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Vaccine Info Statement

Medical Inquiries

Questions About SHINGRIX?
Call: 1 (800) 772-9292
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Patient Counseling

What to Expect

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.

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.

Topics to Discuss with Your Patients

Inform patients of the potential benefits and risks of immunization with SHINGRIX.
 

Shingles Disease Risk

99% 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 with age, especially after age 50.2,3

 

Efficacy

SHINGRIX delivered >90% efficacy against shingles, regardless of age, in patients ≥50 years of age.1,*


 

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, the most common solicited local and general adverse events 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

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Reconstitution &
Administration

See how you and your staff can reconstitute SHINGRIX in four steps. Vaccinate confidently.

Video Center

Watch a range of informative videos including highlights of pivotal trials, MOA and reconstitution videos.

Resources

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. 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. 3. 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. 

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

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