TRYVIO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRYVIO (TRYVIO).
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.
| 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. |
| Molecular Weight | 517 |
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. |
| 1st trimester | Avoid use during first trimester due to risk of teratogenicity; animal studies show fetal harm. |
| 2nd trimester | Use only if potential benefit justifies risk to fetus; may cause oligohydramnios and fetal renal impairment. |
| 3rd trimester | May cause premature closure of ductus arteriosus and oligohydramnios; avoid after 30 weeks gestation. |
Clinical note
Comprehensive clinical and safety monograph for TRYVIO (TRYVIO).
| Placental transfer | Crosses placenta in animal studies; human data limited but predicted to transfer due to low molecular weight. |
| Breastfeeding | TRYVIO is excreted in human milk in low concentrations; monitor infant for diarrhea and rash due to TKI effects. Use with caution. |
| Lactation Rating |
■ 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.
| Serious Effects |
Hypersensitivity to TRYVIO or any excipientPregnancy (unless benefit outweighs risk)
| 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 |
| Food/Dietary | Avoid alcohol as it may increase the risk of ketoacidosis. No specific food interactions; take with or without food. Maintain adequate hydration. |
Loading safety data…
| L3 (Moderately Safe) |
| 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 | Monitor maternal vital signs, renal function, and liver enzymes; fetal monitoring (ultrasound) in late pregnancy if indicated. |
| Fertility Effects | No known effect on fertility in animal studies; human data insufficient. |
| Clinical Pearls | TRYVIO (bexagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Initiate only if eGFR ≥30 mL/min/1.73 m²; discontinue if eGFR persistently below 30. Monitor for volume depletion in elderly, patients on diuretics, or with low blood pressure. Assess for ketoacidosis even if blood glucose is not markedly elevated. Avoid in patients with type 1 diabetes or history of diabetic ketoacidosis. Check renal function before initiation and periodically thereafter. Can cause genital mycotic infections; counsel on hygiene. May increase LDL cholesterol; monitor lipid panel. |
| Patient Advice | Take TRYVIO once daily with or without food. · Drink plenty of fluids to prevent dehydration. · Report symptoms of urinary tract or genital yeast infections (burning, itching, discharge). · Seek immediate medical attention for signs of ketoacidosis: nausea, vomiting, abdominal pain, confusion, unusual fatigue, or difficulty breathing. · Do not use if you have type 1 diabetes or a history of diabetic ketoacidosis. · Avoid alcohol consumption as it may increase the risk of ketoacidosis. · Monitor blood glucose and ketone levels as directed by your healthcare provider. · Inform all healthcare providers that you are taking TRYVIO, especially before surgery or procedures. |