Classes
DEA Class; Rx
Common Brand Names; Impavido
- Antileishmaniasis Agents
Description
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
Indications
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
Contraindications
Pregnancy
SjÖgren-Larsson syndrome
Hypersensitivity
Adverse Effects
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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
weighing 45 kg or more: 150 mg/day PO.
weighing 30 to 44 kg: 100 mg/day PO.
weighing 45 kg or more: 150 mg/day PO.
weighing 30 to 44 kg: 100 mg/day PO.
weighing 45 kg or more: 150 mg/day PO.
weighing 30 to 44 kg: 100 mg/day PO.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Miltefosine
capsule
- 50mg
