Impavido (miltefosine) is a medication used to treat certain types of a parasitic infection called leishmaniasis. This medication comes as capsules that are easy to take, but it can cause a lot of stomach problems and raise the risk of dehydration.
Visceral, cutaneous, and mucosal leishmaniasis in people 12 years of age and older weighing at least 66 lbs (30 kg)
Impavido (miltefosine) is an antiparasitic medication against leishmaniasis. It's not known how Impavido (miltefosine) exactly works against Leishmania parasites. But it's thought that the medication prevents the parasites' cells from growing and functioning properly, which can lead to cell death.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Available as capsules to take by mouth
Can treat three different types of leishmaniasis
Can be taken by adults and children 12 years of age and older
Must be taken with food
Can affect the kidneys and liver
Can't be taken during pregnancy
Take Impavido (miltefosine) with food to lower the risk of stomach upset.
Swallow the capsule whole, and don't chew or break it before swallowing.
It's common to experience vomiting and diarrhea during Impavido (miltefosine) treatment. But this can lead to dehydration and kidney problems. Drink a lot of fluids to stay hydrated and let your provider know right away if you experience severe-related side effects that won't go away.
Impavido (miltefosine) might harm your unborn baby. If you find out that you're pregnant during your treatment with Impavido (miltefosine), stop taking this medication and contact your provider. You can register in the Impavido (miltefosine) pregnancy registry by calling 1-866-588-5405 or visiting the registry website. This registry monitors your and your baby's health after being exposed to Impavido (miltefosine).
Don't breastfeed your baby during your treatment with Impavido (miltefosine) and for 5 months after the last dose. It's not known if Impavido (miltefosine) passes into your breast milk, but there is a risk of serious side effects if your baby is exposed to the medication.
Impavido (miltefosine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Pregnancy
Impavido (miltefosine) might cause harm to your unborn baby, so don't take this medication while you're pregnant. Based on animal studies, Impavido (miltefosine) can raise the risk of pregnancy loss or serious birth defects if taken during pregnancy. Your provider will have you take a pregnancy test to make sure you're not pregnant before starting Impavido (miltefosine). It's recommended for females who can become pregnant to use an effective form of birth control during treatment and for 5 months after the last dose. Speak to your provider to determine which form of birth control is right for you.
If you are a male, Impavido (miltefosine) might make it harder for you to have a baby, because this medication can affect your sperm. Impavido (miltefosine) can lower the ejaculation (semen) amount, sperm count, sperm movement, sperm concentration, and other sperm properties. In clinical studies, all of these problems, except for sperm concentration (the number of sperm in a certain amount of semen), were reversible in most people. They improved within 3 to 6 months after stopping Impavido (miltefosine). Based on animal studies, Impavido (miltefosine) might also affect females and lower their chance of having a baby. Speak to your provider if this is a concern for you.
Risk factors: Taking birth control pills
If you take birth control pills and experience vomiting or diarrhea during your treatment with Impavido (miltefosine), it can affect how well your birth control gets absorbed into your body. This can cause your birth control to not work as well to prevent pregnancy. Make sure to use a back-up contraceptive that doesn't require you to take by mouth, such as condoms with spermicide, if you throw up or have diarrhea during your treatment.
Impavido (miltefosine) can raise the levels of serum creatinine (Cr). Creatinine is a waste product made by your muscles that's typically removed from your body through your kidneys. The amount of creatinine in your blood is a measure of how well your kidneys are working. You will need blood tests done weekly during your treatment and for 4 weeks after so your provider can check the health of your kidneys.
Impavido (miltefosine) can also affect your liver and raise your liver labs to abnormal levels. Your provider will monitor your liver closely during your treatment through blood tests.
Impavido (miltefosine) can lower the level of platelets in people who have visceral leishmaniasis. Platelets are responsible for helping your blood clot when you're bleeding to stop it. Extremely low levels of platelets can lead to bleeding problems. If you're getting treated for visceral leishmaniasis, your provider will monitor your platelet count through blood tests during your treatment. Let your provider know if you experience unusual bleeding or bruising while taking Impavido (miltefosine).
Although rare, Impavido (miltefosine) might cause a serious or life-threatening skin reaction. Get emergency medical help or contact your provider right away if you experience a peeling rash, skin rash with blisters, sores in the mouth, hives, or other allergic reactions.
Body weight of 66 lbs to 98 lbs (30 kg to 44 kg): Take 50 mg by mouth twice daily with food (breakfast and dinner) for 28 days.
Body weight of 99 lbs (45 kg) or greater: Take 50 mg by mouth three times daily with food (breakfast, lunch, and dinner) for 28 days.
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