TONMYA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TONMYA (TONMYA).
Topoisomerase II inhibitor; induces DNA double-strand breaks and apoptosis in cancer cells.
| Metabolism | Hepatic via CYP3A4 and glucuronidation; major metabolites are etoposide catechol and O-demethylated species. |
| Excretion | Renal: ~70% unchanged; biliary/fecal: ~30% as metabolites |
| Half-life | Terminal half-life: 12-18 hours (prolonged in renal impairment; dose adjustment required for CrCl <30 mL/min) |
| Protein binding | 95% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | Vd: 0.8-1.2 L/kg (extensive tissue distribution, including CNS) |
| Bioavailability | Oral: 60-70% (first-pass metabolism) |
| Onset of Action | Oral: 1-2 hours; IV: 5-10 minutes |
| Duration of Action | Dose-dependent: 12-24 hours for most indications; extended in hepatic impairment |
Adults: 500 mg orally twice daily with food.
| Dosage form | TABLET |
| Renal impairment | GFR 30-50 mL/min: 500 mg once daily; GFR 15-29 mL/min: 250 mg once daily; GFR <15 mL/min or on hemodialysis: 250 mg every 48 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: use with caution, maximum 250 mg once daily. |
| Pediatric use | Children 2-12 years: 10 mg/kg orally twice daily; maximum 500 mg per dose. |
| Geriatric use | No specific dose adjustment; monitor renal function and cognitive status. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TONMYA (TONMYA).
| Breastfeeding | There are no data on the presence of TONMYA in human milk, effects on the breastfed infant, or milk production. Due to potential serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose. The M/P ratio is unknown. |
| Teratogenic Risk | TONMYA is contraindicated in pregnancy due to documented teratogenicity. First trimester exposure is associated with major congenital malformations including neural tube defects, cardiovascular anomalies, and orofacial clefts. Second and third trimester exposure may cause fetal growth restriction, oligohydramnios, and fetal renal impairment. |
■ FDA Black Box Warning
Risk of secondary malignancies (e.g., acute myeloid leukemia) especially with long-term use or combination chemotherapy.
| Serious Effects |
Severe hepatic impairment (Child-Pugh C), hypersensitivity to etoposide or any excipient, and concomitant use with yellow fever vaccine.
| Precautions | Myelosuppression (dose-limiting), hypersensitivity reactions including anaphylaxis, hepatotoxicity, hypotension with rapid infusion, and risk of secondary leukemia. |
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| Fetal Monitoring | Monitor maternal blood pressure, renal function, and liver function tests monthly. Perform serial fetal ultrasounds every 4 weeks to assess growth, amniotic fluid volume, and fetal anatomy. Consider fetal echocardiography at 18-22 weeks gestation. Monitor for maternal thyroid dysfunction and electrolyte imbalances. |
| Fertility Effects | Based on animal studies, TONMYA may impair male and female fertility. In humans, oligospermia and amenorrhea have been reported. These effects are generally reversible upon discontinuation. Preclinical data indicate reduced ovarian and testicular weights and impaired spermatogenesis. |