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Impavido

miltefosine
Used for Parasitic Infection
Used for Parasitic Infection

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.

Last reviewed on May 24, 2022
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What is Impavido (miltefosine)?

What is Impavido (miltefosine) used for?

How Impavido (miltefosine) works

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.

Are you looking for information on mifepristone (Mifeprex) instead?

Drug Facts

Common BrandsImpavido
Drug ClassAntiparasitic agent
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Impavido (miltefosine)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Nausea (36%)
  • Motion sickness (29%)
  • Headache (28%)
  • Stomach pain (11%)
  • Diarrhea (8%)
  • Fever (6%)
  • Dizziness (5%)
  • Itching (5%)
  • Vomiting (5%)

Other Side Effects

  • Weakness or tiredness
  • Sleepiness
  • Lower appetite
  • Constipation
  • Gas
  • Difficulty swallowing
  • Feeling of "pin and needles"
  • Pain in testicles
  • Skin infection
  • Rash
  • Hives
  • Anemia (low red blood cells)
  • Swollen or infected lymph nodes
  • Abnormal liver or kidney test

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Severe skin reaction: fever, flu-like symptoms, painful rash, blistering or peeling rash

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Change in vision such as blurry vision, seeing halos around lights, vision loss
  • Eye pain, redness, irritation, or discharge with blurry or decreased vision
  • Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
  • Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
  • Redness, blistering, peeling, or loosening of the skin, including inside the mouth
  • Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Impavido (miltefosine)

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Pros

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

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Cons

Must be taken with food

Can affect the kidneys and liver

Can't be taken during pregnancy

pharmacist-tips

Pharmacist tips for Impavido (miltefosine)

pharmacist
  • 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.

            faqs

            Frequently asked questions about Impavido (miltefosine)

            What is leishmaniasis?
            Leishmaniasis is an infection caused by a parasite called Leishmania. This parasitic infection is generally spread by the bite of infected sand flies. Leishmaniasis isn't commonly found in the United States, but it affects people who travel or live in other countries. Some people who are affected with leishmaniasis might not have any symptoms, while others might experience sores on their skin, nose, mouth, or throat. Leishmaniasis can also affect internal organs, including the spleen, liver, and bone marrow.
            What type of leishmaniasis can Impavido (miltefosine) treat?
            Impavido (miltefosine) can only treat certain types of leishmaniasis. These include visceral leishmaniasis (affecting your internal organs) caused by Leishmania donovani, cutaneous leishmaniasis (affecting the skin) caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis, and mucosal leishmaniasis (affecting the nose, mouth, and throat) caused by Leishmania braziliensis. If you have a different type of leishmaniasis infection, speak with your provider to find the right treatment for you.
            How long is the treatment with Impavido (miltefosine)?
            The treatment with Impavido (miltefosine) is 28 days (4 weeks). Continue taking the medication for the full course of therapy even if your symptoms improve. This will help prevent the parasite from becoming resistant to the medication and becoming harder to treat.
            Is Impavido (miltefosine) available at all pharmacies?
            Impavido (miltefosine) isn't a common medication that your pharmacy typically has in stock. This is because we don't see cases of leishmaniasis very often in the United States; oftentimes, people become infected while traveling or living in other countries. After getting a prescription for Impavido (miltefosine), check with your pharmacy to see if they can order the medication, which might take a few days.
            How long should I wait to have a baby after my treatment with Impavido (miltefosine)?
            Since Impavido (miltefosine) can cause harm to unborn babies, it's recommended to wait until at least 5 months after you've completed treatment to have a baby. If you are a female, continue your birth control for 5 months after the last dose to avoid getting pregnant during this time.
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            What are the risks and warnings for Impavido (miltefosine)?

            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-warning

            Risk of harm to unborn baby

            • 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.

              risk-warning

              Risk of lower ability to have a baby

              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-warning

              Lower absorption of birth control pills due to vomiting or diarrhea

              • 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.

                risk-warning

                Kidney and liver problems

                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.

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                Bleeding problems

                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).

                risk-warning

                Severe skin reactions

                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.

                dosage

                Impavido (miltefosine) dosage forms

                Typical dosing for Impavido (miltefosine)

                • 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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                Impavido (miltefosine) contraindications

                Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Impavido (miltefosine) will not be safe for you to take.

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