FDA approves Impavido to treat tropical disease leishmaniasis
The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites. The disease occurs primarily in people who live in the tropics and subtropics. Most U.S. patients acquire leishmaniasis overseas.... READ MORE
Huffington Post- Impavido, Drug To Treat Parasitic Disease Leishmaniasis, Backed By FDA Panel
Impavido was granted priority review by the FDA, a status that cuts the review time to six months from the standard 10. Priority review is typically given to experimental products that address an unmet medical need or represent a major advance over current treatments.... READ MORE
2010 - present
Fox 35 Orlando-Orlando company helps treat amoeba case
et another Floridian is batting a brain-eating amoeba, but an Orlando-based company may have found the cure. Orlando's Profounda, Inc. delivered their new drug, Impavido, to the patient. Company CEO Todd MacLaughlan, hopes to turn the tables on this bug..... READ MORE
2010 - present
IMPORTANT DRUG SAFETY INFORMATION
Impavido® Higher Weight Patient Registry:
For patients who weigh 99 lbs or more, Impavido is administered at a dose of three (3) of the 50-mg capsules per day for 28 days.
Patients who weigh close to 99 lbs will receive more drug per pound than patients who have higher weights. For example, a patient who weighs 120 pounds will receive 1.25 mg of Impavido per pound each day [150 mg each day / 120 pounds = 1.25 mg per pound each day] whereas a patient who weighs 175 pounds will receive 0.86 mg of Impavido per pound each day [150 mg each day / 175 pounds = 0.86 mg per pound each day]. It is possible that Impavido will be less effective in higher-weight patients who receive less drug per pound than in lower-weight patients who receive more drug per pound.
If you weigh 165 pounds or more while taking Impavido (miltefosine), you are encouraged to enroll in The Higher Weight Registry by calling 1-866-588-5405
If you are exposed to Impavido (miltefosine) during pregnancy, contact your healthcare provider right away; you are also encouraged to enroll in the Pregnancy Registry by calling 1-866-588-5405
Helpful PDF Links
The most common side effects associated with Impavido® include nausea, vomiting and
diarrhea. Other side effects include abdominal pain, decreased appetite, dizziness, headache,
sleepiness, skin itching, and abnormalities in liver or kidney tests.
Tell your healthcare provider if you have any side effect that bothers you or that does not go
away. These are not all the possible side effects of IMPAVIDO. For more information, ask your
You may report side effects to FDA at 1-800-FDA-1088..
Tell your healthcare provider about all of the medicines you're taking, including prescription
and over-the-counter medications, vitamins and herbal supplements.
Tell your healthcare provider about all of your health conditions, including whether you are
pregnant, are planning to become pregnant, or are breastfeeding.
Impavido® has not been studied in children under 12.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.FDA.gov/medwatch or call 1-800-FDA-1088.
Impavido® is available by prescription only. The information on this website should not take the
place of talking with your doctor or healthcare professional. If you have any questions about
your condition, or if you would like more information about Impavido®, talk to your doctor or
healthcare professional and see the full Prescribing Information.
Indication for Impavido® (miltefosine)
IMPAVIDO capsules contain the active ingredient miltefosine, an antileishmanial agent.
IMPAVIDO is an antileishmanial drug indicated in adults and adolescents 12 years of age
weighing 30 kg (66 lbs) for treatment of:
Visceral leishmaniasis due to Leishmania donovani
Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis
Mucosal leishmaniasis due to Leishmania braziliensis
Limitations of use: Leishmania species evaluated in clinical trials were based on epidemiologic
data. There may be geographic variation in the response of the same Leishmania species to
IMPAVIDO (1, 14). The efficacy of IMPAVIDO in the treatment of other Leishmania species
has not been evaluated.
Important Safety Information for Impavido® (miltefosine):
IMPAVIDO may cause serious risks to pregnancy:
Do not take IMPAVIDO if you are pregnant. If you take IMPAVIDO during pregnancy, your baby is at risk for death or serious birth defects.
Women who can become pregnant should use effective birth control (contraception) during IMPAVIDO treatment and for 5 months after stopping IMPAVIDO treatment. Discuss with your healthcare provider which birth control method is right for you
If you become pregnant while taking IMPAVIDO, tell your healthcare provider right away. Talk to your healthcare provider about taking part in the IMPAVIDO Pregnancy Registry. This is a study to learn how IMPAVIDO affects pregnancy and babies. You can enroll in this registry by calling 1-866-588-5405
If you are a woman who can become pregnant and you are not willing to use effective birth control during IMPAVIDO treatment and for 5 months after treatment
Do not take IMPAVIDO if you:
are allergic to miltefosine or any of the ingredients in IMPAVIDO.
are a woman who can become pregnant and have not had a pregnancy test. Women who can get pregnant must have a urine or blood pregnancy test before taking IMPAVIDO.