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SUMMARY PRODUCT INFORMATION

Route of Administration	Dosage Form / Strength	Clinically Relevant Nonmedicinal Ingredients
Intramuscular injection	Suspension for injection 1 dose (0.5 mL pre-filled syringe) contains: Pneumococcal polysaccharide serotype 1 2.2 µg ^a Pneumococcal polysaccharide serotype 3 2.2 µg ^a Pneumococcal polysaccharide serotype 4 2.2 µg ^a Pneumococcal polysaccharide serotype 5 2.2 µg ^a Pneumococcal polysaccharide serotype 6A 2.2 µg ^a Pneumococcal polysaccharide serotype 6B 4.4 µg ^a Pneumococcal polysaccharide serotype 7F 2.2 µg ^a Pneumococcal polysaccharide serotype 9V 2.2 µg ^a Pneumococcal polysaccharide serotype 14 2.2 µg ^a Pneumococcal polysaccharide serotype 18C 2.2 µg ^a Pneumococcal polysaccharide serotype 19A 2.2 µg ^a Pneumococcal polysaccharide serotype 19F 2.2 µg ^a Pneumococcal polysaccharide serotype 23F 2.2 µg ^a	Sodium Chloride, Succinic Acid, Polysorbate 80, Water for Injection

^a conjugated to CRM ₁₉₇ carrier protein and adsorbed on aluminum phosphate (0.125 mg aluminum)

Indications And Clinical Use

Children 6 Weeks to 5 Years of Age

Prevnar 13 is indicated for active immunization of infants and children from 6 weeks to 5 years of age (prior to the 6 ^th birthday) for the prevention of invasive pneumococcal disease (including sepsis, meningitis, bacteraemic pneumonia, pleural empyema and bacteraemia) and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Adults 6 Years to 17 Years of Age

Prevnar 13 is indicated for active immunization of children from 6 years to 17 years of age (prior to the 18th birthday) for the prevention of invasive pneumococcal disease (including sepsis, meningitis, bacteraemic pneumonia, pleural empyema and bacteraemia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Contraindications

General

Immunocompromised individuals may have a reduced antibody response to the vaccine.
Safety and immunogenicity data on Prevnar 13 are not available for individuals in certain immunocompromised groups (e.g., individuals with malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. Some safety and immunogenicity data are available in individuals with sickle cell disease (SCD), with human immunodeficiency virus (HIV) infection, or with hematopoietic stem cell transplant (see PART II, CLINICAL TRIALS).
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Minor illnesses, such as mild respiratory infection, with or without low-grade fever, are not generally contraindications to vaccination. The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. The administration of Prevnar 13 should be postponed in subjects suffering from acute severe febrile illness.
As with any intramuscular injection, Prevnar 13 should be given with caution to infants, children or adults with thrombocytopenia or any coagulation disorder, or to those receiving anticoagulant therapy.
Prevnar 13 will not protect against Streptococcus pneumoniae serotypes not included in the vaccine. Prevnar 13 will not protect against other microorganisms that cause invasive disease, pneumonia or otitis media. This vaccine is not intended to be used for treatment of active infection.
As with any vaccine, Prevnar 13 may not protect all individuals receiving the vaccine from pneumococcal disease.

Infants and Children Aged 6 Weeks to 5 Years

The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccine (PPSV23) in children ≥ 24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness, or who are otherwise immunocompromised. Data on sequential vaccination with Prevnar 13 followed by PPSV23 are not available; data on sequential vaccination with Prevnar (7-valent) vaccine followed by PPSV23 are limited.
As with all injectable pediatric vaccines, the potential risk of apnea should be considered when administering the primary immunization series to premature infants. The need for monitoring for at least 48 hours after vaccination should be considered for very premature infants (born ≤ 30 weeks of gestation) who remain hospitalized at the time of the recommended administration. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Immunization with Prevnar 13 does not substitute for routine diphtheria immunization.
When Prevnar 13 is administered concomitantly with Infanrix hexa (DTaP-HBV-IPV/Hib), there are no data that would suggest that the rates of febrile reactions would be different to those seen with concomitant administration of pneumococcal 7-valent conjugate vaccine and Infanrix hexa. A higher incidence of fever (≥ 38.0°C to ≤ 39.0°C) was reported in infants receiving Infanrix hexa and pneumococcal 7-valent conjugate vaccine compared to infants receiving the hexavalent vaccine alone. Increased reporting rates of convulsions (with or without fever) and hypotonic-hyporesponsive episode (HHE) were observed with concomitant administration of Prevnar 13 and Infanrix hexa (see ADVERSE REACTIONS section).

Special Populations

Pregnant Women:

A reproduction study has been performed in female rabbits at doses equal to the human dose and has revealed no evidence of impaired fertility or harm to the fetus due to Prevnar 13. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed.

Nursing Women:

Safety during lactation has not been established.
It is not known whether vaccine antigens or antibodies are excreted in human milk.

Pediatrics:

The safety and immunogenicity of Prevnar 13 in children below the age of 6 weeks have not been established.

