IMPAVIDO- miltefosine capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

MILTEFOSINE (UNII: 53EY29W7EC) (MILTEFOSINE - UNII:53EY29W7EC)

Tillgänglig från:

Profounda, Inc.

INN (International namn):

MILTEFOSINE

Sammansättning:

MILTEFOSINE 50 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

IMPAVIDO (miltefosine) capsules are indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of: Limitations of Use: IMPAVIDO is contraindicated in patients who are pregnant. Based on animal data, miltefosine may cause fetal harm. [see Boxed Warning, Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. IMPAVIDO is contraindicated in patients who have Sjögren-Larsson-Syndrome [see Clinical Pharmacology (12.3)] . IMPAVIDO is contraindicated in patients who are hypersensitive to miltefosine or any IMPAVIDO excipients. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to IMPAVIDO during pregnancy. Healthcare providers are encouraged to register patients by calling 1-866-588-5405. Risk Summary IMPAVIDO is contraindicated during pregnancy. Based on data from animal reproduction studies, IMPAVIDO may cause embryo-fetal toxicity when administered to pre

Produktsammanfattning:

Each IMPAVIDO capsule contains 50 mg miltefosine in an opaque, red, hard gelatin capsule. IMPAVIDO capsules are supplied in a folded peel/push-through child-resistant blister card. Each blister card contains 14 capsules. Each carton contains two blister cards (NDC 69051-300-01). Store at 20-25 °C (68-77 °F); excursions permitted to 15-30 °C (59-86 °F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense only in the original carton.

Bemyndigande status:

New Drug Application

Bipacksedel

Profounda, Inc.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 8/2023
MEDICATION GUIDE
IMPAVIDO® (Im-PA-vee-do)
(miltefosine)
capsules, for oral use
Read this Medication Guide before you start taking IMPAVIDO and each
time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about IMPAVIDO?
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. If you become
pregnant while taking
IMPAVIDO, stop taking IMPAVIDO and talk to your healthcare provider
right away if you
become pregnant during treatment with IMPAVIDO.
•
You should have a pregnancy test before you start taking IMPAVIDO.
•
Women who can become pregnant should use effective birth control
(contraception) during
IMPAVIDO treatment and for 5 months after their last dose of IMPAVIDO.
Talk to your
healthcare provider about which birth control method is right for you.
•
Pregnancy Registry: There is a registry for women who become pregnant
during treatment with
IMPAVIDO. If you become pregnant or think you may be pregnant while
taking IMPAVIDO, tell
your healthcare provider right away. Talk to your healthcare provider
about registering with the
IMPAVIDO Pregnancy Registry. The purpose of this registry is to
collect information about your
health and your baby’s health. Your healthcare provider can enroll
you in this registry by calling
1-866-588-5405.
What is IMPAVIDO?
IMPAVIDO is prescription medicine used to treat certain types of
leishmaniasis in adults and children 12
years of age and older weighing 66 pounds or more with:
•
visceral leishmaniasis (affecting your internal organs) caused by
Leishmania donovani
•
cutaneous leishmaniasis (affecting the skin) caused by Leishmania
braziliensis, Leis

Produktens egenskaper

IMPAVIDO- MILTEFOSINE CAPSULE
PROFOUNDA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMPAVIDO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IMPAVIDO.
IMPAVIDO (MILTEFOSINE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
WARNING: EMBRYO-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PREGNANCY: IMPAVIDO IS CONTRAINDICATED IN PREGNANCY. BASED ON ANIMAL
DATA,
MILTEFOSINE MAY CAUSE FETAL HARM (4.1, 5.1, 8.1).
FEMALES OF REPRODUCTIVE POTENTIAL: VERIFY PREGNANCY STATUS PRIOR TO
INITIATING
IMPAVIDO TREATMENT IN FEMALES OF REPRODUCTIVE POTENTIAL. TO PREVENT
PREGNANCY,
FEMALES OF REPRODUCTIVE POTENTIAL SHOULD USE EFFECTIVE CONTRACEPTION
DURING
IMPAVIDO TREATMENT AND FOR 5 MONTHS AFTER THE LAST DOSE (2, 5.1, 8.3,
13.1).
RECENT MAJOR CHANGES
Warnings and Precautions, Impaired Semen Quality and Impaired
Spermatogenesis (5.2)
5/2021
Warnings and Precautions, Absorption of Oral Contraceptives (5.4)
5/2021
INDICATIONS AND USAGE
IMPAVIDO is an antileishmanial drug indicated in adults and pediatric
patients 12 years of age and older
weighing greater than or equal to 30 kg (66 lbs) for the treatment of:
•
•
•
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.
DOSAGE AND ADMINISTRATION
Administer with food to ameliorate gastrointestinal adverse reactions.
•
•
DOSAGE FORMS AND STRENGTHS
Each IMPAVIDO capsule for oral use contains 50 mg miltefosine (3).
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
Visceral leishmaniasis due to _Leishmania donovani_ (1).
Cutaneous leishmaniasis due to _Leishmania braziliensis, Leishmania
guyanensis, _and _Leishmania_
_panamensis _(1).
Mucosal leishmaniasis due to _Leishmania braziliensis _(1).
30 to 44 kg: o