Generic Name and Formulations:
Valbenazine 40mg, 80mg; caps.
Neurocrine Biosciences, Inc.
Indications for INGREZZA:
Take with or without food. Initially 40mg once daily; increase to 80mg once daily after 1 week. For some patients, continuation of 40mg once daily may be considered. Moderate or severe hepatic impairment: 40mg once daily. Concomitant with strong CYP3A4 inducers: not recommended. Concomitant with strong CYP3A4 inhibitors: 40mg once daily. Concomitant with strong CYP2D6 inhibitors, CYP2D6 poor metabolizers: consider reducing dose.
Somnolence. Avoid in congenital long QT syndrome or arrhythmias associated with a prolonged QT interval. CYP2D6 poor metabolizers. Severe renal impairment (CrCl <30mL/min): not recommended. Pregnancy. Nursing mothers: not recommended (during and for 5 days after final dose).
Vesicular monoamine transporter 2 (VMAT2) inhibitor.
See Adults. Avoid concomitant with MAOIs (eg, isocarboxazid, phenelzine, selegiline). Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, clarithromycin). May be potentiated by strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine). Antagonized by strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John's wort). Monitor digoxin levels; dose adjustment may be needed.
Somnolence, anticholinergic effects, balance disorders/fall, headache, akathisia, vomiting, nausea, arthralgia.
Caps 40mg—30, 90; 80mg—30