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Note: In March 2010, the Advisory Committee on Immunization Practices (ACIP) released recommendations that pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13 � � �) replace pneumococcal 7-valent conjugate vaccine (PCV7; Prevnar � �) for all doses for immunization of all children 2-59 months of age. Refer to the Pneumococcal Conjugate Vaccine (13-Valent) monograph for additional information.
Immunization of infants and toddlers against Streptococcus pneumoniae infection caused by serotypes included in the vaccine
Immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine
The Advisory Committee on Immunization Practices (ACIP) recommends pneumococcal conjugate vaccine (PCV) for routine vaccination of all children 2-59 months and children 60-71 months with underlying medical conditions. PCV13 should be used to complete the vaccination of children who received ≥1 dose of PCV7.
Hypersensitivity to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid
Dosing established for infants and toddlers.
Refer to adult dosing.
Note: As of March 10, 2010, the Advisory Committee on Immunization Practices (ACIP) recommended that the use of pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13 � � �) replace all doses of pneumococcal 7-valent conjugate vaccine (PCV7; Prevnar � �). The manufacturer, Wyeth Pharmaceuticals, intends to phase out the previous Prevnar � � product. Refer to the Pneumococcal Conjugate Vaccine (13-Valent) monograph for transitioning from PCV7 to PCV13.
Immunization: Infants 2-6 months (manufacturers labeling): IM: 0.5 mL at approximately 2-month intervals for 3 consecutive doses, followed by a fourth dose of 0.5 mL at 12-15 months of age; first dose may be given as young as 6 weeks of age, but is typically given at 2 months of age.
Shake well prior to use. Administer IM (deltoid muscle for toddlers and young children or lateral midthigh in infants). Do not inject IV; avoid intradermal route.
For patients at risk of hemorrhage following intramuscular injection, the ACIP recommends "it should be administered intramuscularly if, in the opinion of the physician familiar with the patients bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. " � Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (CDC, 2011).
Antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (CDC, 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula, 2009).
Simultaneous administration of vaccines helps ensure the patients will be fully vaccinated by the appropriate age. Simultaneous administration of vaccines is defined as administering >1 vaccine on the same day at different anatomic sites. Separate vaccines should not be combined in the same syringe unless indicated by product specific labeling. Separate needles and syringes should be used for each injection. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible. Adolescents and adults should be vaccinated while seated or lying down. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (CDC, 2011).
Store refrigerated at 2 � �C to 8 � �C (36 � �F to 46 � �F); do not freeze. The following stability information has also been reported: May be stored at room temperature for up to 7 days (Cohen, 2007).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension:
Prevnar � �: 2 mcg of each capsular saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 mcg of serotype 6B [bound to diphtheria CRM197 protein ~20 mcg] per 0.5 mL (0.5 mL) [contains aluminum, natural rubber/natural latex in packaging, and yeast]
Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification
Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
Monitor for syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).
>10%:
Central nervous system: Fever, irritability, drowsiness, restlessness
Dermatologic: Erythema
Gastrointestinal: Decreased appetite, vomiting, diarrhea
Local: Induration, tenderness, nodule
1% to 10%: Dermatologic: Rash
Postmarketing and/or case reports: Anaphylactic reaction, anaphylactoid reaction, angioneurotic edema, apnea, bronchospasm, crying, dyspnea, erythema multiforme, facial edema, febrile seizure, hypersensitivity reaction, injection site reaction (eg, dermatitis, lymphadenopathy, pruritus, urticaria), shock
Concerns related to adverse effects:
- Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1:1000) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use.
- Syncope: Syncope has been reported with use of injectable vaccines and may be accompanied by transient visual disturbances, weakness, or tonic-clonic movements. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs.
Disease-related concerns:
- Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Immunization should be delayed during the course of an acute severe febrile illness; may administer to patients with mild acute illness (with or without fever).
- Asplenia: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months of age with asplenia.
- Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration.
- Chronic illness: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months of age with chronic illness.
- HIV: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months of age with HIV infection.
- Pneumococcal infections: Not to be used to treat pneumococcal infections or to provide immunity against diphtheria.
- Sickle cell disease: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months of age with sickle cell disease.
Concurrent drug therapy issues:
- Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist.
Special populations:
- Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy including high dose corticosteroids); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immune competence may receive all age appropriate vaccines. Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months of age who are immunocompromised.
Dosage form specific issues:
- Latex: Packaging may contain natural latex rubber.
C
Reproduction studies have not been conducted. This product is indicated for use in infants and toddlers.
Promotes active immunization against invasive disease caused by S. pneumoniae capsular serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, all which are individually conjugated to CRM197 protein