ZURZUVAE Capsule Ref.[107395] Active ingredients: Zuranolone

2.1 Recommended Dosage

The recommended dosage of ZURZUVAE is 50 mg taken orally once daily in the evening for 14 days. Administer ZURZUVAE with fat-containing food (e.g., 400 to 1,000 calories, 25% to 50% fat) [see Clinical Pharmacology (12.3)]. If patients experience CNS depressant effects within the 14-day period, consider reducing the dosage to 40 mg once daily in the evening within the 14-day period.

ZURZUVAE can be used alone or as an adjunct to oral antidepressant therapy.

The safety and effectiveness of ZURZUVAE use beyond 14 days in a single treatment course have not been established.

2.2 Dosage Modifications for Concomitant Use with CYP3A4 Inducers or CYP3A4 Inhibitors

CYP3A4 Inducers

Avoid concomitant use of ZURZUVAE with CYP3A4 inducers [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

CYP3A4 Inhibitors

Reduce the ZURZUVAE dosage to 30 mg orally once daily in the evening for 14 days when used concomitantly with a strong CYP3A4 inhibitor [see Drug Interactions (7) and Clinical Pharmacology (12.3)]. No dosage modification is recommended when ZURZUVAE is concomitantly used with a moderate CYP3A4 inhibitor.

2.3 Recommended Dosage in Patients with Hepatic Impairment

The recommended dosage of ZURZUVAE in patients with severe hepatic impairment (Child-Pugh C) is 30 mg orally once daily in the evening for 14 days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. The recommended dosage in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment is the same as those in patients with normal hepatic function.

2.4 Recommended Dosage in Patients with Renal Impairment

The recommended dosage of ZURZUVAE in patients with moderate or severe renal impairment (eGFR <60 mL/min/1.73 m²) is 30 mg orally once daily in the evening for 14 days [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

The recommended dosage in patients with mild renal impairment (eGFR 60 to 89 mL/min/1.73 m²) is the same as those in patients with normal renal function.

2.5 Recommendations Regarding a Missed Dose

If a ZURZUVAE evening dose is missed, take the next dose at the regular time the following evening. Do not take extra capsules on the same day to make up for the missed dose. Continue taking ZURZUVAE once daily until the remainder of the 14-day treatment course is completed.

There was a case of intentional overdose with ZURZUVAE reported during premarketing clinical trials. The patient took 330 mg (6.5 times the maximum recommended dose) of ZURZUVAE and was reported to be in an altered state of consciousness. The event resolved the next day, following treatment with intravenous fluids.

Overdosage with ZURZUVAE may result in excessive CNS depressant effects such as somnolence and disturbance in consciousness. There is no specific antidote for ZURZUVAE overdosage.

Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].