Information to help with Reimbursement
(SEND TO HEALTH INSURANCE MEDICAL DIRECTOR) ALONG WITH PRIOR AUTH REQUEST  
 
NDC# 69051-300-01 (28 Capsules per blister packed carton)

 

How to order Impavido (miltefosine)

 

(1) Have Pharmacy Order Product using PO (if needed) along with State License Number by sending to Profounda by email (todd@profounda.com)

 

  • Rx is one 50 mg capsules TID for 28 days (TOTAL 84 capsules). Take with Food.
     

  • Capsules are blister packed into 28 capsules per pack (3 packs needed for 84 capsules)

 

(2) Product will be shipped overnight (If you need sooner please call number below)

 

Have Questions? Get someone to call you by filling out this form.

 

CONSIGNMENT Process (Optional)

 

If you wish to enroll in the  Orphan Drugs On Site Program,  Complete and Fax the Consignment agreement below.  

 

 

 

 

 

 

 

 

 

 

 

 

Questions or concerns? Please click contact us or call 908-635-2326.

Consignment Agreement
Impavido (Miltefosine) is a orphan drug covered by most health plans so copay to patient is low.  At the current time we do not participate in medicare/medicaid or 340B.

October 6, 2017

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IMPORTANT DRUG SAFETY INFORMATION

Impavido® Pregnancy Registry: 

 

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

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

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. 

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:

 

  •  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 (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: 

  •  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.  

  • 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

  •  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

  • 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:

  •  are pregnant

  •  have Sjögren-Larsson-Syndrome

  •  are allergic to miltefosine or any of the ingredients in IMPAVIDO. 

  •  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® (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 

Contact Your Doctor or the CDC to Learn More about IMPAVIDO (miltefosine)

®

Impavido is a registered trademark of Knight Therapeutics Licensed exclusively to Profounda in the USA

© 2015 Profounda, Inc. 

For Emergencies
Call 911