LAGEVRIO- molnupiravir capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MOLNUPIRAVIR (UNII: YA84KI1VEW) (MOLNUPIRAVIR - UNII:YA84KI1VEW)

Available from:

Merck Sharp & Dohme LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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] .

Summary of Product characteristics

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