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miltefosine

Brand and Other Names: IMPAVIDO
Mechanism of Action:

The specific mode of action of miltefosine against Leishmania species is unknown. The mechanism of action of miltefosine is likely to involve interaction with lipids (phospholipids and sterols), including membrane lipids, inhibition of cytochrome c oxidase (mitochondrial function), and apoptosis-like cell death.

Indications:

MPAVIDO is indicated for the treatment of:

  • Visceral leishmaniasis due to Leishmania donovani

  • Cutaneous leishmaniasis due to Leishmania braziliensis, L. guyanensis, and L. panamensis

  • Mucosal leishmaniasis due to Leishmania braziliensis
    Use is limited to patients 12 years and older weighing ≥30 kg

Route: oral
Dose:

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)

Adverse Reactions:

Common adverse reactions (≥2%) include:

  • Gastrointestinal: nausea, vomiting, diarrhea, abdominal pain

  • Neurological: headache, dizziness, somnolence

  • General: decreased appetite, pruritus, fatigue

  • Laboratory: elevated transaminases and creatinine

  • Other: motion sickness, thrombocytopenia

Contraindication:

IMPAVIDO is contraindicated in patients who are pregnant. Based on animal data, miltefosine may cause fetal harm. 

IMPAVIDO is contraindicated in patients who have Sjögren-Larsson-Syndrome.

IMPAVIDO is contraindicated in patients who are hypersensitive to miltefosine or any IMPAVIDO excipients.

Warnings and Precautions:

  • Embryo-fetal toxicity: Contraindicated in pregnancy; causes fetal harm

  • Impaired semen quality: May reduce sperm count and motility

  • Female reproductive toxicity: May impair fertility

  • GI effects: Encourage hydration to avoid dehydration

  • Renal and hepatic toxicity: Monitor function during and after treatment

  • Stevens-Johnson Syndrome: Discontinue if rash appears

  • Ocular complications: Discontinue if eye symptoms develop and consult ophthalmologist

Description:

IMPAVIDO is a red, opaque, hard gelatin oral capsule containing 50 mg miltefosine, an alkylphosphocholine with antileishmanial activity. The empirical formula is C₂₁H₄₆NO₄P with a molecular weight of 407.6. Inactive ingredients include colloidal silicon dioxide, microcrystalline cellulose, lactose monohydrate, talc, and magnesium stearate.

See package insert for full prescribing information.