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ABRYSVO (Respiratory Syncytial Virus Vaccine)
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Our medical information is accurate, up to date, and scientifically balanced.
ABRYSVO Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Immunization of Pregnant Individuals
ABRYSVO is a vaccine indicated for active...
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Dosage and Administration
...
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
Administer a single dose (approximately 0.5 mL) of ABRYSVO intramuscularly.
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
ABRYSVO is a solution for injection. A single dose after reconstitution is approximately 0.5 mL.
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Contraindications
4 CONTRAINDICATIONS
Do not administer ABRYSVO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of ABRYSVO [see Description (11)]...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Potential Risk of Preterm Birth
A numerical imbalance in preterm births in...
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Adverse Reactions
6 ADVERSE REACTIONS
In pregnant individuals, the most commonly reported (≥10%) adverse reactions were pain at the injection site (40.6%), headache (31.0%), muscle pain (26.5%), and nausea (20.0%).
In individuals 60...
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Drug Interactions
7 DRUG INTERACTIONS
In Study 4 in a concomitant administration study of ABRYSVO and a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) in non-pregnant women, no safety concerns were...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors...
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Description
11 DESCRIPTION
ABRYSVO (Respiratory Syncytial Virus Vaccine) is a sterile solution for intramuscular injection. The vaccine is supplied as a vial of Lyophilized Antigen Component that is reconstituted at the time of use with...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Active Immunization
ABRYSVO induces an immune response against RSV pre F that...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
ABRYSVO has not been evaluated for the potential to cause carcinogenicity,...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Study in Pregnant Individuals For Efficacy in Their Infants from Birth Through 6 Months of Age
Study 1 (NCT04424316) is a Phase 3 study that...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ABRYSVO is supplied in a kit that includes a vial of Lyophilized Antigen Component (NDC 0069-0207-01), a...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine:
- •
- Inform vaccine recipient of the potential benefits and risks of vaccination with ABRYSVO.
- •
- Advise vaccine...
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