Adult Dosing

Visceral, cutaneous and mucosal leishmaniasis

• 30-44 kg: 50 mg PO bid (Breakfast and dinner)
• 45 kg: 50 mg PO tid (Breakfast, lunch, and dinner)

Note:

• The treatment duration is 28 consecutive days. Administer therapy with food to ameliorate gastrointestinal adverse reactions

Pediatric Dosing

Visceral, cutaneous and mucosal leishmaniasis

12 years

• 30-44 kg: 50 mg PO bid (Breakfast and dinner)
• 45 kg: 50 mg PO tid (Breakfast, lunch, and dinner)

Note:

• The treatment duration is 28 consecutive days. Administer therapy with food to ameliorate gastrointestinal adverse reactions

• Treatment of visceral, cutaneous and mucosal leishmaniasis in patients 12 years of age weighing 30 kgs

• Hypersensitivity to any of the ingredients of the product
• Pregnant women
• Sjögren-Larsson-Syndrome

• Therapy may cause fetal harm as fetal death and teratogenicity has been reported after administrating miltefosine in animals at doses lower than the recommended human dose.
• Therapy is contraindicated in pregnant women
• Examine serum or urine pregnancy test in females of reproductive potential prior to prescribing miltefosine. Advise females of reproductive potential to use effective contraception during therapy and for 5 months after therapy

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• There may be variations in the response to Leishmania species based on geographic variations
• Therapy may cause fetal harm and is contraindicated in pregnant women. Examine serum or urine pregnancy test in females of reproductive potential prior to prescribing miltefosine. Advise females of reproductive potential to use effective contraception during therapy and for 5 months after therapy
• Elevations of serum creatinine have been reported with therapy. Monitor renal function weekly in patients receiving miltefosine during therapy and for 4 weeks after the end of therapy
• Elevations in liver transaminases (ALT, AST) and bilirubin has been reported with therapy. Monitor liver transaminases (ALT, AST) and bilirubin during therapy in patients receiving miltefosine
• Vomiting and/or diarrhea commonly occur during initiation of miltefosine and may result in volume depletion. Encourage fluid intake to avoid volume depletion
• Thrombocytopenia has been reported in patient with visceral leishmaniasis receiving miltefosine. Monitor platelet count during therapy for visceral leishmaniasis
• Vomiting and diarrhea may occur during therapy may affect the absorption of oral contraceptives, If vomiting and/or diarrhea occur during receiving therapy, instruct females to use additional non-hormonal or alternative method(s) of effective contraception
• Stevens-Johnson syndrome has been reported during miltefosine therapy. Discontinue miltefosine if an exfoliative or bullous rash occurs
• Fertility impairment in animal studies has not been studied in humans

Pregnancy Category:D

Breastfeeding: Breastfeeding should be avoided for 5 months after therapy

• CNS: Dizziness, headache, somnolence
• NEURO: Asthenia
• GI: Diarrhea, vomiting, abdominal pain, nausea
• METABOLIC: Decreased appetite
• DERM: Prurits
• EENT: Motion sickness
• MISC: Pyrexia, lymphangitis
• LOCAL: Malaise

• Antileishmaniasis agent; exact mechanism of action is unknown; immunomodulatory effects may be due to T-cell activation mediated by interleukin-2
• Metabolized by liver; CYP450: 1A1, 1A2, 1B1, 2A6, 2B6, 2C8, 2C9, 2C18, 2C19, 2D6, 2E1, 3A4, 3A5, 3A7, and 4A1
• Excreted in urine (<0.2%) in visceral leishmaniasis patients
• Half life: > 6 days

US Trade Name(s)

• Impavido

US Availability

Impavido

• CAPS: 50 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Antimicrobials

Antiparasitics

Antileishmaniasis Agent

Infectious Disease

Antileishmaniasis Agent