Important Safety Information Prescribing Information
Important Safety Information Prescribing Information
“I have seen firsthand how painful shingles can be. It's important to educate appropriate patients about factors that can increase the risk of developing shingles and make a strong recommendation for SHINGRIX.
KOL Headshot

David Rose, MD*

Allergy and Immunology Specialist

Fort Walton Beach, FL

“I have seen firsthand how painful shingles can be. It's important to educate appropriate patients about factors that can increase the risk of developing shingles and make a strong recommendation for SHINGRIX.

Are your patients at increased risk of shingles? Learn about important risk factors for shingles.

*Dr David Rose is compensated by GSK for participation in this program.
Age, Comorbidities,
and Shingles

Review important risk
factors for shingles

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Why SHINGRIX?

Recommend SHINGRIX to
appropriate patients

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SHINGRIX Dosing Schedule

Find out more about the
2-dose series

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ARE YOUR PATIENTS AT INCREASED RISK?

AGE AND ADDITIONAL RISK FACTORS FOR SHINGLES

Patients ≥50 years old are at increased risk of shingles1

  • 99.5% of people ≥50 years old are infected with the varicella zoster virus (VZV)1,2
  • In 1 in 3 people, dormant VZV reactivates in their lifetime and causes shingles—a blistering rash that can be excruciatingly painful, typically lasting 7 to 10 days1,3
  • The risk of developing shingles sharply increases starting at 50 years old—and continues to increase with age1
Additional Risk Factor Graphic Additional Risk Factor Graphic

Data from a meta-analysis assessing risk factors for HZ. The analysis included a total study population of 198,751,846 individuals, with 3,768,691 HZ cases across 88 studies (68 cohort and 20 case-control studies) from 1966 to 2019. The populations in these studies ranged from people aged 3 months to 104 years old. Eighteen risk factors were identified in the meta-analysis, note not all are presented here. Limitations included the following: most studies were observational and had a higher likelihood of bias; the majority of studies used administrative data, which are subject to miscoding, errors, and can vary between practitioners; finally, heterogeneity was high across studies. This list is not exhaustive and may not present all conditions associated with an increased risk of HZ.4

Cardiovascular conditions included in each individual study in the meta-analysis varied by study and included heart disease, heart failure, hypertension, hyperlipidemia, stroke, atrial fibrillation/flutter, and other cardiovascular disease.4

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

SHINGLES COULD HAVE MORE OF AN IMPACT THAN YOU REALIZE

In studies, ~9 in 10 patients with shingles experienced clinically significant pain.6,‡

  • Patients were asked to rate their “worst pain” on a scale of 0 to 10 using the ZBPI. Clinically significant pain was defined as a score of 3 or greater6

Shingles can lead to serious and long-lasting complications.1

  • PHN occurs in 10%-18% of individuals with shingles. This nerve pain lasts for months (≥90 days) and, in some cases, years1

SHINGRIX is not indicated for the prevention of PHN or other herpes zoster-related complications.5

Comorbidities Graphic Comorbidities Graphic

Data from a post hoc analysis of 2 phase 3 trials of participants in the placebo groups with a confirmed case of herpes zoster in adults ≥50 years old (n=280) and ≥70 years old (n=240).6

UK observational study using Clinical Practice Research Datalink. Among 119,413 patients with shingles (median age 61 years) diagnosed between January 2000 and December 2011, 5.8% developed PHN (defined as pain persisting for ≥90 days following shingles diagnosis). Odds ratios for PHN were modeled for select comorbidities and adjusted for age, sex, socioeconomic status, HIV, leukemia, lymphoma, myeloma, hematopoietic stem cell transplantation, other unspecified cellular immune deficiencies, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, COPD, asthma, CKD, depression, personality disorder, diabetes, recent cancer diagnosis, smoking, BMI category, site of zoster, antivirals, and immunosuppressive therapies.7

