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Prevnar 13

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Prevnar 13

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

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 Prevnar 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 Prevnar 13 [see Use in Specific Populations].

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 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.

Use In Specific Populations

Pregnancy

Pregnancy Category B

A developmental and reproductive toxicity study has been performed in female rabbits at a dose approximately 20 times the human dose (on mg/kg basis) and revealed no evidence of impaired female 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 Mothers

It is not known whether this vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prevnar 13 is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Prevnar 13 in children below the age of 6 weeks have not been established.

Geriatric Use

Of the total number of Prevnar 13 recipients (N=5,667), 3,051/5,667 or 53.8% were 65 years and older and 1,266/5,667 or 22.3% were 75 years and older.

Antibody responses to Prevnar 13 were lower in persons ≥ 65 years of age compared to antibody responses in persons 50 through 59 years of age.

No overall differences in safety outcomes were observed in persons aged ≥ 65 years as compared to persons 50 through 59 years of age.24

High Risk Populations

Individuals with the diseases or conditions listed below are at increased risk of pneumococcal disease. Immunogenicity and safety data in these populations are limited.

Infants Born Prematurely

Immune responses elicited by Prevnar 13 administered on a US schedule to preterm infants have not been studied. When preterm infants ( < 37 weeks gestational age, N = 100) were administered 4 doses of Prevnar 13 on a non-US schedule, the serotype-specific IgG antibody responses after the third and fourth dose were lower compared to responses among term infants ( ≥ 37 weeks gestational age, N = 100) for some serotypes; the effectiveness of Prevnar 13 in preterm infants cannot be established from this study.

Children with Sickle Cell Disease

In an open-label, single-arm, descriptive study, 2 doses of Prevnar 13 were administered 6 months apart to children ≥ 6 to < 18 years of age with sickle cell disease who previously received PPSV23 at least 6 months prior to enrollment. Children with a prior history of pneumococcal conjugate vaccination were excluded. For all vaccine serotypes, anti-pneumococcal opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) were higher after the first dose compared to pre-vaccination (N=95-131); OPA GMTs following the first and second dose were comparable. The effectiveness of Prevnar 13 in this specific population has not been established.

Adults with HIV Infection

In an open-label, single-arm, descriptive study, 3 doses of Prevnar 13 were administered 6 months apart to HIV-infected adults ≥ 50 years of age (median age 55 years), with CD4 counts ≥ 200 cells/μL and serum HIV RNA titer < 50,000 copies/mL. All subjects had been vaccinated previously with PPSV23 at least 6 months prior to enrollment. For all vaccine serotypes anti-pneumococcal OPA GMTs were higher after the first dose compared to pre-vaccination (N=94-108); OPA GMTs following the first, second and third dose were generally comparable. The effectiveness of Prevnar 13 in this specific population has not been established.

Last reviewed on RxList: 9/19/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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