Table of contents:
- Use
- What is miltefosine for?
- How do I use miltefosine?
- How do I store miltefosine?
- Dose
- What is the dose of miltefosine for adults?
- What is the dose of miltefosine for children?
- In what dosage is miltefosine available?
- Side effects
- What side effects can be experienced due to miltefosine?
- Precautions & Warnings
- What should be known before using miltefosine?
- Is miltefosine safe for pregnant and lactating women?
- Interaction
- What medicines may interact with miltefosine?
- Can food or alcohol interact with miltefosine?
- What health conditions can interact with miltefosine?
- Overdose
- What should I do in an emergency or overdose?
- What should I do if I miss a dose?
Use
What is miltefosine for?
Miltefosine is an anti-parasitic drug with the function of treating leishmaniasis, a disease caused by a parasitic infection that enters the body through the bite of an infected sand fly. Miltefosine is used to treat leishmaniasis that affects the skin, 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 the guidelines for this drug.
How do I use miltefosine?
Follow all directions on the recipe label. Do not take this medication in amounts larger or smaller or for longer than recommended.
Drink with food to reduce stomach upset. Do not crush, split or dissolve the miltefosine tablets. Swallow the whole tablet.
Tell your doctor if you change your weight. The dose of miltefosine is based on body weight (especially in children and adolescents), and any change may affect the dose.
Vomiting or diarrhea can cause you to become dehydrated, resulting in kidney failure while you are taking miltefosine. Drink plenty of fluids every day while you are taking this medicine.
While using miltefosine, you may need frequent blood tests. Kidney function will need to be checked during treatment and for 4 weeks after you stop taking miltefosine.
Miltefosine is usually taken by mouth for 28 consecutive days. Use this medication until the time limit specified by the prescription. Symptoms may improve before the infection is completely cleared.
How do I store miltefosine?
This medication is best stored at room temperature, away from direct light and damp places. Don't keep it in the bathroom. Don't freeze it. Other brands of this drug may have different storage rules. Observe the storage instructions on the product package or ask your pharmacist. Keep all medicines away from children and pets.
Do not flush medicines down the toilet or down the drain unless instructed to do so. Discard this product when it has expired or when it is no longer needed. Consult your pharmacist or local waste disposal company about how to safely dispose of your product.
Dose
The information provided is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist before starting treatment.
What is the dose of miltefosine for adults?
Oral
Leishmaniasis of organs
Adults: 100-150 mg per day for 28 days.
Topical / Skin
Mycosis fungoides
Adults: 6% solution applied 1-2 times per day.
Topical / Skin
Breast cancer skin metastases
Adults: 6% solution applied 1-2 times per day.
What is the dose of miltefosine for children?
≥12 years (30-44 kg): 50 mg PO BID x28 consecutive days
≥12 years (≥45 kg): 50 mg PO TID x28 consecutive days
In what dosage is miltefosine available?
Capsule, Oral: 50 mg
Side effects
What side effects can be experienced due to miltefosine?
Get emergency medical help if you have any of these signs of an allergic reaction: hives, difficulty breathing, swollen face, lips, tongue, or throat.
Call your doctor right away if you experience:
- Severe or ongoing stomach problems (nausea, vomiting, diarrhea)
- (In men) Painful scrotum or testicles, abnormal ejaculation
- Easy bruising or bleeding (nosebleeds, bleeding gums)
- Signs of kidney problems - little or no painful urination or difficulty urinating feet or swollen ankles feeling tired or short of breath
- Liver problems - nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice or
- Severe skin reactions — fever, sore throat, swollen face or tongue, burning eyes, sore skin, followed by a red or purple rash that spreads (especially on the face or upper body) and causes the skin to blister and peel.
Common side effects may include:
- Nausea, vomiting, stomach pain, loss of appetite
- Diarrhea
- Headache, dizziness, or drowsiness
- Itchy rash.
Not everyone experiences this side effect. There may be some side effects not listed above. If you want to know about side effects, consult your doctor or pharmacist.
Precautions & Warnings
What should be known before using miltefosine?
Before using it, tell your doctor and pharmacist:
- If you are allergic to miltefosine or other drugs
- The types of prescription and over-the-counter medications you take, including vitamins
- If you are pregnant, planning to become pregnant, or breastfeeding. If you become pregnant while taking it, call your doctor
- If you are undergoing radiation therapy at the same time
Is miltefosine safe for pregnant and lactating women?
There are no adequate studies regarding the risks of using this drug in pregnant or breastfeeding women. Always consult your doctor to weigh the potential benefits and risks before using this medication. This drug is included in the risk of pregnancy category D according to the US Food and Drug Administration (FDA).
The following references the pregnancy risk categories according to the FDA:
- A = No risk,
- B = not at risk in several studies,
- C = May be risky,
- D = There is positive evidence of risk,
- X = Contraindicated,
- N = Unknown
The decision has to be made whether to stop breastfeeding or to stop taking the drug, considering the importance of the medicine to the mother. Breastfeeding should be avoided for 5 months after therapy.
Interaction
What medicines may interact with miltefosine?
Drug interactions may change how medications work or increase the risk of serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription / over-the-counter medicines and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change your dose without your doctor's approval.
Can food or alcohol interact with miltefosine?
Certain drugs cannot be used with meals or when eating certain foods because drug interactions can occur. Consuming alcohol or tobacco with certain drugs can also cause interactions to occur. Talk to your healthcare professional about using your medication with food, alcohol, or cigarettes.
What health conditions can interact with miltefosine?
The presence of other medical problems may affect the use of the drug. Make sure you tell your doctor if you have any other medical problems, especially:
- A rare genetic skin and nerve disorder named Sjogren-Larsson syndrome or
- Liver or kidney disease.
Overdose
What should I do in an emergency or overdose?
In case of an emergency or overdose, contact the local emergency services provider (112) or immediately to the nearest hospital emergency department.
What should I do if I miss a dose?
If you forget a dose of this medicine, use it as soon as possible. However, when it is near the time of the next dose, skip the missed dose and return to the usual dosing schedule. Do not double up on a dose to make up for a missed dose.
Hello Health Group does not provide medical advice, diagnosis or treatment.