VACCINATION STARTS WITH A STRONG RECOMMENDATION

Your strong recommendation can positively influence your patient’s vaccination decision.8

Educate Patients on Shingles Graphic Make the Risk Relatable Graphic Recommend SHINGRIX Graphic

SHINGRIX is not indicated for the prevention of herpes zoster-related complications.5

See the strong recommendation discussion guide here.

aOR=adjusted odds ratio; BMI=body mass index; CI=confidence interval; CKD=chronic kidney disease; COPD=chronic obstructive pulmonary disease; HIV=human immunodeficiency virus; HZ=herpes zoster; PHN=postherpetic neuralgia; RR=relative risk; ZBPI=Zoster Brief Pain Inventory.

References: 1. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30. 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. Shingles Symptoms and Complications. Centers for Disease Control and Prevention. April 19, 2024. Accessed March 18, 2024. https://www.cdc.gov/shingles/signs-symptoms/index.html 4. Marra F, Parhar K, Huang B, Vadlamudi N. Risk factors for herpes zoster infection: A meta-analysis. Open Forum Infect Dis. 2020;7(1):ofaa005. 5. Prescribing Information for SHINGRIX. 6. Curran D, Matthews S, Boutry C, Lecrenier N, Cunningham AL, Schmader K. Natural history of herpes zoster in the placebo groups of three randomized phase III clinical trials. Infect Dis Ther. 2022;11(6):2265-2277. 7. Forbes HJ, Bhaskaran K, Thomas SL, et al. Quantification of risk factors for postherpetic neuralgia in herpes zoster patients: A cohort study. Neurology. 2016;87(1):94-102. 8. Adult immunization standards. Centers for Disease Control and Prevention. Accessed March 15, 2025. https://www.cdc.gov/vaccines-adults/hcp/imz-standards/index.html

Shingles Rash on Back Shingles Rash on Face Shingles Rash on Back Shingles Rash on Face

Patient portrayals.

KNOW THE RISK

  • Shingles is a painful blistering rash caused by the reactivation of the varicella zoster virus (VZV)1
  • 99.5% of people ≥50 years of age are infected with VZV1,2
  • 1 in 3 people will develop shingles in their lifetime1

PROVEN SHINGLES PROTECTION

SHINGRIX delivered:

>90%

EFFICACY AGAINST SHINGLES

regardless of age in those 50 years and older3

EFFICACY BREAKDOWN3

Age 50 through 59*

96.6%

(95% Cl: 89.6, 99.3)

Shingles cases (n)
in SHINGRIX group (N)

3 (3492)

Shingles cases (n)
in placebo group (N)

87 (3525)

Age 60 through 69*

97.4%

(95% Cl: 90.1, 99.7)

Shingles cases (n)
in SHINGRIX group (N)

2 (2141)

Shingles cases (n)
in placebo group (N)

75 (2166)

Age 70 through 79†

91.3%

(95% Cl: 86.0, 94.9)

Shingles cases (n)
in SHINGRIX group (N)

19 (6468)

Shingles cases (n)
in placebo group (N)

216 (6554)

Age ≥80†

91.4%

(95% CI: 80.2, 96.9)

Shingles cases (n)
in SHINGRIX group (N)

6 (1782)

Shingles cases (n)
in placebo group (N)

68 (1792)

Data from the ZOE-50 phase 3 trial.3

Pooled data from ZOE-50 and ZOE-70 phase 3 trials.3

CI=confidence interval.

