SHINGRIX Powder for suspension for injection Ref.[27522] Active ingredients: Human varicela zoster immunoglobulin

Prior to immunisation

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

As with any vaccine, a protective immune response may not be elicited in all vaccinees. The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease.

Do not administer the vaccine intravascularly or intradermally.

Subcutaneous administration is not recommended.

Maladministration via the subcutaneous route may lead to an increase in transient local reactions.

Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

In a post-marketing observational study in individuals aged 65 years or older, an increased risk of Guillain-Barré syndrome (estimated 3 excess cases per million doses administered) was observed during the 42 days following vaccination with Shingrix. Available information is insufficient to determine a causal relationship with Shingrix.

There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine.

There are limited data to support the use of Shingrix in individuals with a history of HZ (see section 5.1). Healthcare professionals therefore need to weigh the benefits and risks of HZ vaccination on an individual basis.

Excipients

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23) or reduced antigen diphtheria-tetanusacellular pertussis vaccine (dTpa). The vaccines should be administered at different injection sites.

In three phase III, controlled, open-label clinical studies, adults ≥50 years of age were randomised to receive 2 doses of Shingrix 2 months apart administered either concomitantly at the first dose or nonconcomitantly with an unadjuvanted inactivated seasonal influenza vaccine (N=828; Zoster-004), a PPV23 vaccine (N=865; Zoster-035) or a dTpa vaccine formulated with 0.3 milligrams Al3+ (N=830; Zoster-042). The immune responses of the co-administered vaccines were unaffected, with the exception of lower geometric mean concentrations (GMCs) for one of the pertussis antigens (pertactin) when Shingrix is co-administered with the dTpa vaccine. The clinical relevance of this data is not known.

The adverse reactions of fever and shivering were more frequent when PPV23 vaccine is coadministered with Shingrix.

Concomitant use with other vaccines is not recommended due to lack of data.

Pregnancy

There are no data from the use of Shingrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy.

Breast-feeding

The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied.

It is unknown whether Shingrix is excreted in human milk.

Fertility

Animal studies do not indicate direct or indirect effects with respect to fertility in males or females (see section 5.3).

No studies on the effects of Shingrix on the ability to drive and use machines have been performed.

Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination. Fatigue and malaise may occur following administration (see section 4.8).

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 placebocontrolled 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 the Table 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.

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

This medicinal product must not be mixed with other medicinal products.