Clinical Information
Gen. Code and Des.
77837 varicella-zoster gE/AS01B/PF INTRAMUSC KIT 50 MCG/0.5
GCN and Des.
43989 varicella-zoster gE/AS01B/PF INTRAMUSC KIT 50 MCG/0.5
Strength
Dose Form
KIT
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
17370 varicella-zoster virus glycoprotein E, recombinant
17371 vaccine adjuvant system, AS01B liposomal
9870 preservative free
Inactive Ingredients
2551 polysorbates 9005645
2598 sucrose 57501
For: Herpes Zoster -- Prophylaxis
Shingrix (zoster vaccine recombinant, adjuvanted) is a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and older. Clinical Information
Gen. Code and Des.
77837 varicella-zoster gE/AS01B/PF INTRAMUSC KIT 50 MCG/0.5
Strength
50 mcg/0.5 mL
Dose Form
KIT
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
17370 varicella-zoster virus glycoprotein E, recombinant
17371 vaccine adjuvant system, AS01B liposomal
9870 preservative free
Inactive Ingredients
2598 sucrose 57501
9865 polysorbate 80 9005656
These highlights do not include all the information needed to use SHINGRIX safely and effectively. See full prescribing information for SHINGRIX.
SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted)
Suspension for Intramuscular Injection
Initial U.S. Approval: 2017
RECENT MAJOR CHANGES
Dosage and Administration, Reconstitution (2.1)
09/2018
INDICATIONS AND USAGE
SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.
Limitations of Use (1):
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SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).
DOSAGE AND ADMINISTRATION
For intramuscular administration only.
Administer 2 doses (0.5 mL each) at 0 and 2 to 6 months. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
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 SHINGRIX is 0.5 mL. (3)
CONTRAINDICATIONS
History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX. (4)
ADVERSE REACTIONS
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Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%). ( 6.1)
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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%). ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2018
