SHINGRIX: LEARN HOW TO IDENTIFY PATIENTS

 

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

The CDC states SHINGRIX is2:

Checklist Icon Recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged ≥50 years
Checklist Icon Recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received zoster vaccine live (ZVL)
Checklist Icon Preferred over ZVL for the prevention of herpes zoster and related complications

Please see Important Considerations below.

 

2018 CDC Recommendations: Important Considerations Related to Alternate Dosing, Concomitant Use, Patients Previously Vaccinated With ZVL, and Persons With a Prior History of Herpes Zoster

 

Alternate Dosing

This article contains dosing schedule information that is inconsistent with the label. According to the Prescribing Information for SHINGRIX, 2 doses (0.5 mL each) should be administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.3

 

Concomitant Use

SHINGRIX was administered concomitantly with FLUARIX QUADRIVALENT (Influenza Vaccine) in an open-label clinical study of subjects 50 years and older (N=828). There was no evidence of interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine. Evaluation of coadministration of SHINGRIX with other vaccines is ongoing.3

 

Patients Previously Vaccinated With ZVL

  • There are limited data on vaccination with SHINGRIX in patients previously vaccinated with ZVL compared to those not previously vaccinated with ZVL3
    • —In a phase 3 study, humoral immunogenicity was non-inferior among subjects previously vaccinated at least 5 years earlier with ZVL
    • —No apparent safety differences were observed between study groups within 30 days post-dose 2 of SHINGRIX
    • —Solicited local and systemic symptoms were similar between study groups
  • The levels of antibodies and immune cells that correlate with protection against shingles have not been clearly defined

 

Persons With a Prior History of Herpes Zoster

The pivotal clinical trials for SHINGRIX excluded patients with a prior history of herpes zoster. Studies of the safety and immunogenicity of SHINGRIX in patients with a prior history of herpes zoster are ongoing.

 

There are no head-to-head clinical trials comparing the efficacy and safety of SHINGRIX to ZVL

CDC=Centers for Disease Control and Prevention.

When a person 50 years of age or older comes in for a flu shot, ask if they’ve been vaccinated against shingles. For details on administering SHINGRIX, please refer to the Administration Tips page of this website.

Indication

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

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

  • SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
  • 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 of SHINGRIX
  • Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%)
  • 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%)
  • SHINGRIX was not studied in pregnant or lactating women, and it is unknown if it is excreted in human milk. Therefore, it cannot be established whether there is vaccine-associated risk with SHINGRIX in pregnant women or if there are effects on breastfed infants or milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

References: 1. Prescribing Information for SHINGRIX. 2. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR. 2018;67(3):103-108. 3. Grupping K, Campora L, Douha M, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine. J Infect Dis. 2017;216(11):1343-1351.

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1004182R0 April 2018