Skip to content

Miltefosine

    Brands

    DEA Class; Rx

    Common Brand Names; Impavido

    • Antileishmaniasis Agents

    Oral anti-leishmanial agent
    Used for the treatment of visceral, cutaneous, and mucosal leishmaniasis in adults and pediatric patients 12 years of age and older and weighing at least 30 kg
    Contraindicated during pregnancy; may impair male fertility

    Indicated for the treatment of leishmaniasis.

    • Visceral leishmaniasis due to Leishmania donovani
    • Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis
    • Mucosal leishmaniasis due to Leishmania braziliensis

    Pregnancy 

    SjÖgren-Larsson syndrome

    Hypersensitivity

    Visceral leishmaniasis

    • Increased transaminases, <3 x ULN (94%)

    • Decreased platelets <150,000 (62%)

    • Vomiting (37.8%)

    • Decreased appetite (23.1%)

    • Diarrhea (20.4%)

    Cutaneous leishmaniasis

    • Nausea (35.9-41.7%)

    • Motion sickness (29.2%)

    • Headache (28.1%)

    • Vomiting (4.5-27.5%)

    • Increased serum creatinine, 1.5-3 x baseline (25%)

    • Diarrhea (15%) Dizziness (4.5-12.5%)

    • Abdominal pain (7.5-11.2%)

    • Decreased appetite (10.8%)

    May cause fetal harm; do not use during pregnancy or become pregnancy within 5 months following therapy completion (see Black Box Warnings)

    Causes impaired fertility in rats and reversible follicular atresia and diestrus in dogs; reduced viable sperm counts and impaired fertility in rats; effects on human fertility have not been studied

    Vomiting and/or diarrhea commonly occur; encourage fluid intake to avoid volume depletion

    Vomiting and/or diarrhea occurring during therapy may affect oral contraceptive absorption and thereby compromise their efficacy; advise females to use additional nonhormonal or alternative method(s) of effective contraception

    Increased serum creatinine, ALT, AST, bilirubin reported; monitor

    Thrombocytopenia reported; monitor platelets

    Stevens-Johnson syndrome reported; discontinue if an exfoliative or bullous rash occurs

    There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to IMPAVIDO during pregnancy

    There are no data on presence of miltefosine in human or animal milk, the effects on breastfed infants or on milk production

    Adults

    weighing 45 kg or more: 150 mg/day PO.
    weighing 30 to 44 kg: 100 mg/day PO.

    Geriatric

    weighing 45 kg or more: 150 mg/day PO.
    weighing 30 to 44 kg: 100 mg/day PO.

    Adolescents

    weighing 45 kg or more: 150 mg/day PO.
    weighing 30 to 44 kg: 100 mg/day PO.

    Children

    12 years and weighing 45 kg or more: 150 mg/day PO.
    12 years and weighing 30 to 44 kg: 100 mg/day PO.
    12 years and weighing less than 30 kg: 2.5 mg/kg/day PO has been used off-label.
    2 to 11 years: 2.5 mg/kg/day PO has been used off-label.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Miltefosine 

    capsule

    • 50mg