PATIENT COUNSELING

Here are topics to discuss with your patients before vaccinating with SHINGRIX.

Icon: Explain Their Risks

Explain their risk of shingles:

  • Help patients understand the increased risk of shingles in immunocompromised patients1
  • Explain that in people who are immunocompromised, the rash tends to be more severe, with a prolonged duration, and the risk of potentially serious shingles-related complications is greater1
Icon: What to Expect

Discuss what to expect:

  • Inform patients that they may experience adverse reactions after receiving SHINGRIX. In clinical trials in immunocompromised patients aged 18 years and older, the following solicited adverse reactions were reported more frequently in the SHINGRIX groups compared to placebo groups*:
    • Local adverse reactions: pain, redness, and swelling
    • General adverse reactions: fatigue, myalgia, headache, gastrointestinal symptoms, shivering, and fever2
  • Explain that the local and general adverse reactions had a median duration of 1 to 3 days across all studies enrolling immunocompromised subjects2

*The safety of SHINGRIX was evaluated in 6 placebo-controlled clinical studies that enrolled 3116 subjects aged 18 years and older from 5 different immunocompromised populations, in which a total of 1587 received SHINGRIX.2

Icon: 2-Dose Series

Explain that SHINGRIX is given as a 2-dose series:

  • The first dose is administered at Month 0 followed by a second dose 2 to 6 months later2
  • For individuals who are or will be immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule, administer a first dose at Month 0 followed by a second dose 1 to 2 months later2

Dosing schedule

The first dose is administered at Month 0 followed by a second dose 2 to 6 months later.2
Dosing Schedule for SHINGRIX infographic

 .

Alternative dosing schedule

For those who are or will be immunodeficient or immunosuppressed and would benefit from a shorter vaccination schedule: administer a first dose at Month 0 followed by a second dose 1 to 2 months later.
Dosing Schedule for SHINGRIX infographic

    

Icon: Syringe

Stress the protection benefit of both doses:

  • The efficacy results of SHINGRIX were demonstrated in clinical trials when administered as a 2-dose series2
  • That is why it is important that your patients receive both doses of SHINGRIX
Icon: Telephone Follow Up

Help ensure series completion:

  • Schedule the follow-up immediately: Patients can receive the second dose 2 to 6 months later. Patients who are immunocompromised and would benefit from a shorter vaccination schedule can receive the second dose 1 to 2 months later2
  • Call ahead: Have the office staff call patients in advance of their follow-up
  • Encourage appointment reminders:
    • Once you set a date, have your patients place a reminder in their calendar
    • Patients can sign up for email, text, and phone reminders at

You may also be interested in:

Reconstitution & Administration

See how you and your staff can reconstitute SHINGRIX in 4 steps.

CDC Recommendations

See what CDC says about SHINGRIX.

Shingles Presentation

Learn about shingles symptoms and potential complications.

Indication & Important Safety Info

Indication

Important Safety Information

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

  • in adults aged 50 years and older.
  • in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

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%)  
  • Solicited local adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were pain (88% and 83%), redness (30% and 35%), and swelling (21% and 18%)  
  • Solicited general adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were fatigue (64% and 54%), myalgia (58% and 52%), headache (44% and 30%), gastrointestinal symptoms (21% and 28%), shivering (31% and 25%), and fever (28% and 18%)
  • 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.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at https://gsk.public.reportum.com or
1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

References

  1. 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.
  2. Prescribing Information for SHINGRIX.

    Questions About SHINGRIX?

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