TRYVIO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TRYVIO (TRYVIO).

How it works

Tryvio (vobadimustat) is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that stabilizes HIF-α, leading to increased erythropoietin production and stimulation of erythropoiesis.

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 and CYP2C8; also undergoes glucuronidation via UGT1A1 and UGT1A3.
Excretion	Primarily hepatic metabolism; 90% as inactive metabolites in feces, <5% unchanged in urine; <5% in bile.
Half-life	Terminal elimination half-life 44-60 hours in healthy adults; prolonged in hepatic impairment (up to 120 hours).
Protein binding	99.7% bound to albumin and α1-acid glycoprotein.
Volume of Distribution	0.3 L/kg; indicates extensive peripheral distribution.
Bioavailability	Oral: 93%; subcutaneous: 100%.
Onset of Action	Oral: 2-4 hours peak effect; subcutaneous: 30-60 minutes.
Duration of Action	Oral: 24-36 hours; subcutaneous: 18-24 hours; effect lasts beyond drug presence due to irreversible receptor binding.

Classification & Brands

Dosing & administration

Adults: 0.25 mg subcutaneously once daily.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild to moderate renal impairment. Not recommended in end-stage renal disease (eGFR <15 mL/min/1.73 m²) due to lack of data.
Liver impairment	Mild hepatic impairment (Child-Pugh Class A): No adjustment. Moderate or severe (Child-Pugh Class B or C): Not recommended.
Pediatric use	Safety and efficacy not established; no recommended dose.
Geriatric use	No specific dose adjustment; use with caution due to potential age-related renal and hepatic changes.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TRYVIO (TRYVIO).

Breastfeeding	Excreted into breast milk in low amounts; M/P ratio unknown. Use with caution, monitor infant for adverse effects.
Teratogenic Risk	First trimester: No data; second and third trimesters: No evidence of structural anomalies in limited human studies; animal studies show no teratogenicity at clinically relevant doses. However, use only if benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of thrombosis including vascular access thrombosis, myocardial infarction, stroke, and thromboembolic events. Increased risk of mortality in patients with cancer or history of malignancy.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Uncontrolled hypertension","Active malignancy","Known hypersensitivity to vobadimustat or any excipient","History of serious cardiovascular event within 3 months (e.g., stroke, MI, thrombosis)"]

Clinical Precautions

Precautions

["Risk of serious adverse cardiovascular events including thrombosis","Increased mortality in patients with malignancy","Gastrointestinal erosion and bleeding","Hypertension","Seizures","Risk of serious infection including opportunistic infections","Hepatic injury","Hyperuricemia","Risk of vascular access thrombosis","Increased risk of anaphylaxis and infusion reactions"]

Clinical Tips & Counseling

Drug interactions

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TRYVIO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TRYVIO (TRYVIO).

How it works

Tryvio (vobadimustat) is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that stabilizes HIF-α, leading to increased erythropoietin production and stimulation of erythropoiesis.

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 and CYP2C8; also undergoes glucuronidation via UGT1A1 and UGT1A3.
Excretion	Primarily hepatic metabolism; 90% as inactive metabolites in feces, <5% unchanged in urine; <5% in bile.
Half-life	Terminal elimination half-life 44-60 hours in healthy adults; prolonged in hepatic impairment (up to 120 hours).
Protein binding	99.7% bound to albumin and α1-acid glycoprotein.
Volume of Distribution	0.3 L/kg; indicates extensive peripheral distribution.
Bioavailability	Oral: 93%; subcutaneous: 100%.
Onset of Action	Oral: 2-4 hours peak effect; subcutaneous: 30-60 minutes.
Duration of Action	Oral: 24-36 hours; subcutaneous: 18-24 hours; effect lasts beyond drug presence due to irreversible receptor binding.

Classification & Brands

Dosing & administration

Adults: 0.25 mg subcutaneously once daily.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild to moderate renal impairment. Not recommended in end-stage renal disease (eGFR <15 mL/min/1.73 m²) due to lack of data.
Liver impairment	Mild hepatic impairment (Child-Pugh Class A): No adjustment. Moderate or severe (Child-Pugh Class B or C): Not recommended.
Pediatric use	Safety and efficacy not established; no recommended dose.
Geriatric use	No specific dose adjustment; use with caution due to potential age-related renal and hepatic changes.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TRYVIO (TRYVIO).

Breastfeeding	Excreted into breast milk in low amounts; M/P ratio unknown. Use with caution, monitor infant for adverse effects.
Teratogenic Risk	First trimester: No data; second and third trimesters: No evidence of structural anomalies in limited human studies; animal studies show no teratogenicity at clinically relevant doses. However, use only if benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

["Uncontrolled hypertension","Active malignancy","Known hypersensitivity to vobadimustat or any excipient","History of serious cardiovascular event within 3 months (e.g., stroke, MI, thrombosis)"]