A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Prevnar Indications, Dosage, Storage, Stability - Pneumococcal 7-valent Conjugate
Prevnar Indications, Dosage, Storage, Stability - Pneumococcal 7-valent Conjugate
INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
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.
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 Schedule
For 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 least 2 months after the third dose.
Previously Unvaccinated Older Infants and Children
For previously unvaccinated older infants and children, who
are beyond the age of the routine infant schedule, the following schedule applies:
35
|
Age at First Dose
|
Total Number of 0.5 mL Doses
|
|
7-11 months of age
|
3*
|
|
12-23 months of age
|
2†
|
|
³24 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
EVENTS 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).
HOW SUPPLIED
Vial, 1 Dose (5 per package) - NDC 0005-1970-67
CPT Code 90669
STORAGE
DO NOT FREEZE. STORE REFRIGERATED, AWAY FROM FREEZER COMPARTMENT,
AT 2°C TO 8°C (36°F
TO 46°F).
REFERENCES
1 Schuchat A, Robinson K, Wenger JD, et al. Bacterial meningitis in the
United States in 1995. N Engl J Med. 1997; 337:970-6.
2 Zangwill KM, Vadheim CM, Vannier AM, et al. Epidemiology of invasive
pneumococcal disease in Southern California: implications for the design and
conduct of a pneumococcal conjugate vaccine efficacy trial. J Infect Dis.
1996; 174:752-9.
3 Pastor P, Medley F, Murphy T. Invasive pneumococcal disease in Dallas
County, Texas: results from population-based surveillance in 1995. Clin Infect
Dis. 1998; 26:590-5.
4 Hofmann J, Cetron MS, Farley MM, et al. The prevalence of drug-resistant
Streptococcus pneumoniae in Atlanta. N Engl J Med. 1995; 333:481-515.
5 Breiman R, Spika J, Navarro V, et al. Pneumococcal bacteremia in Charleston
County, South Carolina. Arch Intern Med. 1990; 150:1401-5.
6 Plouffe J, Breiman R, Facklam R. Franklin County Study Group. Bacteremia
with Streptococcus pneumoniae in adults-implications for therapy and
prevention. JAMA. 1996; 275:194-8.
7 Levine O, Farley M, Harrison LH, et al. Risk factors for invasive pneumococcal
disease in children: a population-based case-control study in North America.
Pediatrics. 1999; 103:1-5.
8 Kaplan SL, Mason EO, Barson WJ, et al. Three-year multicenter surveillance
of systemic pneumococcal infections in children. Pediatrics. 1998; 102:538-44.
9 Arditi M, Mason E, Bradley J, et al. Three-year multicenter surveillance
of pneumococcal meningitis in children: clinical characteristics and outcome
related to penicillin susceptibility and dexamethasone use. Pediatrics. 1998;
102:1087-97.
10 Shappert SM. Ambulatory care visits to physician offices, hospital
outpatient departments, and emergency departments: United States, 1997. National
Center for Health Statistics. Vital Health Sat. 1999; 13(143):1-41.
11 Hall MJ, Lawrence L. Ambulatory surgery in the United States, 1996.
Adv Data Vital Health Stat. 1998; 300:1-16.
12 Teele DW, Klein JO, Rosner B, et al. Epidemiology of otitis media during
the first seven years of life in children in greater Boston: a prospective,
cohort study. J Infect Dis. 1989; 160:83-94.
13 Shappert, SM. Office visits for otitis media: United States, 1975-1990.
Adv Data Vital Health Stat. 1992; 214:1-20.
14 Bluestone CD, Stephenson BS, Martin LM. Ten-year review of otitis media
pathogens. Pediatr Infect Dis J. 1992; 11:S7-S11.
15 Giebink GS. The microbiology of otitis media. Pediatr Infect Dis J.
1989; 8:S18-S20.
16 Rodriguez WJ, Schwartz RH. Streptococcus pneumoniae causes otitis media
with higher fever and more redness of tympanic membrane than Haemophilus influenzae
or Moraxella catarrhalis. Pediatr Infect Dis J. 1999; 18:942-4.
17 Barnett ED, Klein JO. The problem of resistant bacteria for the management
of acute otitis media. Ped Clin North Am. 1995; 42:509-17.
