The information provided on this site is intended only for healthcare professionals in the United States.*
*The products discussed herein may have different product labeling in different countries.
Healthcare Professionals
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Questions about cost to patient?
Impavido is covered by MOST insurance plans with little out of pocket for your patients. Patient Assistance is available to those in need. Cost of medicine to the patient is typically less than $100
Q: Does Insurance cover medicine?
A: Yes in over 95% of the cases the co-pay is $100 or less. Insurance has covered for Leishmaniasis, PAM and AK. We also have a patient assistance program that might help.
Q: Is this an Oral drug?
A: Yes a capsule. 3 times a day for 28 days
Q: What is the most common side effect?
A: Nausea and vomiting. Can happen up to 50% of the time and occurs 3-5 days during the 28 days most often
Q: How is the drug provided?
A:Each capsule contains 50mg of miltefosine in a pack of 28 blister packed capsules.
Q: What if patient cant take the pill orally?
A: Capsule can be opened and placed into feeding tube rinsed with distilled water.
Q:What if I have questions?
A: Contact us.
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ICD-10-CM Diagnosis Code B55: Leishmaniasis
Benefits of Consignment Program
In the new ICD-10-CM coding system, there are four codes referring to leishmaniasis. (See http://www.icd10data.com/ICD10CM/Codes/A00-B99/B50-B64/B55 - for details.)
As the linked-to page states, "Reimbursement claims with a date of service on or after October 1, 2015, require the use of ICD-10-CM codes." These new codes for leishmaniasis are B55.0, B55.1, B55.2, and B55.9.
2015/16 ICD-10-CM Diagnosis Codes B55.* : Leishmaniasis
ICD-10-CM Diagnosis B55 is a Non-Specific Code"> B55 Leishmaniasis
B55.0 Visceral leishmaniasis
B55.1 Cutaneous leishmaniasis
B55.2 Mucocutaneous leishmaniasis
B55.9 Leishmaniasis, unspecified
On Hand Supply of Product: Hospital eliminates emergencies, product outdating or overstocking
Low Cost Solution: Small monthly fee allows for peace of mind.
Essential Medicines WHO Model List : Impavido (miltefosine) is on the list of minimum medicine needs for a basic health‐care system.
The WHO Model list for a basic health-care system lists the most efficacious, safe and cost‐effective medicines for priority conditions.
Priority conditions are selected on the basis of current and estimated future public health relevance and potential for safe and cost‐effective treatment.
CALL PROFOUNDA AT 407-270-7790 to Learn More
Clinical Information
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The skin sores of cutaneous leishmaniasis (CL) usually heal on their own, even without treatment. But this can take months or even years, and the sores can leave ugly scars. In 1-10% of patients with New World CL, Leishmania disseminates from the skin to the nasooropharyngeal mucosa, resulting in mucosal leishmaniasis (ML) and destruction of nasal and pharyngeal structures. Death may occur due to complicating aspiration pneumonia. Mucosal leishmaniasis might not be noticed until years after the original sores healed. The best way to prevent mucosal leishmaniasis is to ensure adequate treatment of the cutaneous infection. Visceral leishmaniasis (VL) is the result of systemic infection. Clinical manifestations include fever, hepatomegaly, splenomegaly, and bone marrow involvement with pancytopenia. Visceral leishmaniasis is fatal if untreated. There are no other current FDA approved drugs for the treatment of CL or ML other than Impavido.
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A disease caused by any of a number of species of protozoa in the genus leishmania. There are four major clinical types of this infection: cutaneous (old and new world) (leishmaniasis, cutaneous), diffuse cutaneous (leishmaniasis, diffuse cutaneous), mucocutaneous (leishmaniasis, mucocutaneous), and visceral (leishmaniasis, visceral).
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A parasitic infection caused by protozoa of the genus leishmania. It is transmitted to humans via the bite of sandflies. There are three main forms of the disease: cutaneous, mucocutaneous, and visceral leishmaniasis. Cutaneous leishmaniasis causes skin ulcers; mucocutaneous leishmaniasis causes destructive lesions of the mucous membranes of the nose, mouth, and throat; visceral leishmaniasis is the most severe form of the disease and is manifested with anemia, weight loss, hepatomegaly and splenomegaly.
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Disease caused by any of a number of species of protozoa in the genus leishmania; there are four major clinical types of this infection: cutaneous (old and new world), diffuse cutaneous, mucocutaneous, and visceral; visceral is characterized by fever, chills, vomiting, anemia, hepatosplenomegaly, leukopenia, hypergammaglobulinemia, emaciation, and an earth-gray color of the skin; cutaneous is characterized by development of single or multiple localized lesions on exposed areas of skin that typically ulcerate.
Impavido is on Site for Immediate Use:
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Cook Children’s Medical Center Fort Worth TX 76104
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Childrens Medical Center Dallas Dallas TX 75235
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Palmetto Health Richland Columbia SC 29203
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James A. Haley VA Medical Center Tampa FL 33612
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Carolina Medical Center Charlotte NC 28203
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Orlando Health Orlando FL 32806
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Johns Hopkins All Children's Hospital St. Petersburg, FL 33701
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UPMC Presbyterian Shadyside Pittsburgh PA 15203
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Texas Childrens Hospital Houston TX 77030
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U of MN Medical Center Fairview Minneapolis MN 55454
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Tampa General Hospital Tampa FL 33606
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Lee Memorial Health System Fort Myers FL 33908
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University Health Shreveport Shreveport LA 71103
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Shands Teaching Hospital & Clinics Gainesville FL 32610
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Nebraska Medicine Omaha NE 68198
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Lakeland Regional Medical Center, Lakeland, FL 33805
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Nicklaus Children's Hospital, Miami, FL 33155
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Nemours Childrens Hospital, Orlando, FL 32827
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Joe DiMaggio Childrens Hospital,Hollwood FL 33021
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Arkansas Children's Hospital, Little Rock, AR 72202
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Pomona Valley Hospital Medical Center, Pomona, CA 91767
IMPORTANT DRUG SAFETY 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:
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Visceral leishmaniasis due to Leishmania donovani
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Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis
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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:
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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.
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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
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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
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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:
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are pregnant
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have Sjögren-Larsson-Syndrome
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are allergic to miltefosine or any of the ingredients in IMPAVIDO.
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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
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.
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