Medicinal Products

DETICENE 100 mg

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Dacarbazine
laboratory: Sanofi-Aventis France

Powder and solvent for solution for IV infusion
Box of 10 vials of powder + 10 ml solvent ampoules
All forms

Indication

· Malignant melanomas,

· Combination chemotherapy in Hodgkin's and non-Hodgkin's lymphomas, and in soft tissue sarcomas in adults.

Dosage DETICENE 100 mg Powder and solvent for solution for infusion IV Box of 10 vials of powder + ampoules of 10 ml solvent

This drug should be administered as intravenous infusion or, in some tumor sites, intra-arterial infusion.

The dosage varies depending on whether the product is used alone or in combination:

· In monotherapy: the doses used vary from 2.4 to 4.5 mg / kg / day for 4 to 5 days.
(NB: higher doses have also been tested).

· In multidrug therapy: in standard protocols, the usual dose is 250 mg / m 2 / d IV infusion for 5 days every 3 to 4 weeks.

Administration mode:

In case of extravasation, the administration will be interrupted immediately.

How to handle:

The preparation of injectable cytotoxic solutions must be carried out by specialized and trained personnel with knowledge of the drugs used, under conditions ensuring the protection of the environment and especially the protection of the personnel handling. It requires a preparation room reserved for this purpose. It is forbidden to smoke, eat, drink in this room. Manipulators must have a set of equipment suitable for handling, including long-sleeved gowns, face masks, hood, safety goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. waste. Excreta and vomit must be handled with care. Pregnant women should be warned and avoid manipulation of cytotoxics. Any broken container must be treated with the same precautions and considered as contaminated waste. Disposal of contaminated waste is by incineration in rigid containers labeled for this purpose.

These provisions can be envisaged within the framework of the oncology network (circular DGS / DH / 98 n ° 98/188 of March 24, 1998) in collaboration with any suitable structure and fulfilling the required conditions.

Against indications

Pregnant or breastfeeding woman

Vaccine against yellow fever (see section Interactions with other medicinal products and other forms of interaction ).

Deticene side effects

Immediate reaction

· Nausea, vomiting: beginner 1 to 3 hours after injection and may last up to 12 hours in up to 90% of patients; the intensity of these disorders progressively diminishes the following days;

· Influenza-like illness with fatigue, myalgia, malaise and fever has been reported in up to 2% of patients;

· More rarely: facial paresthesias, hot flushes, allergic reactions;

· In case of extravasation during intravenous infusion: local pain and risk of tissue damage;

· Photosensitization reactions have been reported in the days following the injection. The patient must be warned of the risks of recurrence and the interest of photoprotection measures in the days following the subsequent courses.

Delayed reaction

· Bone marrow failure: leukopenia, thrombocytopenia, anemia, pancytopenia;

· As with other alkylating agents, some cases of myelodysplastic syndrome and acute leukemia have been reported in patients treated with dacarbazine in combination with other cytotoxic agents, particularly nitrosoureas;

· Eosinophilia;

· More rarely: renal or hepatic toxicity: nadir may occur later than for other alkylating agents (approximately 21 days);

· Central nervous system toxicity with seizures and dementia has been reported with high doses of dacarbazine;

Moderate alopecia;

· A veno-occlusive disease or Budd-Chiari syndrome has been observed when the drug is used at very high doses (in the context of marrow transplantation);

· Amenorrhea;

Azoospermia.

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