Miltefosine
Indications
Miltefosine is used for:
Visceral leishmaniasis, Mycosis fungoides, Skin metastases of breast cancer
Adult Dose
Adult : PO Visceral Leishmaniasis 100-150 mg/day for 28 days.
Child Dose
Child: PO 2.5 mg/kg/day bid
>12 y: 30–44 kg: 100 mg/day bid
>45 kg: 150 mg/day tid
Renal Dose
Administration
Contra Indications
Pregnancy, lactation, concurrent radiation therapy.
Precautions
Metastases grown over breast implants. Increased serum creatinine, ALT, AST, bilirubin reported; monitor. Thrombocytopenia reported; monitor platelets
Stevens-Johnson syndrome reported; discontinue if an exfoliative or bullous rash occurs
Lactation: Unknown if distributed in human breast milk; avoid breastfeeding during therapy and for 5 months following therapy
Pregnancy-Lactation
Pregnancy Category: D (see Black Box Warnings); Human pregnancy data are not available; however, embryofetal toxicity, including death and teratogenicity, was observed in embryo-fetal studies in rats and rabbits
Clinical considerations: During pregnancy, visceral leishmaniasis may be life-threatening for the mother and may result in adverse fetal outcomes, including spontaneous abortion, congenital disease due to vertical transmission, small for gestational age newborn, and severe anemia
Lactation: Unknown if distributed in human breast milk; avoid breastfeeding during therapy and for 5 months following therapy
Interactions
Adverse Effects
Side effects of Miltefosine :
>10%
Visceral leishmaniasis
Increased transaminases, <3 x ULN (94%), Decreased platelets <150, 000 (62%), Vomiting (37.8%), Decreased appetite (23.1%), Diarrhea (20.4%)
1-10%
Visceral leishmaniasis
Increased serum creatinine, >1.5 x baseline (10%), Asthenia (6.3%), Increased transaminases, 3-5 x ULN (6%), Decreased platelets <50, 000 (2.4%)
Mechanism of Action
Miltefosine is a phospholipid derivative thought to work by disrupting cell-membrane function.