Miscellaneous neurodegenerative disorders:

Indications for INGREZZA:

Tardive dyskinesia.

Adult Dosage:

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 or CYP2D6 inhibitors, or CYP2D6 poor metabolizers: 40mg once daily.

Children Dosage:

Not established.

INGREZZA Warnings/Precautions:

Somnolence. Avoid in congenital long QT syndrome or arrhythmias associated with a prolonged QT interval. Known CYP2D6 poor metabolizers. Parkinsonism: reduce dose or discontinue if significant signs/symptoms develop. Moderate or severe hepatic impairment: reduce dose (see Adults). Pregnancy. Nursing mothers: not recommended (during and for 5 days after final dose).

INGREZZA Classification:

Vesicular monoamine transporter 2 (VMAT2) inhibitor.

INGREZZA Interactions:

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.

Adverse Reactions:

Somnolence, anticholinergic effects, balance disorders/fall, headache, akathisia, vomiting, nausea, arthralgia.

Metabolism:

CYP3A4/5 (primarily), CYP2D6.

Drug Elimination:

Renal (major), fecal. Half-life: 15–22 hours.

Generic Drug Availability:

NO

How Supplied:

Caps 40mg—30, 90; 80mg—30; Initiation pack (4-week)—28 (7x40mg + 21x80mg)