FLUAD FOR YOUR ELDERLY PATIENTS:

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1 FLUAD FOR YOUR ELDERLY PATIENTS: The first adjuvanted seasonal flu vaccine, from Novartis 1,2 FLUAD is an inactivated influenza virus vaccine indicated for active immunization against influenza in the elderly (65 years of age and older). Consistently numerically higher immune responses to tested heterovariant and homologous strains were observed for FLUAD in the elderly population and the difference was statistically significant for some strains and/or some endpoints, as compared to the comparator. The National Advisory Committee on Immunization (NACI) encourages annual vaccination for all Canadians who have no contraindication (CCDR 2009). Vaccine should be offered to the elderly up to and even after influenza virus activity is documented in a community. Comparative clinical significance is unknown.

2 INFLUENZA IN CANADA: AN OVERVIEW

3 INFLUENZA: A SIGNIFICANT BURDEN FOR ELDERLY CANADIANS Medical risk factors In older adults, the combination of immunosenescence and frequent comorbidities increases susceptibility to infection and the risk of severe outcomes 3-5 Waning immunity 3 and comorbidities (chronic disease) 4 Increased susceptibility to infection 3 Increased severity of infection 5 Increased risk of hospitalization 6 Increased mortality rate 7,8 FLUAD is not indicated to reduce complications or mortality associated with influenza.

4 UP TO 9 IN 10 DEATHS DUE TO FLU OCCUR IN THE ELDERLY 80 90% of influenza-attributable deaths occur in adults 65 years of age 7 Deaths due to influenza, pneumonia, and chronic lung disease shown to increase during influenza season (based on data) 7 Annual average of 3,484 influenza-attributable deaths ( ) 8 Elderly people are at increased risk of flu complications, especially if they have conditions like diabetes, CV or respiratory disease 9,10 FLUAD is not indicated to reduce complications or mortality associated with influenza. A study designed to examine the impact of influenza-associated respiratory illnesses on the Winnipeg health care system, including hospitalizations, physician visits and emergency room visits. Their impact on mortality was also examined. Administrative data were used to track health care use and mortality over four influenza seasons ( to ). Weekly mortality data for Canada from the to the influenza seasons were analyzed by cause of death, age group, and place of death to estimate the impact of influenza on mortality.

5 A CLOSER LOOK AT IMPACT IN THE ELDERLY Hospitalization and mortality rates due to pneumonia and influenza ( ) Rate per 1,000 people Hospitalization rate Mortality rate Adapted from Sebastian et al. 6 FLUAD is not indicated in patients under the age of 65, nor to reduce complications or mortality associated with influenza A study designed to examine associations between influenza medical visits and population-wide hospitalization/mortality due to pneumonia and influenza using administrative datasets in British Columbia, Canada. Provincial and national influenza surveillance reports were reviewed to characterize each influenza season in BC from to Data pertain to patients aged 65 years.

6 CONSIDER THE RISK OF ANTIGENIC DRIFT In the elderly, vaccine effectiveness is about half of that of healthy adults and varies depending on the outcome and the study population. 10 Antibody against one influenza virus type or subtype may confer limited or no protection against another 1 Antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype 1 Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics 1

7 FLUAD : INFLUENZA PROTECTION FOR YOUR ELDERLY PATIENTS

8 FLUAD : THE FIRST TRIVALENT, ADJUVANTED INFLUENZA VACCINE 1,2 A trivalent, surface antigen, inactivated influenza vaccine containing the three strains recommended by WHO and NACI each year: 1 A/California/7/2009 (H1N1)pdm09-like virus A/Texas/50/2012(H3N2)-like virus B/Massachusetts/2/2012-like virus FLUAD with MF59 adjuvant has been shown to increase antibody production vs. non-adjuvanted vaccine 1 FLUAD is adjuvanted with MF59, an oil-in-water emulsion composed of squalene as the oil phase, stabilized with the surfactants polysorbate 80 and sorbitan trioleate, in citrate buffer 1 FLUAD may have trace amounts of antibiotics (kanamycin, neomycin), ovalbumin, formaldehyde, CTAB (cetyltrimethylammonium bromide), or barium 1 FLUAD is an inactivated influenza virus vaccine indicated for active immunization against influenza in the elderly (65 years of age and older). Comparative clinical significance is unknown.

