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PREVENAR 13

Vaccine

PREVENAR 13

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

 

PREVENAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

 

Dosage forms and Strengths

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

Description

Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 µg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides, 4.4 μg of 6B saccharides, 34 µg CRM197 carrier protein, 100 µg polysorbate 80, 295 µg succinate buffer and 125 µg aluminum as aluminum phosphate adjuvant. The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

Indications and Usage

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

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

In adults 18 years of age and older, Prevenar 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.

Dosage and Administration

Preparation for Administration: Shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. This product should not be used if particulate matter or discoloration is found. Do not mix Prevenar 13 with other vaccines/products in the same syringe.

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.

Vaccination Schedule

Infants and Toddlers: Prevenar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age. Dose 1 may be given as early as 6 weeks of age.

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

Age at First Dose

Total Number of  Doses

7–11 months of age

3 (The first 2 doses at least 8 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months)

12–23 months of age

2 (Two doses at least 2 months apart)

24 months through 5 years of age (prior to the 6th birthday)

1

 

Children 6 Years through 17 Years of Age and Adults 18 Years of Age and Older: Prevenar 13 is administered as a single dose.

Contraindications

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

Warnings and Precautions

Management of Allergic Reactions: Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevenar 13.

Altered Immunocompetence: Individuals with altered immunocompetence, including those at higher risk for invasive pneumococcal disease (e.g., individuals with congenital or acquired splenic dysfunction, HIV infection, malignancy, hematopoietic stem cell transplant, nephrotic syndrome), may have reduced antibody responses to immunization with Prevenar 13.

Apnea in Premature Infants: Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevenar 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.

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%).

• 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%).

• 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%).

Drug Interactions

Concomitant Immunizations: In clinical trials, Prevenar 13 was administered concomitantly with the following vaccines: Diphtheria, Tetanus, Pertussis, Hepatitis B (Recombinant), Poliovirus, Haemophilus b Conjugate, Meningococcal, Measles, Mumps, Rubella, Varicella, Hepatitis A, inactivated influenza vaccines, trivalent and quadrivalent.

When Prevenar 13 is administered at the same time as another injectable vaccine(s), the vaccines should always be administered with different syringes and given at different injection sites.

Pregnancy and Lactation

Available data on Prevenar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Studies revealed no evidence of harm to the fetus due to Prevenar 13. Data are not available to assess the effects of Prevenar 13 on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Prevenar 13 and any potential adverse effects on the breastfed child from Prevenar 13 or from the underlying maternal condition.

Storage and Handling

After shipping, Prevenar 13 may arrive at temperatures between 2°C to 25°C.

Upon receipt, store refrigerated at 2°C to 8°C.

Do not freeze. Discard if the vaccine has been frozen.