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Impavido is used to treat certain infections caused by leishmania parasites. Common side effects include nausea, vomiting, diarrhea, headache, loss of appetite, dizziness, drowsiness, and stomach pain. Stop this medicine right away and call your health care provider if you get a rash. Use birth control while taking Impavido and for five months after your last dose if you can get pregnant. Tell your health care provider right away if you are pregnant or think you may be pregnant.

Uses

What is Impavido used for?

Impavido (miltefosine) is commonly used to treat certain infections caused by leishmania parasites, including the following.

  • Infections of the internal organs
  • Infections of the skin 
  • Infections of the nose, mouth, and throat

Impavido may not be the right medicine for some of the infections listed above, depending on which parasites are causing the infection. Parasites in some locations may have developed resistance to Impavido, which will make it not work as well.

Impavido may also be used for other conditions as determined by your health care provider.

How does Impavido work (mechanism of action)?

Impavido may kill certain parasites by disrupting their cell structures and blocking certain important cellular functions.

How is Impavido supplied (dosage forms)?

Brands and other names

  • Impavido

Dosage forms and strengths

  • 50 mg oral capsules

How should I store Impavido?

Impavido should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. 

Side Effects

What are the most common side effects of Impavido?

The most common side effects of Impavido are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea, vomiting, and diarrhea (see below)
  • Headache
  • Loss of appetite
  • Dizziness and drowsiness
  • Stomach pain
  • Abnormal laboratory test results (see below)
  • Itching

There may be other side effects of Impavido that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Impavido?

While less common, the most serious side effects of Impavido are described below, along with what to do if they happen.

Severe Allergic Reactions. Impavido may cause allergic reactions, which can be serious. Stop taking Impavido and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Abnormal Laboratory Test Results. Impavido may cause certain laboratory blood test results to be higher than usual. These include tests that are commonly done to check your kidney or liver health. Your health care provider may regularly check your blood to make sure Impavido is safe for you to take. Keep all appointments to have your blood checked.

Nausea, Vomiting, and Diarrhea. Stomach pain, nausea, vomiting, and diarrhea are common side effects of Impavido. However, these side effects may be persistent or severe. Drink enough water to prevent dehydration. Tell your health care provider if you have any of these side effects that do not go away.

Severely Low Platelet Levels. Impavido can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help form blood clots. Having a low level of platelets may increase your risk of bleeding. Tell your health care provider if you have any of the following symptoms of low platelet levels.

  • Easy bruising or bleeding
  • Bleeding that does not stop
  • Nosebleeds

Severe Skin Reactions. Impavido can cause a severe skin reaction, called Stevens-Johnson syndrome (SJS), that can lead to death if not treated. If you develop a rash, stop Impavido and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including fever, chills, and muscle aches

Warnings & Precautions

Who should not use Impavido?

Allergies to Ingredients. People who are allergic to any of the following should not take Impavido.

  • Impavido
  • Miltefosine
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Impavido.

Pregnancy. Do not take Impavido if you are pregnant. If you become pregnant, contact your health care provider right away. See the Pregnancy section for more details.

Sjögren-Larsson Syndrome. Do not take Impavido if you have Sjögren-Larsson syndrome, a genetic condition that causes dry and scaly skin, intellectual disability, and speech problems.

What should I know about Impavido before using it?

Do not take Impavido unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Impavido with other people, even if they have the same condition as you. It may harm them.

Keep Impavido out of the reach of children.

Take the capsules whole. Do not break, crush, dissolve, or chew the capsules. Taking Impavido with food may reduce any stomach upset that this medicine may cause.

Impavido may make it hard for you to get pregnant or get your partner pregnant. If you would like to have a child or father a child one day, talk to your health care provider. 

What should I tell my health care provider before using Impavido?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Impavido is right for you.

In particular, make sure that you discuss any of the following.

Use of Birth Control Pills. Tell your health care provider if you are taking a birth control pill. Diarrhea or vomiting, which can occur while taking Impavido, may reduce the effectiveness of birth control pills. Your health care provider may prescribe or recommend other contraceptive methods such as condoms with spermicide while you are taking Impavido.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney problems
  • Liver problems

Pregnancy. Do not take Impavido if you are pregnant. Impavido may cause harm to a fetus. If you can become pregnant, use effective birth control when taking this medicine and for five months after your last dose. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant while taking Impavido, you can sign up for the Impavido Pregnancy Registry by calling 866-588-5405. This registry collects safety information about the use of Impavido during pregnancy.

Breastfeeding. It is not known if Impavido passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Impavido. Do not breastfeed for five months after you stop this medicine.

How can I get more information about Impavido?

For more information about Impavido, you can visit the drugmaker’s website at www.impavido.com or call them at 407-723-0101.

Interactions

Does Impavido interact with foods or drinks?

There are no known interactions between Impavido and foods or drinks.

It is unknown if drinking alcohol will affect Impavido, but heavy drinking can slow your immune response and make it harder for your body to fight infection.

Does Impavido interact with other medicines (drug interactions)?

There are no known interactions between Impavido and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Impavido?

If you or someone else has used too much Impavido, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Impavido?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

It is important to complete your prescribed course of Impavido, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Impavido or other similar medicines.