FLULAVAL TETRA (2021-2022)

1 FLULAVAL TETRA (2020-2021) GlaxoSmithKline Approved: Page 1 of 28 PRODUCT MONOGRAPH FLULAVAL TETRA (2021-2022) Quadrivale nt Influe nza Vaccine (Split Virion, Inactivate d) Suspension for Injection ATC Code: J07BB02 Manufactured by: ID Biomedical Corporation of Quebec Quebec, Quebec, Canada Distributed by: GlaxoSmithK line Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Intial Authorization: February 6, 2014 Date of Approval: September 24, 2021 Control No.: 245185 2021 GSK group of com panies or its licensor. Tradem arks are owned by or licensed to the GSK group of com panies. FLULAVAL TETRA (2021-2022) GlaxoSmithK line Approved: Page 2 of 28 Table of Conte nts PART I: HEALTH PROFESSIONAL INFORMATION .. 3 SUMMARY PRODUCT INFORMATION ..3 DESCRIPTION.

2 3 INDICATIONS AND CLINICAL USE ..4 CONTRAINDICATIONS ..4 WARNINGS AND PRECAUTIONS ..4 ADVERSE DRUG INTERACTIONS .. 14 DOSAGE AND ADMINISTRATION .. 15 OVERDOSAGE .. 16 ACTION AND CLINICAL 17 STORAGE AND STABILITY .. 17 SPECIAL HANDLING INSTRUCTIONS .. 17 DOSAGE FORMS, COMPOSITION AND PACKAGING .. 18 PART II: SCIENTIFIC INFORMATION .. 19 PHARMACEUTICAL INFORMATION .. 19 CLINICAL TRIALS .. 19 TOXICOLOGY .. 24 REFERENCES .. 25 PART III: CONSUMER 26 FLULAVAL TETRA (2021-2022) GlaxoSmithK line Approved: Page 3 of 28 FLULAVAL TETRA (2021-2022) Quadrivalent influenza vaccine (split virion, inactivated) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Adminis tration Dos age Form / Stre ngth Clinically Re le vant Nonme dicinal Ingre die nts Intramuscular Suspension for Injection available in multidose vial and single-dose prefilled syringe* Each mL dose contains 15 g of influenza virus haemagglutinin/stra in for each strain listed below (see Description) Egg proteins, sodium deoxycholate, ethanol, formaldehyde, sucrose, -tocopheryl hydrogen succinate, polysorbate 80.

3 Thimerosal preservative in the multidose presentation only. For a complete listing see Dosage Forms, Composition and Packaging section. *The prefilled syringe presentation is not available for the 2021-2022 season DESCRIPTION FLULAVAL TETRA is a quadrivalent split-virion, inactivated influenza vaccine prepared from virus grown in the allantoic cavity of embryonated hens eggs. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation and disrupted with sodium deoxycholate. This vaccine complies with the World Health Organization (WHO) recommendation (Northern Hemisphere) for the 2021-2022 season. Each dose of vaccine contains 15 micrograms haemagglutinin of each of the following four influenza virus strains: 15 g HA - A/Victoria/2570/2019 (H1N1)pdm09-like virus 15 g HA - A/Cambodia/e0826360/2020 (H3N2)-like virus 15 g HA - B/Phuket/3073/2013-like virus from B/Yamagata lineage 15 g HA - B/Washington/02/2019-like virus from B/Victoria lineage FLULAVAL TETRA (2021-2022) GlaxoSmithK line Approved: Page 4 of 28 INDICATIONS AND CLINICAL USE FLULAVAL TETRA is a quadrivalent vaccine indicated for active immunization of adults and children from 6 months of age for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine.

4 The National Advisory Committee on Immunization (NACI) provides additional guidance on the use of the influenza vaccine in Canada. Please refer to published Statement on Seasonal Influenza Vaccine for the current season. CONTRAINDICATIONS FLUVIRAL TETRA should not be administered to subjects with known history of hypersensitivity to any component of the vaccine or following a previous dose of any influenza vaccine produced in eggs. WARNINGS AND PRECAUTIONS FLULAVAL TETRA should under no circumstances be administered intravascularly. Ge ne ral It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and the possible occurrence of undesirable events) and a clinical examination. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.

