VAXNEUVANCE- pneumococcal 15-valent conjugate vaccine crm197 protein adsorbed injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (UNII: 54EC0SE5PZ) (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN - UNII:54EC0SE5PZ), STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (UNII: 2VF3V7175U) (STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN - UNII:2VF3V7175U), STREPTOCOCCUS PNEUMONIAE TYPE

Available from:

Merck Sharp & Dohme LLC

Administration route:

INTRAMUSCULAR

Therapeutic indications:

VAXNEUVANCE™ is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid. [See Description (11).] Risk Summary All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no adequate and well-controlled studies of VAXNEUVANCE in pregnant women. Available data on VAXNEUVANCE administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Developmental toxicity studies have been performed in female rats administered a human dose of VAXNEUVANCE on four

Product summary:

VAXNEUVANCE is supplied as follows: Carton of one 0.5 mL single-dose prefilled Luer Lock syringes with tip caps. NDC 0006-4329-02 Carton of ten 0.5 mL single-dose prefilled Luer Lock syringes with tip caps. NDC 0006-4329-03 Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. The tip cap and plunger stopper of the prefilled syringe are not made with natural rubber latex.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

VAXNEUVANCE- PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE CRM197 PROTEIN
ADSORBED INJECTION, SUSPENSION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VAXNEUVANCE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VAXNEUVANCE.
VAXNEUVANCE™ (PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Indications and Usage (1)
06/2022
Dosage and Administration (2.3, 2.4)
06/2022
Warnings and Precautions (5.1, 5.3)
06/2022
INDICATIONS AND USAGE
VAXNEUVANCE™ is a vaccine indicated for active immunization for the
prevention of invasive disease
caused by _Streptococcus pneumoniae_ serotypes 1, 3, 4, 5, 6A, 6B, 7F,
9V, 14, 18C, 19A, 19F, 22F, 23F and
33F in individuals 6 weeks of age and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR INJECTION ONLY.
Each dose of VAXNEUVANCE is 0.5 mL. (2.1)
Children: Administer VAXNEUVANCE as a 4-dose series at 2, 4, 6 and 12
through 15 months of age. (2.3)
Adults: Administer VAXNEUVANCE as a single dose in adults 18 years of
age and older. (2.3)
DOSAGE FORMS AND STRENGTHS
Suspension for injection (0.5 mL dose), supplied as a single-dose
prefilled syringe. (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of
VAXNEUVANCE or to diphtheria
toxoid. (4)
WARNINGS AND PRECAUTIONS
Apnea following intramuscular vaccination has been observed in some
infants born prematurely. A
decision about when to administer VAXNEUVANCE to infants born
prematurely should be based on
consideration of the individual infant’s medical status and the
potential benefits and possible risks of
vaccination. (5.3)
ADVERSE REACTIONS
The most commonly reported solicited adverse reactions:
in children vaccinated with a 4-dose series at 2, 4, 6 and 12 through
15 months of age, provided as a
range across the series, were: irritability (57.3% to 63.4%),
somnolence (24.2% to 47.5%), injection-site
pain (25.9% to 40.