Miltefosine

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Miltefosine Brand Name– IMPAVIDO

What is Miltefosine

Miltefosine is an alkyllysophospholipid analog, indicated for the treatment of the three main types of leishmaniasis: visceral leishmaniasis caused by Leishmania donovani; mucosal leishmaniasis caused by L. braziliensis; and cutaneous leishmaniasis caused by L. braziliensisL. guyanensis, and L. panamensis. Leishmania is an intracellular protozoan parasite transmitted to humans via the bite of a female sandfly.

Visceral leishmaniasis is a systemic infection that affects internal organs; these infections are fatal is left untreated. Cutaneous leishmaniasis affects the skin, and presents as ulcers at the site of the bite; most cases will resolve spontaneously after forming a scar.

Mucosal leishmaniasis occurs following dissemination of Leishmania from the skin to the naso-oropharyngeal mucosa.

These infections result in destruction of nasal and pharyngeal tissue. Miltefosine is the first medication to receive approval from the FDA to treat all three leishmaniasis infection types.

This approval was based on the results of four clinical trials, which showed a 94% final cure rate for visceral, 66—85% definitive cure rate for cutaneous, and a 62% complete resolution rate for mucosal leishmaniasis.

The drug has the potential to cause fetal death and teratogenicity; therefore, its use during pregnancy is contraindicated.

A Black Box Warning has been issued to remind health care providers of the need for a pregnancy tests prior to initiating treatment. In addition, female patients of reproductive potential must be instructed to use effective contraception during and for 5 months after therapy.

Miltefosine was FDA-approved for use in patients >= 12 years of age and weighing >= 30 kg in March 2014

Indications

  1. Leishmania braziliensis
  2. Leishmania donovani
  3. Leishmania guyanensis
  4. Leishmania panamensis
  5. leishmaniasis

Side Effects

  1. abdominal pain
  2. agranulocytosis
  3. anemia
  4. asthenia
  5. constipation
  6. decreased ejaculate volume
  7. diarrhea
  8. dizziness
  9. drowsiness
  10. dysphagia
  11. edema
  12. elevated hepatic enzymes
  13. epistaxis
  14. fatigue
  15. fetal death
  16. fever
  17. flatulence
  18. headache
  19. jaundice
  20. lymphadenopathy
  21. malaise
  22. melena
  23. nausea
  24. paresthesias
  25. peripheral edema
  26. pruritus
  27. rash
  28. seizures
  29. Stevens-Johnson syndrome
  30. teratogenesis
  31. testicular pain
  32. testicular swelling
  33. thrombocytopenia
  34. urticaria
  35. vomiting

Monitoring Parameters

  • CBC with differential
  • LFTs
  • pregnancy testing
  • serum bilirubin
  • serum creatinine

Contraindications

  • breast-feeding
  • contraception requirements
  • dehydration
  • hepatic disease
  • infertility
  • pregnancy
  • pregnancy testing
  • renal impairment
  • reproductive risk
  • serious rash
  • thrombocytopenia

Interactions

  • Anticoagulants
  • Antithrombin III
  • Apixaban
  • Argatroban
  • Betrixaban
  • Bivalirudin
  • Dabigatran
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Dienogest; Estradiol valerate
  • Drospirenone
  • Drospirenone; Estradiol
  • Drospirenone; Ethinyl Estradiol
  • Drospirenone; Ethinyl Estradiol; Levomefolate
  • Edoxaban
  • Elagolix; Estradiol; Norethindrone acetate
  • Enoxaparin
  • Estradiol; Levonorgestrel
  • Estradiol; Norethindrone
  • Estradiol; Norgestimate
  • Ethinyl Estradiol
  • Ethinyl Estradiol; Desogestrel
  • Ethinyl Estradiol; Ethynodiol Diacetate
  • Ethinyl Estradiol; Etonogestrel
  • Ethinyl Estradiol; Levonorgestrel
  • Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
  • Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
  • Ethinyl Estradiol; Norelgestromin
  • Ethinyl Estradiol; Norethindrone
  • Ethinyl Estradiol; Norethindrone Acetate
  • Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
  • Ethinyl Estradiol; Norethindrone; Ferrous fumarate
  • Ethinyl Estradiol; Norgestimate
  • Ethinyl Estradiol; Norgestrel
  • Fondaparinux
  • Heparin
  • Lepirudin
  • Leuprolide; Norethindrone
  • Levonorgestrel
  • Mestranol; Norethindrone
  • Norethindrone
  • Norgestrel
  • Oral Contraceptives
  • Pentosan
  • Rivaroxaban
  • Segesterone Acetate; Ethinyl Estradiol
  • Tinzaparin
  • Warfarin

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