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Indications and clinical use:
- SHINGRIX is indicated for prevention of herpes zoster (HZ, or shingles) in adults 50 years of age or older and in adults 18 years of age or older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.
Contraindications:
- Individuals 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
- Increased risk of Guillain-Barré syndrome was observed in a post-marketing observational study in individuals 65 years of age or older within 42 days following vaccination (estimated 3 excess cases per million doses administered), with insufficient information available to determine a causal relationship with SHINGRIX
