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What is Impavido?
IMPAVIDO is a prescription medicine used to treat certain types of leishmaniasis:
visceral leishmaniasis (affecting your internal organs)
cutaneous leishmaniasis (affecting your skin)
mucosal leishmaniasis (affecting your nose, mouth and throat)
Impavido is the first and only FDA-approved drug to treat cutaneous or mucosal leishmaniasis, in addition to Viceral leishmaniasis.
It is not known if IMPAVIDO is safe and effective in children under 12 years of age.
While indicated to treat the three types of leishmaniasis, the CDC has stated that Impavido (Miltefosine) has also shown promise in treating free-living ameba (FLA)–a single-cell living organism commonly found in warm freshwater or soil. FLA infections are considered to be “low incidence but high impact”—meaning, they are rare but deadly. You may have heard of FLA Infections such as the "Brain Eating Amoeba".
The CDC stated that Impavido (Miltefosine) is promising for the treatment of free-living ameba (FLA) infections caused by Naegleria fowleri, Balamuthia mandrillaris, and Acanthamoeba species. While they have orphan designation for its use, Impavido is seen as "off label" when treating these amoebas. Please contact us to learn more about these treatments.
IMPAVIDO Drug Description
IMPAVIDO capsules contain the active ingredient miltefosine, an antileishmanial agent. The chemical name of miltefosine is 2-[[(hexadecyloxy)hydroxyphosphenyl]oxy]-N,N,Ntrimethylethylammonium inner salt. Miltefosine is a white powder that is freely soluble in water, 0.1 N HCl or NaOH, methanol, and ethanol. It has the empirical formula of C21H46NO4P with a molecular weight of 407.6 and the following structural formula:
The inactive ingredients are colloidal silicon dioxide, microcrystalline cellulose, lactose monohydrate, talc, and magnesium stearate. The capsule shell contains gelatin, titanium dioxide, ferric oxide, and purified water.
26 Hospitals Carry Impavido On-site.
Hospitals with Impavido on-site for Immediate Use:
Cook Children’s Medical Center Fort Worth TX 76104
Childrens Medical Center Dallas Dallas TX 75235
Palmetto Health Richland Columbia SC 29203
James A. Haley VA Medical Center Tampa FL 33612
Carolina Medical Center Charlotte NC 28203
Orlando Health Orlando FL 32806
Johns Hopkins All Children's Hospital St. Petersburg, FL 33701
UPMC Presbyterian Shadyside Pittsburgh PA 15203
Texas Childrens Hospital Houston TX 77030
U of MN Medical Center Fairview Minneapolis MN 55454
Tampa General Hospital Tampa FL 33606
Lee Memorial Health System Fort Myers FL 33908
University Health Shreveport Shreveport LA 71103
Shands Teaching Hospital & Clinics Gainesville FL 32610
Nebraska Medicine Omaha NE 68198
Lakeland Regional Medical Center, Lakeland, FL 33805
Nicklaus Children's Hospital, Miami, FL 33155
Nemours Childrens Hospital, Orlando, FL 32827
Joe DiMaggio Childrens Hospital,Hollwood FL 33021
Arkansas Children's Hospital, Little Rock, AR 72202
Pomona Valley Hospital Medical Center, Pomona, CA 91767
Parkview Regional Medical Center, Fort Wayne, IN 46845
Vidant Health, Greenville, SC 27834
Children's Hospital Colorado, Aurora, CO 80045
UNC Health, Chapel Hill, NC 27514
Learn more How Impavido (Miltefosine) Can help you
IMPORTANT DRUG SAFETY INFORMATION
Adverse Event Reporting and Medical Information Question (Patients & HealthCare Professionals)
If you want to report an adverse event, if you have medical information inquires, or product complaints, please contact:
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.
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.
Impavido® (miltefosine) is an FDA-approved treatment for cutaneous, mucosal and visceral leishmaniasis in patients 12 years of age and older. PLEASE SEE FULL PRESCRIBING INFO