9 FLUAD : EFFICACY PROFILE

10 FLUAD PIVOTAL STUDY V7P17: DESIGN A randomized, comparator-controlled, observer-blind clinical study 1 Designed to support immunogenicity of FLUAD vs. the non-adjuvanted vaccine, AGRIFLU, in patients 65 years of age 1

11 FLUAD : INCREASED IMMUNE RESPONSE SHOWN VS. NON-ADJUVANTED AGRIFLU FLUAD subjects developed statistically higher antibody levels vs. non-adjuvanted AGRIFLU at day 28 (homologous strains) 1 Geometric mean titer (GMT) H3N2 H1N1 B FLUAD (n=147) AGRIFLU (n=150) 206 Adapted from Product Monograph 1 Vaccine group ratio (99.17% CI): H3N2: 1.81 ( ); H1N1: 1.38 ( ); B: 1.41 ( ) Comparative clinical significance is unknown. A randomized, comparator-controlled, observer-blind clinical study in subjects 65 years to support the immunogenicity of FLUAD compared with conventional non-adjuvanted influenza vaccine (AGRIFLU ).

12 FLUAD : NUMERICALLY OR STATISTICALLY HIGHER SEROCONVERSION RATES SHOWN VS. NON-ADJUVANTED AGRIFLU (HOMOLOGOUS STRAINS) 1 Postvaccination seroconversion at day 28 (HI assay) 1 Subjects with seroconversion/significant increase in HI titer (%) Statistically superior 55 Numerically superior Statistically superior 48 H3N2 H1N1 B 33 FLUAD (n=147) AGRIFLU (n=150) Adapted from Product Monograph 1 Vaccine group difference (99.17% CI): H3N2: 19 (4 33); H1N1: 11 (-3 25, not statistically significant); B: 16 (1 30) Comparative clinical significance is unknown.

13 FLUAD STUDY V7P3: DESIGN An immunogenicity study vs. AGRIFLU 1 Designed to analyze cross-reactivity to heterovariant influenza strains in patients aged 65 years 1

14 NUMERICALLY OR STATISTICALLY HIGHER IMMUNE RESPONSE SHOWN AGAINST ANTIGENICALLY DRIFTED STRAINS VS. NON-ADJUVANTED AGRIFLU Postvaccination circulating antibody levels (GMTs) at day 28 for heterovariant influenza strains (HI assay) 1 Numerically superior Statistically superior 300 Geometric mean titer (GMT) FLUAD (n=39) AGRIFLU (n=35) 0 H3N2 H1N1 B Adapted from Product Monograph 1 Vaccine group ratio (99.17% CI): H3N2: 1.75 ( ); H1N1: 2.03 ( ); B: 1.9 ( ) Comparative clinical significance is unknown.

15 FLUAD : SAFETY PROFILE, ADMINISTRATION AND PACKAGING

16 FLUAD : A PROVEN SAFETY PROFILE Most frequently reported adverse events in trials FLUAD (n=3,713) Comparator (n=1,656) 20 Patients (%) Injection site pain Temperature at injection site Erythema Fatigue Headache Malaise Myalgia Adapted from Product Monograph 1 Most frequently reported local and systemic events were mild to moderate and transient 3% and 1% of subjects reported a severe local or systemic reaction, respectively Local adverse events occurring within 4 days of vaccination. Systemic adverse events occurring within 4 days of vaccination.

