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RASAGILINE MYLAN is a brand name for Rasagiline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rasagiline Mylan is indicated in adults for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The recommended dose of rasagiline is 1 mg (one tablet of Rasagiline Mylan) once daily, to be taken with or without levodopa. 2). 3). Rasagiline use in patients with moderate hepatic impairment should be avoided. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment.
2). Renal impairment No special precautions are required in patients with renal impairment. Paediatric population The safety and efficacy of rasagiline in children and adolescents have not been established. There is no relevant use of rasagiline in the paediatric population in the indication Parkinson’s disease.
Method of administration For oral use. Rasagiline may be taken with or without food.
8. Serious adverse reactions have been reported with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors. Therefore, in view of the MAO inhibitory activity of rasagiline, antidepressants should be administered with caution.
Agents that affect CYP1A2 activity In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline. CYP1A2 inhibitors Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%.
Co-administration of rasagiline and theophylline (a substrate of CYP1A2) did not affect the pharmacokinetics of either product. Thus, potent CYP1A2 inhibitors may alter rasagiline plasma levels and should be administered with caution.
CYP1A2 inducers There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to induction of the metabolising enzyme CYP1A2. 5 ng/ml in Parkinson’s disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
3). Levodopa and other Parkinson’s disease medicinal products In Parkinson’s disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%. 5 or 1 mg/day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
5). At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline. At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
5). Concomitant use of rasagiline and levodopa Since rasagiline potentiates the effects of levodopa, the adverse reactions of levodopa may be increased and pre-existing dyskinesia exacerbated. Decreasing the dose of levodopa may ameliorate this adverse reaction.
There have been reports of hypotensive effects when rasagiline is taken concomitantly with levodopa. Patients with Parkinson’s disease are particularly vulnerable to the adverse reactions of hypotension due to existing gait issues. Dopaminergic effects Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with rasagiline. 7). Impulse control disorders (ICDs) ICDs can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Similar reports of ICDs have also been received post-marketing with rasagiline. Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware of the behavioural symptoms of impulse control disorders that were observed in patients treated with rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying.
Melanoma A retrospective cohort study suggested a possibly increased risk of melanoma with the use of rasagiline, especially in patients with longer duration of rasagiline exposure and/or with the higher cumulative dose of rasagiline.
1. g. St. 5). At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine. Severe hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6 Fertility, pregnancy and lactation Pregnancy There are no data from the use of rasagiline in pregnant women. 3). As a precautionary measure, it is preferable to avoid the use of rasagiline during pregnancy. Breast-feeding Non-clinical data indicate that rasagiline inhibits prolactin secretion and thus, may inhibit lactation.
It is not known whether rasagiline is excreted in human milk. Caution should be exercised when rasagiline is administered to a breast-feeding mother. Fertility No human data on the effect of rasagiline on fertility are available. Non-clinical data indicate that rasagiline has no effect on fertility.
7 Effects on ability to drive and use machines In patients experiencing somnolence/sudden sleep episodes, rasagiline may have major influence on the ability to drive and use machines. Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that rasagiline does not affect them adversely.
g. operating machines) until they have gained sufficient experience with rasagiline and other dopaminergic medications to gauge whether or not it affects their mental and/or motor performance adversely. g. ) are experienced at any time during treatment, the patients should not drive or participate in potentially dangerous activities.
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 rasagiline. g. g. 4). 8 Undesirable effects Summary of the safety profile In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
These adverse reactions were not associated with an elevated rate of drug discontinuation. Tabulated list of adverse reactions Adverse reactions are listed below in Tables 1 and 2 by system organ class and frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Monotherapy The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies, in patients receiving 1 mg/day rasagiline. System Organ Class Very common Common Uncommon Not known Infections and infestations Influenza Neoplasms […]
Any suspicious skin lesion should be evaluated by a specialist. Patients should therefore be advised to seek medical review if a new or changing skin lesion is identified. Hepatic impairment Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment.
Rasagiline use in patients with moderate hepatic impairment should be avoided. 2).