Special Warning : אזהרת שימוש

4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE

It is recommended that dacarbazine should only be administered under the supervision of a physician specialised in oncology who has the facilities for regular monitoring of clinical, biochemical and haematological effects, during and after therapy.

If symptoms of a liver or kidney functional disorder or symptoms of a hypersensitivity reaction are observed, immediate cessation of therapy is required. If veno-occlusive disease of the liver occurs, further therapy with dacarbazine is contraindicated.

Note: The responsible physician should be aware of a rarely observed severe complication during therapy resulting from liver necrosis due to occlusion of intrahepatic veins. Therefore, frequent monitoring of liver size, function and blood counts (especially eosinophils) is required. In single cases of suspected veno-occlusive disease, early therapy with high- dose corticosteroids (for example hydrocortisone 300 mg/day) with or without fibrinolytic agents like heparin or tissue plasminogen activator was successful (see Section 4.8).



Long-term therapy can cause cumulative bone marrow toxicity. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells and platelet levels. Haemopoietic toxicity may warrant temporary suspension or cessation of therapy.

Extravasation of the medicinal product during I.V. administration may result in tissue damage and severe pain.
Concomitant use with phenytoin should be avoided because reduced absorption of phenytoin from the gastrointestinal tract may predispose the patient to convulsions (see Section 4.5).

Dacarbazine is a moderate immunosuppressive agent. Administration of live vaccines to patients who are immunocompromised as a result of treatment with chemotherapeutics such as dacarbazine can cause serious and potentially fatal infections. Immunisation with live vaccines should therefore be avoided during dacarbazine therapy. It is generally advised to use live virus vaccines with caution after stopping chemotherapy and to take the patient's immune status into account, depending also on the disease and other therapies. Vaccination with live vaccines should be administrated no sooner than 3 months after the completion of chemotherapy. Inactivated vaccines can be used if available.

Concomitant use of fotemustine can cause acute pulmonary toxicity (adult respiratory distress syndrome), which may lead to a fatal outcome. Fotemustine and dacarbazine should not be used concomitantly.

Hepatotoxic medicinal products and alcohol should be avoided during chemotherapy.

Contraceptive measures:
Men are advised to take contraceptive measures during and for 6 months after cessation of therapy.
Paediatric population:
Dacarbazine is not recommended for use in the paediatric age group until further data become available. For precaution on handling, please see Section 6.5 and 6.6.

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