CLINICAL CORNER
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Clinical Corner
Brief Clinical Overview of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) Suspension for Intramuscular Injection Sylvia A. Thomas, PharmD, MS, BCPS, vice president, clinical pharmacy services, Innovatix
DRUG NAME Recombinant Zoster Vaccine (RZV), Adjuvanted, Suspension for Intramuscular Injection (Shingrix, GlaxoSmithKline)1 FDA-APPROVED INDICATION AND USAGE RZV was licensed by the U.S. Food and drug Administration (FDA) on October 20, 2017. It is indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older. RZV is not indicated for prevention of primary varicella infection (chickenpox) or for the treatment of shingles or postherpetic neuralgia.2, 3 PATHOPHYSIOLOGY AND MECHANISM OF ACTION Shingles is a localized, painful cutaneous eruption caused by reactivation of dormant varicella zoster virus (VZV). The incidence of shingles is one in three adults in the U.S., increasing with age from five cases per 1000 at age 50 to 11 cases per 1000 in those over 80. Complications from shingles, including postherpetic neuralgia (PHN), can be serious and long-lasting. With increasing age, there is a decline in VZV-specific immunity; studies show that RZV likely protects against zoster disease by boosting the VZV-specific immune response.4, 5 DOSAGE AND ADMINISTRATION RZV is supplied as a single-dose vial of lyophilized VZV glycoprotein E (gE) antigen component, which is reconstituted at the time of use with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of 34 |
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RZV contains 50 mcg of the recombinant gE antigen in each 0.5 mL dose. RZV does not contain preservatives.6 RZV is given by intramuscular injection in two doses (0.5 mL each) at month zero, followed by a second dose administered any time after two and up to six months.7 To prepare RZV for administration:
■■ Cleanse the two vial stoppers. ■■ Use a sterile syringe and needle to withdraw the adjuvant vial contents (vial one).
■■ Transfer the syringe contents into the gE vial (vial two). ■■ Shake the contents until powder is completely dissolved. ■■ Withdraw the 0.5 mL dose of the reconstituted suspension and administer intramuscularly.8
DOSING IN SPECIAL POPULATIONS Pregnancy: There are no human data to establish any vaccineassociated risks with RZV in pregnant women. Lactation: There are no human data to establish vaccineassociated risks with RZV in either a breast-fed infant or on milk production. The benefits of breastfeeding in the infant and potential adverse effects on the child must be considered along with the underlying maternal condition. Geriatric: No clinically meaningful differences in efficacy have been found among seniors and younger adults. Pediatric: Safety and efficacy have not been studied for individuals 18 or younger.9