Increased Dyskinesia-Free ON Time

ZELAPAR Increased Dyskinesia-Free ON Time

Many patients experience dyskinesia with levodopa therapy¹

More than 25% after 13 to 24 months
Nearly 40% by years 4 to 6

Adding ZELAPAR gave patients an average of 1.8 hours more dyskinesia-free ON time vs 0.4 hours more with placebo^2,3

In a multicenter, randomized placebo-controlled trial (N=140), 94 patients were randomized to ZELAPAR and 46 to placebo.³

Patients treated with ZELAPAR received a daily dose of 1.25 mg for the first 6 weeks and 2.5 mg for the last 6 weeks
Patients were all treated with concomitant levodopa/carbidopa products and could additionally have been taking concomitant dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial; catechol-O-methyltransferase (COMT) inhibitors were not allowed
Dose reductions of levodopa/carbidopa were allowed during this study only if dopaminergic side effects, including dyskinesia and hallucinations, emerged; no dose increases were allowed
ON time and dyskinesia-free ON time were secondary efficacy end points

If you have any questions about ZELAPAR and would like to contact us, please call Customer Service at 1-800-556-1937 or e-mail pharmcs@valeant.com.

IMPORTANT SAFETY INFORMATION

Indication

Zelapar is indicated as an adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this strategy. There is no evidence from controlled studies that Zelapar has any beneficial effect in the absence of concurrent levodopa therapy.

Important Safety Information

Zelapar is contraindicated in patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar. Zelapar is also contraindicated for use with meperidine and other selegiline products; at least 14 days should elapse between discontinuation of Zelapar and beginning these therapies. Zelapar should not be administered with the analgesic agents tramadol, methadone and propoxyphene, or with the antitussive agent dextromethorphan. In general, treatment with tricyclic antidepressants, SSRIs, and SNRIs should be avoided in combination with Zelapar.

Daily doses of Zelapar should not exceed 2.5 mg/day because of the risks associated with nonselective inhibition of MAO.

In clinical trials, the incidence of adverse orthostatic hypotension was higher in geriatric patients but not in non-geriatric patients. Zelapar may potentiate the dopaminergic side effects of levodopa and may cause or worsen preexisting dyskinesia. Decreasing the dose of levodopa may improve this side effect. Zelapar should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

The most common adverse events in controlled trials were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis and dyspepsia.

Click here for full prescribing information.

Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord. 2001;16(3):448-458.
Tetrud JW, Koller WC. A novel formulation of selegiline for the treatment of Parkinson's disease. Neurology. 2004;63(7 suppl 2):S2-S6.
Waters CH, Sethi KD, Hauser RA, Molho E, Bertoni JM; Zydis Selegiline Study Group. Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: a 3-month, randomized, placebo-controlled study. Mov Disord. 2004;19(4):426-432.

Site Map | Privacy & Legal Statement | Contact Us | Valeant