IMPAVIDO®

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 see package insert for Clinical Trials].
• Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis [see package insert for Clinical Trials].
• Mucosal leishmaniasis caused by Leishmania braziliensis [see  see package insert for Clinical Trials].

Limitations of Use

• Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data .
• There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO.
• The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.

1. Embryo Fetal Toxicity. Do not use in pregnant women. Obtain a urine or serum pregnancy test prior to initiation of therapy. Advise use of effective contraception in females of reproductive potential (Boxed
   Warning).
2. Reproductive effects. Miltefosine caused testicular atrophy and impaired fertility in male rats and impaired fertility in female rats. Advise patients of reproductive toxicities in animal studies and that the
   potential effects on human fertility have not been adequately evaluated
3. Renal Effects. Monitor serum creatinine during therapy and for 4 weeks
   after end of therapy
4. Hepatic Effects. Monitor transaminases and bilirubin during therapy
5. Gastrointestinal Effects. Encourage fluid intake (5.5).
6. Thrombocytopenia. Monitor platelet count during therapy for visceral
   leishmaniasis
7. Absorption of Oral Contraceptives. Advise use of alternative method of contraception if vomiting and/or diarrhea occur
8. Stevens-Johnson syndrome. Discontinue IMPAVIDO

Adverse reactions occurring in ≥2% of patients include nausea,
vomiting, diarrhea, headache, decreased appetite,dizziness, abdominal
pain, pruritus, somnolence, elevated transaminases, and elevated creatinine

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DRUG INTERACTIONS
-------------------------------
•IMPAVIDO did not inhibit human cytochrome P450 enzymes in vitro.
•IMPAVIDO did not induce cytochrome 3A activity in rats

Miltefosine Dosage

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.