INFORMATION TO BE COLLECTED BY THE REGISTRY

 

1. Screening information to determine eligibility to be in the Registry and other data to be collected at the start of the Registry

 

Demographics: gender, age, weight, race, ethnicity

Leishmaniasis: type, way in which diagnosis was made

Impavido treatment: daily dose, day treatment started and ended, storage conditions

Contraception: method used and at what time with respect to present pregnancy

Pregnancy: month of conception and how determined

Obstetrical history

Substance use: tobacco, alcohol, illicit drugs

Medical history: Immunodeficiency

           

2. Information to be recorded at the end of the second trimester

 

Significant adverse events for the mother during the trimester

High blood pressure

Severe nausea/vomiting/dehydration

Diabetes

Obesity/abnormal weight gain

Anemia

Kidney or bladder infection

Vaginal bleeding

Medication history: other medications used up to this point in the pregnancy

           

3. Information to be recorded at delivery / termination of pregnancy

 

Significant adverse events for the mother during the trimester

High blood pressure

Severe nausea/vomiting/dehydration

Diabetes

Obesity/abnormal weight gain

Anemia

 Kidney or bladder infection

Vaginal bleeding

Abruptio placenta

Placenta previa

Premature rupture of membranes

Preterm labor

Medication history: other medications used up to this point in the pregnancy

Pregnancy Outcome: either

Spontaneous abortion (loss before 20 weeks)

Elective termination

Fetal death/stillbirth (loss after 20 weeks)

Live birth

 

 

4. Fetal outcomes if live birth:

 

Low birth weight (<2500 grams)

Heart and circulation defects

Genital and urinary tract defects

Nervous system and eye defects

Club foot

Cleft lip with or without cleft palate

Other abnormalities

 

NOTE: Dissemination of information

 

Registry information will be sent as per FDA requirements to the FDA at the end of each year and at the end of the 10-year period of this Registry.

     

The results of the full 10-year study may be published at the discretion of Knight Therapeutics (USA) Inc.

     

No personal identifying data will be available in any communication to the FDA or publication.

 

OR Call the Registry at 1-866-588-5405

General Information about Impavido:

 

Please refer to the following links for

          Prescribing Information (Product Label)

          Medication Guide

          Information to be collected by the Registry

What is Impavido (miltefosine)?

Impavido (miltefosine) is approved in the United States to treat certain types of leishmaniasis.Impavido might also be prescribed by your doctor for another disease.

 

Impavido is not approved for use during pregnancy. Women should notify their doctor if they become pregnant or plan to become pregnant while taking Impavido or during the 5 months after taking Impavido.

 

The U.S. Food and Drug Administration (FDA)  has required that a registry be established to establish a Pregnancy Registry to learn more information about pregnant women who have become pregnant while taking Impavido or during the 5 months after taking Impavido, about the outcome of the pregnancies, and about their baby’s birth. The Registry will be operational between March 2015 and March 2024.

 

Participation in the Registry is voluntary for the patient. Lack of enrollment in the Registry will not influence or interfere with the treatment plan recommended by the patient's health care provider. Impavido is not provided by the Registry.

IMPAVIDO is prescription medicine used to treat certain types ofleishmaniasis:

 

  • visceral leishmaniasis (affecting your internal organs)

  • cutaneous leishmaniasis (affecting your skin)

  • mucosal leishmaniasis (affecting your nose, mouth and throat)

 

It is not known if IMPAVIDO is safe and effective in children under 12 years of age.

IMPAVIDO capsules contain the active ingredient miltefosine, an antileishmanial agent. The chemical name of miltefosine is 2-[[(hexadecyloxy)hydroxyphosphenyl]oxy]-N,N,Ntrimethylethylammonium inner salt.

 

Miltefosine is a white powder that is freely soluble in water, 0.1 N HCl or NaOH, methanol, and ethanol. It has the empirical formula of C21H46NO4P with a molecular weight of 407.6 and the following structural formula: 

The inactive ingredients are colloidal silicon dioxide, microcrystalline cellulose, lactose monohydrate, talc, and magnesium stearate. The capsule shell contains gelatin, titanium dioxide, ferric oxide, and purified water.

Important Drug Safety 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. (click here…)

  •  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.

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. (link to PI)

Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information including Boxed WARNINGS.