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Patient Counseling
What to Expect
Inform patients they may experience adverse reactions after receiving SHINGRIX. In clinical trials, the most common adverse reactions observed were pain, redness, and swelling at the injection site, myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms.1
Because each patient’s clinical situation is unique, GSK has no specific recommendations on adverse reaction management. GSK recommends healthcare professionals use their clinical judgment. Specific management of adverse reactions was not studied in the clinical trials of SHINGRIX.
2-Dose Series
Explain to patients that the efficacy results of SHINGRIX were demonstrated in clinical trials when administered as a 2-dose series. That is why it is important that your patients receive both doses of SHINGRIX.1
To help ensure series completion, encourage your patients to schedule their second dose for anytime between 2 and 6 months after their first dose.
- *In an open-label clinical study, subjects 50 years and older received 1 dose each of SHINGRIX and FLUARIX QUADRIVALENT (Influenza Vaccine) (QIV) at Month 0 and 1 dose of SHINGRIX at Month 2 (n=413), or 1 dose of QIV at Month 0 and 1 dose of SHINGRIX at Months 2 and 4 (n=415). There was no evidence for interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine.1
- †SHINGRIX has not been studied with other influenza vaccines, including those that have an adjuvant component.
Topics to Discuss with Your Patients
Inform patients of the potential benefits and risks of immunization with SHINGRIX.
Shingles Disease Risk
99.5% of people ≥50 years of age are at risk for developing shingles, and 1 out of 3 people will get shingles in their lifetime. The risk increases sharply after age 50.2-5
Indication
SHINGRIX is indicated for prevention of shingles in adults aged 50 years and older.
SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).
Safety
In clinical trials with SHINGRIX, the most common solicited local and general adverse reactions were pain, redness, and swelling at the injection site, myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms.1 Please see the Safety Profile section for more information.
- ‡Data from the phase 3 ZOE-50 (≥50 years of age) trial and pooled data in individuals ≥70 years of age from the phase 3 ZOE-50 and ZOE-70 trials from subjects who received 2 doses of SHINGRIX (N=7344 and 8250, respectively) or placebo (N=7415 and 8346, respectively) and did not develop a confirmed case of herpes zoster within 1 month after the second dose. See study designs on Efficacy page for more details.1
You may also be interested in:
Watch a range of informative videos including highlights of pivotal trials, MOA and reconstitution videos.
Our library of resources includes handouts for patients, plus pocket and reference guides for you and your staff.
References: 1. Prescribing Information for SHINGRIX. 2. Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014;4(6):e004833. 3. Kilgore PE, Kruszon-Moran D, Seward JF, et al. Varicella in Americans from NHANES III: implications for control through routine immunization. J Med Virol. 2003;70(suppl 1):S111-S118. 4. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR-5):1-30. 5. Shingles (Herpes Zoster): Clinical Overview. Centers for Disease Control and Prevention website. https://www.cdc.gov/shingles/hcp/clinical-overview.html. Reviewed August 14, 2019. Accessed October 15, 2020.
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