5 It is important that procedures are in place to avoid injury from faints. As with any vaccine, a protective immune response may not be elicited in all vaccinees. FLULAVAL TETRA is not effective against all possible strains of influenza virus. FLULAVAL TETRA is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains. Se rious Warnings and Pre cautions 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. FLULAVAL TETRA (2021-2022) GlaxoSmithK line Approved: Page 5 of 28 Fe brile or acute dis e as e As with other vaccines, vaccination with FLULAVAL TETRA should be postponed in subjects suffering from an acute severe febrile illness.

6 The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. He matologic As with other vaccines administered intramuscularly, FLULAVAL TETRA should be given with caution to individua ls with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. Immune An adequate immune response may not be elicited in patients receiving immunosuppress ive treatment or patients with immunodefic iency. Local Skin Re actions at Vaccination Site s Soreness and redness at the injection site may occur and may last for up to two days. Prophylactic acetaminophen may decrease the frequency of pain at the injection site. Ne urologic If Guillain-Barr syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLULAVAL TETRA should be based on the careful consideration of the potential benefits and risks.

7 Immunization should be delayed in a patient with an active neurologic disorder, but should be considered when the disease process has been stabilized. Re s piratory Revaccination of individua ls who have previously experienced oculo-respiratory symptoms is safe. Previously affected individuals should be encouraged to be revaccinated. The risk of recurrence of oculo-respiratory symptoms after revaccination is minimal compared to the serious threat posed by influenza. Please refer to the most current NACI recommendations regarding revaccination of subjects who experienced more severe oculo-respiratory syndrome. Spe cial Populations Pre gnant Wome n: The safety of FLULAVAL TETRA when administered to pregnant women has not been evaluated in clinical trials. A systematic literature review on inactivated influenza vaccines do not indicate an increased risk of adverse pregnancy outcomes.

8 Animal studies with FLULAVAL TETRA do not indicate direct or indirect harmful effects with respect to reproductive and developmental toxicity. The FLULAVAL TETRA vaccine may be administered to pregnant women following an assessment of the risks and benefits. FLULAVAL TETRA (2021-2022) GlaxoSmithK line Approved: Page 6 of 28 Nurs ing Women: The safety of FLULAVAL TETRA when administered to breast-feeding women has not been evaluated. It is unknown whether FLULAVAL TETRA is excreted in human breast milk. FLULAVAL TETRA should only be used during breast-feeding when the possible advantages outweigh the potential risks. ADVERSE REACTIONS Adve rs e Drug Re action Ove rview In clinical trials, FLULAVAL TETRA was administered to more than 1,960 children between 6 35 months of age, more than 3,500 children between 3 17 years of age and more than 1,200 adults.

9 In adults, the most common ( 10%) solicited local reaction was pain (60%); the most common solicited systemic adverse events were myalgia (26%), headache (22%), fatigue (22%), and arthralgia (15%). In children 3 to 17 years of age, the most common ( 10%) solicited local reaction was pain (65%). In children 3 to 4 years of age, the most common ( 10%) solicited systemic adverse events were irritability (26%), drowsiness (21%), and loss of appetite (17%). In children 5 to 17 years of age, the most common ( 10%) systemic adverse events were muscle aches (29%), fatigue (22%), headache (22%), arthralgia (13%), and gastrointestinal symptoms (10%). In children 6 to 35 months of age, injection site pain was the most common ( 10%) solicited local reaction (40%).

10 The most common solicited systemic adverse events were irritability (49%), drowsiness (37%), and loss of appetite (29%). Clinical Trial Adve rs e Drug Re actions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In clinical trials, FLULAVAL TETRA was administered to more than 6,660 subjects. Adverse reactions reported for FLULAVAL TETRA are listed per dose according to the following frequency categories: FLULAVAL TETRA (2021-2022) GlaxoSmithK line Approved: Page 7 of 28 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 The following adverse reactions have been reported in all age categories: Sys te m Organ Clas s Adve rs e Re actions Fre que ncy General disorder and administration site condition Injection site pain Very common Injection site redness and fever Common Infections and infestations Upper respiratory tract infection Uncommon The following adverse reactions have also been reported depending of the age category: Childre n (5-17) and Adults.