SAFETY PROFILE

Solicited local adverse reactions within 7 days of vaccination (ZOE-50/-70)3
  50 through 59 years old 60 through 69 years old ≥70 years old
Local adverse
reactions		 SHINGRIX %
n=1315		 Placebo %
n=1312		 SHINGRIX %
n=1311		 Placebo %
n=1305		 SHINGRIX %
n=2258		 Placebo %
n=2263
Pain 88 14 83 11 69 9
Pain, Grade 3* 10 1 7 1 4 0.2
Redness 39 1 38 2 38 1
Redness, >100 mm 3 0 3 0 3 0
Swelling 31 1 27 1 23 1
Swelling, >100 mm 1 0 1 0 1 0
Solicited local adverse reactions within 7 days of vaccination (ZOE-50/-70)3
50 through 59 years old
Local adverse
reactions		 SHINGRIX %
n=1315		 Placebo %
n=1312
Pain 88 14
Pain, Grade 3* 10 1
Redness 39 1
Redness, >100 mm 3 0
Swelling 31 1
Swelling, >100 mm 1 0
60 through 69 years old
Local adverse
reactions		 SHINGRIX %
n=1311		 Placebo %
n=1305
Pain 83 11
Pain, Grade 3* 7 1
Redness 38 2
Redness, >100 mm 3 0
Swelling 27 1
Swelling, >100 mm 1 0
≥70 years old
Local adverse
reactions		 SHINGRIX %
n=2258		 Placebo %
n=2263
Pain 69 9
Pain, Grade 3* 4 0.2
Redness 38 1
Redness, >100 mm 3 0
Swelling 23 1
Swelling, >100 mm 1 0

In ZOE-50/-70, data on solicited local and general adverse reactions were collected using standardized diary cards for 7 days following each vaccine dose or placebo (ie, day of vaccination and the next 6 days) in a subset of subjects (n=4886 receiving SHINGRIX, n=4881 receiving placebo with at least 1 documented dose). Solicited local adverse reactions were collected in subjects 50-69 years old from ZOE-50 and from pooled data from ZOE-50 and ZOE-70 for subjects ≥70 years old.

Grade 3 pain defined as significant pain at rest; prevents normal everyday activities.

n=number of subjects with at least 1 documented dose of either SHINGRIX or placebo included in the total vaccinated cohort for safety.

Solicited general adverse reactions within 7 days of vaccination by age (ZOE-50/-70)3
  50 through 59 years old 60 through 69 years old ≥70 years old
General adverse
reactions		 SHINGRIX %
n=1315		 Placebo %
n=1312		 SHINGRIX %
n=1309		 Placebo %
n=1305		 SHINGRIX %
n=2252		 Placebo %
n=2264
Myalgia 57 15 49 11 35 10
Myalgia, Grade 3* 9 1 5 1 3 0.4
Fatigue 57 20 46 17 37 14
Fatigue, Grade 3* 9 2 5 1 4 1
Headache 51 22 40 16 29 12
Headache, Grade 3* 6 2 4 0.2 2 0.4
Shivering 36 7 30 6 20 5
Shivering, Grade 3* 7 0.2 5 0.3 2 0.3
Fever† 28 3 24 3 14 3
Fever, Grade 3‡ 0.4 0.2 1 0.2 0.1 0.1
GI§ 24 11 17 9 14 8
Gl, Grade 3* 2 1 1 1 1 0.4
Solicited general adverse reactions within 7 days of vaccination by age (ZOE-50/-70)3
50 through 59 years old
General adverse
reactions		 SHINGRIX %
n=1315		 Placebo %
n=1312
Myalgia 57 15
Myalgia, Grade 3* 9 1
Fatigue 57 20
Fatigue, Grade 3* 9 2
Headache 51 22
Headache, Grade 3* 6 2
Shivering 36 7
Shivering, Grade 3* 7 0.2
Fever† 28 3
Fever, Grade 3‡ 0.4 0.2
GI§ 24 11
Gl, Grade 3* 2 1
60 through 69 years old
General adverse
reactions		 SHINGRIX %
n=1309		 Placebo %
n=1305
Myalgia 49 11
Myalgia, Grade 3* 5 1
Fatigue 46 17
Fatigue, Grade 3* 5 1
Headache 40 16
Headache, Grade 3* 4 0.2
Shivering 30 6
Shivering, Grade 3* 5 0.3
Fever† 24 3
Fever, Grade 3‡ 1 0.2
GI§ 17 9
Gl, Grade 3* 1 1
≥70 years old
General adverse
reactions		 SHINGRIX %
n=2252		 Placebo %
n=2264
Myalgia 35 10
Myalgia, Grade 3* 3 0.4
Fatigue 37 14
Fatigue, Grade 3* 4 1
Headache 29 12
Headache, Grade 3* 2 0.4
Shivering 20 5
Shivering, Grade 3* 2 0.3
Fever† 14 3
Fever, Grade 3‡ 0.1 0.1
GI§ 14 8
Gl, Grade 3* 1 0.4

