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Patient Engagement
Important counseling points
Inform patients that 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.
The Immunization Action Coalition (IAC) recommends if localized reaction occurs, such as soreness, redness, itching, or swelling at the injection site, to apply a cold compress to the injection site. Consider giving an analgesic (pain reliever) or antipruritic (anti-itch) medication. These are general recommendations from IAC and have not been evaluated with SHINGRIX.2
Explain to patients that the efficacy of SHINGRIX was only studied in patients who received 2 doses of the vaccine. That is why it is important that your patients receive both doses of SHINGRIX.1
Topics to discuss with your patients
Inform patients of the potential benefits and risks of immunization with SHINGRIX.
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).1
Safety
In clinical trials with SHINGRIX, the majority of solicited reactions were mild to moderate (grade 1 or 2) and had a median duration of 2 to 3 days. Some grade 3 reactions were observed.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-70 and ZOE-50 trials from subjects randomized to receive 2 doses of SHINGRIX (N=7698 and 8250, respectively) or placebo (N=7713 and 8346, respectively). See study designs on Efficacy page for details.1,5
References:
- Prescribing Information for SHINGRIX.
- Immunization Action Coalition. Medical Management of Vaccine Reactions in Adult Patients. www.immunize.org/catg.d/p3082.pdf. Accessed November 1, 2017.
- 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.
- 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.
- Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096.
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
