国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
MILTEFOSINE (UNII: 53EY29W7EC) (MILTEFOSINE - UNII:53EY29W7EC)
Profounda, Inc.
MILTEFOSINE
MILTEFOSINE 50 mg
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
Profounda, Inc. ---------- 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 阅读完整的文件
IMPAVIDO- MILTEFOSINE CAPSULE PROFOUNDA, INC. ---------- 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 阅读完整的文件