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Shingrix

Generic Name: Zoster Vaccine Recombinant
Class: Vaccines

Medically reviewed on Nov 13, 2017

Introduction

Zoster vaccine recombinant is a non-live, recombinant virus vaccine containing lyophilized recombinant varicella zoster virus (vzv) glycoprotein E (gE).1

Uses for Shingrix

Zoster vaccine recombinant has the following uses:

Zoster vaccine recombinant is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.1

Zoster vaccine recombinant has the following limitations of use:

Zoster vaccine recombinant is not indicated for prevention of primary varicella infection (chickenpox).1

Shingrix Dosage and Administration

General

Zoster vaccine recombinant is available in the following dosage form(s) and strength(s):

Suspension for injection supplied as a single-dose vial of lyophilized varicella zoster virus glycoprotein E (gE) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of zoster vaccine recombinant is 0.5 mL.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage & Administration Section

For intramuscular administration only.1

Administer 2 doses (0.5 mL each) at 0 and 2 to 6 months.1

Cautions for Shingrix

Contraindications

History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of zoster vaccine recombinant.1

Warnings/Precautions

Preventing and Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the 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 of zoster vaccine recombinant.1

Specific Populations

Pregnancy

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no available human data to establish whether there is vaccine-associated risk with zoster vaccine recombinant in pregnant women. A reproductive and developmental toxicity study was performed in female rats administered zoster vaccine recombinant or the AS01B adjuvant alone prior to mating, during gestation, and during lactation. The total dose was 0.2 mL on each occasion (a single human dose of zoster vaccine recombinant is 0.5 mL). This study revealed no adverse effects on fetal or pre-weaning development due to zoster vaccine recombinant.1

In a reproductive and developmental toxicity study, female rats were administered zoster vaccine recombinant or the AS01B adjuvant alone by intramuscular injection 28 and 14 days prior to mating, on gestation Days 3, 8, 11, and 15, and on lactation Day 7. The total dose was 0.2 mL on each occasion (a single human dose of zoster vaccine recombinant is 0.5 mL). No adverse effects on pre-weaning development up to post-natal Day 25 were observed. There were no vaccine-related fetal malformations or variations.1

Lactation

It is not known whether zoster vaccine recombinant is excreted in human milk. Data are not available to assess the effects of zoster vaccine recombinant on the breastfed infant or on milk production/excretion.1

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zoster vaccine recombinant and any potential adverse effects on the breastfed child from zoster vaccine recombinant or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.1

Pediatric Use

Safety and effectiveness in individuals younger than 18 years have not been established. Zoster vaccine recombinant is not indicated for prevention of primary varicella infection (chickenpox).1

Geriatric Use

Of the total number of subjects who received at least 1 dose of zoster vaccine recombinant in the 2 efficacy trials (n = 14,645), 2,243 (15.3%) were aged 60 to 69 years, 6,837 (46.7%) were aged 70 to 79 years, and 1,921 (13.1%) were 80 years and older. There were no clinically meaningful differences in efficacy across the age groups or between these subjects and younger subjects.1

The frequencies of solicited local and general adverse events in subjects aged 70 years and older were lower than in younger adults (aged 50 through 69 years).1

Common Adverse Effects

Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%).1

Solicited general adverse reactions in subjects aged 50 years and older were myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%).1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

The risk of developing herpes zoster (HZ) increases with age and appears to be related to a decline in VZV-specific immunity. Zoster vaccine recombinant was shown to boost VZV-specific immune response, which is thought to be the mechanism by which it protects against zoster disease.1

Advice to Patients

Patient Counseling Information

Inform patients of the potential benefits and risks of immunization with zoster vaccine recombinant and of the importance of completing the 2-dose immunization series according to the schedule.1

Inform patients about the potential for adverse reactions that have been temporally associated with administration of zoster vaccine recombinant.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Zoster Vaccine Recombinant, Adjuvanted

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Kit, for IM use only

For injectable suspension, for IM use, 50 mcg of recombinant varicella zoster virus glycoprotein E per 0.5 mL

Injectable suspension, for IM use, AS01B adjuvant containing 50 mcg of 3-O-desacyl-4′-monophosphoryl lipid A (MPL) and 50 mcg of Quillaja saponaria Molina (QS21) per 0.5 mL

Shingrix

GlaxoSmithKline

AHFS Drug Information. © Copyright 2018, Selected Revisions November 13, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. GlaxoSmithKline. Shingrix (Zoster vaccine recombinant, adjuvanted) prescribing information. 2017 Oct. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0280849d-5c78-4a9d-8941-4eab429f6bd8

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