DOSING AND ADMINISTRATION

 
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SHINGRIX should be refrigerated. DO NOT FREEZE:

Store both the antigen and adjuvant between
2º and 8ºC (36º and 46ºF) before reconstitution (discard if frozen).1

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SHINGRIX is supplied as an adjuvant and antigen for reconstitution: The antigen is to be reconstituted only with the accompanying adjuvant suspension. After reconstitution, SHINGRIX should be administered immediately or stored refrigerated between 2° and 8°C (36° and 46°F) and used within 6 hours. Discard reconstituted vaccine if not used within 6 hours. Do not freeze. Discard if the reconstituted vaccine has been frozen.1

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SHINGRIX is a recombinant vaccine for intramuscular injection only.1


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SHINGRIX is administered as a 2-dose series:

The second dose should be administered anytime between 2 and 6 months after the first dose to complete the 2-dose series as directed.1

 
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The CDC has issued guidance on the SHINGRIX dosing schedule2,3,†

  • Following the first dose of SHINGRIX, the second dose should be given 2-6 months later
  • If more than 6 months have elapsed since the first dose, administer the second dose as soon as possible. You should not restart the vaccine series
  • However:
    • The efficacy of alternative dosing regimens has not been evaluated
    • Data regarding the safety of alternative regimens are limited
    • Individuals might remain at risk for herpes zoster during a longer than recommended interval between doses 1 and 2

PRESCRIBING SHINGRIX

SHINGRIX Prescription from Doctor
 

  RECONSTITUTION VIDEO

  View reconstitution instructions for SHINGRIX.

In a phase 3 clinical study designed to help establish the dosing interval for SHINGRIX, all primary endpoints were met for dosing at a 0- and 6-month interval when compared to dosing at a 0- and 2-month interval. However, a co-primary endpoint (noninferiority) of the immune response was missed for dosing at a 0- and 12-month interval. (The upper limit of the 97.5% confidence interval was 1.53, above the predefined limit of <1.5.)4 GSK has not studied the safety or immune response of 3 doses of SHINGRIX in the indicated population (patients ≥50 years of age).1
CDC=Centers for Disease Control and Prevention.

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. Centers for Disease Control and Prevention. Frequently Asked Questions About Shingrix. https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/faqs.html. Updated August 22, 2018. Accessed September 11, 2018. 4. Lal H, Poder A, Campora L, et al. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: results of a phase III, randomized, open-label, multicenter study. Vaccine. 2018;36(1):148-154.

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1009726R0 September 2018