IMPAVIDO

Agents for Leishmaniasis and/or Trypanosomiasis

Hazardous Drugs Classification
NIOSH (Draft) 2020 List: Table 2
Approved by FDA after NIOSH 2016 list published. NIOSH recommends this drug be handled as a hazardous drug.
Observe and exercise appropriate precautions for handling, preparation, administration, and disposal of hazardous drugs.
Use gloves to handle. Cutting, crushing, or otherwise manipulating tablets/capsules will increase exposure and require additional protective equipment. Oral liquid drugs require double chemotherapy gloves and protective gown; may require eye/face protection.

Administer with a meal.
Swallow capsule whole.

epididymitis / Delayed / 3.0-3.0
Stevens-Johnson syndrome / Delayed / 0-2.0
seizures / Delayed / Incidence not known
agranulocytosis / Delayed / Incidence not known
fetal death / Delayed / Incidence not known
teratogenesis / Delayed / Incidence not known

elevated hepatic enzymes / Delayed / 0-50.0
thrombocytopenia / Delayed / 2.4-2.4
dysphagia / Delayed / 0-2.0
constipation / Delayed / 0-2.0
lymphadenopathy / Delayed / 0-2.0
anemia / Delayed / 0-2.0
testicular swelling / Early / 0-2.0
melena / Delayed / Incidence not known
peripheral edema / Delayed / Incidence not known
edema / Delayed / Incidence not known
jaundice / Delayed / Incidence not known

nausea / Early / 35.9-41.7
vomiting / Early / 4.5-37.8
headache / Early / 28.1-28.1
diarrhea / Early / 7.9-20.4
dizziness / Early / 4.5-12.5
testicular pain / Early / 0-12.0
abdominal pain / Early / 7.5-11.2
asthenia / Delayed / 6.3-6.3
pruritus / Rapid / 4.5-5.8
fever / Early / 5.6-5.6
malaise / Early / 3.4-3.4
drowsiness / Early / 3.4-3.4
flatulence / Early / 0-2.0
fatigue / Early / 0-2.0
paresthesias / Delayed / 0-2.0
urticaria / Rapid / 0-2.0
rash / Early / 0-2.0
epistaxis / Delayed / Incidence not known
spermatogenesis inhibition / Delayed / Incidence not known
decreased ejaculate volume / Delayed / Incidence not known

Miltefosine is contraindicated for use during pregnancy. If a woman becomes pregnant while being treated with miltefosine, discontinue therapy and counsel the patient about the potential risk to the fetus. Based on data from animal reproduction studies, miltefosine may cause embryo-fetal toxicity when administered to pregnant women. There are no available data on miltefosine use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal and/or fetal outcomes. In animal studies, fetal death and fetal malformations occurred at oral doses that were 0.06 to 0.3 times the maximum recommended human dose (MRHD), respectively. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to miltefosine during pregnancy. Register patients by calling 1-866-588-5405 or visiting online at http://www.impavido.com/mother-registry.

Miltefosine is associated with reproductive risk. Verify the pregnancy status in females of reproductive potential with pregnancy testing before initiating treatment with miltefosine. Discuss contraception requirements with the patients. Advise females of reproductive potential to use effective contraception during treatment with miltefosine and for 5 months after the last dose. Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting and/or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception. Miltefosine may cause infertility in males and females of reproductive potential. Reductions in sperm parameters (semen volume, total sperm count, sperm concentration, sperm morphology, and sperm motility) were observed in an open-label clinical study (n = 58) in males receiving a target dose of miltefosine 2.5 mg/kg/day for 28 days. For all parameters, except sperm concentration, the observed reductions were reversible in most affected patients and improved within 3 to 6 months. Sperm concentration reductions of 50% or more persisted in approximately 26% of patients on follow-up assessments at 3 and 6 months after treatment completion, and sperm concentration reductions to the lower limit of normal (less than 20 million/mL) persisted in up to 8% of patients on their last observed assessment. There were no clinically meaningful changes in serum testosterone of FSH concentrations. Semen analyses were not conducted beyond 6 months, therefore the duration of effect of miltefosine on sperm concentration after treatment is unknown. Reductions in ejaculate volume and temporary absence of ejaculate were reported in an observational study of male patients receiving miltefosine. These adverse effects resolved in all patients upon completion of therapy. Based on animal fertility studies, miltefosine may also impair fertility in females of reproductive potential. When miltefosine was administered to rats at the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison, estrus cycle arrest occurred. At doses of 0.3 to 1 times the MRHD based on BSA comparison, increased numbers of embryonic and fetal resorptions and dead fetuses were observed. Female dogs administered doses of 0.2 times MRHD based on BSA comparison, experienced reversible follicular atresia and diestrus. The effects in dogs were fully reversible after a recovery period of 6 weeks.

