Here's what you need to know if you decide to take part in the registry:
Your participation is completely voluntary
Only routine information will be collected from you, your physician who prescribed Impavido, your obstetrician and your child’s pediatrician
The information collected is confidential
There will be no extra office visits, tests, or additional medicines to take
You can stop participating in the registry at any time
If you are interested in taking part in this registry, an initial phone call by you or your doctor to the registry coordinating center is all it will take to get started.
During this initial phone call, the registry coordinating center will:
Confirm your eligibility
Get your verbal consent
Collect basic information about you
Get your permission to contact your doctors and your baby’s pediatrician
There are no office visits, tests, or additional medicines to take if you participate in the registry.
During your participation, information will be collected about you and your baby for up to 21 months during your pregnancy and lasting up and until your child is born or the prgnancy is terminated. This information is collected from you, your physician who prescribed Impavido, your obstetrician and your child’s pediatrician.
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.
What is Impavido (miltefosine)?
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 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
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)