MELARSOPROL injectable

Prescription under 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. NEVER BY IM OR SC INJECTION.

Dosage and duration

– Patients must be treated in hospital, under close medical supervision.
– 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, psychical disorders, usually between the 5th and the 8th day of the ten-day treatment (but sometimes later, even after the patient has been discharged) or just before/during the 2nd course of the intermittent treatment;
• 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.
– Use a completely dry syringe: the solution precipitates in presence of water. As propylene glycol can dissolve plastic, the drug should preferably be administered using a glass syringe (only if sterilisation is reliable), otherwise inject immediately (but slowly) using a plastic syringe.
– PregnancyCONTRA-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 -