APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

4.1. Therapeutic indications

Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Apexxnar should be used in accordance with official recommendations.

4.3. Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, or to diphtheria toxoid.

4.2. Posology and method of administration

Posology

Individuals 18 years of age and older

Apexxnar is to be administered as a single dose to individuals 18 years of age and older.

The need for revaccination with a subsequent dose of Apexxnar has not been established.

No data on sequential vaccination with other pneumococcal vaccines or a booster dose are available for Apexxnar. Based on the clinical experience with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Apexxnar), if the use of 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23 [PPSV23]) is considered appropriate, Apexxnar should be given first (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

The safety and efficacy of Apexxnar in children and adolescents younger than 18 years of age have not been established. No data are available.

Special populations

There are no data with Apexxnar in special populations.

Limited experience from clinical studies with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Apexxnar) are available in adults at higher risk of pneumococcal infection either immunocompromised individuals or following bone marrow transplantation (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Based on these data the following posology was recommended for Prevenar 13:

• Individuals at higher risk of pneumococcal infection (e.g., individuals with sickle cell disease or HIV infection), including those previously vaccinated with 1 or more doses of PPSV23, were recommended to receive at least 1 dose of Prevenar 13.
• In individuals with a hematopoietic stem cell transplant (HSCT), the recommended immunisation series with Prevenar 13 consisted of 4 doses of 0.5 mL each. The primary series consisted of 3 doses, with the first dose given 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A booster dose was recommended 6 months after the third dose (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Please also refer to sections 4.4. and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration

For intramuscular use only.

One dose (0.5 mL) of Apexxnar should be administered intramuscularly, preferably in the deltoid muscle, with care to avoid injection into or near nerves and blood vessels.

For instructions on the handling of the vaccine before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.