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Prevnar 13

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Prevnar 13

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

Data on the safety and effectiveness of Prevnar 13 when administered to immunocompromised individuals 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) are not available. Individuals in these groups may have reduced antibody response to active immunization due to impaired immune responsiveness.

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 wellcontrolled 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 or on or after the 6th birthday have not been established.

Immune responses elicited by Prevnar 13 among infants born prematurely have not been specifically studied.

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.

Last reviewed on RxList: 1/14/2013
This monograph has been modified to include the generic and brand name in many instances.

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