In ZOE-50/-70, data on solicited local and general adverse reactions were collected using standardized diary cards for 7 days following each vaccine dose or placebo (ie, day of vaccination and the next 6 days) in a subset of subjects (n=4886 receiving SHINGRIX, n=4881 receiving placebo with at least 1 documented dose). Solicited general adverse reactions were collected in subjects 50-69 years old from ZOE-50 and from pooled data from ZOE-50 and ZOE-70 for subjects ≥70 years old.

Grade 3 myalgia, fatigue, headache, shivering, and Gl: defined as preventing normal activity.

Fever defined as ≥37.5°C/99.5°F for oral, axillary, or tympanic route, or ≥38°C/100.4°F for rectal route.

Grade 3 fever defined as >39.0°C/102.2°F.

Included nausea, vomiting, diarrhea, and/or abdominal pain.

n=number of subjects with at least 1 documented dose of either SHINGRIX or placebo included in the total vaccinated cohort for safety.

SHINGRIX IS $0 FOR MOST PATIENTS ≥50 YEARS OLD7,8,*

FOR PATIENTS WITH
COMMERCIAL INSURANCE PLANS8,*,†

98% of commercial patients pay $0 for SHINGRIX

Average copays are just $4 or less

FOR YOUR
MEDICARE PART D PATIENTS9

Due to the Inflation Reduction Act, Medicare Part D patients can get SHINGRIX for $0 through their pharmacy

Coverage and cost may vary and are subject to change without notice. Reimbursement decisions are made by individual insurance plans.

SOURCE: Based on IQVIA data of paid 2023 SHINGRIX claims.

Click here to view a guide to referring your patients to a pharmacy for vaccination.

References: 1. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30. 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. Prescribing Information for SHINGRIX. 4. 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. 5. Cunningham AL, Lal H, Kovac M, et al, for the ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-1032. 6. Data on file. Study 113077 (NCT01165229). GSK Study Register. Study entry at: https://www.gskstudyregister.com/en/trial-details/?id=113077 7. Data on file, GSK. 8. Kirchhoff SM. Selected Health Provisions of the Inflation Reduction Act. Congressional Research Service. 2022;1-3. Accessed October 8, 2024. https://crsreports.congress.gov/product/pdf/IF/IF12203

Shield Icon

Help protect your appropriate patients 50 years and older from shingles.

IT IS CRITICAL TO RECEIVE BOTH DOSES TO GET THE PROTECTION OFFERED BY SHINGRIX1

SHINGRIX is administered intramuscularly as a 2-dose series1

  • Administer the second dose between 2 and 6 months after the first dose1
  • It is important to receive both doses. The efficacy results of SHINGRIX were demonstrated in clinical trials when administered as a 2-dose series1
Dosing Schedule Graphic

PROVEN SHINGLES PROTECTION

SHINGRIX delivered:

>90%

EFFICACY AGAINST SHINGLES

regardless of age in those 50 years and older1,*

Data from the phase 3 ZOE-50 (≥50 years of age) trial (median follow-up period 3.1 years) and pooled data in individuals ≥70 years of age from the phase 3 ZOE-50 and ZOE-70 trials (median follow-up period 4 years) in subjects who received 2 doses of SHINGRIX (n=7344 and 8250, respectively) or placebo (n=7415 and 8346, respectively). These populations represented the modified Total Vaccinated Cohort, defined as patients who received 2 doses (0 and 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of herpes zoster within 1 month after the second dose.1,2

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

WHAT YOU SAY MATTERS

Protecting patients starts with
a strong recommendation from you.

