Remleas Special Precautions

Somnolence: REMLEAS can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by REMLEAS [see Adverse Reactions].
QT Prolongation: REMLEAS may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. In patients taking a strong CYP2D6 or CYP3A4 inhibitor, or who are CYP2D6 poor metabolizers, REMLEAS concentrations may be higher and QT prolongation clinically significant [see Pharmacology: Pharmacodynamics under Actions]. For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary. For patients taking a strong CYP3A4 inhibitor, reduce the dose of REMLEAS to 40 mg once daily [see Dosage & Administration]. REMLEAS should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
Parkinsonism: REMLEAS may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. In the 3 placebo-controlled clinical studies in patients with tardive dyskinesia, the incidence of parkinson-like adverse events was 3% of patients treated with REMLEAS and <1% of placebo-treated patients. Postmarketing safety reports have described parkinson-like symptoms, some of which were severe and required hospitalization. In most cases, severe parkinsonism occurred within the first two weeks after starting or increasing the dose of REMLEAS. Associated symptoms have included falls, gait disturbances, tremor, drooling and hypokinesia. In cases in which follow-up clinical information was available, parkinson-like symptoms were reported to resolve following discontinuation of REMLEAS therapy. Reduce the dose or discontinue REMLEAS treatment in patients who develop clinically significant parkinson-like signs or symptoms.
Effects on ability to drive and use machines: REMLEAS may impair patient's ability to drive or operate hazardous machinery [see Precautions].