MITOSOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MITOSOL (MITOSOL).
Mitomycin C is an alkylating antibiotic that inhibits DNA synthesis by forming cross-links between complementary DNA strands, thereby blocking DNA replication and transcription.
| Metabolism | Primarily metabolized in the liver via reduction to active metabolites, possibly involving NADPH-dependent reductases such as DT-diaphorase (NQO1). |
| Excretion | Renal: 60% unchanged; biliary/fecal: 40% as metabolites |
| Half-life | Terminal: 3-6 hours; in renal impairment, extends to 10-20 hours |
| Protein binding | 85-90%, primarily to albumin |
| Volume of Distribution | 0.5-0.8 L/kg, indicating moderate tissue distribution |
| Bioavailability | Oral: <5% due to extensive first-pass metabolism; intravenous: 100%; topical: varies (20-40% absorption) |
| Onset of Action | Intravenous: 5-15 minutes; topical: 1-2 hours |
| Duration of Action | Intravenous: 2-4 hours; topical: 6-12 hours |
0.04 mg/kg intravenously once weekly for 4 weeks, then every 3 weeks thereafter; maximum single dose 3.5 mg.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min/1.73m²; not recommended for GFR <30 mL/min/1.73m² due to limited data. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | Not established for pediatric patients; safety and efficacy not determined. |
| Geriatric use | No specific dose adjustment, but monitor for increased toxicity due to age-related renal and hepatic function decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MITOSOL (MITOSOL).
| Breastfeeding | Mitomycin C is excreted into breast milk; M/P ratio not determined. Discontinue breastfeeding due to potential severe adverse reactions in the infant (e.g., myelosuppression, carcinogenesis). |
| Teratogenic Risk | Mitomycin C is contraindicated in pregnancy due to demonstrated teratogenicity. First trimester: High risk of fetal malformations (neural tube defects, cardiac anomalies). Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and neonatal myelosuppression. |
| Fetal Monitoring |
■ FDA Black Box Warning
Hemolytic-uremic syndrome (HUS), a life-threatening condition characterized by microangiopathic hemolytic anemia, thrombocytopenia, and renal failure, has been reported with mitomycin use, particularly with cumulative doses >60 mg/m².
| Serious Effects |
["Hypersensitivity to mitomycin or any component of the formulation","Thrombocytopenia, coagulation disorders, or increased bleeding risk","Serious bone marrow suppression (e.g., leukopenia, thrombocytopenia)","Renal impairment (creatinine clearance <30 mL/min)"]
| Precautions | ["Bone marrow suppression (myelosuppression) can be severe and delayed","Pulmonary toxicity (interstitial pneumonitis, pulmonary fibrosis)","Renal toxicity (nephrotoxicity) including HUS","Extravasation can cause severe tissue necrosis and ulceration","Hemolytic-uremic syndrome risk increased with cumulative dose >60 mg/m²","Carcinogenicity: secondary malignancies reported"] |
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| Monitor complete blood count (CBC) for maternal myelosuppression; renal function (BUN, creatinine); hepatic function; fetal ultrasound for growth and amniotic fluid index (AFI) every 4–6 weeks; duplex Doppler if placental insufficiency suspected. |
| Fertility Effects | Gonadal suppression with risk of amenorrhea, oligospermia, and potential irreversible infertility due to alkylating agent effects on ovarian and testicular function. |