• Visceral leishmaniasis, cutaneous leishmaniasis and mucosal leishmaniasis.

Contraindicated in:

• Hypersensitivity
• Sjögren-Larsson-Syndrome (due to metabolic defect)
• OB: Pregnancy (may cause fetal harm)
• OB: Lactation.

Use Cautiously in:

• Renal impairment
• Hepatic impairment
• Patients with reproductive potential.
• Pedi: Children <12 yr (safety and effectiveness not established).

Derm: pruritus, RASH INCLUDING STEVENS-JOHNSON SYNDROME, urticaria.

F and E: volume depletions (due to GI effects).

GI: abdominal pain, ↓appetite, diarrhea, vomiting, abdominal distention, constipation, dysphagia, flatulence, ↑ liver enzymes, nausea.

GU: ↓fertility (males), ↑ serum creatinine, testicular pain/swelling.

Hemat: anemia, thrombocytopenia.

Neuro: dizziness, drowsiness, headache, weakness.

Misc: fever, lymphadenopathy, lymphangitis, malaise.

Drug-Drug:

• Vomiting and/or diarrhea may ↓ absorption and effectiveness of oral contraceptives..

• Capsules: 50 mg;

• PO (Adults and Children 12 yr and 45 kg): 50 mg three times daily for 28 consecutive days.
• PO (Adults and Children 12 yr and 30–<45 kg): 50 mg twice daily for 28 consecutive days.

Impavido

• Interacts with lipids and sterols in the Leishmania membrane resulting in inhibition of mitochondria and apoptotic cell death.

• Resolution of Leishmania infections.

Spectrum:

• Active against the following organisms:
  • Leishmania braziliensis
  • Leishmania donovani
  • Leishmania guyanensis
  • Leishmania panamensis.

Therapeutic Classification: antileishmanials

Pharmacologic Classification: alkylphosphocholines

Absorption: Absorption is prolonged and may persist for 8–12 hr.

Distribution: Unknown.

Protein Binding: 98%.

Metabolism/Excretion: Slowly broken in the liver, releasing choline; remaining portion is further metabolized and enters fatty acid metabolism ; <0.2% excreted in urine.

Half-life: >6 days.

† Persists in the body for up to 5 mo.

• Instruct patient to take miltefosine as directed for 28 consecutive days. Advise patient to read the Medication Guide before beginning therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional immediately if skin rash with blisters occurs. Discontinue therapy if exfoliative or bullous rash occurs.
• May cause dizziness and drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
• Instruct patient to notify healthcare professional if abdominal pain, nausea, vomiting, or diarrhea are persistent or severe. Advise to maintain hydration to prevent kidney damage.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during and for at least 5 mo after last dose of therapy. Nausea and vomiting may decrease absorption of oral hormonal contraceptives. Advise patient to use a non-hormonal or alternative method of effective contraception. May cause scrotal pain and decreased or absent ejaculation in males decreasing fertility, usually improved within 3–6 months. May impair female fertility.

mil-te-FOS-een

NDC Code^*

• 69051- Profounda, Inc.
  • 69051-300- IMPAVIDO
    • 69051-300-01- 2 BLISTER PACK in 1 CARTON (69051-300-01) > 14 CAPSULE in 1 BLISTER PACK