Equfina Special 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 [see Clinically Significant Adverse Reactions: Somnolence (1.9%), sudden onset of sleep (0.4%) under Adverse Reactions].
Equfina 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 [see Clinically Significant Adverse Reactions: Impulse-control disorder (0.2%) under Adverse Reactions].
Equfina 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 [see Other Adverse Reactions under Adverse Reactions].
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): Equfina should not be administered. Blood concentration of this drug may increase. Such patients were excluded from clinical studies [see Contraindications].
Patients with moderate hepatic impairment (Child-Pugh B): Blood concentration of this drug may increase [see Precautions Concerning Dosage and Administration under Dosage & Administration and Pharmacology: Pharmacokinetics: Patients with Specific Backgrounds: Patients with Hepatic Impairment under Actions].
Patients with Reproductive Potential: See Use in Pregnancy & Lactation section for further information.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: There was no clinical study conducted in children.