Zurzuvae

Posology The recommended dose is 50 mg zuranolone (two 25 mg capsules) taken orally once daily for 14 days as a single course of treatment. No data on additional treatment in case of a relapse or an insufficient response to zuranolone are available.

4). If required, dosing may be stopped without down- titration. 1). Zuranolone should be taken in the evening. If an evening dose is missed, the patient should be instructed to take the next dose at their regular time in the evening of the next day.

The patient should not take additional capsules on the same day to make up for the missed dose. The patient should continue taking zuranolone once daily until the full treatment course (14 days) is completed. Concomitant use with strong CYP3A inhibitors The recommended dose is 30 mg taken orally once daily during the 14 day treatment period when used with strong CYP3A inhibitors.

Special populations Renal impairment The recommended dose in patients with moderate (estimated glomerular filtration rate [eGFR] 30 to 59 mL/min) or severe renal impairment (eGFR < 30 mL/min not requiring dialysis) is 30 mg taken orally once daily during the 14 day treatment period.

2). Hepatic impairment The recommended dose in patients with severe hepatic impairment (Child-Pugh class C) is 30 mg taken orally once daily during the 14 day treatment period. 2). Paediatric population The safety and efficacy of Zurzuvae in postpubertal females less than 18 years old have not been established.

No data are available. There is no relevant use of Zurzuvae in prepubertal females. g. 2). Zurzuvae capsules are swallowed whole. 4

2%). 3%). The frequency of zuranolone-treated subjects who discontinued treatment due to ADRs was 2%. These ADRs were somnolence (2%) and sedation (1%). 3%. 1%). Tabulated list of adverse reactions ADRs are presented in the Table 1. The ADRs are listed by system organ class (SOC) and frequency.

Frequency categories were defined according to very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), and not known (cannot be estimated from the available data).

Table 1. 2% of subjects. 3% of sedation events occurring within the first 2 days of treatment. Confusional state Confusional state was reported in 1 subject who received zuranolone 50 mg and resulted in dose reduction. Serious confusional state occurred in 1 subject who received 30 mg and resolved the same day following interruption of treatment, with treatment resuming at a reduced dose.

7 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Impaired ability to drive or engage in potentially hazardous activities Zuranolone impairs the ability to drive due to central nervous system (CNS) depressant effects. Patients should be counselled not to drive or engage in other potentially hazardous activities until at least 12 hours after taking each dose of zuranolone.

7). 8). 5). 5). 5). Abuse potential and dependence Zuranolone has potential for abuse. 5 mg and 3 mg) on positive subjective measures of “drug liking”, “overall drug liking”, “take drug again”, “high”, and “good drug effects”. Based on data from clinical trials, zuranolone has low physical dependence potential.

Caution should be used in individuals with a history of abuse or addiction to alcohol or other substances. Excipients Sodium content This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'.

1. 6).