Miltefosine

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.

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 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.

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.

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

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.

Miltefosine is part of the drug class:

• OTHER ANTINEOPLASTIC AGENTS

Before you take miltefosine, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney or liver problems. Your healthcare provider should do blood tests to check your kidneys and liver before you start, during and after your treatment with miltefosine.
• are pregnant or planning to become pregnant. Miltefosine may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if miltefosine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take miltefosine. You should avoid breastfeeding while you take miltefosine and for 5 months after you stop taking miltefosine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Store miltefosine at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect miltefosine from moisture.
• Keep miltefosine and all medicines out of the reach of children. 

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.

Antiprotozoal agent; alkylphosphocholine analog.1 2 5 6 7 12 23

Administration

Oral Administration

Administer orally with food to ameliorate adverse GI effects.1

Swallow capsule whole;1 do not break, chew, or crush.1

Dosage

Pediatric Patients

Children and adolescents ≥12 years of age weighing ≥30 kg: Dosage based on weight.1 (See Table 1.)

Usual treatment duration is 28 consecutive days.1 2 3 4 5 6 7 46 372 374 375 376

Adults

Dosage based on weight.1 (See Table 2.)

Usual treatment duration is 28 consecutive days.1 2 3 4 5 6 7 46 372 374 375 376

Special Populations

Hepatic Impairment

Manufacturer makes no dosage recommendations.1

Renal Impairment

Manufacturer makes no dosage recommendations.1

Storage

Oral

20–25°C (may be exposed to 15–30°C).1

Dispense in original container;1 protect from moisture.1

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For miltefosine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to miltefosine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of miltefosine in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of miltefosine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of miltefosine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Kidney disease or
• Liver disease—Use with caution. May make these conditions worse.

• Sjögren-Larsson-Syndrome (a rare disease)—Should not be used in patients with this condition.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about miltefosine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about miltefosine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using miltefosine.

Review Date: October 4, 2017