Approved January 14, 2009

MILNACIPRAN HYDROCHLORIDE
(FDA Category 1S)

SAVELLA(TM) (Forest Pharmaceuticals) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia.

DOSING INFORMATION: The recommended initial 7-day milnacipran hydrochloride dose titration is as follows: 12.5 milligrams (mg) orally once on day 1, 12.5 mg orally twice daily on days 2 and 3, and 25 mg twice daily on days 4 to 7. Following the initial 7-day titration, the recommended maintenance dose is 50 mg orally twice daily. The dose may be increased based on individual tolerability to a maximum dose of 100 mg orally twice daily.

PHARMACOKINETICS: Milnacipran hydrochloride is well absorbed following oral administration, unaffected by food, and reaches maximum concentrations within 2 to 4 hours following a dose. The absolute bioavailability is approximately 85% to 90%. The elimination half-life is 6 to 8 hours excreted primarily by the kidneys. Plasma exposure and half-life are increased in patients with renal impairment and severe hepatic impairment. Caution should be exercised in patients with severe liver dysfunction and dose reduction considered among patients with severe renal impairment (CrCl less than 30 mL/min).

CAUTIONS: Contraindicated in patients receiving concomitant monoamine oxidase inhibitors (MAOIs), within 14 days of discontinuing a MAOI, and in patients with uncontrolled narrow-angle glaucoma. Milnacipran hydrochloride may increase the risk of suicidal ideation, thinking, and behavior in patients age 24 and younger (not indicated in pediatric patients) with major depressive or other psychiatric disorders. Monitor patients of any age for clinical worsening or unusual behavioral changes. Elevated blood pressure and heart rate, hepatotoxicity, and abnormal bleeding have occurred. Use with caution in patients with a history of seizure disorder or obstructive uropathies, elevated ALT and AST, concomitant use of NSAID, aspirin, or other drugs affecting coagulation. The concomitant use of serotonergic drugs is not recommended.

FDA APPROVED INDICATIONS: Milnacipran hydrochloride is indicated for the management of fibromyalgia.