18 Butler JC, Breiman RF, Lipman HB, et al. Serotype distribution of Streptococcus
pneumoniae infections among preschool children in the United States, 1978-1994:
implications for development of a conjugate vaccine. J Infect Dis. 1995; 171:885-9.
19 Paisley JW, Lauer BA, McIntosh K, et al. Pathogens associated with
acute lower respiratory tract infection in young children. Pediatr Infect
Dis J. 1984; 3:14-9.
20 Heiskanen-Kosma T, Korppi M, Jokinen C, et al. Etiology of childhood
pneumonia: serologic results of a prospective, population-based study. Pediatr
Infect Dis J. 1998; 17:986-91.
21 American Academy of Pediatrics Committee on Infectious Diseases. Therapy
for children with invasive pneumococcal infections. Pediatrics. 1997; 99:289-300.
22 Hausdorff WP, Bryant J, Paradiso PR, Siber GR. Which pneumococcal serogroups
cause the most invasive disease: implications for conjugate vaccine formulation
and use, part I. Clin Infect Dis. 2000; 30:100-21.
23 Butler JC, Hoffman J, Cetron MS, et al. The continued emergence of
drug-resistant Streptococcus pneumoniae in the United States. An Update
from the Centers for Disease Control and Prevention’s Pneumococcal Sentinel
Surveillance System. J Infect Dis. 1996; 174:986-93.
24 Lederle Laboratories, Data on File: D118-P8.
25 Black S, Shinefield H, Ray P, et al. Efficacy, safety and immunogenicity
of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect
Dis J. 2000; 19:187-195.
26 Lederle Laboratories, Data on File: D118-P809.
27 Eskola J, Kilpi T, Palma A, et al. Efficacy of a pneumococcal conjugate
vaccine against acute otitis media. N Engl J Med. 2001; 344:403-409.
28 Fireman B, Black S, Shinefield H, et al. The impact of the pneumococcal
conjugate vaccine on otitis media. Pediatr Infect Dis J. In press.
29 Lederle Laboratories, Data on File: D118-P16.
30 Lederle Laboratories, Data on File: D118-P8 Addendum DTaP Immunogenicity.
31 Shinefield HR, Black S, Ray P. Safety and immunogenicity of heptavalent
pneumococcal CRM197 conjugate vaccine in infants and toddlers.
Pediatr Infect Dis J. 1999; 18:757-63.
32 Lederle Laboratories, Data on File: D118-P12.
33 Rennels MD, Edwards KM, Keyserling HL, et al. Safety and immunogenicity
of heptavalent pneumococcal vaccine conjugated to CRM197 in United
States infants. Pediatrics. 1998; 101(4):604-11.
34 Lederle Laboratories, Data on File: D118-P3.
35 Lederle Laboratories, Data on File: Integrated Summary on Catch-Up.
36 Report of the Committee on Infectious Diseases 24th Edition.
Elk Grove Village, IL: American Academy of Pediatrics. 1997; 31-3.
37 Update: Vaccine Side Effects, Adverse Reactions, Contraindications,
and Precautions. MMWR. 1996; 45 (RR-12):1-35.
38 Recommendations of the Advisory Committee on Immunization Practices
(ACIP): use of vaccines and immunoglobulins in persons with altered immunocompetence.
MMWR. 1993; 43(RR-4):1-18.
39 Vernacchio L, Neufeld EJ, MacDonald K, et al. Combined schedule of
7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal
vaccine in children and young adults with sickle cell disease. J Pediatr.
1998; 103:275-8.
40 Immunization of children infected with human immunodeficiency virus
– supplementary ACIP statement. MMWR. 1988; 37(12):181-83.
41 Centers for Disease Control and Prevention. General recommendations
on immunization. Recommendations of the Advisory Committee on Immunization
Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR.
2002; 51(RR-2):1-36.
42 Fawcett HA, Smith NP. Injection-site granuloma due to aluminum. Archives
Dermatology. 1984; 120:1318-22.
43 Vaccines Adverse Event Reporting System – United States. MMWR. 1990;
39:730-3.
Manufactured by: LEDERLE LABORATORIES, Division
American Cyanamid Company Pearl River, NY 10965 USA US GOVERNMENT LICENSE NO.
17
Marketed by: Wyeth-Ayerst Laboratories Philadelphia,
PA 19101, W10430C002 ET01 Rev 05/03
top
