM 200mcg dose, titrate using multiples of the 200mcg film. Increase the dose by 200mcg in each subsequent episode until the patient reaches a dose that provides relief with tolerable adverse effects.
Do not use more than 4 of the OnsolisTM 200mcg films simultaneously. When multiple films are used, they should not be placed on top of each other and may be placed on both sides of the mouth. Single doses should be separated by at least 2 hours. Single doses above 1200mcg should not be used. OnsolisTM film should be limited to 4 or fewer doses per day. The need for more frequent dosing of breakthrough pain medication should indicate that the routine opioid medication dose needs to be increased.
The black-box warning on OnsolisTM stresses the importance of beginning therapy with the 200mcg strength and following the strict dose titration guidelines. The warning also states that OnsolisTM film cannot be substituted in place of the other transmucosal fentanyl products (Actiq and Fentora) due to substantial differences in the extent of absorption of fentanyl among these products.
Lastly, the warning reflects the initial impact of the FDA's new REMS authority upon opioid therapy. Specifically, because of the risk for misuse, abuse and overdose, this product is available only through a restricted distribution program, called the FOCUS Program (Full Ongoing Commitment to User Safety Program). Under the FOCUS Program, only physicians, pharmacists, and patients registered with the program are able to prescribe, dispense, and receive OnsolisTM. Participating pharmacists and physicians are required to receive training on the FOCUS program.
Practitioners and patients may enroll in the program at http://www.onsolisfocus.com/.
OnsolisTM (fentanyl buccal soluble film)
For the management of breakthrough cancer pain in hospice and palliative care patients who are already receiving and are tolerant of opioid therapy
Available Strengths: 200mcg per film 400mcg per film 600mcg per film 800mcg per film 1200mcg per film
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