Eton Pharmaceuticals Announces U.S. Commercial Availability of IMPAVIDO® (miltefosine) Capsules

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Impavido (miltefosine) capsules
Disease Education

About
Leishmaniasis

Leishmaniasis is a parasitic disease caused by Leishmania parasites, spread through the bite of infected phlebotomine sand flies. It is classified by the World Health Organization (WHO) as a Neglected Tropical Disease (NTD), affects an estimated 12 million people across 98 endemic countries, and puts roughly 350 million more at risk.

Woman talking with her clinician in a bright exam room

Cutaneous

The most common form. Causes skin sores on exposed areas of the body that can leave lifelong scars and serious disability.

Mucosal

Affects the nasal, oral, and pharyngeal mucosa. Can cause partial or complete destruction of the mucous membranes.

Visceral

Affects internal organs — usually the spleen, liver, and bone marrow — and is fatal in over 95% of cases if left untreated.

What is Leishmaniasis?

Leishmaniasis is an important human and veterinary disease caused by Leishmania parasites that affect 12 million people in over 98 endemic countries. It is a parasitic disease found in parts of the tropics, subtropics, and southern Europe, and is classified as a Neglected Tropical Disease (NTD). The disease is now emerging in Europe due to climate change and massive population displacement. The parasite is known to rapidly adapt to novel environments with important consequences for disease outcome, and it has therefore been recognized as an emerging public health threat for the EU.

Leishmaniasis is caused by infection with Leishmania parasites, which are spread by the bite of phlebotomine sand flies. There are several different forms of leishmaniasis in people. The most common forms are:

  • cutaneous leishmaniasis, which causes skin sores;
  • mucosal leishmaniasis, which affects the nasal, oral, and pharyngeal mucosa;
  • and visceral leishmaniasis, which affects several internal organs (usually spleen, liver, and bone marrow).

Leishmaniasis is among the five most important parasitic diseases worldwide, with an estimated 350 million people at risk of infection. The disease causes a spectrum of clinical manifestations ranging from disfiguring cutaneous to fatal visceral forms, which results from infection by different species of Leishmania parasites. These unicellular parasites adapt to a remarkable range of hosts. They grow as extracellular parasites inside phlebotomine sand flies that transmit Leishmania to a variety of vertebrates, such as rodents, dogs, and humans, where they grow inside immune cells, notably macrophages, causing severe pathologies that may lead to death.

Leishmaniasis is one of the most neglected diseases and as a consequence attracts limited attention. There is no human vaccine and only a few treatments are available.

How do people get infected with Leishmania parasites?

The main way is through the bite of infected female phlebotomine sand flies. Sand flies become infected by sucking blood from an infected animal or person. People might not realize that sand flies are present because:

  • They do not make any noise;
  • They are small: they are only about one third the size of typical mosquitoes or even smaller;
  • Their bites might not be noticed (the bites can be painless or painful).

Sand flies usually are most active in twilight, evening, and night-time hours (from dusk to dawn). Although sand flies are less active during the hottest time of the day, they may bite if they are disturbed (for example, if a person brushes up against the trunk of a tree or other site where sand flies are resting).

Some types (species) of Leishmania parasites also may be spread via contaminated needles (needle sharing) or blood transfusions. Congenital transmission (spread from a pregnant woman to her baby) has been reported.

Lifecycle in the sand fly

The sand fly feeds on blood from an infected mammal and takes the amastigote form of the parasite into the abdominal midgut (1). There the parasite transforms to the procyclic promastigote form (2), attaches to the midgut wall (3, 4), and migrates back toward the mouthparts (5). Just before reaching the mouthparts it converts to its mammalian-infectious metacyclic promastigote form (6), ready to be regurgitated into the bite at the next blood meal (7, 8).

Diagram of the Leishmania parasite lifecycle inside the sand fly, from amastigote in the midgut to metacyclic promastigote at the mouthparts
Development of Leishmania parasites within the sand fly vector.

What is IMPAVIDO
(miltefosine)?

IMPAVIDO is a prescription medicine taken by mouth to treat certain types of leishmaniasis in adults and adolescents who are at least 12 years of age and weigh at least 30 kg (66 lbs).

  • Taken by mouthAvailable as a capsule.
  • A prescription treatmentApproved to treat certain forms of leishmaniasis caused by Leishmania species.
  • For adults and adolescentsApproved for patients 12 years of age and older who weigh at least 30 kg (66 lbs).

One oral treatment

Three forms of leishmaniasis

  • CutaneousSkin
  • MucosalNose, mouth, and throat
  • VisceralInternal organs

Warning: Embryo-Fetal Toxicity

IMPAVIDO® (miltefosine) may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy.

Use

IMPAVIDO® (miltefosine) is a prescription medicine used to treat certain forms of leishmaniasis in adults and adolescents 12 years of age and older who weigh at least 30 kg (66 lbs), including:

  • Visceral leishmaniasis
  • Cutaneous leishmaniasis
  • Mucosal leishmaniasis

IMPAVIDO has only been studied in certain Leishmania species. Ask your healthcare provider if you have questions about whether IMPAVIDO is right for you.

Important Safety Information

Important Warning: IMPAVIDO can cause serious harm to an unborn baby.

Before starting treatment, your healthcare provider will perform a pregnancy test if you are able to become pregnant.

Use effective birth control during treatment and for 5 months after your last dose. If you experience vomiting or diarrhea while taking IMPAVIDO, birth control pills may not work as well. Talk with your healthcare provider about using another effective form of birth control that is not taken by mouth.

Do not become pregnant while taking IMPAVIDO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

Always take IMPAVIDO exactly as your healthcare provider directs.

Do not take IMPAVIDO if you:

  • are pregnant.
  • have Sjögren-Larsson syndrome.
  • are allergic to miltefosine or any of the ingredients in IMPAVIDO.

Fertility

IMPAVIDO may affect male fertility. Changes in sperm have been observed after treatment, and it is not known how long some effects may last. IMPAVIDO affected female fertility in animal studies; its effects on fertility in women have not been adequately evaluated. Talk with your healthcare provider if you have concerns about fertility before starting treatment.

Kidney and Liver Problems

IMPAVIDO may affect your kidneys or liver. Your healthcare provider should monitor your kidney function weekly while you take IMPAVIDO and for 4 weeks after treatment ends. Your healthcare provider should also monitor your liver during treatment.

Vomiting and Diarrhea

Vomiting and diarrhea are common with IMPAVIDO and may lead to dehydration. Drink plenty of fluids during treatment. Contact your healthcare provider if vomiting or diarrhea is severe or persistent.

Low Platelet Counts

Patients treated for visceral leishmaniasis may develop low platelet counts. Your healthcare provider should monitor your blood counts during treatment.

Serious Skin Reactions

Serious skin reactions, including Stevens-Johnson syndrome, have been reported. Stop taking IMPAVIDO and contact your healthcare provider immediately if you develop blistering, peeling, or a severe skin rash.

Eye Problems

Serious eye problems have been reported in people taking IMPAVIDO and may affect vision. Stop taking IMPAVIDO right away and contact an eye doctor if you develop eye pain, redness, sensitivity to light, increased tearing, or changes in your vision.

The most common side effects of IMPAVIDO include nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, stomach pain, itching, sleepiness, and changes in certain blood tests that measure liver and kidney function.

Do not breastfeed while taking IMPAVIDO or for 5 months after your last dose. IMPAVIDO has not been established as safe or effective in children younger than 12 years of age.

For more information, please visit IMPAVIDO.com.

You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

Please see Full Prescribing Information, including Boxed Warning, for more information.