| Important Precautions | Precaution on Special Populations | Precaution Concerning Dosage & Administration | Precaution Concerning Use |
Important Precautions
- This drug may induce daytime somnolence or sudden onset of sleep with no signs. Therefore, patients should be cautioned against engaging in dangerous activities such as driving a car, operating machinery, or working at heights under administration of this drug.
- Safinamide may induce impulse-control disorder such as pathological gambling (persistent repetition of gambling despite socially adverse consequences including disruption of personal life), pathological hypersexuality, compulsive shopping, and hyperphagia. Therefore, if any of such symptoms is observed, appropriate measures including discontinuation of treatment should be taken. In addition, patients and their family members should be informed of these symptoms of impulse-control disorder.
- Safinamide may induce orthostatic hypotension or hypotension. Therefore, if dizziness, lightheadedness, wobble, or any other symptoms which are suspected orthostatic hypotension or hypotension are observed, appropriate measures including discontinuation of treatment should be taken. Patients with Parkinson’s disease are at an increased risk of falls associated with motor dysfunction and, if orthostatic hypotension occurs, they may experience fracture and/or trauma due to a fall.
Precautions on Special Populations
Patients with complication or history of diseases, etc.
Patients with active or a history of retina-related disease
Patients with retinal degeneration, uveitis, hereditary retinopathy, or severe progressive diabetic retinopathy, patients with a history of eye disorders that are highly likely to affect the retina (eg, retinitis pigmentosa, any form of active retinopathy, family history of hereditary retinal disease), and patients with albinism should be regularly monitored for any change in acuity- and field related symptoms. Such patients were excluded from clinical studies. In animals, a repeated-dose oral toxicity study (rats) and carcinogenicity studies (mice and rats) demonstrated dose- and duration-dependent retinal degeneration and exacerbation due to light exposure in rats. This change was not observed in monkeys.
Patients with Hepatic Impairment
Patients with severe hepatic impairment (Child-Pugh C)
Safinamide should not be administered. Blood concentration of this drug may increase. Such patients were excluded from clinical studies.
Patients with moderate hepatic impairment (Child-Pugh B)
Blood concentration of this drug may increase.
Patients with Reproductive Potential
Women of childbearing potential should be instructed to use appropriate contraception during treatment with this drug and for a certain period of time after completion of treatment with this drug. In animals (rats), a reproductive and developmental toxicity study showed mild decreases in the corpora lutea count and the number of implantation sites in female rats.
Pediatric Use
There was no clinical study conducted in children.
Precaution Concerning Dosage & Administration
- Co-administration with levodopa-containing products may cause adverse reactions of levodopa origin (dyskinesia, etc.). Therefore, patients should be closely monitored when the dosing of this drug is started or the dose of this drug is increased, and if such adverse reactions occur, the dose of this drug or levodopa-containing products should be adjusted.
- The dose of safinamide should not exceed 50 mg daily for patients with moderate hepatic impairment (Child-Pugh B).
Precaution Concerning Use
Precautions Concerning the Dispensing of the Drug
For drugs that are dispensed in a press-through package (PTP), instruct patients to remove the drug from the package before use. If the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa and cause a perforation, resulting in severe complications including mediastinitis.