miltefosine (Rx)

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Brand and Other Names:Impavido

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 50mg
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Leishmaniasis

≥45 kg: 50 mg PO TID x28 consecutive days

<45 kg: 50 mg PO BID x28 consecutive days

Indications

  • Visceral leishmaniasis due to Leishmania donovani
  • Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis
  • Mucosal leishmaniasis due to Leishmania braziliensis

Dosing Considerations

Leishmania species evaluated in clinical trials were based on epidemiologic data

There may be geographic variation in the response of the same Leishmania species to miltefosine

Efficacy for other Leishmania species has not been evaluated

Administration

Administer with meals to decrease GI adverse effects

Swallow capsule whole; do not chew or break apart

Instruct patient to complete full course of therapy

Dosage Forms & Strengths

capsule

  • 50mg
more...

Leishmaniasis

<12 years, or ≥12 years weighing <30 kg: Safety and efficacy not established

≥12 years (30-44 kg): 50 mg PO BID x28 consecutive days

≥12 years (≥45 kg): 50 mg PO TID x28 consecutive days

Indications

  • Visceral leishmaniasis due to Leishmania donovani
  • Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis
  • Mucosal leishmaniasis due to Leishmania braziliensis

Dosing Considerations

Leishmania species evaluated in clinical trials were based on epidemiologic data

There may be geographic variation in the response of the same Leishmania species to miltefosine

Efficacy for other Leishmania species has not been evaluated

Administration

Administer with meals to decrease GI adverse effects

Swallow capsule whole; do not chew or break apart

Instruct patient to complete full course of therapy

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Adverse Effects

>10%

Visceral leishmaniasis

  • Increased transaminases, <3 x ULN (94%)
  • Decreased platelets <150,000 (62%)
  • Vomiting (37.8%)
  • Decreased appetite (23.1%)
  • Diarrhea (20.4%)

Cutaneous leishmaniasis

  • Nausea (35.9-41.7%)
  • Motion sickness (29.2%)
  • Headache (28.1%)
  • Vomiting (4.5-27.5%)
  • Increased serum creatinine, 1.5-3 x baseline (25%)
  • Diarrhea (15%) Dizziness (4.5-12.5%)
  • Abdominal pain (7.5-11.2%)
  • Decreased appetite (10.8%)

1-10%

Visceral leishmaniasis

  • Increased serum creatinine, ≥1.5 x baseline (10%)
  • Asthenia (6.3%)
  • Increased transaminases, 3-5 x ULN (6%)
  • Decreased platelets <50,000 (2.4%)

Cutaneous leishmaniasis

  • Diarrhea (7.9%)
  • Lymphangitis (5.8%)
  • Pyrexia (5.6%)
  • Pruritus (4.5-5.8%)
  • Malaise (3.4%)
  • Somnolence (3.4%)

Postmarketing Reports

Blood and lymphatics disorders: Thrombocytopenia, agranulocytosis

GI disorders: Melena

General disorders: Generalized edema, peripheral edema

Hepatobiliary disorders: Jaundice

Nervous system disorders: Seizure

Reproductive system and breast disorders: Scrotal pain, decreased ejaculate volume, absent ejaculation

Vascular disorders: Epistaxis

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Warnings

Black Box Warnings

Do not administer to pregnant women; may cause fetal harm

Fetal death and teratogenicity occurred in animals administered at doses lower than the recommended human dose

Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing

Advise females of reproductive potential to use effective contraception during therapy and for 5 months after therapy

Contraindications

Pregnancy (see Black Box Warnings)

Sjögren-Larsson syndrome

Hypersensitivity

Cautions

May cause fetal harm; do not use during pregnancy or become pregnancy within 5 months following therapy completion (see Black Box Warnings)

Causes impaired fertility in rats and reversible follicular atresia and diestrus in dogs; reduced viable sperm counts and impaired fertility in rats; effects on human fertility have not been studied

Vomiting and/or diarrhea commonly occur; encourage fluid intake to avoid volume depletion

Vomiting and/or diarrhea occurring during therapy may affect oral contraceptive absorption and thereby compromise their efficacy; advise females to use additional nonhormonal or alternative method(s) of effective contraception

Increased serum creatinine, ALT, AST, bilirubin reported; monitor

Thrombocytopenia reported; monitor platelets

Stevens-Johnson syndrome reported; discontinue if an exfoliative or bullous rash occurs

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Pregnancy & Lactation

Pregnancy Category: D (see Black Box Warnings); Human pregnancy data are not available; however, embryofetal toxicity, including death and teratogenicity, was observed in embryo-fetal studies in rats and rabbits

Clinical considerations: During pregnancy, visceral leishmaniasis may be life-threatening for the mother and may result in adverse fetal outcomes, including spontaneous abortion, congenital disease due to vertical transmission, small for gestational age newborn, and severe anemia

Lactation: Unknown if distributed in human breast milk; avoid breastfeeding during therapy and for 5 months following therapy

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Specific mode of action against Leishmania species is unknown; the mechanism is likely to involve interaction with lipids (phospholipids and sterols), including membrane lipids, inhibition of cytochrome C oxidase (mitochondrial function), and apoptosislike cell death

Absorption

Absolute bioavailability not determined

Distribution

Protein bound: >98%

Metabolism

Metabolized by phospholipase D to choline, which is incorporated into tissues, and hexadecanol, which is oxidized to palmitic acid

Not a substrate, inhibitor, or inducer of CYP450 enzymes

Elimination

Excretion: Urine, <0.2% of administered dose

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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