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This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.

PREVNAR 13TM

Indication

  • It is indicated for the active immunization of infants and children against invasive disease, meningitis, pneumonia, and otitis media caused by Streptococcus pneumoniae serotypes(1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)

Warnings

  • Prevnar 13TM will NOT protect against Streptococcus pneumoniae disease other than that caused by the 13 serotypes indicated above, nor will it protect against other microorganisms that cause invasive disease, pneumonia and otitis media.

Pharmacology

  • Prevnar 13TM contains 13 pneumococcal capsular polysaccharides which are conjugated to a protein carrier (a non-toxic variant of diphtheria toxin).
  • The immunologic response to the vaccine ultimately results in antibody production by B cells

Side Effects

  • Commom LOCAL reactions, experienced within 2 days following immunization with Prevnar 13TM, include erythema (~12%), induration (~10%) and tenderness (~28%)
  • Common SYSTEMIC reactions, experienced within 2 days following immunization with Prevnar 13TM include fever (~20%), irritability (~50%), drowsiness (20-40%), restless sleep (~20%), decreased appetite (~20%), vomiting (~14%) and diarrhea (~10%)

Administration

  • 0.5 mL IM (anterolateral aspect of the thigh).
  • Do NOT mix with other vaccines in the same syringe.
  • Can be co-administered with DPTP-Hib vaccines but MUST be given in a separate syringe and given at a separate site of injection

Dosing Schedule

  • The typical dosing schedule for LOW risk infants is vaccination at 2, 4 and 12 months of age.
  • The typical dosing schedule for HIGH** risk infants is vaccination at 2, 4, 6 and 15 months of age.
    • **HIGH risk includes babies with chronic lung, heart or renal disease
  • See the Product Monograph for previously unvaccinated older infants and children.

Contraindications

  • Hypersensitivity to the diphtheria toxoid or any other component of the vaccine
  • Thrombocytopenia or coagulation disorders that would contraindicate IM injection.

Availability

  • Prevnar 13TM is available as a single dose syringe, 0.5mL vial, containing 0.5 mL of product.
  • The product is available as a suspension; therefore, the syringe needs to be shaken vigorously immediately prior to use to obtain a uniform, white suspension. Do NOT use if there is particulate matter or discolouration present.
  • Store in the refrigerator.
  • Do NOT freeze. Discard the vaccine if it has been frozen.
  • Prevnar 13TM is stable for 4 days at 40 degrees C.

References

  1. Prevnar 13TM Product Monograph
  2. Prevnar 13TM: a pneumococcal conjugated vaccine for infants and young children. Issues in Emerging Health Technologies. Number 14: Feb, 2003.
  3. Ipp, M & B. Tapiero. Introducing Prevnar 13TM (pamphlet). Montreal: Wyeth-Ayerst Canada Inc.
  4. Middlesex - London Health Unit Health Care Professional Letter (19 August 2003)
  5. Prevnar 13TM product Monograph, accessed November 2010.
  6. Prevnar 13TM Eligibility, Ontario Ministry of Health, accessed November 2010.

Prepared by Lenny Janecka (Pharmacy Student) 20 August 2003
Edited by David Knoppert 10 October 2003
Updated by David Knoppert 19 November 2010




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