VOYXACT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VOYXACT (VOYXACT).

How it works

GABAA receptor positive allosteric modulator; a neuroactive steroid that potentiates GABAergic inhibition.

What the body does with it

Metabolism	Primarily via CYP3A4 and CYP3A5; also undergoes aldo-keto reductase (AKR1C1, AKR1C2, AKR1C3) metabolism.
Excretion	Primarily hepatic metabolism via CYP3A4, with 53% of the dose excreted in feces (mainly as metabolites) and 27% in urine (mostly as metabolites); less than 1% excreted unchanged in urine.
Half-life	Terminal elimination half-life approximately 37 hours (range 24-51 hours), supporting once-daily dosing with steady-state achieved in 5-8 days.
Protein binding	Approximately 99% bound to plasma proteins, primarily albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Apparent volume of distribution 9-12 L/kg, indicating extensive extravascular distribution.
Bioavailability	Oral bioavailability approximately 90% with minimal food effect.
Onset of Action	Oral administration: clinical improvement observed within 2-4 weeks, with maximal effect at 8-12 weeks.
Duration of Action	Sustained over 24 hours with once-daily dosing; steady-state conditions maintained with regular administration.

Classification & Brands

Dosing & administration

Adults: 200 mg orally once daily with food.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). For severe renal impairment (CrCl <30 mL/min), reduce dose to 100 mg once daily. For end-stage renal disease (ESRD) not on dialysis, use is not recommended.
Liver impairment	Child-Pugh A: No dose adjustment. Child-Pugh B: Reduce dose to 100 mg once daily. Child-Pugh C: Not recommended.
Pediatric use	Safety and efficacy not established in pediatric patients under 18 years of age.
Geriatric use	No specific dose adjustment is recommended based on age alone, but monitor renal function and consider renal adjustment criteria if CrCl <30 mL/min.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for VOYXACT (VOYXACT).

Breastfeeding	Contraindicated. M/P ratio unknown; drug likely excreted in breast milk due to small molecular weight. Potential for severe adverse effects in nursing infant.
Teratogenic Risk	Category X: Contraindicated in pregnancy. First trimester: high risk of major congenital malformations (neural tube defects, craniofacial anomalies, cardiac defects). Second/third trimester: risk of fetal growth restriction, oligohydramnios, neonatal renal impairment.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Common Effects	Nausea Vomiting Stomach pain Indigestion Heartburn Loss of appetite Diarrhea
Serious Effects

Absolute Contraindications

Concomitant use with strong CYP3A4 inducers.

Clinical Precautions

Precautions

["Somnolence/sedation","Suicidal thoughts and behaviors","Risk of CNS depression with alcohol or other CNS depressants","Hypersensitivity reactions including angioedema"]

Clinical Tips & Counseling

Drug interactions

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VOYXACT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VOYXACT (VOYXACT).

How it works

GABAA receptor positive allosteric modulator; a neuroactive steroid that potentiates GABAergic inhibition.

What the body does with it

Metabolism	Primarily via CYP3A4 and CYP3A5; also undergoes aldo-keto reductase (AKR1C1, AKR1C2, AKR1C3) metabolism.
Excretion	Primarily hepatic metabolism via CYP3A4, with 53% of the dose excreted in feces (mainly as metabolites) and 27% in urine (mostly as metabolites); less than 1% excreted unchanged in urine.
Half-life	Terminal elimination half-life approximately 37 hours (range 24-51 hours), supporting once-daily dosing with steady-state achieved in 5-8 days.
Protein binding	Approximately 99% bound to plasma proteins, primarily albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Apparent volume of distribution 9-12 L/kg, indicating extensive extravascular distribution.
Bioavailability	Oral bioavailability approximately 90% with minimal food effect.
Onset of Action	Oral administration: clinical improvement observed within 2-4 weeks, with maximal effect at 8-12 weeks.
Duration of Action	Sustained over 24 hours with once-daily dosing; steady-state conditions maintained with regular administration.

Classification & Brands

Dosing & administration

Adults: 200 mg orally once daily with food.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). For severe renal impairment (CrCl <30 mL/min), reduce dose to 100 mg once daily. For end-stage renal disease (ESRD) not on dialysis, use is not recommended.
Liver impairment	Child-Pugh A: No dose adjustment. Child-Pugh B: Reduce dose to 100 mg once daily. Child-Pugh C: Not recommended.
Pediatric use	Safety and efficacy not established in pediatric patients under 18 years of age.
Geriatric use	No specific dose adjustment is recommended based on age alone, but monitor renal function and consider renal adjustment criteria if CrCl <30 mL/min.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for VOYXACT (VOYXACT).

Breastfeeding	Contraindicated. M/P ratio unknown; drug likely excreted in breast milk due to small molecular weight. Potential for severe adverse effects in nursing infant.
Teratogenic Risk	Category X: Contraindicated in pregnancy. First trimester: high risk of major congenital malformations (neural tube defects, craniofacial anomalies, cardiac defects). Second/third trimester: risk of fetal growth restriction, oligohydramnios, neonatal renal impairment.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Common Effects	Nausea Vomiting Stomach pain Indigestion Heartburn Loss of appetite Diarrhea
Serious Effects

Absolute Contraindications

Concomitant use with strong CYP3A4 inducers.

Clinical Precautions

Precautions

["Somnolence/sedation","Suicidal thoughts and behaviors","Risk of CNS depression with alcohol or other CNS depressants","Hypersensitivity reactions including angioedema"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…