IMPAVIDO

Rx

Oral anti-leishmanial agent
Used for the treatment of visceral, cutaneous, and mucosal leishmaniasis in adults and pediatric patients 12 years of age and older and weighing at least 30 kg
Contraindicated during pregnancy; may impair male fertility

50 mg PO 3 times daily for 28 days. For visceral disease, miltefosine is an alternative to liposomal amphotericin B. Combination therapy with liposomal amphotericin B may be considered in HIV-infected patients with refractory visceral disease. Chronic maintenance therapy with a lipid formulation amphotericin B or alternately, pentavalent antimony is recommended for HIV-infected patients with visceral disease and immunocompromised patients with multiple cutaneous relapses.[34362] [56867] [63762]

50 mg PO twice daily for 28 days. For visceral disease, miltefosine is an alternative to liposomal amphotericin B. Combination therapy with liposomal amphotericin B may be considered in HIV-infected patients with refractory visceral disease. Chronic maintenance therapy with a lipid formulation amphotericin B or alternately, pentavalent antimony is recommended for HIV-infected patients with visceral disease and immunocompromised patients with multiple cutaneous relapses.[34362] [56867] [63762]

50 mg PO 3 times daily for 28 days. For visceral disease, miltefosine is an alternative to liposomal amphotericin B. Combination therapy with liposomal amphotericin B may be considered in HIV-infected patients with refractory visceral disease. Chronic maintenance therapy with a lipid formulation amphotericin B or alternately, pentavalent antimony is recommended for HIV-infected patients with visceral disease and immunocompromised patients with multiple cutaneous relapses.[34362] [56867] [63762]

50 mg PO twice daily for 28 days. For visceral disease, miltefosine is an alternative to liposomal amphotericin B. Combination therapy with liposomal amphotericin B may be considered in HIV-infected patients with refractory visceral disease. Chronic maintenance therapy with a lipid formulation amphotericin B or alternately, pentavalent antimony is recommended for HIV-infected patients with visceral disease and immunocompromised patients with multiple cutaneous relapses.[34362] [56867] [63762]

2.5 mg/kg/day PO divided once or twice daily (rounded to nearest 10-mg [international] or 50-mg strength [US]) for 28 days.[63762] [64598] [64600] [64601] [64602] In clinical studies, lower cure rates and lower plasma drug exposures have been observed in younger children with this dosing regimen. An allometric dosing regimen, based on fat-free mass and height, has been studied. This proposed dosing algorithm results in higher daily doses for those with very low body weights (i.e., 3 to 4 mg/kg/day).[64597] [64598] [64599]

Specific guidelines for dosage adjustments in hepatic impairment are not available. Patients with baseline serum ALT or AST >= 3x upper limit of normal and/or bilirubin >= 2x upper limit of normal were excluded from clinical trials.
 

Specific guidelines for dosage adjustments in renal impairment are not available. Patients with baseline serum creatinine or BUN >= 1.5x upper limit of normal were excluded from clinical trials.

