Medicinal Products

AMETYCIN 10 mg

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

Powder for solution for injection
box of 1 vial of 10 mg
All forms

Indication

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

Dosage AMETYCIN 10 mg powder for solution for injection 1 vial of 10 mg

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

Against indications

This medicine is contraindicated:

· In pregnant or breastfeeding women (see section on Pregnancy and breastfeeding ),

· In association with :

o the yellow fever vaccine,

o Phenytoin for prophylaxis (see section Interactions with other medicinal products and other forms of interaction ).

This medicine is generally NOT recommended for patients with impaired renal function: creatinine is twice as normal (see section 4.8 ) and in combination with live attenuated vaccines.

Adverse effects Ametycine

Systemic way

Hematologic 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.

Dermal toxicity: alopecia, desquamation, pruritus, rash, local necrosis in the event of extravasation occurring as a rule a few days after the infusion, palmar-plantar erythrodysaesthesia (PIP).

Pulmonary toxicity: diffuse interstitial lung disease to be systematically evoked in the presence of dyspnea, dry cough, hypoxia, and may progress to fibrosis. Cases of pulmonary arterial hypertension and pulmonary veno-occlusive disease (MVOP) have been reported. Exceptional cases of pulmonary 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 insufficiency, haemolytic anemia, thrombocytopenia, micro-angiopathy ...).

Other : azoospermia, amenorrhea.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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