Version July 2025
Miltefosine is contraindicated in pregnancy. Based on animal data, miltefosine may cause fetal harm. Verify pregnancy status prior to initiating miltefosine. To prevent pregnancy, patients of reproductive potential should use effective contraception during treatment and for 5 months after the last dose.
Leishmaniasis:
Cutaneous or mucosal: Note: Efficacy is species and locale dependent; individualize treatment (Ref).
Immunocompetent:
30 to 44 kg: Oral: 50 mg twice daily for 28 days.
≥45 kg: Oral: 50 mg 3 times daily for 28 days.
Immunocompromised, including patients with HIV: Oral: 2.5 mg/kg/day (maximum daily dose: 150 mg) in 2 or 3 divided doses for 28 days (Ref).
Visceral: Note: For visceral leishmaniasis caused by Leishmania donovani (Ref).
Immunocompetent (alternative agent):
30 to 44 kg: Oral: 50 mg twice daily for 28 days.
≥45 kg: Oral: 50 mg 3 times daily for 28 days.
Immunocompromised, including patients with HIV: Oral: 50 mg twice daily in combination with liposomal amphotericin. Duration of miltefosine is 14 days (Southeast Asia) or 28 days (East Africa) (Ref).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Miltefosine: Pediatric drug information")
Leishmaniasis: Children ≥12 years and Adolescents weighing ≥30 kg: Oral: Cutaneous, mucosal, visceral leishmaniasis: Note: Efficacy is species- and locale-dependent.
30 to 44 kg: 50 mg twice daily for 28 days.
≥45 kg: 50 mg 3 times daily 28 days.
Naegleria fowleri infection (free-living ameba): Very limited data available; efficacy results variable; Note: Due to the poor prognosis of infection and lack of successful treatment options, expert recommendations suggest adding miltefosine as a component of treatment regimen (Ref):
Children and Adolescents: Oral:
<45 kg: 50 mg twice daily for 28 days (Ref); an 8-year-old (weight not reported) received 50 mg 3 times daily (Ref).
≥45 kg: 50 mg 3 times daily for 28 days (Ref).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
>10%:
Gastrointestinal: Abdominal pain (8% to 11%), decreased appetite (11% to 23%), diarrhea (8% to 20%), motion sickness (29%), nausea (36% to 42%), vomiting (5% to 38%)
Genitourinary: Asthenospermia, decreased ejaculate volume, oligospermia, scrotal pain (tenderness), spermatozoa disorder (reduction in sperm morphology)
Hematologic & oncologic: Decreased platelet count (<150,000: 62%; <50,000: 2%)
Hepatic: Increased serum transaminases (<3 × ULN: 94%; ≥3 × ULN: 6%)
Nervous system: Dizziness (5% to 13%), headache (28%)
Renal: Increased serum creatinine (≥1.5 × baseline: 10% to 25%)
1% to 10%:
Dermatologic: Cellulitis (<2%), ecthyma (<2%), pruritus (5% to 6%), pyoderma (<2%), skin rash (<2%), Stevens-Johnson syndrome (<2%), urticaria (<2%)
Gastrointestinal: Abdominal distention (<2%), constipation (<2%), dysphagia (<2%), flatulence (<2%)
Genitourinary: Dry ejaculation, epididymitis, testicular pain (<2%), testicular swelling (<2%)
Hematologic & oncologic: Anemia (<2%), lymphadenopathy (<2%), lymphangitis (6%)
Infection: Abscess (<2%)
Nervous system: Asthenia (6%), drowsiness (3%), fatigue (<2%), malaise (3%), paresthesia (<2%)
Miscellaneous: Fever (6%)
Frequency not defined:
Hepatic: Increased serum bilirubin
Neuromuscular & skeletal: Arthritis
Postmarketing:
Cardiovascular: Edema, peripheral edema
Endocrine & metabolic: Acute gout attack, increased uric acid
Gastrointestinal: Melena
Hematologic & oncologic: Agranulocytosis, thrombocytopenia
Hepatic: Jaundice
Nervous system: Seizure
Ophthalmic: Corneal disease, iritis, keratitis, ophthalmic signs and symptoms (including blindness [may be permanent], corneal opacity, corneal ulcer, decreased visual acuity, eye pain, eye redness, lacrimation, photophobia), scleritis (acute), uveitis (including anterior uveitis)
Respiratory: Epistaxis
Hypersensitivity to miltefosine or any component of the formulation; Sjogren-Larsson syndrome; pregnancy
Concerns related to adverse effects:
• Dermatologic toxicity: Stevens-Johnson syndrome has been reported; discontinue miltefosine if an exfoliative or bullous rash occurs during therapy.
• Gastrointestinal effects: Nausea, vomiting and diarrhea may occur with use; administer with food to decrease GI effects. Ensure adequate fluid intake during therapy to prevent dehydration.
• Hematologic toxicity: Thrombocytopenia has been reported during therapy for visceral leishmaniasis; monitor platelet count during therapy in these patients.
• Hepatic effects: Increased liver transaminases and bilirubin have been reported during therapy for visceral leishmaniasis. Assess ALT, AST, and bilirubin during therapy.
