"The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites."...
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].
- Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis [see Clinical Trials].
- Mucosal leishmaniasis caused by Leishmania braziliensis [see Clinical Trials].
Limitations of Use
- Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data [see Clinical Trials].
- There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO [see Clinical Trials].
- The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.
DOSAGE AND ADMINISTRATION
The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions.
Table 1: Miltefosine Dosage
|Weight||Dosage and Administration|
|30 kg to 44 kg||One 50 mg capsule twice daily with food (breakfast and dinner)|
|45 kg or greater||One 50 mg capsule three times daily with food (breakfast, lunch, and dinner)|
Dosage Forms And Strengths
IMPAVIDO® (miltefosine) oral capsules are opaque, red, hard gelatin capsules with “PLB” imprinted on the capsule body and “MILT 50” imprinted on the cap using a white ink. Each capsule contains 50 mg miltefosine [see DESCRIPTION, Storage and Handling].
Storage And Handling
Each IMPAVIDO capsule contains 50 mg miltefosine in an opaque, red, hard gelatin capsule. IMPAVIDO capsules are supplied in a folded peel/push-through blister card. Each blister card contains 14 capsules. Each carton contains two blister cards (NDC 61744-050-01).
Store at 20-25°C (68–77 °F); excursions permitted to 15-30°C (59 – 86°F). [See USP Controlled Room Temperature]. Protect from moisture.
Dispense only in the original carton.
Distributed by: Paladin Therapeutics Inc., Corporation Trust Center, 1209 Orange Street, Wilmington, DE 19801. Revised: March 2014
Last reviewed on RxList: 3/31/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Impavido Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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