IMPAVIDO
miltefosine
Manufacturer: Knight Therapeutics (USA)
Black Box Warning (Boxed Warning)
A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.
FDA-Approved Indications (5)
Treatment of visceral leishmaniasis due to Leishmania donovani; cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis; and mucosal leishmaniasis due …
treatment of cutaneous leishmaniasis caused by Leishmania braziliensis
Population: adults and adolescents ≥12 years of age weighing ≥30 kg
treatment of cutaneous leishmaniasis caused by Leishmania guyanensis
Population: adults and adolescents ≥12 years of age weighing ≥30 kg
treatment of visceral leishmaniasis caused by Leishmania donovani
Population: adults and adolescents ≥12 years of age weighing ≥30 kg
treatment of mucosal leishmaniasis caused by Leishmania braziliensis
Population: adults and adolescents ≥12 years of age weighing ≥30 kg
Indications & Usage
1 INDICATIONS AND USAGE IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents ≥12 years of age weighing ≥ 30 kg for the treatment of: Visceral leishmaniasis caused by Leishmania donovani [see Clinical Trials ( 14.1 )] . Cutaneous leishmaniasis caused by Leishmania braziliensis , Leishmania guyanensis , and Leishmania panamensis [see Clinical Trials ( 14.2 )] . Mucosal leishmaniasis caused by Leishmania braziliensis [see Clinical Trials ( 14.3 )] . Limitations of Use: Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data [see Clinical Trials ( 14.1 , 14.2 )] . There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO [see Clinical Trials ( 14.1 , 14.2 )] . The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated. IMPAVIDO is an antileishmanial drug indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs) for treatment of: Visceral leishmaniasis due to Leishmania donovani ( 1 ). Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis ( 1 ). Mucosal leishmaniasis due to Leishmania braziliensis ( 1 ). Limitations of use : Leishmania species evaluated in clinical trials were based on epidemiologic data. There may be geographic variation in the response of the same Leishmania species to IMPAVIDO ( 1 , 14 ). The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.
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