pneumococcal vaccine 20-valent (Rx)

Brand and Other Names:Prevnar 20
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, IM suspension

  • 0.5mL single-dose prefilled syringe

Streptococcus pneumoniae Immunization

Pneumococcal vaccine 13-valent (PCV13) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F

Current CDC immunization schedules

Dosing Considerations

Contains all serotypes in Prevnar 13 plus 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) responsible for 40% pf pneumococcal disease cases and deaths in the United States

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and pneumococcal vaccine 20-valent

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Aged 18-59 years

            • Pain at injection site (>70%)
            • Muscle pain (>50%)
            • Fatigue (>40%)
            • Headache (>30%)
            • Arthralgia (>10%)
            • Injection site swelling (>10%)

            Aged ≥60 years

            • Pain at injection site (>50%)
            • Muscle pain (>30%)
            • Fatigue (>30%)
            • Headache (>20%)
            • Arthralgia (>10%)

            Postmarketing Reports

            Based on experience with 13-valent pneumococcal vaccine

            Immune system disorders: Anaphylactic/anaphylactoid reaction, including shock

            Skin and subcutaneous tissue disorders: Angioneurotic edema, erythema multiforme

            Blood and lymphatic system disorders: Lymphadenopathy localized to injection site region

            General disorders and administration site conditions: Vaccination-site dermatitis, vaccination-site pruritus, vaccination-site urticaria

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            Warnings

            Contraindications

            Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or to diphtheria toxoid

            Cautions

            Administer in medically supervised setting with treatments to manage acute allergic reactions

            Safety and immunogenicity data are not available for individuals in immunocompromised groups; based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses; consider vaccination on an individual basis

            Drug interaction overview

            • Receipt of the 23-valent pneumococcal vaccine 1-5 years prior resulted in diminished immune responses measured by opsonophagocytic activity (OPA) assay
            • Individuals with impaired immune responsiveness owing to immunosuppressive therapy (eg, irradiation, corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant females; data are insufficient to assess vaccine-associated risks in pregnancy

            Animal studies

            • Female rabbits were administered the vaccine IM twice prior to mating (17 days and 4 days prior to mating) and twice during gestation (Gestation Days 10 and 24) with 0.5 mL/rabbit/occasion (a single human dose)
            • No adverse effects on preweaning development observed
            • There were no vaccine-related fetal malformations or variations

            Lactation

            Data are not available to assess effects on breastfed infants or on milk production/excretion

            Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for vaccine and any potential adverse effects on breastfed child from vaccine or from underlying maternal condition; for preventive vaccines, the underlying maternal condition is susceptibility to disease as prevented by vaccine

            Pregnancy Categories

            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

            Protection against pneumococcal disease is conferred mainly by opsonophagocytic killing of S pneumoniae by generated antibodies

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            Administration

            Incompatibilities

            Do not mix with other vaccines/products in same syringe

            IM Preparation

            Step 1: Hold prefilled syringe horizontally between thumb and forefinger and shake vigorously until vaccine is a homogeneous white suspension; do not use if unable to resuspended

            Step 2: Visually inspect for large particulate matter and discoloration; do not use if observed; if vaccine is not a homogeneous suspension, repeat steps

            Step 3: Remove the syringe cap by slowly turning cap counterclockwise while holding the Luer lock adapter; avoid pressing syringe plunger rod while removing syringe cap

            Step 4: Attach sterile needle for IM administration

            IM Administration

            For IM injection only

            Storage

            Shipping: May arrive at temperatures between 2-25ºC (36-77ºF)

            Upon receipt, refrigerate at 2-8ºC (36-46ºF)

            Store syringes horizontally in refrigerator to minimize resuspension time

            Do not freeze; discard if frozen

            Administer as soon as possible after removed from refrigeration

            Can be administered provided total (cumulative multiple excursions) time out of refrigeration (at temperatures between 8-25ºC) does not exceed 96 hr; cumulative multiple excursions between 0-2ºC are also permitted as long as total time does not exceed 72 hr; these are not, however, recommendations for storage

            Tip cap and plunger stopper do contain natural rubber latex

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.