zoster vaccine recombinant (Rx)

Brand and Other Names:Shingrix
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Dosing & Uses

AdultPediatric

Dosage Forms and Strengths

injection, single-dose IM suspension

  • 0.5mL

Shingles Prophylaxis

Indicated for prevention of herpes zoster (shingles) in adults ≥50 years

<50 years: Safety and efficacy has not been established

≥50 years: 0.5 mL IM x2 doses administered 2-6 months apart

ACIP recommendation

  • Administer 2 doses of recombinant zoster vaccine (RZV) (Shingrix) 2-6 months apart to adults aged ≥50 years regardless of past episode of herpes zoster or receipt of zoster vaccine live (ZVL) (Zostavax)
  • Administer 2 doses of RZV 2-6 months apart to adults who previously received ZVL at least 2 months after ZVL
  • For adults aged ≥60 years, administer either RZV or ZVL (RZV is preferred)
  • Current immunization schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

Dosing Considerations

Limitation of use

  • Shingrix is not indicated for prevention of primary varicella infection (chickenpox)

Safety and effectiveness have not been established

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Interactions

Interaction Checker

and zoster vaccine recombinant

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
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            Adverse Effects

            >10%

            50-59 years

            • Pain (88.4%)
            • Fatigue (57%)
            • Myalgia (56.9%)
            • Headache (50.6%)
            • Redness (38.7%)
            • Shivering (35.8%)
            • Swelling (30.5%)
            • Fever (27.8%)
            • Gastrointestinal [GI] symptoms (24.3%)
            • Pain, grade 3 (10.3%)
            • Redness >100 mm (2.8%)
            • Swelling >100 mm (1.1%)

            60-69 years

            • Pain (82.8%)
            • Myalgia (49%)
            • Fatigue (45.7%)
            • Headache (39.6%)
            • Redness (38.4%)
            • Shivering (30.3%)
            • Swelling (26.5%)
            • Fever (23.9%)
            • GI symptoms (16.7%)

            70-79 years

            • Pain (69.2%)
            • Myalgia (35.1%)
            • Fatigue (36.6%)
            • Redness (37.7%)
            • Swelling (23%)
            • Headache (29%)
            • Shivering (19.5%)
            • Fever (14.3%)
            • GI symptoms (13.5%)

            1-10%

            50-59 years

            • Myalgia, grade 3 (8.9%)
            • Fatigue, grade 3 (8.5%)
            • Shivering, grade 3 (6.8%)
            • Headache (6%)
            • Redness >100 mm (2.8%)
            • GI symptoms, grade 3 (2.1%)
            • Swelling >100 mm (1.1%)

            60-69 years

            • Pain, grade 3 (6.9%)
            • Shivering, grade 3 (4.5%)
            • Redness, >100 mm (2.6%)
            • Swelling (1%)

            70-79 years

            • Pain, grade 3 (4%)
            • Fatigue, grade 3 (3.5%)
            • Redness >100 mm (3.1%)
            • Myalgia, grade 3 (2.8%)
            • Shivering, grade 3 (2.2%)
            • Headache, grade 3 (1.5%)
            • Swelling >100 mm (1.3%)
            • GI symptoms, grade 3 (1.2%)

            <1%

            50-59 years

            • Fever, grade 3 (0.4%)

            60-69 years

            • GI symptoms, grade 3 (0.9%)
            • Pain, grade 3 (0.5%)
            • Fever, grade 3 (0.5%)

            70-79 years

            • Fever, grade 3 (0.1%)

            Postmarketing Reports

            General disorders and administration site conditions: Decreased mobility of injected arm which may persist for >1 week

            Immune system disorders: Hypersensitivity reactions, including angioedema, rash, and urticaria

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            Warnings

            Contraindications

            Hypersensitivity (eg, anaphylaxis) to any component of the vaccine

            Cautions

            Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions; appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration (see Contraindications)

            Drug interactions overview

            • Use caution with concomitant use of vaccine administration of zoster recombinant with inactivated influenza
            • Immunosuppressive therapies may reduce effectiveness of the zoster vaccine
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            Pregnancy

            Pregnancy

            There is no available human data to establish vaccine-associated risks with the vaccine in pregnant women

            Lactation

            Unknown whether zoster vaccine is excreted in human milk

            Data are not available to assess effects of the zoster vaccine on the breastfed infant or on milk production/excretion

            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

            Conveys active immunity by stimulating production of endogenously produced antibodies

            Vaccine boosts VZV-specific immune response, which is thought to be the mechanism by which it protects against zoster disease

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            Administration

            IM Preparation

            Reconstitute lyophilized varicella zoster virus glycoprotein E (gE) antigen with the AS01B adjuvant suspension

            Reconstituted vaccine should be an opalescent, colorless to pale brownish liquid

            Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit

            IM administration

            IM use only

            Withdraw 0.5 mL from reconstituted vial

            Administer IM immediately

            Store in refrigerator at 2-8°C (36-46°F) for up to 6 hr if unable to administer immediately

            Preferred site for IM injection is the deltoid region of the upper arm

            Storage

            Before reconstitution

            • Vials of adjuvant suspension and antigen component
            • Refrigerate at 2-8°C (36-46°F)
            • Protect from light
            • Do not freeze; discard if adjuvant suspension or antigen component have been frozen

            Reconstituted vials

            • If not administered immediately, refrigerate at 2-8°C (36-46°F) for up to 6 hr
            • Discard reconstituted vaccine if not used within 6 hr
            • Do not freeze; discard if the vaccine has been frozen
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            Images

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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 quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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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.