IMPAVIDO — Profounda, Inc. drug label update
The FDA updated the drug label for IMPAVIDO (miltefosine) capsules, clarifying that the treatment is indicated for adults and adolescents at least 12 years of age weighing at least 30 kg for specific forms of leishmaniasis.
This update affects Profounda, Inc. and medical/regulatory personnel responsible for the management of visceral, cutaneous, and mucosal leishmaniasis treatments.
The update establishes specific weight and age parameters for adolescent use, which suggests a refinement of the safety or efficacy profile for younger populations. The explicit link between certain Leishmania species and clinical manifestations (visceral, cutaneous, or mucosal) may require clinical teams to ensure species identification is part of the diagnostic workflow before treatment initiation.
Regulatory and labeling teams should verify that all current product inserts accurately reflect the weight and age thresholds (≥12 years and ≥30 kg) and ensure clinical documentation aligns with the specific Leishmania species indicated.
IMPAVIDO (Profounda, Inc.). 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 Clinic
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