IDVYNSO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IDVYNSO (IDVYNSO).

How it works

IDVYNSO is a selective dopamine D3 receptor antagonist, which modulates dopaminergic neurotransmission in the mesolimbic pathway.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4 and CYP2D6
Excretion	Renal excretion of unchanged drug accounts for approximately 60% of elimination; biliary/fecal excretion accounts for 30%, with the remainder metabolized.
Half-life	Terminal elimination half-life is 12–18 hours, supporting twice-daily dosing in patients with normal renal function.
Protein binding	Approximately 85% bound, primarily to albumin and α1-acid glycoprotein.
Volume of Distribution	Vd = 1.5–2.5 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral: 75–85% (first-pass effect minimal); intravenous: 100%.
Onset of Action	Oral: 1–2 hours; Intravenous: 5–10 minutes.
Duration of Action	Oral: 12–24 hours; Intravenous: 6–12 hours, with dose-dependent prolongation.

Classification & Brands

Dosing & administration

5 mg/kg IV once daily for 14 days; then 2.5 mg/kg IV once daily for 14 days.

Dosage form	TABLET
Renal impairment	CrCl >= 60 mL/min: no adjustment. CrCl 30-59: 2.5 mg/kg IV once daily for 28 days. CrCl < 30: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: 2.5 mg/kg IV once daily for 28 days. Child-Pugh C: not recommended.
Pediatric use	Not approved for pediatric use. Safety and efficacy not established.
Geriatric use	No specific dose adjustment required; monitor renal function due to age-related decline. Use lowest effective dose.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for IDVYNSO (IDVYNSO).

Breastfeeding	Excreted in human milk; M/P ratio not established. Potential for serious adverse reactions in nursing infants; discontinue breastfeeding or discontinue drug.
Teratogenic Risk	Pregnancy Category X. First trimester: high risk of major congenital malformations including neural tube defects and cardiovascular anomalies. Second and third trimesters: risk of fetal growth restriction, oligohydramnios, and premature closure of the ductus arteriosus. Contraindicated in pregnancy.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with strong CYP3A4 inducers. History of QT prolongation or torsade de pointes.

Clinical Precautions

Precautions

May cause QT prolongation; monitor ECG. Risk of extrapyramidal symptoms. Caution in patients with hepatic impairment.

Clinical Tips & Counseling

Drug interactions

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IDVYNSO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IDVYNSO (IDVYNSO).

How it works

IDVYNSO is a selective dopamine D3 receptor antagonist, which modulates dopaminergic neurotransmission in the mesolimbic pathway.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4 and CYP2D6
Excretion	Renal excretion of unchanged drug accounts for approximately 60% of elimination; biliary/fecal excretion accounts for 30%, with the remainder metabolized.
Half-life	Terminal elimination half-life is 12–18 hours, supporting twice-daily dosing in patients with normal renal function.
Protein binding	Approximately 85% bound, primarily to albumin and α1-acid glycoprotein.
Volume of Distribution	Vd = 1.5–2.5 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral: 75–85% (first-pass effect minimal); intravenous: 100%.
Onset of Action	Oral: 1–2 hours; Intravenous: 5–10 minutes.
Duration of Action	Oral: 12–24 hours; Intravenous: 6–12 hours, with dose-dependent prolongation.

Classification & Brands

Dosing & administration

5 mg/kg IV once daily for 14 days; then 2.5 mg/kg IV once daily for 14 days.

Dosage form	TABLET
Renal impairment	CrCl >= 60 mL/min: no adjustment. CrCl 30-59: 2.5 mg/kg IV once daily for 28 days. CrCl < 30: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: 2.5 mg/kg IV once daily for 28 days. Child-Pugh C: not recommended.
Pediatric use	Not approved for pediatric use. Safety and efficacy not established.
Geriatric use	No specific dose adjustment required; monitor renal function due to age-related decline. Use lowest effective dose.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for IDVYNSO (IDVYNSO).

Breastfeeding	Excreted in human milk; M/P ratio not established. Potential for serious adverse reactions in nursing infants; discontinue breastfeeding or discontinue drug.
Teratogenic Risk	Pregnancy Category X. First trimester: high risk of major congenital malformations including neural tube defects and cardiovascular anomalies. Second and third trimesters: risk of fetal growth restriction, oligohydramnios, and premature closure of the ductus arteriosus. Contraindicated in pregnancy.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with strong CYP3A4 inducers. History of QT prolongation or torsade de pointes.

Clinical Precautions

Precautions

May cause QT prolongation; monitor ECG. Risk of extrapyramidal symptoms. Caution in patients with hepatic impairment.

Clinical Tips & Counseling

Drug interactions

Loading safety data…