Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
In adults aged 50 years and above, the most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose; 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose; 3.0% severe/dose) and headache (26.3% overall/dose; 1.9% severe/dose). Most of these reactions were not long-lasting (median duration of 2 to 3 days). Reactions reported as severe lasted 1 to 2 days.

In adults ≥ 18 years of age who are immunodeficient or immunosuppressed due to disease or therapy (referred to as immunocompromised (IC)), the safety profile was consistent with that observed in adults 50 years and above. There are limited data in adults aged 18-49 years at increased risk of HZ who are not IC.

Overall, there was a higher incidence of some adverse reactions in younger age groups: - studies in IC adults ≥ 18 years of age (pooled analysis): the incidence of pain at the injection site, fatigue, myalgia, headache, shivering and fever was higher in adults aged 18-49 years compared to those aged 50 years and above.
- studies in adults ≥ 50 years of age (pooled analysis): the incidence of myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms was higher in adults aged 50-69 years compared to those aged 70 years and above.

Tabulated list of adverse reactions
The safety profile presented below is based on a pooled analysis of data generated in placebo- controlled clinical studies on 5 887 adults 50-69 years of age and 8 758 adults ≥ 70 years of age.

In clinical studies in IC adults ≥ 18 years of age (1,587 subjects) the safety profile is consistent with the data presented in Table 1 below.

Adverse reactions reported during post-marketing surveillance are also tabulated below.
Adverse reactions reported are listed according to the following frequency: 
Very common              (≥ 1/10)
Common                   (≥ 1/100 to < 1/10)
Uncommon                 (≥ 1/1 000 to < 1/100)
Rare                     (≥ 1/10 000 to < 1/1 000)
Very rare                (< 1/10 000)

Within each frequency grouping the adverse reactions are reported in the order of decreasing seriousness.
Table 1: Adverse Reactions

System Organ Class1               Frequency                     Adverse reactions 
Blood and lymphatic system           Uncommon             lymphadenopathy disorders

Immune system disorders              Rare                 hypersensitivity reactions including rash, urticaria, angioedema2

Nervous system disorders             Very common          headache

Gastrointestinal disorders            Very common         gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain)

Musculoskeletal and connective       Very common          myalgia tissue disorders
Uncommon             arthralgia

General disorders and                Very common          injection site reactions (such as pain, administration site conditions                            redness, swelling), fatigue, chills, fever 
Common               injection site pruritus, malaise
1
According to MedDRA (medical dictionary for regulatory activities) terminology 2
Adverse reactions from spontaneous reporting

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/.
Additionally, you should also report to GSK Israel (il.safety@gsk.com).