Eton Pharmaceuticals Announces U.S. Commercial Availability of IMPAVIDO® (miltefosine) Capsules
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IMPAVIDO® (miltefosine) capsules now commercially available in the U.S. through Eton Pharmaceuticals.
Sending an IMPAVIDO prescription for outpatient use.
IMPAVIDO is dispensed exclusively through Anovo® specialty pharmacy, so every outpatient prescription is sent directly to Anovo — by e-prescribe or fax. Anovo confirms receipt, verifies benefits, enrolls the patient in the Eton Cares Program®, and coordinates delivery.
Patients and healthcare providers with questions about an IMPAVIDO prescription can call Anovo at 877-469-4078.
Select Anovo #5
Remove the geographical radius in the search criteria so Anovo appears.
Fax the completed patient referral form and prescription information directly to Anovo.
877-469-4078Select Option #3
For patients and healthcare providers with questions about a prescription.
8:00 AM – 5:00 PM CST
Getting IMPAVIDO to patients in the hospital setting.
Hospital pharmacies can access IMPAVIDO for inpatient use through direct purchase or the hospital consignment program, supporting on-site availability when treatment is needed.
Contact Anovo Specialty Pharmacy at 877-469-4078 to establish access.
- NDC
- 71863-0135-28
- Product
- IMPAVIDO (miltefosine)
- Strength
- 50 mg
- Dosage Form
- Capsule
- Package Size
- 28 Capsules
Hospital Stocking
Order from Anovo specialty wholesale. If you have an account — or need to create an account with Anovo to place an order — call Anovo and select Option #2.
Select Option #2
Hospital consignment process for inpatient use.
Consignment Stocking Program
To utilize the consignment program, hospitals will need a wholesale agreement with Anovo.
Select Option #2
- Upon completion of the wholesale agreement, Anovo will ship a box of IMPAVIDO (miltefosine) 50 mg capsules to the hospital.
How the consignment process works
- 1Once a hospital opens the box for use, please inform Anovo of initiation of use.
- 2Anovo will work with the hospital pharmacy to ensure they receive a new box prior to the in-use expiry or before product is consumed during a patient stay. If the full box is used during the inpatient stay, Anovo will invoice the hospital and ship a new box.
- 3After the written in-use expiration date, the hospital must return the opened box to Anovo for verification of return credit.
- 4Once Anovo verifies the returned quantity (capsules for IMPAVIDO), Anovo will invoice the hospital for the full box, less the credit for the partial return.
Urgent or time-sensitive need?
For urgent or time-sensitive patient needs, Anovo maintains an established emergency access pathway with treating clinicians, CDC representatives, and hospital pharmacies.
The pathway is designed to evaluate the fastest available source of product and delivery option based on the patient’s need-by time and the treating institution’s location.
Anovo is available day or night for support and delivery of emergency cases.
Select Option #1
Hospitals with IMPAVIDO on-site for immediate inpatient use
The following institutions stock IMPAVIDO on-site, supporting timely access to therapy. If access through one of these locations is needed, please contact Anovo, who will coordinate directly with the appropriate institution.
Arkansas Children's Hospital
1 Children's Way, Little Rock, AR 72202
Atrium Health Carolinas Medical Center
1000 Blythe Blvd, Charlotte, NC 28207
Children's Hospital Colorado
13123 East 16th Avenue, Aurora, CO 80045
Children's Medical Center Dallas
1935 Medical District Dr, Dallas, TX 75235
Cook Children's Medical Center
801 7th Ave, Fort Worth, TX 76104
James A. Haley Veterans' Hospital
13000 Bruce B Downs Blvd, Tampa, FL 33612
Joe DiMaggio Children's Hospital
1005 Joe DiMaggio Drive, Hollywood, FL 33021
Johns Hopkins All Children's Hospital
501 6th Avenue South, St. Petersburg, FL 33701
Lakeland Regional Health Medical Center
1324 Lakeland Hills Blvd, Lakeland, FL 33805
Lee Memorial Hospital (UF Health Shands Hospital)
2776 Cleveland Ave, Fort Myers, FL 33901
M Health Fairview University of Minnesota Medical Center
2450 Riverside Avenue, Minneapolis, MN 55454
Nebraska Medicine
987400 Nebraska Medical Center, Omaha, NE 68198
Nemours Children's Hospital, Florida
6535 Nemours Parkway, Orlando, FL 32827
Nicklaus Children's Hospital
3100 SW 62nd Avenue, Miami, FL 33155
Orlando Health Orlando Regional Medical Center
52 W Underwood St, Orlando, FL 32806
Pomona Valley Hospital Medical Center
1798 N. Garey Ave, Pomona, CA 91767
Prisma Health Richland Hospital
5 Richland Medical Park Dr., Columbia, SC 29203
Tampa General Hospital
1 Tampa General Circle, Tampa, FL 33606
Texas Children's Hospital
6621 Fannin Street, Houston, TX 77030
UF Health Shands Hospital (Lee Memorial Health)
1600 SW Archer Rd, Gainesville, FL 32610
UNC Hospitals
101 Manning Drive, Chapel Hill, NC 27514
UPMC Presbyterian Shadyside
200 Lothrop Street, Pittsburgh, PA 15213
Questions about IMPAVIDO?
Patients, caregivers, healthcare providers, and hospital pharmacies can reach us using the information below.
Anovo Specialty Pharmacy
Fax referrals
Eton Pharmaceuticals
Indication
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.
- 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. The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.
Important Safety Information
Contraindications
IMPAVIDO is contraindicated in pregnancy because it may cause fetal harm; in patients with Sjögren-Larsson syndrome; and in patients with hypersensitivity to miltefosine or any component of the formulation.
Warnings and Precautions
- Embryo-Fetal Toxicity: IMPAVIDO may cause fetal harm when administered during pregnancy. Obtain a pregnancy test before initiating therapy in females of reproductive potential. Advise females of reproductive potential to use effective contraception during treatment and for 5 months after completion of therapy. If vomiting or diarrhea occurs during treatment, oral contraceptive effectiveness may be reduced; advise use of an additional non-hormonal contraceptive method.
- Reproductive Effects: Miltefosine caused impaired fertility in animal studies. The potential effects on human fertility have not been adequately evaluated.
- Renal Effects: Monitor serum creatinine during treatment and for 4 weeks after completion of therapy.
- Hepatic Effects: Monitor liver transaminases and bilirubin during treatment.
- Gastrointestinal Effects: Vomiting and diarrhea are common and may result in dehydration. Encourage adequate fluid intake during treatment.
- Thrombocytopenia: Monitor platelet counts during therapy in patients treated for visceral leishmaniasis.
- Stevens-Johnson Syndrome: Stevens-Johnson syndrome has been reported. Discontinue IMPAVIDO if an exfoliative or bullous rash develops.
Adverse Reactions
The most common adverse reactions (≥2%) are nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, pruritus, somnolence, elevated transaminases, and elevated serum creatinine.
To report a suspected adverse event related to IMPAVIDO, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/MedWatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning regarding Embryo-Fetal Toxicity.