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

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Impavido (miltefosine) capsules

When leishmaniasis strikes, answer.

The first and only FDA-approved oral therapy for leishmaniasis1

Support & Resources What is Leishmaniasis?
Pharmacist handing a prescription to a smiling male patient

1.IMPAVIDO® (miltefosine) 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, and 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 response of the same species. Efficacy in treating other Leishmania species has not been evaluated.

Please see Important Safety Information below.

FDA-approved oral therapy

An oral capsule form for a disease that historically required injections.

A defined treatment course

IMPAVIDO is taken for 28 consecutive days as prescribed by your healthcare provider.

Supported by Eton Cares®

$0 copay* for eligible patients and dedicated patient support.

*Restrictions, limitations, and/or eligibility requirements may apply.

The Disease

What is 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 and affects an estimated 12 million people across 98 endemic countries.

Learn more about the disease

Cutaneous

The most common form; causes chronic skin sores that can leave lifelong scars.

Mucosal

Affects the nose, mouth, and throat mucosa; can cause disfiguring lesions.

Visceral

Affects internal organs (spleen, liver, bone marrow) and can be fatal if untreated.

Fast facts

FDA approval
First & only oral therapy
Indications
Cutaneous · Mucosal · Visceral
Ages
Patients 12+ weighing ≥ 66 lbs
Course
50 mg capsule TID × 28 days
NDC
71863-0135-28
Eton Cares® Patient Support

Your rare disease journey is personal. So is our support.

When your doctor prescribes IMPAVIDO, you're automatically enrolled in Eton Cares Patient Support — designed to support you and your family every step of the way with welcome calls, insurance verification, financial assistance, and ongoing pharmacy support.

*Restrictions, limitations, and/or eligibility requirements may apply.

Learn About Eton Cares
Eton Cares $0 copay card

Ordering IMPAVIDO may be easier than you think.

Straightforward pharmacy ordering and a dedicated support team.We help patients get treatment fast.

Support & Resources

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.