Geriatrics:

Prevnar 13 has been studied in the geriatric population (see PART II, CLINICAL TRIALS section).

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13.

PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine
[Diphtheria CRM 197 Protein])
Suspension for intramuscular injection
Initial U.S. Approval: 2010

INDICATIONS AND USAGE

In children 6 weeks through 5 years of age (prior to the 6 th birthday), Prevnar 13 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 and 23F. ( 1.1)
active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A. ( 1.1)

In children 6 years through 17 years of age (prior to the 18 th birthday), Prevnar 13 is indicated for:

active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. ( 1.2)

In adults 18 years of age and older, Prevnar 13 is indicated for:

active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. ( 1.3)

Limitations of Prevnar 13 Use and Effectiveness

Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine. ( 1.4)

DOSAGE AND ADMINISTRATION

Children 6 weeks through 5 years: The four-dose immunization series consists of a 0.5 mL intramuscular injection administered at 2, 4, 6, and 12–15 months of age. ( 2.3)

Children 6 through 17 years of age: a single dose. ( 2.5)

Adults 18 years and older: a single dose. ( 2.6)

DOSAGE FORMS AND STRENGTHS

0.5 mL suspension for intramuscular injection, supplied in a single-dose prefilled syringe. ( 3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine. ( 4)

WARNINGS AND PRECAUTIONS

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13, 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

In infants and toddlers vaccinated at 2, 4, 6, and 12–15 months of age in US clinical trials, the most commonly reported solicited adverse reactions (>5%) were irritability (>70%), injection site tenderness (>50%), decreased appetite (>40%), decreased sleep (>40%), increased sleep (>40%), fever (>20%), injection site redness (>20%), and injection site swelling (>20%). ( 6.1)
In children aged 5 through 17 years, the most commonly reported solicited adverse reactions (>5%) were injection site tenderness (>80%), injection site redness (>30%), injection site swelling (>30%), irritability (>20%), decreased appetite (>20%), increased sleep (>20%), fever (>5%), and decreased sleep (>5%). ( 6.1)
In adults aged 18 years and older, the most commonly reported solicited adverse reactions (>5%) were pain at the injection site (>50%), fatigue (>30%), headache (>20%), muscle pain (>20%), joint pain (>10%), decreased appetite (>10%), injection site redness (>10%), injection site swelling (>10%), limitation of arm movement (>10%), vomiting (>5%), fever (>5%), chills (>5%), and rash (>5%). ( 6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

USE IN SPECIFIC POPULATIONS

Pediatric Use: Safety and effectiveness of Prevnar 13 in children below the age of 6 weeks have not been established. ( 8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2019

1 INDICATIONS AND USAGE

1.1 Children 6 Weeks Through 5 Years of Age

In children 6 weeks through 5 years of age (prior to the 6 th birthday), Prevnar 13 ® 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 and 23F.
active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.

1.2 Children 6 Years Through 17 Years of Age

In children 6 years through 17 years of age (prior to the 18 th birthday), Prevnar 13 is indicated for:

active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

1.3 Adults 18 Years of Age and Older

In adults 18 years of age and older, Prevnar 13 is indicated for:

active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

1.4 Limitations of Prevnar 13 Use and Effectiveness

Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see Description (11)]. This product should not be used if particulate matter or discoloration is found.

Do not mix Prevnar 13 with other vaccines/products in the same syringe.

2.2 Administration Information

For intramuscular injection only.

Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers, 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.

2.3 Vaccination Schedule for Infants and Toddlers

Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age.

Table 1: Vaccination Schedule for Infants and Toddlers
Dose	Dose 1 *,†	Dose 2 †	Dose 3 †	Dose 4 ‡
* Dose 1 may be given as early as 6 weeks of age. † The recommended dosing interval is 4 to 8 weeks. ‡ The fourth dose should be administered at approximately 12–15 months of age, and at least 2 months after the third dose.
Age at Dose	2 months	4 months	6 months	12–15 months

2.4 Vaccination Schedule for Unvaccinated Children 7 Months Through 5 Years of Age

For children 7 months through 5 years of age who have not received Prevnar ® or Prevnar 13, the catch-up schedule in Table 2 applies:

Table 2: Vaccination Schedule for Unvaccinated Children 7 Months of Age Through 5 Years of Age
Age at First Dose	Total Number of 0.5 mL Doses
* The first 2 doses at least 4 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months. † Two doses at least 2 months apart.
7–11 months of age	3 *
12–23 months of age	2 †
24 months through 5 years of age (prior to the 6 th birthday)	1

The immune responses induced by this catch-up schedule may result in lower antibody concentrations for some serotypes, compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12–15 months). In children 24 months through 5 years of age, lower antibody concentrations were observed for some serotypes, compared to antibody concentrations following 3 doses of Prevnar 13 (given at 2, 4, and 6 months).

2.5 Vaccination Schedule for Children 6 Years Through 17 Years of Age

In children 6 years through 17 years of age, Prevnar 13 is administered as single dose. If Prevnar was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.

2.6 Vaccination Schedule for Adults 18 Years of Age and Older

Prevnar 13 is administered as a single dose.

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