Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
MOLNUPIRAVIR (UNII: YA84KI1VEW) (MOLNUPIRAVIR - UNII:YA84KI1VEW)
Merck Sharp & Dohme LLC
ORAL
PRESCRIPTION DRUG
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product LAGEVRIO™ for treatment of adults with mild-to-moderate coronavirus disease 2019 (COVID-19): - who are at high risk for progression to severe COVID-19, including hospitalization or death. Refer to CDC website1 for additional details, and for - whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. LIMITATIONS OF AUTHORIZED USE - LAGEVRIO is not authorized for use in patients who are less than 18 years of age [see Warnings and Precautions (5.3)] . - LAGEVRIO is not authorized for initiation of treatment in patients hospitalized due to COVID-192. Benefit of treatment with LAGEVRIO has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19 [see Dosing and Administration (2.1)] . - LAGEVRIO is not authorized for use for longer than 5 consecutive days. - LAGEVRIO is
How Supplied LAGEVRIO capsules are supplied as follows: Storage and Handling Store LAGEVRIO capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .
LAGEVRIO- MOLNUPIRAVIR CAPSULE MERCK SHARP & DOHME LLC ---------- FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR LAGEVRIO™ (MOLNUPIRAVIR) CAPSULES HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) THESE HIGHLIGHTS OF THE EUA DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAGEVRIO UNDER THE EUA. SEE THE FULL FACT SHEET FOR HEALTHCARE PROVIDERS FOR LAGEVRIO. LAGEVRIO™ (MOLNUPIRAVIR) CAPSULES, FOR ORAL USE ORIGINAL EUA AUTHORIZED DATE: 12/23/2021 REVISED EUA AUTHORIZED DATE: 10/2023 MANDATORY REQUIREMENTS FOR ADMINISTRATION OF LAGEVRIO UNDER EMERGENCY USE AUTHORIZATION Refer to FULL FACTSHEET for details. --------------RECENT MAJOR CHANGES----------- Mandatory Requirements Box, Emergency Use Authorization (Section 1): Updated 10/2023 Limitations of Authorized Use (Section 1): Updated 10/2023 Adverse Reactions: Removal of Section 6.5 10/2023 Adverse Reactions (Section 6.2): update to post-authorization experience section 07/2023 Mandatory Requirements Box, Use in Specific Populations (Section 8.1): Updates to pregnancy registry information 02/2023 Emergency Use Authorization (Section 1): Removal of requirement of SARS-CoV-2 viral testing 02/2023 Dosage and Administration (Section 2.3): Addition of preparation and administration instructions via nasogastric and orogastric tube. 02/2023 Microbiology (Section 12.4): Addition of Omicron subvariants 02/2023 Nonclinical Toxicology (Section 13.1): Updated carcinogenicity data 02/2023 Microbiology (Section 12.4): addition of viral RNA rebound 08/2022 -----DOSAGE FORMS AND STRENGTHS----- Capsules: 200 mg (3) ------------ CONTRAINDICATIONS- ----------- No contraindications have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA. (4) ------WARNINGS AND PRECAUTIONS------ Embryo-Fetal Toxicity: LAGEVRIO is not recommended for use during pregnancy. (5.1, 8.1, 8.3) Hypersensitivity reactions, including anaphylaxis have been reported with LAGEVRIO. If signs and symptoms of a clinically significant Đọc toàn bộ tài liệu