Pneumococcal 7-Valent Conjugate Vaccine

Trade Names:
Prevnar
- Injection, suspension 2 mcg each of 6 polysaccharide isolates, and 4 mcg of serotype 6B per 0.5 mL dose

Pharmacology

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Induces antibodies against serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) of Streptococcus pneumoniae , which are directly conjugated to the protein carrier CRM ₁₉₇ to form glycoconjugate.

Indications and Usage

Active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine; active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine.

Contraindications

Hypersensitivity to any component of the vaccine, including diphtheria toxoid.

Dosage and Administration

IM 3 doses of 0.5 mL each, at approximately 2-mo intervals, followed by a fourth dose of 0.5 mL at 12 to 15 mo of age. Usually the first dose is at 2 mo of age; however, it can be given as young as 6 wk of age. The recommended dosing interval is 4 to 8 wk. Administer the fourth dose at least 2 mo after the third dose.

IM 1 dose of 0.5 mL.

IM 2 doses of 0.5 mL at least 2 mo apart.

IM 3 doses of 0.5 mL, administer 2 doses at least 4 wk apart and the third dose after the 1-yr birthday. Administer the third dose at least 2 mo after the second dose.

General Advice

• Preferred sites of IM injection are the anterolateral aspect of the thigh in infants or deltoid muscle of the upper arm in toddlers and young children. Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel.
• For IM injection only. Not for IV, subcutaneous, or intradermal administration.
• Can be administered simultaneously with DTap-HbOC or IPV, hepatitis B, MMR, and varicella vaccine.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• Shake vial vigorously immediately prior to use to obtain a uniform suspension.
• Examine vial after shaking. Suspension should be homogeneous and white. Do not use if particulate matter or discoloration is noted or if vaccine cannot be resuspended.
• Administer immediately after drawing vaccine into syringe.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration and name and title of person administering vaccine.
• Use 1 dose per vial; do not re-enter the vial. Discard unused portion.
• Take precautions to avoid injection into or near a blood vessel or nerve.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

Because bleeding may occur following IM injection, use with caution.

Children may not respond optimally to active immunization.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Irritability (59%); fussiness (54%); drowsiness (41%); decreased appetite (30%); restless sleep (25%).

Dermatologic

Erythema (48%); urticarial rash (1%); angioneurotic edema, erythema multiforme (postmarketing).

GI

Vomiting (17%); diarrhea (12%).

Hematologic-Lymphatic

Lymphadenopathy localized to injection site (postmarketing).

Hypersensitivity

Hypersensitivity reaction including anaphylactic/anaphylactoid reaction (including shock), bronchospasm, dyspnea, face edema (postmarketing).

Local

Tenderness (82%); induration (48%); injection-site dermatitis, pruritus, urticaria (postmarketing).

Miscellaneous

Interference with limb movement (39%); fever (37%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 6 wk of age or after the tenth birthday.

Elderly

Not recommended for use in adult population.

Efficacy

Will not protect against S. pneumoniae disease other than that caused by the 7 serotypes included in the vaccine.

Fever/Seizures

Fever and, rarely, febrile seizures have been reported in children. For children at higher risk of seizures than the general population, appropriate antipyretics may be given around the time of vaccination, to reduce the possibility of postvaccination fever.

Immunocompromised patients

Pneumococcal 7-valent conjugate vaccine does not replace the 23-valent pneumococcal polysaccharide vaccination in children 24 mo of age and older with sickle cell disease, asplenia, HIV infection, or chronic illness, or those who are immunocompromised.

Latex sensitivity

Use with caution because packaging contains dry natural rubber.

Overdosage

Symptoms

Most individuals experiencing overdosage were asymptomatic.

Patient Information

• Advise parent or guardian that vaccine provides protection against the 7 most common and serious pneumococcal infections in infants and toddlers but does not provide protection from other causes of bacterial infection.
• Review immunization schedule and advise parent or guardian that entire series must be completed to provide maximum benefit.
• Provide parent or guardian with immunization history record.
• Advise parent or guardian to use OTC analgesics (eg, acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site.
• Advise parent or guardian to notify health care provider if bothersome side effects last more than 24 h.

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