17 FLUAD : DOSAGE AND ADMINISTRATION (ADULTS 65 YEARS OF AGE) ml intramuscularly, preferably in the region of the deltoid muscle of the upper arm (not intravascularly or subcutaneously) - FLUAD should not be injected in the gluteal region or areas where there may be a major nerve trunk FLUAD should not be mixed with other vaccines in the same syringe Separate injection limbs should be used if more than one vaccine is being administered during the same visit FLUAD should under no circumstances be administered by any other route than intramuscularly. Duration of postvaccination immunity to homologous strains or strains closely related to the vaccine varies, but is usually 6 12 months 1 Seroprotection with FLUAD is generally obtained within 2 to 3 weeks after vaccination 1.

18 FLUAD : STORAGE AND STABILITY 1 Store FLUAD between 2 and 8 C Do not freeze Do not use if vaccine has been frozen Protect from light Do not use vaccine after expiration date FLUAD can be administered following a 2-hour exposure at temperatures between 8 and 25ºC. This is not, however, a recommendation for storage

19 FLUAD : PACKAGING 1 A sterile milky-white suspension for intramuscular injection in 1 ml prefilled glass syringes containing a 0.5 ml dose The syringe plunger does not contain latex FLUAD is considered safe for use in persons with latex allergies Supplied in packages containing ten single-dose prefilled syringes

20 FLUAD : DEMONSTRATED NUMERICALLY OR STATISTICALLY SUPERIOR IMMUNE RESPONSE VS. NON-ADJUVANTED AGRIFLU FLUAD is the first and only seasonal flu vaccine coupled with the MF59 adjuvant 1 Numerically or statistically superior immunogenicity shown vs. non-adjuvanted AGRIFLU Numerically or statistically higher immune response against antigenically drifted strains shown vs. AGRIFLU Established safety profile Comparative clinical significance is unknown.

21 Indications and clinical use: FLUAD is an inactivated influenza virus vaccine indicated for active immunization against influenza in the elderly (65 years of age and older). The National Advisory Committee on Immunization (NACI) encourages annual vaccination for all Canadians who have no contraindication (CCDR 2009). Vaccine should be offered to the elderly up to and even after influenza virus activity is documented in a community. Contraindications: Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimethylammonium bromide (CTAB) Patients who have had a life-threatening reaction to previous influenza vaccination Relevant warnings and precautions: Intramuscular administration Patients with clinically significant bleeding disorders Patients with endogenous or iatrogenic immunosuppression Patients who have had Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine Availability of appropriate medical treatment and supervision in case of a rare anaphylactic event following administration of the vaccine Patients with febrile illness or acute infections For more information: Please consult the Product Monograph at FluadMonograph for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling the Medical Information department at References: 1. FLUAD Product Monograph. Novartis Pharmaceuticals Canada Inc., May 7, Data on file. Novartis Pharmaceuticals Canada Inc. 3. Percival SL. Ageing theories, diseases and microorganisms. In: Percival SL, editor. Microbiology and Aging. Clinical manifestations. Flintshire, UK: Humana Press; p Ohlsen K et al. Infections in the elderly. In: Percival SL, editor. Microbiology and aging: Clinical manifestations. Flintshire, UK: Humana Press; p Hayden G. Influenza in the elderly. In: Cooper JW, editor. Antivirals in the elderly. Binghamton, NY: Pharmaceutical Products Press; p Sebastian R, Skowronski DM, Chong M et al. Age-related trends in the timeliness and prediction of medical visits, hospitalizations and deaths due to pneumonia and influenza, British Columbia, Canada, Vaccine 2008;26: Menec VH, Black C, MacWilliam L and Aoki FY. The impact of influenza-associated respiratory illnesses on hospitalizations, physician visits, emergency room visits, and mortality. Can J Public Health 2003;94: Schanzer DL, Tam TW, Langley JM and Winchester BT. Influenza-attributable deaths, Canada Epidemiol Infect 2007;135: World Health Organization. Influenza vaccines: WHO position paper. Wkly Epidemiol Rec 2005;80: Public Health Agency of Canada. Statement on seasonal influenza vaccine for CCDR August 2012;38(ACS-2):1-36. FLUAD, AGRIFLU and MF59 are registered trademarks. Product Monographs available on request. Printed in Canada Novartis Pharmaceuticals Canada Inc FLU012E