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ONSOLIS

Last Updated: November 25, 2009

Manufacturer:

Meda Pharmaceuticals

Pharmacological Class:

Opioid analgesic

Active Ingredient(s):

Fentanyl (as citrate) 200mcg, 400mcg, 600mcg, 800mcg, 1200mcg; buccal soluble film.

Indication(s):

Breakthrough pain, only in opioid-tolerant patients who are already receiving and are tolerant to continuous (not prn) 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.

Pharmacology:

Onsolis is an oral transmucosal form of the potent opioid analgesic, fentanyl. It has two layers: a pink bioadhesive layer that contains the active ingredient, and a white inactive layer. The amount of fentanyl delivered is proportional to the surface area of the film. Like other pure opioid agonists, fentanyl acts on the mu-receptors in the CNS to produce analgesia and CNS depression. It also causes miosis and reduced gastrointestinal motility.

The absorption of fentanyl from this product is a combination of an initial rapid transmucosal delivery and a more prolonged absorption of swallowed drug from the GI tract. If a film is chewed and swallowed, it will likely result in lower peak concentrations and lower bioavailability than if used as directed.

Legal Classification:

CII

Adults:

≥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 4 x 200mcg films or one 1200mcg film. Max one dose/episode; no more than 4 doses/day at least 2hrs apart. If titrating above 4 x 200mcg 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.

Children:

<18yrs: not recommended.

Contraindication(s):

Not for opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER).

Warnings/Precautions:

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.

Interaction(s):

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).

Adverse Reaction(s):

GI upset, dizziness, dehydration, dyspnea, somnolence; respiratory or circulatory depression, hypotension, shock, drowsiness, anticholinergic effects, others.

Notes:

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.