Miltefosine

Miltefosine is a prescription medication used for the treatment of leishmaniasis. 

• Miltefosine is available under various brand names: Impavido

Common side effects of Miltefosine include:

• vomiting
• nausea
• diarrhea
• decreased appetite
• dizziness
• motion sickness
• headache
• weakness
• stomach or abdominal pain
• general feeling of being unwell (malaise)
• fever
• drowsiness
• itching, and 
• testicular pain

Serious side effects of Miltefosine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• sudden vision loss,
• blurred vision,
• tunnel vision,
• eye pain or swelling,
• seeing halos around lights,
• fast, irregular, or pounding heartbeats,
• fluttering in your chest,
• shortness of breath,
• sudden dizziness,
• lightheadedness,
• fainting,
• severe headache,
• confusion,
• slurred speech,
• arm or leg weakness,
• trouble walking,
• loss of coordination,
• feeling unsteady,
• very stiff muscles,
• high fever,
• profuse sweating, and
• tremor.

Rare side effects of Miltefosine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult  and pediatric dosage

Capsule

• 50 mg

Leishmaniasis

Adult dosage

• Weighing above 45 kg: 50 mg orally thrice daily for 28 consecutive days
• Weighing below 45 kg: 50 mg orally twice daily for 28 consecutive days

Pediatric dosage

• Below 12 years, or above 12 years weighing below 30 kg: Safety and efficacy not established
• Above 12 years (30-44 kg): 50 mg orally twice daily for 28 consecutive days
• Above 12 years (Weighing above 45 kg): 50 mg orally thrice daily for 28 consecutive days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Miltefosine has no noted severe interactions with any other drugs.
• Miltefosine has no noted serious interactions with any other drugs.
• Miltefosine has no noted moderate interactions with any other drugs.
• Miltefosine has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Pregnancy (see Black Box Warnings)
• Sjögren-Larsson syndrome
• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Miltefosine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Miltefosine?”

Cautions

• May cause fetal harm; do not use during pregnancy or become pregnant within 5 months following therapy completion (see Black Box Warnings)
• Causes impaired fertility in rats and reversible follicular atresia and diestrus in dogs; reduced viable sperm counts and impaired fertility in rats; effects on human fertility have not been studied
• Vomiting and/or diarrhea commonly occur; encourage fluid intake to avoid volume depletion
• Vomiting and/or diarrhea occurring during therapy may affect oral contraceptive absorption and thereby compromise their efficacy; advise females to use additional nonhormonal or alternative method(s) of effective contraception
• Increased serum creatinine, ALT, AST, and bilirubin reported; monitor
• Thrombocytopenia reported; monitor platelets
• Stevens-Johnson syndrome reported; discontinue if an exfoliative or bullous rash occurs

Pregnancy & Lactation

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to IMPAVIDO during pregnancy; Healthcare providers are encouraged to register patients by calling 1-866-588-5405 or vising online at http://www.impavido.com/mother-registry
• Contraindicated during pregnancy; based on data from animal reproduction studies, therapy may cause embryo-fetal toxicity when administered to pregnant women; there are no available data on use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal and/or fetal outcomes
• If a woman becomes pregnant while being treated, treatment should be discontinued and the patient counseled about the potential risk to the fetus
• Embryo-fetal toxicity, including death and fetal malformations, was observed in embryo-fetal studies in rats and rabbits administered oral miltefosine during organogenesis at doses that were respectively 0.06 and 0.2 times the maximum recommended human dose (MRHD) of 3.33 mg/kg/day
• Numerous visceral and skeletal fetal malformations were observed in a fertility study in female rats administered miltefosine prior to mating through day 7 of pregnancy at doses 0.3 times the MRHD
• Verify pregnancy status prior to initiating therapy in females of reproductive potential
• Advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose
• Vomiting and/or diarrhea occurring during therapy may affect the absorption of oral contraceptives and therefore compromise their efficacy
• If vomiting and/or diarrhea occur during therapy, advise females to use an additional non-oral method of effective contraception
• Infertility
  • Females
    • Based on animal fertility studies, therapy may impair fertility in females of reproductive potential
    • The effects of therapy on human female fertility have not been formally studied
  • Males
    • Based on animal fertility and postmarketing studies, therapy may impair fertility in males of reproductive potential
• In an open-label, uncontrolled, single-center study that assessed the effects of the drug on sperm parameters; treatment was associated with reductions in all sperm parameters at the end of treatment; all sperm parameters, except for sperm concentration, recovered on follow-up assessments at 3 and 6 months after treatment completion; for sperm concentration, small mean decreases persisted on follow-up assessments at 3 and 6 months after treatment completion
• No clinically meaningful changes were observed in serum testosterone or FSH concentrations
• Reductions in ejaculate volume and temporary absence of ejaculate were reported in an observational study of male patients who received the therapy; these adverse reactions resolved in all patients in this study upon completion of therapy
• The effect of therapy on spermatogenesis may persist for an unknown duration; whether therapy affects male fertility is unknown
• Lactation
  • There are no data on the presence of miltefosine in human or animal milk, the effects on breastfed infants, or on milk production; because of the potential for serious adverse reactions, breastfeeding is not recommended during treatment and for 5 months after the last dose