Impavido
Impavido (miltefosine) is a medication used to treat certain types of a parasitic infection called leishmaniasis. This medication comes as capsules that are easy to take, but it can cause a lot of stomach problems and raise the risk of dehydration.
What is Impavido (miltefosine)?
What is Impavido (miltefosine) used for?
- Visceral, cutaneous, and mucosal leishmaniasis in people 12 years of age and older weighing at least 66 lbs (30 kg)
How Impavido (miltefosine) works
Impavido (miltefosine) is an antiparasitic medication against leishmaniasis. It's not known how Impavido (miltefosine) exactly works against Leishmania parasites. But it's thought that the medication prevents the parasites' cells from growing and functioning properly, which can lead to cell death.
Drug facts
Side effects of Impavido (miltefosine)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nausea (36%)
- Motion sickness (29%)
- Headache (28%)
- Stomach pain (11%)
- Diarrhea (8%)
- Fever (6%)
- Dizziness (5%)
- Itching (5%)
- Vomiting (5%)
Less Common Side Effects
- Weakness or tiredness
- Sleepiness
- Lower appetite
- Constipation
- Gas
- Difficulty swallowing
- Feeling of "pin and needles"
- Pain in testicles
- Skin infection
- Rash
- Hives
- Anemia (low red blood cells)
- Swollen or infected lymph nodes
- Abnormal liver or kidney test
Impavido (miltefosine) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe skin reaction: fever, flu-like symptoms, painful rash, blistering or peeling rash
The following Impavido (miltefosine) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision such as blurry vision, seeing halos around lights, vision loss
- Eye pain, redness, irritation, or discharge with blurry or decreased vision
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Impavido (miltefosine)
Pros
- Available as capsules to take by mouth
- Can treat three different types of leishmaniasis
- Can be taken by adults and children 12 years of age and older
Cons
- Must be taken with food
- Can affect the kidneys and liver
- Can't be taken during pregnancy
Pharmacist tips for Impavido (miltefosine)
- Take Impavido (miltefosine) with food to lower the risk of stomach upset.
- Swallow the capsule whole, and don't chew or break it before swallowing.
- It's common to experience vomiting and diarrhea during Impavido (miltefosine) treatment. But this can lead to dehydration and kidney problems. Drink a lot of fluids to stay hydrated and let your provider know right away if you experience severe-related side effects that won't go away.
- Impavido (miltefosine) might harm your unborn baby. If you find out that you're pregnant during your treatment with Impavido (miltefosine), stop taking this medication and contact your provider. You can register in the Impavido (miltefosine) pregnancy registry by calling 1-866-588-5405 or visiting the registry website. This registry monitors your and your baby's health after being exposed to Impavido (miltefosine).
- Don't breastfeed your baby during your treatment with Impavido (miltefosine) and for 5 months after the last dose. It's not known if Impavido (miltefosine) passes into your breast milk, but there is a risk of serious side effects if your baby is exposed to the medication.
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Risks and warnings for Impavido (miltefosine)
Impavido (miltefosine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of harm to unborn baby
- Risk factors: Pregnancy
Impavido (miltefosine) might cause harm to your unborn baby, so don't take this medication while you're pregnant. Based on animal studies, Impavido (miltefosine) can raise the risk of pregnancy loss or serious birth defects if taken during pregnancy. Your provider will have you take a pregnancy test to make sure you're not pregnant before starting Impavido (miltefosine). It's recommended for females who can become pregnant to use an effective form of birth control during treatment and for 5 months after the last dose. Speak to your provider to determine which form of birth control is right for you.
Risk of lower ability to have a baby
If you are a male, Impavido (miltefosine) might make it harder for you to have a baby, because this medication can affect your sperm. Impavido (miltefosine) can lower the ejaculation (semen) amount, sperm count, sperm movement, sperm concentration, and other sperm properties. In clinical studies, all of these problems, except for sperm concentration (the number of sperm in a certain amount of semen), were reversible in most people. They improved within 3 to 6 months after stopping Impavido (miltefosine). Based on animal studies, Impavido (miltefosine) might also affect females and lower their chance of having a baby. Speak to your provider if this is a concern for you.
Lower absorption of birth control pills due to vomiting or diarrhea
- Risk factors: Taking birth control pills
If you take birth control pills and experience vomiting or diarrhea during your treatment with Impavido (miltefosine), it can affect how well your birth control gets absorbed into your body. This can cause your birth control to not work as well to prevent pregnancy. Make sure to use a back-up contraceptive that doesn't require you to take by mouth, such as condoms with spermicide, if you throw up or have diarrhea during your treatment.
Kidney and liver problems
Impavido (miltefosine) can raise the levels of serum creatinine (Cr). Creatinine is a waste product made by your muscles that's typically removed from your body through your kidneys. The amount of creatinine in your blood is a measure of how well your kidneys are working. You will need blood tests done weekly during your treatment and for 4 weeks after so your provider can check the health of your kidneys.
Impavido (miltefosine) can also affect your liver and raise your liver labs to abnormal levels. Your provider will monitor your liver closely during your treatment through blood tests.
Bleeding problems
Impavido (miltefosine) can lower the level of platelets in people who have visceral leishmaniasis. Platelets are responsible for helping your blood clot when you're bleeding to stop it. Extremely low levels of platelets can lead to bleeding problems. If you're getting treated for visceral leishmaniasis, your provider will monitor your platelet count through blood tests during your treatment. Let your provider know if you experience unusual bleeding or bruising while taking Impavido (miltefosine).
Severe skin reactions
Although rare, Impavido (miltefosine) might cause a serious or life-threatening skin reaction. Get emergency medical help or contact your provider right away if you experience a peeling rash, skin rash with blisters, sores in the mouth, hives, or other allergic reactions.
Impavido (miltefosine) dosage
Typical dosage for Impavido (miltefosine)
- Body weight of 66 lbs to 98 lbs (30 kg to 44 kg): Take 50 mg by mouth twice daily with food (breakfast and dinner) for 28 days.
- Body weight of 99 lbs (45 kg) or greater: Take 50 mg by mouth three times daily with food (breakfast, lunch, and dinner) for 28 days.
Impavido (miltefosine) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Impavido (miltefosine) will not be safe for you to take.
- Currently pregnant
- Sjögren-Larsson-Syndrome