To communicate the importance of vaccination
with SHINGRIX, follow a simple 3-step plan:

1 EDUCATE PATIENTS ON SHINGLES

2 MAKE THE RISK OF SHINGLES RELATABLE

3 ADMINISTER OR SCHEDULE SHINGRIX TODAY

See more information on dosing and administration here.

References: 1. Prescribing Information for SHINGRIX. 2. Data on file. Study 113077 (NCT01165229). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=113077

x2 Calendar Image

Recommend 2 doses of SHINGRIX to appropriate patients 50 years and older to help prevent shingles.

Facts about shingles and vaccination

The risk of developing shingles sharply increases starting at 50 years old—and continues to increase with age.1

  • Approximately 99.5% of people ≥50 years old are latently infected with the varicella zoster virus (VZV).1,2
  • In 1 in 3 people, dormant VZV reactivates in their lifetime and causes shingles—a blistering rash that can be excruciatingly painful, typically lasting 7 to 10 days.1,3

Nationally, an estimated 36% of adults ≥50 years old have received a shingles vaccine.4,*

How many patients may be at increased risk of developing shingles in Florida?

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In Florida, approximately 9.4 million people are age 50 or older (41.5% of the state population).5,†

Did you know?

Certain conditions have been associated with an increased risk of shingles including asthma, cardiovascular conditions,‡ chronic obstructive pulmonary disease (COPD), diabetes, and chronic kidney disease (CKD).6

Data from the 2022 National Health Interview Survey. Respondents ≥50 years of age (N=15,306) were asked if they ever received a shingles vaccine.

Population based off US Census 2023 Age and Sex 1-Year Community Survey Estimates. Population estimates rounded to the nearest hundred thousand. Data are based on a sample size and are subject to sampling variability. Note, not all individuals may be at increased risk of shingles as the population size represents the estimated number of all adults 50 years and older and does not adjust for individuals who are vaccinated against herpes zoster or who already had herpes zoster.

Cardiovascular conditions included heart disease, heart failure, hypertension, hyperlipidemia, stroke, atrial fibrillation/flutter, and other cardiovascular disease.6

References: 1. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30. 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. Shingles Symptoms and Complications. Centers for Disease Control and Prevention. Updated April 19, 2024. Accessed March 18, 2024. https://www.cdc.gov/shingles/signs-symptoms/index.html 4. Vaccination coverage among adults in the United States, National Health Interview Survey, 2022. Centers for Disease Control and Prevention. Updated October 4, 2024. Accessed March 18, 2024. www.cdc.gov/adultvaxview/publications-resources/adult/vaccination-coverage-2022.html 5. Annual estimates of the American community survey by single year of age and sex for the United States and states: January 1, 2023 and December 31, 2023 (2023: ACS-1-Year Estimates). United States Census Bureau. Accessed October 14, 2024. https://data.census.gov/table/ACSST1Y2023 6. Marra F, Parhar K, Huang B, Vadlamudi N. Risk factors for herpes zoster infection: a meta-analysis. Open Forum Infect Dis. 2020;7(1):ofaa005.

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How many patients may be at increased risk of developing shingles in Florida?

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Indication

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) 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
  • In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
  • Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Solicited local adverse reactions reported in individuals aged 50 years and older were pain (78%), redness (38%), and swelling (26%)
  • Solicited general adverse reactions reported in individuals aged 50 years and older were myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and gastrointestinal symptoms (17%)
  • The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women
  • It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

Please see full Prescribing Information for SHINGRIX.