Important safety information

Indications and clinical use:

  • Indicated for prevention of herpes zoster (HZ, or shingles) in adults 50 years of age or older

Contraindications:

  • Patients with a known hypersensitivity to the active substance or to any component of the vaccine

Most serious warnings and precautions:

  • Administration: Do not administer the vaccine intravascularly, intradermally or subcutaneously

Other relevant warnings and precautions:

  • A protective immune response may not be elicited in all vaccinees
  • Not for prevention of primary varicella infection or treatment of HZ or postherpetic neuralgia
  • Postpone in those with acute severe febrile illness
  • Use with caution in those with thrombocytopenia or any coagulation disorder
  • Syncope following or before any vaccination as a psychogenic response
  • Fever and shivering were more frequent when the 23-valent pneumococcal polysaccharide (PPV23) vaccine was co-administered with SHINGRIX
  • Use in special populations such as pregnant or nursing women or pediatrics (<18 years of age) has not been established
  • Limited data in immunocompromised adults 50 years of age or older

Adverse events:

  • Solicited local and general adverse reactions that occurred in clinical trials within 7 days of vaccination in subjects aged 50–69 and ≥70 years respectively were: pain (85.6%, 69.2%), redness (38.5%, 37.7%), swelling at the injection site (28.5%, 23.0%), myalgia (53.0%, 35.1%), fatigue (51.3%, 36.6%), headache (45.2%, 29.0%), shivering (33.1%, 19.5%), fever (25.9%, 14.3%), gastrointestinal symptoms (20.5%, 13.5%)
  • Unsolicited adverse reactions that occurred in clinical trials within 30 days of vaccination in ≥1% of subjects and ≥2-fold higher than placebo recipients included chills (3.5%), injection site pruritus (2.2%), malaise (1.7%)
  • Post-market adverse reactions are: hypersensitivity reactions (rare), including rash, urticaria, angioedema

For more information:

Please consult the product monograph at gsk.ca/SHINGRIX/PM for important information relating to dosing and administration, adverse reactions, contraindications and drug interactions which have not been discussed in this piece. To request a product monograph, or to report an adverse event please call 1-800-387-7374.

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PM-CA-SGX-WCNT-210001 | November 2021