pneumococcal vaccine 13-valent (Rx) - Prevnar 13

 
 
 

Adult Dosing & Uses

Dosing Forms & Strengths

suspension for IM injection

  • 0.5mL/syringe

Immunization

Indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; there have been no controlled trials in adults demonstrating a decrease in pneumococcal pneumonia or invasive disease after vaccination with Prevnar 13

<50 years: Not indicated, use pneumococcal polyvalent vaccine (ie, 23-valent)

50 years or older: 0.5 mL IM as a single dose

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Pediatric Dosing & Uses

Dosing Forms & Strengths

suspension for IM injection

  • 0.5mL/syringe

Immunization

Streptococcus pneumoniae: Indicated for active immunization to prevent invasive disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F

Otitis media: Indicated for prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F

6 weeks through 5 years: Series of 4 doses (0.5 mL/dose) to be administered IM at ages 2, 4, 6 and 12-15 months

May administer 1st dose as early as age 6 weeks

Dosing interval between 1st and 2nd doses, and 2nd and 3rd doses is 4-8 weeks

Administer 4th dose at approximately age 12-15 months, and at least 2 months after 3rd dose

Administer IM in anterolateral aspect of thigh for infants or deltoid muscle of upper arm in toddlers or young children

Catch-up Schedule

  • If beyond age of routine infant schedule (7 months or older) and have not received Prevnar or Prevnar 13, the following catch-up schedule applies
  • Initiated at age 7-11 months: 3 doses; administer 2nd dose at least 4 weeks after 1st dose; administer 3rd dose after 1st birthday (and at least 2 months after 2nd dose)
  • Initiated at age 12-23 months: 2 doses administered at least 2 months apart
  • Initiated at 24 months through 5 years of age: Administer 1 dose

Schedule if Previously Vaccinated with Heptavalent Vaccine

  • Children who have received 1 or more doses of pneumococcal heptavalent vaccine (Prevnar): Complete 4-dose immunization series with Prevnar 13
  • Children aged 15 months through 5 years: If already received 4 doses of Prevnar, may receive 1 dose of Prevnar 13 to elicit immune responses to the 6 additional serotypes
  • The immune responses induced by the 1-dose Prevnar 13 transition schedule may result in lower antibody concentrations for the 6 additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared with antibody concentrations following 4 doses of Prevnar 13 (clinical relevance of these lower antibody responses is unknown)
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Drug Interactions

Interaction Checker

pneumococcal vaccine 13-valent and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Fever

            Irritability

            Altered sleep duration (increased or decreased)

            Decreased appetite

            Redness, swelling, and tenderness at injection site

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            Contraindications & Cautions

            Contraindications

            Documented hypersensitivity to any component or diphtheria toxoid

            Cautions

            Apnea observed following IM vaccination in some premature infants

            IM use only, do not administer IV under any circumstances; take special care to prevent injection into or near a blood vessel or nerve

            Does not replace use of 23-valent pneumococcal polysaccharide vaccination in children >24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immunocompromised

            Because of IM injection, caution in coagulation disorders

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            View Category Definitions

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: N/A

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Elicits antibodies in response to antigenic stimulation

            Capsular polysaccharide vaccine against 13 strains of pneumococci, conjugated to nontoxic diphtheria protein

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            IV & IM Information

            Incompatibilities

            Syringe: Do not mix with over vaccines or products

            Preparation

            Shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container

            Do not use if it cannot be resuspended

            Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration

            This product should not be used if particulate matter or discoloration is found

            Storage

            Store refrigerated at 2-8 degrees C (36-46 degrees F)

            Do not freeze; discard if vaccine has been frozen

            Vial stopper, tip cap, and rubber plunger of prefilled syringe do not contain latex

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            Pricing & Images

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