Generic Name and Formulations:
Miltefosine 50mg; hard gel caps.
Indications for IMPAVIDO:
Treatment of visceral, cutaneous, and mucosal leishmaniasis due to susceptible Leishmania species.
Limitations Of use:
Not evaluated in treatment of other Leishmania species. Leishmania species studied in clinical trials were based on epidemiologic data; geographic variation in clinical response of the same Leishmania species may exist.
Swallow whole. Take with food. Treat for 28 consecutive days. ≥12yrs (30–44kg): 50mg twice daily (breakfast and dinner); (≥45kg): 50mg three times daily (breakfast, lunch, and dinner).
Pregnancy (Cat.D). Sjӧgren-Larsson-Syndrome.
Embryo-fetal toxicity; obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing; use effective contraception during therapy and for 5 months after completion; use additional non-hormonal or alternative methods of contraception if vomiting/diarrhea occur during therapy. Possibly reproductive effects (eg, impaired fertility). Monitor renal function weekly during therapy and for 4 weeks after completion. Monitor platelets (for visceral leishmaniasis), ALT, AST, and bilirubin during therapy. Maintain adequate hydration. Discontinue if exfoliative or bullous rash develops. Nursing mothers: not recommended (during and for 5 months after therapy).
Nausea, vomiting, diarrhea, decreased appetite, headache, motion sickness, dizziness, abdominal pain, pruritus, somnolence, elevated transaminases, elevated creatinine; thrombocytopenia, others.
Caps—28 (2 × 14 blister cards)