Prevnar
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Questions & Answers
Side Effects & Adverse Reactions
THIS VACCINE WILL NOT PROTECT AGAINST S. PNEUMONIAE DISEASE CAUSED BY SEROTYPES UNRELATED TO THOSE IN THE VACCINE, NOR WILL IT PROTECT AGAINST OTHER MICROORGANISMS THAT CAUSE INVASIVE INFECTIONS SUCH AS BACTEREMIA AND MENINGITIS OR NON-INVASIVE INFECTIONS SUCH AS OTITIS MEDIA.
This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer this vaccine to children with coagulation disorders, it should be given with caution. (See DRUG INTERACTIONS.)
Immunization with Prevnar® does not substitute for routine diphtheria immunization.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Prevnar® is indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). The routine schedule is 2, 4, 6, and 12-15 months of age.
The decision to administer Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar® should be based primarily on its efficacy in preventing invasive pneumococcal disease. As with any vaccine, Prevnar® may not protect all individuals receiving the vaccine from invasive pneumococcal disease.
Prevnar® is also indicated for active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of S. pneumoniae represented in the vaccine, protection against all causes of otitis media is expected to be low.
(See CLINICAL PHARMACOLOGY for estimates of efficacy against invasive disease and otitis media).
For additional information on usage, see DOSAGE AND ADMINISTRATION.
This vaccine is not intended to be used for treatment of active infection.
History
There is currently no drug history available for this drug.
Other Information
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar®, is a sterile solution of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F individually conjugated to diphtheria CRM197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography. The polysaccharides are chemically activated to make saccharides which are directly conjugated to the protein carrier CRM197 to form the glycoconjugate. This is effected by reductive amination. CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium. CRM197 is purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography. The individual glycoconjugates are purified by ultrafiltration and column chromatography and are analyzed for saccharide to protein ratios, molecular size, free saccharide, and free protein.
The individual glycoconjugates are compounded to formulate the vaccine, Prevnar®. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens, and by the saccharide to protein ratios in the individual glycoconjugates.
Prevnar® is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant.
After shaking, the vaccine is a homogeneous, white suspension.
Sources
Prevnar Manufacturers
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Wyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.
![Prevnar (Pneumococcal 7-valent) Injection, Suspension [Wyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Prevnar | Wyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.
For intramuscular injection only. Do not inject intravenously.
The dose is 0.5 mL to be given intramuscularly.
Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a uniform suspension in the vaccine container. The vaccine should not be used if it cannot be resuspended.
After shaking, the vaccine is a homogeneous, white suspension.
The vaccine is not to be mixed with other vaccines/products in the same syringe.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (see DESCRIPTION). This product should not be used if particulate matter or discoloration is found.
The vaccine should be injected intramuscularly. The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in toddlers and young children. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. Before injection, the skin at the injection site should be cleansed and prepared with a suitable germicide. After insertion of the needle, aspirate and wait to see if any blood appears in the syringe, which will help avoid inadvertent injection into a blood vessel. If blood appears, withdraw the needle and prepare for a new injection at another site.
Vaccine ScheduleFor infants, the immunization series of Prevnar® consists of three doses of 0.5 mL each, at approximately 2-month intervals, followed by a fourth dose of 0.5 mL at 12-15 months of age. The customary age for the first dose is 2 months of age, but it can be given as young 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.
Vaccination schedule for infants and toddlers Dose: Dose 1*† Dose 2† Dose 3† Dose 4‡ Age at Dose: 2 months 4 months 6 months 12-15 months * 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. Previously Unvaccinated Older Infants and ChildrenFor previously unvaccinated older infants and children, who are beyond the age of the routine infant schedule, the following schedule applies:31
Vaccine schedule for previously unvaccinated children ≥7 months of age Age at First Dose Total Number of 0.5 mL Doses 7-11 months of age 3* 12-23 months of age 2† ≥24 months through 9 years of age 1 * 2 doses at least 4 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months.
† 2 doses at least 2 months apart.(See CLINICAL PHARMACOLOGY section for the limited available immunogenicity data and ADVERSE REACTIONS section for limited safety data corresponding to the previously noted vaccination schedule for older children).
Safety and immunogenicity data are either limited or not available for children in specific high risk groups for invasive pneumococcal disease (eg, persons with sickle cell disease, asplenia, HIV-infected).
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