Remleas

Remleas

valbenazine

Manufacturer:

Neurocrine Biosciences

Distributor:

Pharmaforte

Marketer:

Mitsubishi Tanabe Pharma
Concise Prescribing Info
Contents
Valbenazine tosylate
Indications/Uses
Dosage/Direction for Use
Adult Initially 40 mg once daily, increase to 80 mg once daily after 1 wk. May consider continuation of 40 mg once daily for some patients. Patient receiving strong CYP3A4 & CYP2D6 inhibitors & those CYP2D6 poor metabolizers 40 mg once daily. Moderate or severe hepatic impairment (Child-Pugh score 7-15) 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
May prolong QT interval. Avoid use in patients w/ congenital long QT syndrome or w/ arrhythmias associated w/ prolonged QT interval; assess QT interval before increasing the dosage. May cause parkisonism in patients w/ tardive dyskinesia. Reduce dose or discontinue treatment in patients who develop clinically significant parkinson-like signs or symptoms. Not recommended to use concomitantly w/ strong CYP3A4 inducers. Possible somnolence; may impair ability to drive or operate hazardous machinery. Pregnancy. Advise not to breastfeed during treatment & for 5 days after final dose. Ped patients.
Drug Interactions
May increase risk of AR eg, serotonin syndrome or attenuated effect of Remleas w/ MAOIs (eg, isocarboxazid, phenelzine, selegiline). Increased Cmax & AUC w/ strong CYP3A4 (eg, itraconazole, ketoconazole, clarithromycin) & CYP2D6 (eg, paroxetine, fluoxetine, quinidine) inhibitors. Decreased exposure w/ strong CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, St. John's wort). Increased digoxin levels.
MIMS Class
Neurodegenerative Disease Drugs / Neuromuscular Disorder Drugs
ATC Classification
N07XX13 - valbenazine ; Belongs to the class of other nervous system drugs.
Presentation/Packing
Form
Remleas hard cap 40 mg
Packing/Price
1 × 30's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in