Medicinal Products


Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Mitomycin
laboratory: Prostrakan Pharma

Powder for solution for injection
box of 1 vial of 20 mg
All forms


Adenocarcinomas of the stomach, pancreas, colon, rectum, breast and their metastases.

Dosage AMETYCIN 20 mg powder for solution for injection 1 vial of 20 mg

Adenocarcinomas of the stomach, pancreas, colon, rectum, breast and their metastases.

Against indications

This medicine is contraindicated:
- in pregnant or nursing women:
. Pregnancy: Mitomycin C has mutagenic effects and can lead to malformations. Its use during pregnancy is contraindicated.
. breastfeeding: in the absence of data and given the nature of the molecule, breastfeeding is contraindicated.
- in association with:
. the vaccine against yellow fever,
. phenytoin for prophylaxis (see interactions).
This medicine is generally NOT recommended for renal impairment: serum creatinine is twice as normal (see side effects) and in combination with live attenuated vaccines (except yellow fever).

Adverse effects Ametycine

- Hematological toxicity : damage to all 3 lines but most often to the platelet line. This toxicity is dose-dependent and cumulative. It can appear either very early during treatment or later (up to 8 weeks after the last injection). The recovery is usually done in 6 to 8 weeks.
- Gastrointestinal toxicity : nausea, vomiting, anorexia, diarrhea, stomatitis, frequent and generally moderate.
- Cutaneous toxicity : alopecia, desquamation, pruritus, rash, local necrosis in the event of extravasation occurring as a rule a few days after the infusion.
- Pulmonary toxicity : diffuse interstitial lung disease to be systematically evoked in case of dyspnea, dry cough, hypoxia, and may progress to fibrosis.
Exceptional case of pulmonary arterial hypertension.
- Cardiac toxicity : A few rare cases of heart failure have been reported, usually in patients receiving or having received doxorubicin.
- Liver toxicity : Elevation of liver enzymes generally moderate, exceptional cases of hepatic veno-occlusive disease have been reported after administration of high doses of mitomycin C, usually followed by autologous bone marrow transplantation.
- Renal toxicity : moderate renal insufficiency or in the context of a haemolytic uremic syndrome (renal failure, haemolytic anemia, thrombocytopenia, microangiopathy ...).
- Other : azoospermia, amenorrhea.

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