Bexsero Product Monograph - GSK

1 March 31, 2022 Product Monograph Master Template Template Date: September 2020 Bexsero , Multicomponent Meningococcal B Vaccine Page 1 of 54 Product Monograph INCLUDING PATIENT MEDICATION INFORMATION Bexsero Multicomponent Meningococcal B Vaccine (recombinant, adsorbed) Suspension for Injection Active Immunizing Agent for the Prevention of Meningococcal Disease ATC Code: J07AH09 GlaxoSmithKline Inc. 100 Milverton Drive Suite 800 Mississauga, Ontario L5R 4H1 Date of Initial Authorization: December 6, 2013 Date of Revision: March 31, 2022 Submission Control Number: 257000 2022 GSK group of companies or its licensor Trademarks are owned by or licensed to the GSK group of companies March 31, 2022 Product Monograph Master Template Template Date: September 2020 Bexsero , Multicomponent Meningococcal B Vaccine Page 2 of 54 RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment JUN 2020 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.

2 RECENT MAJOR LABEL CHANGES .. 2 TABLE OF CONTENTS .. 2 1 INDICATIONS .. 4 Pediatrics .. 4 Geriatrics .. 4 2 CONTRAINDICATIONS .. 4 4 DOSAGE AND ADMINISTRATION .. 5 Recommended Dose and Dosage Adjustment .. 5 Administration .. 5 5 OVERDOSAGE .. 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .. 6 7 WARNINGS AND PRECAUTIONS .. 6 Special Populations .. 8 Pregnant Women .. 8 Breast-feeding .. 8 Pediatrics (< 2 months of age) .. 9 Geriatrics (> 65 years of age) .. 9 8 ADVERSE 9 Adverse Reaction Overview .. 9 Clinical Trial Adverse Reactions .. 9 Clinical Trial Adverse Reactions 25 Less Common Clinical Trial Adverse Reactions .. 25 Less Common Clinical Trial Adverse Reactions Pediatrics.

3 26 Post-Market Adverse Reactions .. 26 9 DRUG INTERACTIONS .. 26 March 31, 2022 Product Monograph Master Template Template Date: September 2020 Bexsero , Multicomponent Meningococcal B Vaccine Page 3 of 54 Drug-Drug Interactions .. 26 Drug-Food Interactions .. 27 Drug-Herb Interactions .. 27 Drug-Laboratory Test 27 10 CLINICAL PHARMACOLOGY .. 27 Mechanism of Action .. 27 Pharmacodynamics .. 29 11 STORAGE, STABILITY AND DISPOSAL .. 29 12 SPECIAL HANDLING INSTRUCTIONS .. 29 PART II: SCIENTIFIC INFORMATION .. 30 13 PHARMACEUTICAL INFORMATION .. 30 14 CLINICAL TRIALS .. 30 Trial Design and Study Demographics .. 30 Immunogenicity .. 35 15 MICROBIOLOGY .. 47 16 NON-CLINICAL TOXICOLOGY.

4 47 PATIENT MEDICATION INFORMATION .. 49 March 31, 2022 Product Monograph Master Template Template Date: September 2020 Bexsero , Multicomponent Meningococcal B Vaccine Page 4 of 54 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Bexsero is indicated for active immunization of individuals from 2 months through 25 years old against invasive disease caused by N. meningitidis serogroup B strains. As the expression of antigens included in the vaccine is epidemiologically variable in circulating group B strains, meningococci that express them at sufficient levels are predicted to be susceptible to killing by vaccine-elicited antibodies (see 10 CLINICAL PHARMACOLOGY). Pediatrics Pediatrics (<2 months): No data are available to Health Canada.

5 Geriatrics Geriatrics (> 65 years of age): No data are available to Health Canada. 2 CONTRAINDICATIONS Bexsero should not be administered to individuals who are hypersensitive to this vaccine or to any ingredient in the formulation or components of the container closure. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING of the Product Monograph . March 31, 2022 Product Monograph Master Template Template Date: September 2020 Bexsero , Multicomponent Meningococcal B Vaccine Page 5 of 54 4 DOSAGE AND ADMINISTRATION Recommended Dose and Dosage Adjustment Age at First Dose Primary Doses Intervals between Primary Doses Booster Infants, 2 months to 5 months 3+1 schedule: Three doses, each of mL Not less than 1 month 1 booster in 2nd year of life with an interval of at least 6 months between the primary doses and booster.

6 * 2+1 schedule: Two doses, each of mL Not less than 2 months 1 booster in 2nd year of life with an interval of at least 6 months between the primary doses and booster.* Infants, 6 months to 11 months Two doses, each of mL Not less than 2 months 1 booster in 2nd year of life with an interval of at least 2 months between the primary doses and booster.* Children, 12 months to 23 months Two doses, each of mL Not less than 2 months 1 booster given at an interval of 12 to 23 months between the primary series and booster.* Children, Adolescents and Adults, 2 through 25 years Two doses, each of mL Not less than 1 month 1 booster considered in individuals at continued risk of exposure to meningococcal disease, based on guideline recommendations.

7 *The need for, and timing of further doses has not yet been determined (see 14 CLINICAL TRIALS). Sufficient data are not available on the safety and effectiveness of using Bexsero and other meningococcal group B vaccines interchangeably to complete the vaccination series. Therefore, it is recommended that subjects who receive a first dose of Bexsero complete the vaccination course with Bexsero . Administration Bexsero should be given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older individuals. Separate injection sites must be used if more than one vaccine is administered at the same time.

8 The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe. Bexsero must not be mixed with other medicinal products. 5 OVERDOSAGE There are no data with regard to overdose. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended. March 31, 2022 Product Monograph Master Template Template Date: September 2020 Bexsero , Multicomponent Meningococcal B Vaccine Page 6 of 54 For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the Product lot number and expiry date.

9 Bexsero is supplied as a mL suspension in a pre-filled syringe (Type I glass). The tip cap of the syringe may contain natural rubber latex (see 7 WARNINGS AND PRECAUTIONS). Available in packs of 1 or 10 syringes, supplied with or without needles. Table 1 Dosage Form, Strength, Composition and Packaging *From the manufacturing process. 7 WARNINGS AND PRECAUTIONS General As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients. Bexsero is not expected to provide protection against all circulating meningococcal serogroup B strains. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intramuscular injection Suspension for injection.

10 Each mL dose contains: Recombinant Neisseria meningitidis serogroup B NHBA fusion protein, 50 mcg 1,2,3. Recombinant Neisseria meningitidis serogroup B NadA protein, 50 mcg 1,2,3. Recombinant Neisseria meningitidis serogroup B fHbp fusion protein, 50 mcg 1,2,3. Outer membrane vesicles (OMV) from Neisseria meningitidis serogroup B strain NZ98/254, 25 mcg measured as amount of total protein containing the PorA 2. 1 Produced in E. coli by recombinant DNA technology. 2 Adsorbed on aluminium hydroxide ( mg aluminium). 3 NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein). Aluminium hydroxide mg, histidine mg, sodium chloride mg, sucrose 10 mg, water for injection.