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FREE LIVING AMOEBA - Primary Amebic Meningoencephalitis (PAM) - Naegleria fowleri, Balamuthia, Acanthamoeba Keratitis
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Brain Eating Amoeba Treatment
Before Treatment with Impavido Leishmaniasis lesion on arm
Eye with acanthamoeba keratitis

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.

Female sand fly Impavido, Miltefosine, Leishmaniasis

Important Links:

Patient Assistance Program IMPAVIDO

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: 

Before Treatment with miltefosine a leishmaniasis parasitic infection
structure of miltefosine

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.

healing leshmaniasis lesions

26 Hospitals Carry Impavido On-site.

Make YOUR hospital Next.
It could save a life.

Hospitals with Impavido on-site for Immediate Use:

  1. Cook Children’s Medical Center Fort Worth TX 76104

  2. Childrens Medical Center Dallas Dallas TX 75235

  3. Palmetto Health Richland Columbia SC 29203

  4. James A. Haley VA Medical Center Tampa FL 33612

  5. Carolina Medical Center Charlotte NC 28203

  6. Orlando Health Orlando FL 32806

  7. Johns Hopkins All Children's Hospital St. Petersburg, FL 33701

  8. UPMC Presbyterian Shadyside Pittsburgh PA 15203

  9. Texas Childrens Hospital Houston TX 77030

  10. U of MN Medical Center Fairview Minneapolis MN 55454

  11. Tampa General Hospital Tampa FL 33606

  12. Lee Memorial Health System Fort Myers FL 33908

  13. University Health Shreveport Shreveport LA 71103

  14. Shands Teaching Hospital & Clinics Gainesville FL 32610

  15. Nebraska Medicine Omaha NE 68198

  16. Lakeland Regional Medical Center, Lakeland, FL 33805

  17. Nicklaus Children's Hospital, Miami, FL 33155

  18. Nemours Childrens Hospital, Orlando, FL 32827

  19. Joe DiMaggio Childrens Hospital,Hollwood  FL 33021

  20. Arkansas Children's Hospital, Little Rock, AR 72202

  21. Pomona Valley Hospital Medical Center, Pomona, CA 91767

  22. Parkview Regional Medical Center, Fort Wayne, IN 46845 

  23. Vidant Health, Greenville, SC 27834

  24. Children's Hospital Colorado, Aurora, CO 80045

  25. UNC Health, Chapel Hill, NC 27514

Learn more How Impavido (Miltefosine) Can help you

leishmaniasis Information

primary amebic meningoencephalitis (PAM) "brain eating amoeba"

on-site hospitals
Female sand fly can cause leishmaniasis parasitic infection
What Primary Amoebic Menegioenchephalitis looks like

Acanthamoeba parasite- eye

Military Use

Eye with AK infection

News Media

Profounda Fox News Story
Leishmaniasis in the miltary

Ordering Information

How to order Impavido

Dog patients

Dogs can get infected with the parasite Leishmanisis

IMPORTANT DRUG SAFETY INFORMATION

 

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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:
medinfo@knighttx.com
1-844-483-5636 (phone)

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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:

 

  • ï‚· Visceral leishmaniasis due to Leishmania donovani

  • ï‚· 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:

  • ï‚· are pregnant

  • ï‚· have Sjögren-Larsson-Syndrome

  • ï‚· are allergic to miltefosine or any of the ingredients in IMPAVIDO. 

  • ï‚· 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

Impavido® Pregnancy Registry: 

 

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

Just an image of people running

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 

healthcare provider.

 

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. 

Important drug safety info

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

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