Azilect Rasagiline Mesylate

Brand Name: Azilect

Generic Name: RASAGILINE MESYLATE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2018-10-05

AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).

AZILECT is not a controlled substance.

Studies conducted in mice and rats did not reveal any potential for drug abuse and dependence. Clinical trials have not revealed any evidence of the potential for abuse, tolerance or physical dependence; however, systematic studies in humans designed to evaluate these effects have not been performed.

Studies conducted in mice and rats did not reveal any potential for drug abuse and dependence. Clinical trials have not revealed any evidence of the potential for abuse, tolerance or physical dependence; however, systematic studies in humans designed to evaluate these effects have not been performed.

Hypertension

Advise patients that treatment with recommended doses of AZILECT may be associated with elevations of blood pressure. Tell patients who experience elevation of blood pressure while taking AZILECT to contact their healthcare provider.

The risk of using higher than recommended daily doses of AZILECT should be explained, and a brief description of the tyramine associated hypertensive reaction provided.

Advise patients to avoid certain foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of AZILECT because of the potential for large increases in blood pressure. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Tell patients to inform their physician if they are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and over-the-counter cold medications, since there is a potential for interaction with AZILECT. Because patients should not use meperidine or certain other analgesics with AZILECT, they should contact their healthcare provider before taking analgesics [see Contraindications (4) and Warnings and Precautions (5.2)].

Falling Asleep During Activities of Daily Living and Somnolence

Advise and alert patients about the potential for sedating effects associated with AZILECT and other dopaminergic medications, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. Because somnolence can be a frequent adverse reaction with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with AZILECT and other dopaminergic medications to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Patients should not drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of AZILECT.

Because of possible additive effects, advise patients to exercise caution when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with AZILECT or when taking concomitant medications that increase plasma levels of rasagiline (e.g., ciprofloxacin) [see Warnings and Precautions (5.3)].

Ciprofloxacin or Other CYP1A2 Inhibitors

Inform patients that they should contact their healthcare provider of AZILECT if they take ciprofloxacin or a similar drug that could increase blood levels of rasagiline because of the need to adjust the dose of AZILECT [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)].

Hepatic Impairment

Tell patients who have hepatic problems to contact their healthcare provider regarding possible changes in AZILECT dosing [see Warnings and Precautions (5.5)].

Hypotension / Orthostatic Hypotension

Patients should be advised that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Accordingly, patients should be cautioned against standing up rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially, at the initiation of treatment with AZILECT [see Warnings and Precautions (5.6)].

Dyskinesia

Advise patients taking AZILECT as adjunct to levodopa that there is a possibility of dyskinesia or increased dyskinesia [see Warnings and Precautions (5.7)].

Hallucinations / Psychotic-Like Behavior

Inform patients that hallucinations or other manifestations of psychotic-like behavior can occur when taking AZILECT. Advise patients that, if they have a major psychotic disorder, that AZILECT should not ordinarily be used because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of AZILECT [see Warnings and Precautions (5.8)].

Impulse Control/Compulsive Behaviors

Advise patients that they may experience intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease (including AZILECT). Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges, or other urges while being treated with AZILECT. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking AZILECT. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking AZILECT [see Warnings and Precautions (5.9)].

Withdrawal-Emergent Hyperpyrexia and Confusion

Tell patients to contact their healthcare provider if they wish to discontinue AZILECT [see Warnings and Precautions (5.10)].

Missing Dose

Instruct patients to take AZILECT as prescribed. If a dose is missed, the patient should not double-up the dose of AZILECT. The next dose should be taken at the usual time on the following day.

Marketed by: TEVA Neuroscience, Inc., Overland Park, KS 66211
Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454