Miltefosine (Oral route)
Miltefosine may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer miltefosine to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing miltefosine. Females of reproductive potential should be advised to use effective contraception during miltefosine therapy and for 5 months after therapy .
Uses of This Medicine:
Miltefosine is used to treat certain types of leishmaniasis, such as visceral leishmaniasis (affects the internal organs), cutaneous leishmaniasis (affects the skin), or mucosal leishmaniasis (affects the nose, mouth, or throat).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
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.
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.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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.
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 this medicine. 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.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole. Do not crush, break, or chew it.
Take this medicine with food to help prevent stomach problems.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For leishmaniasis:
- Adults and children 12 years of age and older weighing 45 kg or more—50 mg three times a day, with food (breakfast, lunch, and dinner), taken for 28 days.
- Adults and children 12 years of age and older weighing 30 to 44 kilograms (kg)—50 milligrams (mg) two times a day, with food (breakfast and dinner), taken for 28 days.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For leishmaniasis:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your or your child's progress at regular visits. This will allow your to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 5 months after the last dose of this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.
You must have a negative urine or blood pregnancy test before you will be allowed to take this medicine. If you miss a period while you are using this medicine, tell your doctor right away.
Vomiting or diarrhea may occur while taking this medicine. These side effects may prevent birth control pills from working properly. You may use other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
Side Effects of This Medicine:
- Incidence not known
- Abdominal or stomach pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody, black, or tarry stools
- chills or fever
- itching or rash
- pain in the scrotum
- pinpoint red spots on the skin
- smaller amount of semen ejaculated than usual
- severe diarrhea or vomiting
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
- More common
- Decreased appetite
- lack or loss of strength
- Less common
- General feeling of discomfort or illness
- itching skin
- sleepiness or unusual drowsiness
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014