Drug Database: Miltefosine

What is miltefosine? What is miltefosine?

What is miltefosine?

Miltefosine is an antiprotozoal prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of leishmaniasis.

Leishmaniasis can be an opportunistic infection (OI) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as people with HIV—than in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

How is miltefosine used in people with HIV? How is miltefosine used in people with HIV?

How is miltefosine used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV include recommendations on the use of miltefosine to treat leishmaniasis, including visceral leishmaniasis (affecting the entire body) and cutaneous leishmaniasis, in people with HIV.

The recommended uses may not always be consistent with FDA-approved uses of miltefosine. See the Guidelines for complete information on recommended uses of miltefosine in adults with HIV. Miltefosine may have other recommended uses not listed above.

What should I tell my health care provider before taking miltefosine? What should I tell my health care provider before taking miltefosine?

What should I tell my health care provider before taking miltefosine?

Before taking miltefosine, tell your health care provider:

• If you are allergic to miltefosine or any other medicines.
• About any medical conditions you have or have had, including kidney or liver problems.
• About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills.
• If you are pregnant or plan to become pregnant. Miltefosine can harm an unborn baby and should not be used during pregnancy. Talk to your health care provider about the risks of taking miltefosine during pregnancy.
• If you are breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are taking before you start breastfeeding.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Miltefosine may interact with other medicines or supplements. For a list of medicines and supplements that may interact with miltefosine, see the drug label or ask your health care provider or pharmacist.

How should I take miltefosine? How should I take miltefosine?

How should I take miltefosine?

Take miltefosine according to your health care provider’s instructions. Your health care provider will tell you how much miltefosine to take and when to take it.

It is important to complete the full prescribed course of treatment with miltefosine, even if you begin to feel better. If you stop using miltefosine too soon or skip doses, your infection may not be fully treated and may become harder to treat (resistant).

Before you start miltefosine and each time you get a refill, read any printed information that comes with your medicine.

What side effects can miltefosine cause? What side effects can miltefosine cause?

What side effects can miltefosine cause?

Miltefosine may cause side effects that can be mild or serious. To learn about possible side effects of miltefosine, see the FDA drug label or talk to your health care provider or pharmacist. Tell your health care professional if you have any side effect that bothers you or that does not go away. Your health care professional may be able to tell you about ways to prevent or reduce some side effects.

You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should miltefosine be stored? How should miltefosine be stored?

How should miltefosine be stored?

• Store miltefosine at room temperature, 68°F to 77°F (20°C to 25°C), and away from moisture.
• Keep miltefosine in the container that it came in and keep the container tightly closed.
• Do not use miltefosine if the original seal over the container opening is broken or missing.
• Throw away miltefosine that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep miltefosine and all medicines out of reach of children.

Where can I find more information about miltefosine? Where can I find more information about miltefosine?

Where can I find more information about miltefosine?

• Recommendations on the HIV-related uses of miltefosine, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
• This Patient Version drug summary is based on the following FDA label(s): Capsule. The Medication Guide includes information for people taking miltefosine.
• Miltefosine-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)