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

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Impavido (miltefosine) capsules
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IMPAVIDO
resources and
support

Everything you need in one place.

Whether you're beginning treatment or looking for additional information along the way, this resource center brings together everything you need in one convenient location.

Explore the Eton Cares® patient support program, ordering and pharmacy information, educational materials, downloadable guides, information about accessing IMPAVIDO, financial assistance resources, and additional tools designed to support patients, families, and caregivers throughout treatment.

We're committed to helping make the treatment journey as straightforward and manageable as possible.

Man at home speaking with the patient support team by phone
Eton Cares®
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.

Eton Cares $0 copay card

Orders & Pharmacy Support

When your doctor sends your prescription to our specialty pharmacy Anovo®, this is what you can expect:

Welcome call

A Care Coordinator verifies your prescription, offers support, and answers your questions.

Insurance verification

Your coverage and benefits are reviewed so you know what to expect.

Financial assistance review

Copay programs and other support options are explored on your behalf.

Medication delivery

IMPAVIDO arrives with instructions and product-specific information.

Ongoing pharmacy support

Refill coordination, reminders, and access to a pharmacist when you need one.

Pharmacists Ambassador Support

A dedicated Pharmacists Ambassador provides clinical education and ongoing support for patients and families needing additional hands-on guidance.

For questions or support, please contact us at our specialty pharmacy Anovo:

Our team is here to help with prescriptions, refills, insurance, and financial assistance.

877-469-4078

Monday–Friday, 8:00 AM–5:00 PM CST

A helpful tip

We recommend saving Anovo’s phone number in your contacts so you can easily recognize important calls about your prescription, refills, or insurance updates.

Anovo specialty pharmacy

News & Resources

Articles, references, and official resources about IMPAVIDO (miltefosine) and leishmaniasis.

Centers for Disease Control and Prevention

Leishmaniasis — Parasites overview

The CDC's overview of leishmaniasis, including biology, epidemiology, prevention, and travel guidance.

National Institute of Allergy and Infectious Diseases

NIAID — Leishmaniasis research

Federal research programs on leishmaniasis, including therapeutic development and vaccine research.

These are independent organizations and resources. No representations are made by Eton Pharmaceuticals regarding the contents of these sites.

Helpful Downloads

DailyMed

Prescribing Information

Full Prescribing Information for IMPAVIDO (miltefosine) capsules, including Boxed Warning.

DailyMed

Medication Guide

Important information for patients about taking IMPAVIDO (miltefosine) safely.

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.