MELARSOPROL injectable

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    Last updated: December 2023

     

    Prescription under medical supervision

     

     
    Due to high toxicity and numerous adverse effects of melarsoprol, patients must be treated in hospital, under close medical supervision.

     

    Therapeutic action

    • Trypanocide (arsenical derivative)

    Indications

    • Meningoencephalitic stage of African trypanosomiasis due to T. b. gambiense and T. b. rhodesiense

    Forms and strengths, route of administration

    • 180 mg in 5 ml ampoule (36 mg/ml), 3.6 % solution in propylene glycol, for slow IV injection
    • DO NOT ADMINISTER BY IM or SC INJECTION.

    Dosage and duration

    • Child and adult: 2.2 mg/kg (max. 5 ml) once daily for 10 days

    Contra-indications, adverse effects, precautions

    • May cause:
      • reactive encephalopathy (5-10% of cases): repeated or prolonged seizures, coma, mental disorders, usually between the 5th and the 8th day of treatment (but sometimes later, even after the patient has been discharged);
      • arsenical reactions: headache, fever, tachycardia, hypertension, jaw pain, neurological disorders (hyperreflexia);
      • gastrointestinal disturbances, skin reactions (exfoliative dermatitis, urticaria), peripheral neuropathy, haematological disorders (haemolytic anaemia in patients with G6PD deficiency, agranulocytosis), hepatic or renal impairment, myocardial damage;
      • swelling, pain, phlebitis, venous sclerosis, necrosis at injection site in the event of extravasation during IV administration.
    • As propylene glycol can dissolve plastic, syringes should be prepared just before injections.
    • Pregnancy: CONTRA-INDICATED

    Remarks

    • Oral prednisolone is frequently associated during the course of treatment.
    • For the meningoencephalitic stage of gambiense trypanosomiasis, the treatment of choice is nifurtimox + eflornithine (NECT).

    Storage

     
    –  Below 25 °C 
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