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 |
| Molecular Weight | 396.4 Da |
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 | Contraindicated; risk of fetal nephrotoxicity and oligohydramnios. |
| 2nd trimester | Contraindicated; risk of fetal nephrotoxicity and oligohydramnios. |
| 3rd trimester | Contraindicated; risk of fetal nephrotoxicity and oligohydramnios, premature closure of ductus arteriosus, and pulmonary hypertension. |
Clinical note
Comprehensive clinical and safety monograph for TONMYA (TONMYA).
| Placental transfer | Crosses placenta; documented in human studies with measurable fetal serum concentrations. |
| Breastfeeding | Excreted into breast milk in low amounts but risk of infant renal impairment and gastrointestinal effects. Use caution; alternative preferred. |
| Lactation Rating |
■ FDA Black Box Warning
Risk of secondary malignancies (e.g., acute myeloid leukemia) especially with long-term use or combination chemotherapy.
| Serious Effects |
Hypersensitivity to TONMYASevere renal impairment (eGFR <30 mL/min/1.73m²)Concomitant NSAID useThird trimester of pregnancy
| Precautions | Myelosuppression (dose-limiting), hypersensitivity reactions including anaphylaxis, hepatotoxicity, hypotension with rapid infusion, and risk of secondary leukemia. |
| Food/Dietary | No specific food interactions. No restriction with food intake. |
| Clinical Pearls |
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| L4 (possibly hazardous) |
| 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. |
| 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. |
| TONMYA (sugammadex) is a selective relaxant binding agent used for reversal of neuromuscular blockade induced by rocuronium or vecuronium. Administer as a rapid IV bolus over 10 seconds. For routine reversal (train-of-four count 2-4): 2 mg/kg; for immediate reversal (1-2 post-tetanic counts): 4 mg/kg; for rescue (if no response to TOF): 16 mg/kg. Monitor for bradycardia and hypotension. Avoid co-administration with toremifene, flucloxacillin, or fusidic acid as they may displace rocuronium from sugammadex. |
| Patient Advice | Report any difficulty breathing, swallowing, or muscle weakness after surgery. · Inform your doctor if you have kidney problems, as dose adjustment may be needed. · Avoid driving or operating heavy machinery for 24 hours after receiving TONMYA. · Tell your healthcare provider about all medications you take, especially hormonal contraceptives (may reduce effectiveness for 7 days). |