Generic Name and Formulations:
Fentanyl (as citrate) 200mcg, 400mcg, 600mcg, 800mcg, 1200mcg; buccal soluble film.
- FDA Approves Single REMS for Transmucosal Immediate-Release Fentanyl Products
- Preventing Inappropriate Opioid Use with REMS (Risk Evaluation and Mitigation Strategy)
- Onsolis available soon for breakthrough cancer pain
Indications for ONSOLIS:
Breakthrough pain, only in opioid-tolerant patients who are already receiving and are tolerant to continuous (not "as needed") opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week.
≥18yrs: Do not cut film. Place on moistened area inside cheek; wait at least 5min before drinking liquids, do not manipulate film or eat until film has dissolved. Titrate with 200mcg film(s) then switch to one film at the titrated dose. Initially 200mcg; titrate in 200mcg increments, up to max 4x200mcg films or one 1200mcg film. Max one dose/episode; no more than 4 doses/day at least 2hrs apart. If titrating above 4x200mcg films, switch to one 1200mcg film; max 1200mcg/dose. Do not convert from other fentanyl products on a mcg-mcg basis. Do not interchange with other fentanyl products. Do not put one film on top of another. May use another rescue drug 30min after film placement if needed.
<18yrs: not recommended.
Not for opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER).
Respiratory disorders or depression. Head injury. Increased intracranial pressure. Bradycardia. Impaired pulmonary, cardiovascular, renal, or hepatic function. Store and dispose of properly. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.
Not recommended within 14 days of MAOIs . Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, skeletal muscle relaxants, antihistamines, hypnotics). Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, aprepitant, protease inhibitors, nefazodone, verapamil, diltiazem). Antagonized by CYP3A4 inducers (eg, barbiturates, efavirenz, modafinil, nevirapine, anticonvulsants, pioglitazone, troglitazone, rifabutin, rifampin, St. John's wort).
GI upset, dizziness, dehydration, dyspnea, somnolence; respiratory or circulatory depression, hypotension, shock, drowsiness, anticholinergic effects, others.
Available by restricted distribution program. Call (877) 4ONSOLIS or visit www.OnsolisFocus.com to enroll. Caution patients and caregivers in proper handling and disposal; may be fatal to children.
- 200mcg films (Qty:30)
- appx. price $664.00