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Impavido
Miltefosine
$1620.00
10mg · 56 capsules
BrandBranded medicine· By Paesel + Lorei
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FDA boxed warningEmbryo-fetal toxicity
IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy
Advise females of reproductive potential to use effective contraception during therapy and for 5 months after therapy.
About Impavido
Overview
Impavido capsules contain miltefosine, an antileishmanial medicine used in adults and adolescents aged 12 years and older who weigh at least 30 kg. It treats visceral leishmaniasis caused by Leishmania donovani, cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis or Leishmania panamensis, and mucosal leishmaniasis caused by Leishmania braziliensis. Miltefosine acts against the Leishmania parasites responsible for these infections.
What it treats
For adults and adolescents aged 12 years or older who weigh at least 30 kg: - Visceral leishmaniasis caused by Leishmania donovani. - Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis or Leishmania panamensis. - Mucosal leishmaniasis caused by Leishmania braziliensis.
Safety information
Side effects
Common side effects include nausea, vomiting, diarrhea, headache, reduced appetite, dizziness, abdominal pain, itching and sleepiness. Blood tests may also show increased liver enzymes or creatinine, a marker used to assess kidney function. Serious risks that warrant contacting a doctor include kidney or liver problems, a low platelet count and Stevens-Johnson syndrome, a serious skin reaction. Impavido must be stopped if Stevens-Johnson syndrome occurs. Kidney function should be monitored during treatment and for four weeks afterward. Liver blood tests are needed during treatment, and platelet counts should be monitored when treating visceral leishmaniasis. Vomiting and diarrhea can affect the absorption of oral contraceptives. Use an alternative method of contraception if either occurs, and maintain fluid intake. Impavido must not be used during pregnancy because it can harm an unborn baby. A pregnancy test is required before treatment, and effective contraception is needed for anyone who could become pregnant. Contact your doctor if you become pregnant. Miltefosine caused testicular damage and impaired fertility in animal studies; its potential effects on human fertility have not been adequately evaluated.
FDA boxed warning
Embryo-fetal toxicity
IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy
Advise females of reproductive potential to use effective contraception during therapy and for 5 months after therapy.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Impavido if you are pregnant, have Sjögren-Larsson syndrome, or are allergic to miltefosine or any of its ingredients. If you can become pregnant, a urine or blood pregnancy test is required before treatment. Use effective contraception during treatment and for 5 months afterward. If vomiting or diarrhea occurs, use an alternative contraceptive method because oral contraceptive absorption may be affected. If you are breastfeeding, discuss with your prescriber whether to stop breastfeeding or not take Impavido, depending on your need for treatment. Avoid breastfeeding for 5 months after treatment. Impavido may affect the kidneys and liver. Kidney function must be monitored during treatment and for 4 weeks afterward; liver blood tests are needed during treatment. Platelet counts should also be monitored when treating visceral leishmaniasis. Maintain fluid intake if gastrointestinal symptoms occur. Stop Impavido if Stevens-Johnson syndrome occurs. Miltefosine caused reproductive harm and impaired fertility in animal studies. Its potential effects on human fertility have not been adequately evaluated.
Using Impavido
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.] (DailyMed, retrieved 19 September 2026).
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