HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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):
•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
•Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%). ( 6.1)
•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%). ( 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: 10/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Reconstitution
2.2 Administration Instructions
2.3 Dose and Schedule
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Preventing and Managing Allergic Vaccine Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Concomitant Vaccine Administration
7.2 Immunosuppressive Therapies
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Efficacy in Subjects 50 Years and Older
14.2 Efficacy in Subjects 70 Years and Older
14.3 Pooled Efficacy Analyses across Studies 1 and 2
14.4 Immunological eva luation to Support Dosing Schedule
14.5 Concomitant Administration with Influenza Vaccine
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 Storage before Reconstitution
16.2 Storage after Reconstitution
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.
Limitations of Use:
•SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).
2 DOSAGE AND ADMINISTRATION
For intramuscular injection only.
2.1 Reconstitution
Prepare SHINGRIX by reconstituting