miltefosine

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

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

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

Contraindications ⬆ ⬇

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

Black Box Warnings ⬆ ⬇

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

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

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/Breast Feeding ⬆ ⬇

Pregnancy Category:D

Breastfeeding: Breastfeeding should be avoided for 5 months after therapy

Adverse Reactions ⬆ ⬇

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

Clinical Pharmacology ⬆ ⬇

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

Brands and Availability ⬆ ⬇