"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
ONSOLIS (fentanyl buccal soluble film) is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 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.
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.
DOSAGE AND ADMINISTRATION
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.
Only prescribers enrolled in the FOCUS Program may prescribe ONSOLIS [see WARNINGS AND PRECAUTIONS].
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.
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]. Patients who require 1200 mcg ONSOLIS, should dispose of all remaining unused 200 mcg ONSOLIS films [see Disposal of ONSOLIS]. 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].
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.
Dosage Forms And Strengths
ONSOLIS is a buccal soluble film with a white side and a pink side. The pink side contains a bioadhesive polymer and the active ingredient. Each strength is marked on the white side of the film with an identifying number. ONSOLIS is available in 200 mcg, 400 mcg, 600 mcg, 800 mcg, and 1200 mcg strengths [see Storage and Handling].
Storage And Handling
ONSOLIS is supplied in individually-sealed child-resistant foil packages. The amount of fentanyl contained in ONSOLIS can be fatal to a child. The entire ONSOLIS film should be used immediately after opening the child-resistant package. Patients and their caregivers must be instructed to keep ONSOLIS out of the reach of children [see BOXED WARNING - WARNINGS: Importance of Proper Patient Selection and Potential For Abuse, WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION].
Store at 20-25°C (68-77°F) with excursions permitted between 15-30°C (59-86°F) until ready to use (see USP Controlled Room Temperature). Protect ONSOLIS from freezing and moisture. Do not use if the foil package has been opened.
Disposal Of ONSOLIS
Patients and members of their household must be instructed to dispose of any unneeded films remaining from a prescription as soon as they are no longer needed. The ONSOLIS film should be removed from its foil package and dropped into the toilet. This should be repeated for each ONSOLIS film. Flush the toilet after all unneeded films have been put into the toilet. Do not flush the ONSOLIS foil packages or cartons down the toilet.
Instructions for disposal are also included in Disposal of Unneeded ONSOLIS Films and in the Medication Guide.
If additional assistance is required, call Meda Pharmaceuticals Inc. at 1-800-526-3840.
ONSOLIS is supplied in five dosage strengths. Each film is individually wrapped in a child-resistant, protective foil package. These foil packages are packed 30 per carton.
ONSOLIS is a bilayer film with one white side and one pink side. The white side is debossed with an identifying number. The dosage strength of each film is indicated by the code on the white side of the film, and the dosage strength is marked on the foil package and the 30-film carton. See package and carton for product information.
|ONSOLIS Dosage Strength (fentanyl base)||Deboss Code(s)||Package Color *||NDC Number|
|200 mcg||2||Bright Blue Aqua||NDC 0037-5200-30|
|400 mcg||4||Bright Magenta||NDC 0037-5400-30|
|600 mcg||6||Bright Lime Green||NDC 0037-5600-30|
|800 mcg||8||Bright Orange||NDC 0037-5800-30|
|1200 mcg||12||Bright Purple||NDC 0037-5120-30|
|* Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.|
Last reviewed on RxList: 1/26/2015
This monograph has been modified to include the generic and brand name in many instances.
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