AZILECT (rasagiline mesylate) is indicated for the treatment of the signs and symptoms of idiopathic Parkinsons disease as initial monotherapy and as adjunct therapy to levodopa.

The effectiveness of AZILECT was demonstrated in patients with early Parkinsons disease who were receiving AZILECT as monotherapy and who were not receiving any concomitant dopaminergic therapy. The effectiveness of AZILECT as adjunct therapy was demonstrated in patients with Parkinsons disease who were treated with levodopa.

Tyramine-rich foods, beverages, or dietary supplements and amines (from over-the-counter cough/cold medications) should be avoided to prevent a possible hypertensive crisis/"cheese reaction" during rasagiline treatment. (SEE WARNINGS, Need for Restriction of Dietary Tyramine and Amines Contained in Medications)

Monotherapy

The recommended AZILECT dose for the treatment of Parkinsons disease patients is 1 mg administered once daily.

The recommended initial dose is 0.5 mg administered once daily. If a sufficient clinical response is not achieved, the dose may be increased to 1 mg administered once daily.

Change of levodopa dose in adjunct therapy: When AZILECT is used in combination with levodopa, a reduction of the levodopa dosage may be considered based upon individual response. During the controlled trials of AZILECT as adjunct therapy to levodopa, levodopa dosage was reduced in some patients. In clinical studies, dosage reduction of levodopa was allowed within the first 6 weeks if dopaminergic side effects, including dyskinesia and hallucinations, emerged. In Study 1, levodopa dosage reduction occurred in 8 % of patients in the placebo group and in 16 % and 17 % of patients in the 0.5 mg/day and 1 mg/day rasagiline groups, respectively. In those patients who had levodopa dosage reduced, the dose was reduced on average by about 7 %, 9%, and 13 % in the placebo, 0.5 mg/day, and 1 mg/day groups, respectively. In Study 2, levodopa dosage reduction occurred in 6 % of patients in the placebo group and in 9 % in the rasagiline 1 mg/day group. In patients who had their levodopa dosage reduced, the dose was reduced on average by about 13% and 11 % in the placebo and the rasagiline groups, respectively.

Patients with Hepatic Impairment: AZILECT plasma concentrations will increase in patients with hepatic impairment. Patients with mild hepatic impairment should use 0.5 mg daily of AZILECT. AZILECT should not be used in patients with moderate or severe hepatic impairment (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency and WARNINGS, Hepatic Insufficiency).

Patients Taking Ciprofloxacin and Other CYP1A2 Inhibitors: Rasagiline plasma concentrations are expected to double in patients taking concomitant ciprofloxacin and other CYP1A2 inhibitors. Therefore, patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should use 0.5 mg daily of AZILECT. AZILECT (See CLINICAL PHARMACOLOGY, Drug-Drug Interaction Ciprofloxacin and Effect of other drugs on the metabolism of AZILECT; and WARNINGS, Ciprofloxacin and Other CYP1A2 Inhibitors.)

AZILECT 0.5 mg Tablets:

White to off-white, round, flat, beveled tablets, debossed with "GIL 0.5" on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 68546-229-56).

AZILECT 1 mg Tablets:

White to off-white, round, flat, beveled tablets, debossed with "GIL 1" on one side and plain on the other side.

Supplied as bottles of 30 tablets (NDC 68546-142-56).

Storage: Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

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