Miltefosine is an anti-parasitic drug used to treat leishmaniasis, a disease caused by an infection with parasites that enter the body through the bite of an infected sand fly.

Miltefosine is used to treat leishmaniasis affecting the skin, internal organs (such as the liver, spleen or bone marrow), and mucous membranes (nose, mouth, and throat).

Miltefosine may also be used for purposes not listed in this medication guide.

In animal studies, miltefosine has caused birth defects and death of unborn offspring. It is not known whether these effects would occur in people. You should not use miltefosine if you are pregnant.

You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while you are taking miltefosine and for at least 5 months after your treatment ends.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take with food to lessen upset stomach.

Do not crush, chew, break, or dissolve a miltefosine tablet. Swallow it whole.

Tell your doctor if you have any changes in weight. Miltefosine doses are based on weight (especially in children and teenagers), and any changes may affect the dose.

Vomiting or diarrhea can cause you to become dehydrated. This can lead to kidney failure while you are taking miltefosine. Drink plenty of water each day while you are taking this medicine.

While using miltefosine, you may need frequent blood tests. Your kidney function will need to be checked during treatment and for 4 weeks after you stop using miltefosine.

Miltefosine is usually taken for 28 days in a row. Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Store at room temperature away from moisture and heat. Keep each tablet in its blister pack until you are ready to take it.

Usual Adult Dose for Leishmaniasis:

Weight 30 to 44 kg: 50 mg orally twice a day
Weight at least 45 kg: 50 mg orally 3 times a day
Duration of therapy: 28 consecutive days

Uses: For the treatment of:
-Visceral leishmaniasis due to Leishmania donovani
-Cutaneous leishmaniasis due to L braziliensis, L guyanensis, and L panamensis
-Mucosal leishmaniasis due to L braziliensis

Usual Pediatric Dose for Leishmaniasis:

12 years or older:
-Weight 30 to 44 kg: 50 mg orally twice a day
-Weight at least 45 kg: 50 mg orally 3 times a day
Duration of therapy: 28 consecutive days

Uses: For the treatment of:
-Visceral leishmaniasis due to L donovani
-Cutaneous leishmaniasis due to L braziliensis, L guyanensis, and L panamensis
-Mucosal leishmaniasis due to L braziliensis

You should not use miltefosine if you are allergic to it, or if you have:

• a rare genetic skin and nerve disorder called Sjogren-Larsson syndrome; or

• if you are pregnant.

To make sure miltefosine is safe for you, tell your doctor if you have:

• liver or kidney disease.

In animal studies, miltefosine caused birth defects and death of unborn offspring, and also affected fertility in male and female adults. It is not known whether these effects would occur in people using miltefosine. Ask your doctor about your risk.

FDA pregnancy category D. You should not use miltefosine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while you are taking miltefosine and for at least 5 months after your treatment ends.

Vomiting or diarrhea caused by miltefosine can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy if you have vomiting and/or diarrhea while taking miltefosine.

If you become pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of miltefosine on the baby.

It is not known whether miltefosine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using miltefosine, and for at least 5 months after your treatment ends.

Miltefosine should not be given to a child younger than 12 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Miltefosine may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing stomach problems (nausea, vomiting, diarrhea);

• (in men) pain in the scrotum or testicles, abnormal ejaculation;

• easy bruising or bleeding (nosebleeds, bleeding gums);

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

• liver problems--nausea, upper stomach pain, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of miltefosine may include:

• nausea, vomiting, stomach pain, loss of appetite;

• diarrhea;

• headache, dizziness, drowsiness; or

• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with miltefosine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.