Anticoagulants: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Antithrombin III: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Apixaban: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Argatroban: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Betrixaban: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Bivalirudin: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Dabigatran: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Dalteparin: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Desirudin: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Desogestrel; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Dienogest; Estradiol valerate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Drospirenone: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Drospirenone; Estetrol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Drospirenone; Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Drospirenone; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Drospirenone; Ethinyl Estradiol; Levomefolate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Edoxaban: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Elagolix; Estradiol; Norethindrone acetate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Enoxaparin: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Estradiol; Levonorgestrel: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Estradiol; Norethindrone: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Estradiol; Norgestimate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Ethinyl Estradiol; Norelgestromin: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Ethinyl Estradiol; Norethindrone Acetate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Ethinyl Estradiol; Norgestrel: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Ethynodiol Diacetate; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Etonogestrel; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Fondaparinux: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Heparin: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Leuprolide; Norethindrone: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Levonorgestrel: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Levonorgestrel; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Norethindrone: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Norethindrone; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Norgestimate; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Norgestrel: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Oral Contraceptives: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Pentosan: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Relugolix; Estradiol; Norethindrone acetate: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Rivaroxaban: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.
Segesterone Acetate; Ethinyl Estradiol: (Moderate) Miltefosine-induced vomiting and/or diarrhea may affect absorption of oral contraceptives and compromise their efficacy. If vomiting or diarrhea occur during miltefosine therapy, advise females to use an additional non-oral method of effective contraception.
Warfarin: (Moderate) Caution is advised when administering miltefosine with anticoagulants, as use of these drugs together may increase risk for bleeding. Miltefosine, when administered for the treatment of visceral leishmaniasis, has been associated with thrombocytopenia; monitor platelet counts in patients receiving treatment for this indication. In addition, monitor closely for increased bleeding if use in combination with an anticoagulant.

IMPAVIDO Oral Cap: 50mg

weighing 45 kg or more: 150 mg/day PO.
weighing 30 to 44 kg: 100 mg/day PO.

weighing 45 kg or more: 150 mg/day PO.
weighing 30 to 44 kg: 100 mg/day PO.

weighing 45 kg or more: 150 mg/day PO.
weighing 30 to 44 kg: 100 mg/day PO.

12 years and weighing 45 kg or more: 150 mg/day PO.
12 years and weighing 30 to 44 kg: 100 mg/day PO.
12 years and weighing less than 30 kg: 2.5 mg/kg/day PO has been used off-label.
2 to 11 years: 2.5 mg/kg/day PO has been used off-label.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Miltefosine is an alkyllysophospholipid analog with activity against certain Leishmania species in the amastigote (leishmanial) and promastigote (leptomonad) stages. The drug has been shown to be effective against L. donovani, L. braziliensis, L. guyanensis, and L. panamensis, with L. donovani being most susceptible and L. braziliensis being least susceptible. The proposed mechanism by which the drug exerts its antiprotozoan activity includes interacting with Leishmania phospholipids/sterols (including membrane lipids), and inhibiting the mitochondrial cytochrome c oxidase enzyme; thus resulting in apoptosis-like cell death. Miltefosine requires transportation into the cell via protein complexes on the plasma membrane. Resistance (intrinsic and acquired) may occur with reduced concentrations of these translocation proteins or from increased concentrations of drug efflux pumps; both will result in decreased accumulation of the drug within the parasite.

Miltefosine is administered orally. Following administration, it is widely distributed with 98% bound to plasma protein. Miltefosine is not a substrate for the cytochrome P450 (CYP) enzymes; instead, it undergoes a slow metabolic breakdown by phospholipase D-like cleavage to release choline and hexadecanol. The choline metabolite is incorporated into tissues, while hexadecanol is oxidized to form palmitic acid. The terminal half-life is approximately 30 days, with < 0.2% of the daily dose excreted unchanged in the urine.
 
Affected cytochrome P450 isoenzymes and drug transporters:  none

The absolute bioavailability of oral miltefosine has not been determined. In many patients, maximum plasma concentrations are achieved just prior to the next dose, suggesting absorption continues throughout the entire dosing interval. In addition, because of the long half-life, plasma concentrations do not reach steady-state during the 28 day treatment period.

Miltefosine is contraindicated for use during pregnancy. If a woman becomes pregnant while being treated with miltefosine, discontinue therapy and counsel the patient about the potential risk to the fetus. Based on data from animal reproduction studies, miltefosine may cause embryo-fetal toxicity when administered to pregnant women. There are no available data on miltefosine use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal and/or fetal outcomes. In animal studies, fetal death and fetal malformations occurred at oral doses that were 0.06 to 0.3 times the maximum recommended human dose (MRHD), respectively. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to miltefosine during pregnancy. Register patients by calling 1-866-588-5405 or visiting online at http://www.impavido.com/mother-registry.

There are no data on the presence of miltefosine in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Due to the potential for serious adverse reactions, breast-feeding is not recommended during treatment and for 5 months after the last miltefosine dose.