Treatment visceral leishmaniasis, cutaneous leishmaniasis and mucocal leishmanisis in adults and adolescents.
Interacts with lipids and sterols in the Leismania membrane resulting in inhibition of mitochondria and apoptotic cell death.
Resolution of Leismania infections.
Absorption: Absorption is prolonged and may persist for 8–12 hr.
Protein Binding: 98%.
Metabolism and 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.
|PO||unknown||4–7 hr (blood level)||unknown†|
- Sjögren-Larsson-Syndrome (due to metabolic defect);
- OB: Pregnancy (may cause fetal harm)
- OB: Discontinue miltefosine or discontinue breastfeeding during treatment and for 5 mos following treatment.
Use Cautiously in:
- Renal impairment (BUN or Cr ≥1.5 x upper limit of normal)
- Hepatic impairment (ALT or AST ≥3 x upper limit of normal)
- Patients with reproductive potential.
- Pedi: Safe and effective use in children <12 yr has not been established.
Adverse Reactions/Side Effects
CNS: dizziness, drowsiness, headache, weakness
GI: abdominal pain, ↓ appetite, diarrhea, vomiting, abdominal distention, constipation, dysphagia, flatulence, ↑ liver enzymes, nausea
GU: ↑ creatinine, testicular pain/swelling
Derm: pruritus, RASH INCLUDING STEVENS-JOHNSON SYNDROME, urticaria
F and E: volume depletions (due to GI effects)
Hemat: anemia, thrombocytopenia
Misc: fever, lymphadenopathy, lymphangitis, malaise
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
May ↓ absorption and effectiveness of oral hormonal contraceptives. .
PO (Adults and adolescents ≥45 kg): 50 mg three times daily for 28 consecutive days.
PO (Adults and adolescents 30–44 kg): 50 mg twice daily for 28 consecutive days.
Capsules: 50 mg
- Assess visible lesions periodically during therapy.
- Monitor for vomiting and diarrhea. Encourage fluid intake to avoid dehydration.
Lab Test Considerations: Obtain a negative urine pregnancy test prior to beginning therapy.
- Monitor renal function weekly and for 4 wks after completion of therapy. May ↑ serum creatinine.
- Monitor AST, ALT, and serum bilirubin periodically during therapy. May cause ↑ in AST, ALT, and bilirubin.
- Monitor platelet count periodically during therapy. May cause thrombocytopenia and agranulocytosis.
- Administer with food to decrease GI side effects for 28 consecutive days. Swallow capsule whole; do not open, dissolve or chew.
- 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 t 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.
- Caution patient that miltefosine may cause teratogenic effects during pregnancy and may impair fertility. Advise female patient to use effective contraception during and for at least 5 mo after completion of therapy. Nausea and vomiting may decrease absorption of 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. Advise females to avoid breastfeeding during and for at least 5 mo after completion of therapy.
Resolution of signs and symptoms of leishmaniasis.
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