• Ocular effects: Ocular complications, including anterior iritis/uveitis, keratitis, keratopathy, and acute scleritis, have occurred; may occur within a few days to several weeks of treatment. Partial or complete blindness (sometime permanent), corneal opacities/ulceration, eye pain, increased lacrimation, photophobia, red eye, and decreased visual acuity were also commonly reported. Due to the long half-life, ocular effects may not resolve immediately after discontinuation of therapy. Instruct patients to discontinue treatment and follow up with an ophthalmologist if any adverse ocular effects occur; treatment with ocular anti-inflammatory agents may be needed. Consider alternative therapy if ocular effects are determined to be related to miltefosine.
• Renal toxicity: May increase serum creatinine. Assess kidney function weekly while on therapy and for 4 weeks after the end of therapy.
Ordering and distribution information may be obtained by calling 1-908-635-2326 or visiting http://www.impavido.com/order-page.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Impavido: 50 mg
No
Capsules (Impavido Oral)
50 mg (per each): $713.57
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Miltefosine may be ordered directly from Profunda by any licensed pharmacy; it is not available through wholesalers. For ordering and distribution information call 1-908-635-2326 or visit http://www.impavido.com/order-page.
Oral: Administer with food to decrease GI distress. Twice daily dosing should be administered with breakfast and dinner; 3 times daily dosing with breakfast, lunch, and dinner.
Oral: Administer with food to decrease GI distress. Twice-daily dosing should be administered with breakfast and dinner; 3-times daily dosing with breakfast, lunch, and dinner.
Hazardous agent (NIOSH 2024 [table 2]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Impavido: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM390972.pdf
Leishmaniasis: Treatment of visceral (caused by Leishmania donovani), cutaneous (caused by L. braziliensis, L. guyanensis, and L. panamensis), and mucosal leishmaniasis (caused by L. braziliensis) in adults and adolescents ≥12 years of age weighing ≥30 kg.
Limitations of use: Efficacy of miltefosine in the treatment of other Leishmania species has not been evaluated; there may be geographic variation in clinical response of the same Leishmania species to miltefosine.
Free-living ameba infection
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).
None known.
There are no known significant interactions.
Verify pregnancy status prior to treatment initiation. Patients who may become pregnant should use effective contraception during therapy and for 5 months after the last dose of miltefosine. If oral contraceptives are used and nausea, vomiting, and/or diarrhea occur during therapy, additional nonhormonal or alternative methods of effective contraception should be used.
Miltefosine may reduce ejaculate volume, total sperm count, sperm concentration, sperm morphology, and sperm motility, resulting in impaired fertility. Duration of adverse events is unknown. However, improvements of most parameters occurred within 3 to 6 months following the last miltefosine dose.
Based on data from animal reproduction studies, in utero exposure to miltefosine may cause fetal harm. Embryo-fetal toxicity was observed in animal studies with doses less than the maximum recommended human dose. Use is contraindicated in pregnant patients.
Leishmaniasis is also associated with adverse pregnancy outcomes. Untreated visceral leishmaniasis may be life-threatening to the mother and may result in adverse fetal outcomes (eg, spontaneous abortion, congenital disease due to vertical transmission, small for gestational age newborn, severe anemia); untreated cutaneous leishmaniasis may manifest with larger and atypical appearing lesions and may be associated with adverse fetal outcomes (eg, preterm births, stillbirths).
Agents other than miltefosine are recommended for the treatment of leishmaniasis during pregnancy (Fontenele e Silva 2013; IDSA/ASTMH [Aronson 2016]).
Data collection to monitor pregnancy and infant outcomes following exposure to miltefosine is ongoing. Health care providers are encouraged to enroll patients exposed to miltefosine during pregnancy in the pregnancy registry (1-866-588-5405).
It is not known if miltefosine is present in breast milk.
Agents other than miltefosine are recommended for the treatment of leishmaniasis in breastfeeding patients (Fontenele e Silva 2013; IDSA/ASTMH [Aronson 2016]).
Due to the potential for serious adverse reactions in the breastfeeding infant, breastfeeding is not recommended by the manufacturer during treatment and for 5 months after the last miltefosine dose.
Baseline and as clinically indicated during therapy: liver function tests (AST, ALT, alkaline phosphatase, bilirubin) and BUN/serum creatinine; platelet count; baseline eye exam.
Evaluate pregnancy status prior to use in patients who may become pregnant.
Exact mechanism unknown; likely interaction with phospholipids and steroids in parasitic cell membranes, inhibition of cytochrome c oxidase (mitochondrial function), and apoptosis-like cell death.
Protein binding: 98%.
Metabolism: Hepatic; phospholipase D-like cleavage of miltefosine releases choline. Fatty alcohol-containing fragment may be oxidized to palmitic acid and undergo fatty acid metabolism.
Half-life elimination: t½ alpha: >6 days; t½ beta: ~31 days.
Time to peak, serum: 4 to 7 hours.
Excretion: Urine (<0.2% as unchanged drug).
