VAXNEUVANCE® SUSPENSION FOR INJECTION [SIN16944P]

Product Info

VAXNEUVANCE® SUSPENSION FOR INJECTION

[SIN16944P]

Indication

1. INDICATIONS AND USAGE

VAXNEUVANCE is a vaccine indicated in infants, children and adolescents from 6 weeks through 17 years of age (prior to the 18^th birthday) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

VAXNEUVANCE is indicated in adults 18 years of age and older for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

VAXNEUVANCE may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.

Dosing

2. DOSAGE AND ADMINISTRATION

2.1 General
The vaccination schedule for VAXNEUVANCE should be based on official recommendations. The national immunization practice recommendations/guidelines should also be considered.

Dosage
Administer a 0.5 mL dose of VAXNEUVANCE intramuscularly.

Method of Administration
For intramuscular use only. Do not inject intravascularly.

The preferred site for injection is the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.

2.2 Pediatrics
Routine Vaccination Schedule for Infants and Toddlers
4-Dose Regimen (Three-Dose Primary Series Followed by a Toddler Dose)
The recommended vaccination regimen consists of 4 doses of VAXNEUVANCE, with the first dose given as early as 6 to 12 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series. The fourth dose should be administered at approximately 11 through 15 months of age and at least 2 months after the third dose.

3-Dose Regimen (Two-Dose Primary Series Followed by a Toddler Dose)
The alternative vaccination regimen consists of 3 doses of VAXNEUVANCE, with the first dose given as early as 6 weeks of age, and a second dose administered 8 weeks later. The third dose should be administered at approximately 11 through 15 months of age.

Preterm Infants
Preterm infants (<37 weeks gestation at birth) should receive a 4-dose regimen (three-dose primary series followed by a toddler dose) of VAXNEUVANCE, with the first dose given as early as 6 to 12 weeks of age, with an interval of 4 to 8 weeks between doses in the primary series. The fourth dose should be administered at approximately 11 through 15 months of age and at least 2 months after the third dose. [See Warnings and Precautions (5) and Use in Specific Populations (7.5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]

Prior Vaccination with Another Pneumococcal Conjugate Vaccine
The vaccination regimen can be completed with VAXNEUVANCE if initiated with another pneumococcal conjugate vaccine [see Clinical Studies (10) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Catch-Up Vaccination Schedule for Children 7 Months Through 17 Years of Age

For children 7 months through 17 years of age who are pneumococcal vaccine-naïve or not fully vaccinated or completed a dosing regimen with lower-valency pneumococcal conjugate vaccines, the following catch-up schedule should be considered:

Infants 7 Through 11 months of age
Three doses, with the first two doses given at least 4 weeks apart. The third dose is given after 12 months of age, separated from the second dose by at least 2 months.

Children 12 Through 23 months of age
Two doses, with an interval of 2 months between doses.

Children and adolescents 2 Through 17 years of age
One single dose.

If a previous pneumococcal conjugate vaccine was administered, at least 2 months should elapse before receiving VAXNEUVANCE.

2.3 Adults
One single dose.

2.4 Special Populations
The dosing schedule in special populations should be guided by official recommendations and may include more than one dose of VAXNEUVANCE [see Use in Specific Populations (7.5) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Contraindications

4. CONTRAINDICATIONS

VAXNEUVANCE is contraindicated in individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or any diphtheria toxoid-containing vaccine. [See Pharmaceutical Particulars (13.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.]