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Pregnancy Category: D
Pharmacologic: temporary class
ClassificationTherapeutic: temporary class
Pharmacologic: temporary class
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†|
Contraindicated in: Hypersensitvity; Sjögren-Larsson-Syndrome (due to metabolic defect); Obstetric: Pregnancy (may cause fetal harm); Obstetric: 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..) Pediatric: Safe and effective use in children <12 yr has not been established.
Adverse Reactions/Side Effects
Central nervous system
- dizziness (most frequent)
- abdominal pain (most frequent)
- ↓ appetite (most frequent)
- diarrhea (most frequent)
- vomiting (most frequent)
- abdominal distention
- ↑ liver enzymes
- ↑ creatinine
- testicular pain/swelling
- rash including Stevens-Johnson Syndrome (life-threatening)
Fluid and Electrolyte
- volume depletions (due to GI effects)
Drug-Drug interactionMay ↓ absorption and effectiveness of oral hormonal contraceptives..
Oral (Adults and adolescents ≥45 kg) 50 mg three times daily for 28 consecutive days.
Oral (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.
Potential Nursing DiagnosesImpaired skin integrity (Indications)
Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)
- 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.
miltefosineAn oral alkyl phosphocholine analogue used to treat cutaneous and visceral leishmaniasis.
Nausea, vomiting, diarrhoea, rigors, increased transaminases, grade-III hepatotoxicity and renal damage.
Miltefosine interferes with cell-signalling pathways and membrane synthesis of Leishmania donovani and L infantum, as well as with mitogenic signal transduction; it also induces apoptosis. It has been used in treating HIV disease because miltefosine inhibits the PI3K/Akt pathway, removing HIV-infected macrophages from circulation without affecting normal cells.