CAPVAXIVE Aug 2025
Before prescribing, please review the Product Information available at www.msdinfo.com.au/capvaxivepi
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
Before prescribing, please review the Product Information available at www.msdinfo.com.au/capvaxivepi
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
INDICATIONS: CAPVAXIVE is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults 18 years of age and older. 1
CAPVAXIVE may not prevent disease caused by S. pneumoniae serotypes that are not listed in the indication. The use of CAPVAXIVE should be guided by official recommendations.1
SELECTED SAFETY INFORMATION
CONTRAINDICATIONS: Individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to the active substances, diphtheria toxoid or to any of the excipients.1
PRECAUTIONS: Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of CAPVAXIVE. Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response toCAPVAXIVE. Across all treatment groups, the opsonophagocytic activity (OPA) responses in individuals 65 years of age and older were generally lower than those observed in individuals less than 65 years of age. The safety andeffectiveness of CAPVAXIVE in children younger than 18 years of age have not been established. Pregnancy category B1.1
ADVERSE EFFECTS: In clinical studies, solicited adverse reactions were injection-site pain, fatigue, headache, myalgia, injection-site erythema, injection-site swelling and pyrexia. There were 2 serious adverse events (0.05%; bronchospasm, cellulitis) assessed by the investigator to be related to CAPVAXIVE.1
Reference: 1. CAPVAXIVE Product Information, 15 May 2025.
Before prescribing, please review the Product Information available at www.msdinfo.com.au/capvaxivepi
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
INDICATIONS: CAPVAXIVE is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults 18 years of age and older. 1
CAPVAXIVE may not prevent disease caused by S. pneumoniae serotypes that are not listed in the indication. The use of CAPVAXIVE should be guided by official recommendations.1
SELECTED SAFETY INFORMATION
CONTRAINDICATIONS: Individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to the active substances, diphtheria toxoid or to any of the excipients.1
PRECAUTIONS: Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of CAPVAXIVE. Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response toCAPVAXIVE. Across all treatment groups, the opsonophagocytic activity (OPA) responses in individuals 65 years of age and older were generally lower than those observed in individuals less than 65 years of age. The safety andeffectiveness of CAPVAXIVE in children younger than 18 years of age have not been established. Pregnancy category B1.1
ADVERSE EFFECTS: In clinical studies, solicited adverse reactions were injection-site pain, fatigue, headache, myalgia, injection-site erythema, injection-site swelling and pyrexia. There were 2 serious adverse events (0.05%; bronchospasm, cellulitis) assessed by the investigator to be related to CAPVAXIVE.1
Reference: 1. CAPVAXIVE Product Information, 15 May 2025.