Family Doctor 2008

CSL Biotherapies BRIEF SUMMARY OF PRESCRIBING INFORMATION AFLURIA Inﬂuenza Virus Vaccine Suspension for Intramuscular Injection ® Before prescribing, please consult full prescribing information, a brief summary of which follows. Some text and references refer to full prescribing information. 4 CONTRAINDICATIONS AFLURIA® is contraindicated in individuals with known hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or in anyone who has had a life-threatening reaction to previous inﬂuenza vaccination. 5 WARNINGS AND PRECAUTIONS 5.1 Guillain-Barré Syndrome (GBS) If GBS has occurred within 6 weeks of previous inﬂuenza vaccination, the decision to give AFLURIA® should be based on careful consideration of the potential beneﬁts and risks. 5.2 Altered Immunocompetence If AFLURIA® is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished. 5.3 Preventing and Managing Allergic Reactions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. 5.4 Limitations of Vaccine Effectiveness Vaccination with AFLURIA® may not protect all individuals. 6 ADVERSE REACTIONS 6.1 Overall Adverse Reactions Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AFLURIA®. The most common local (injection-site) adverse reactions observed in clinical studies with AFLURIA® were tenderness, pain, redness, and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches. 6.2 Safety Experience from Clinical Studies Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another vaccine and may not reﬂect the rates observed in clinical practice. Clinical safety data for AFLURIA® have been obtained in two clinical studies (see Clinical Studies [14]). A US study (Study 1) included 1,357 subjects for safety analysis, ages 18 to less than 65 years, randomized to receive AFLURIA®, Inﬂuenza Virus Vaccine Suspension for Intramuscular Injection, (1,089 subjects) or placebo (268 subjects) (see Clinical Studies [14] for study demographics). There were no deaths or serious adverse events reported in this study. A UK study (Study 2) included 275 subjects, ages 65 years and older, randomized to receive preservative-free AFLURIA® (206 subjects) or a European-licensed trivalent inactivated inﬂuenza vaccine as an active control (69 subjects) (see Clinical Studies [14]). There were no deaths or serious adverse events reported in this study. The safety assessment was identical for the two studies. Local (injection-site) and systemic adverse events were solicited by completion of a symptom diary card for 5 days post-vaccination (Table 1). Unsolicited local and systemic adverse events were collected for 21 days post-vaccination (Table 2). These unsolicited adverse events were reported either spontaneously or when subjects were questioned about any changes in their health post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators. Table 1: Proportion of Subjects With Solicited Local or Systemic Adverse Events* Within 5 Days After Administration of AFLURIA® or Placebo, Irrespective of Causality† Study 1 Subjects ≥ 18 to < 65 years Placebo § AFLURIA ® ‡ n=268 n=1089 Study 2 Subjects ≥ 65 years AFLURIA ® n=206 Redness Swelling Bruising Systemic Headache Malaise Muscle aches Nausea Chills/ Shivering Fever ≥ 37.7°C (99.86 °F) Vomiting Study 1 Subjects ≥ 18 to < 65 years 16% 8% 9% 1% 5% 1% Study 2 Subjects ≥ 65 years 23% 11% 4% 26% 20% 13% 6% 3% 1% 1% 26% 19% 9% 9% 2% 1% 1% 15% 10% 14% 3% 7% 1% 0% * In Study 1, 87% of solicited local and systemic adverse events were mild, 12% were moderate, and 1% were severe. In Study 2, 76.5% were mild, 20.5% were moderate, and 3% were severe. In both studies, most solicited local and systemic adverse events lasted no longer than 2 days. † Values rounded to the nearest whole percent. ‡ Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA®. § Thimerosal-containing placebo. II Tenderness deﬁned as pain on touching. ¶ Pain deﬁned as spontaneously painful without touch. Table 2: Adverse Events* Reported Spontaneously by � 1% of Subjects Within 21 Days After Administration of AFLURIA® or Placebo, Irrespective of Causality† Subjects AFLURIA ® ‡ n=1089 8% 1% 1% 1% 3% 3% 2% 2% 2% 0.4% Adverse Event Headache Nasal Congestion Cough Rhinorrhea Pharyngolaryngeal Pain Reactogenicity Event Diarrhea Back Pain Upper Respiratory Tract Infection Viral Infection Lower Respiratory Tract Infection Myalgia Muscle Spasms Study 1 18 to < 65 years Placebo § n=268 6% 1% 0.4% 1% 1% 3% 3% 0.4% Study 2 Subjects 65 years AFLURIA ® n=206 8% 7% 5% 5% 5% 0% 1% 2% 0.5% 1% 1% 0% 1% 1% 0% 1% 1% 0% 0% 1% 0.4% * In Study 1, 63% of unsolicited adverse events were mild, 35% were moderate, and 2% were severe. In Study 2, 47% were mild, 51% were moderate, and 3% were severe. In both studies, most unsolicited adverse events lasted no longer than 5 days. † Values greater than 0.5% rounded to the nearest whole percent. ‡ Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA®. § Thimerosal-containing placebo. Solicited Adverse event Local Tenderness Pain ¶ 60% 40% 18% 9% 34% 9% 6.3 Postmarketing Experience Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or inﬂuenza immunizations speciﬁcally; 2) are potentially serious; or 3) have been reported frequently. The following adverse reactions also include those identiﬁed during postapproval use of AFLURIA®, Inﬂuenza Virus Vaccine Suspension for Intramuscular Injection, outside the US since 1985. Blood and lymphatic system disorders Transient thrombocytopenia Immune system disorders Allergic reactions including anaphylactic shock and serum sickness Nervous system disorders Neuralgia, paresthesia, and convulsions; encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS Vascular disorders Vasculitis with transient renal involvement Skin and subcutaneous tissue disorders Pruritus, urticaria, and rash General disorders and administration site conditions Inﬂuenza-like illness (e.g., pyrexia, chills, headache, malaise, myalgia), injection-site inﬂammation (e.g., pain, erythema, swelling, warmth), and induration 6.4 Other Adverse Reactions Associated With Inﬂuenza Vaccination Anaphylaxis has been reported after administration of AFLURIA®. Although

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Family Doctor 2008 Foreward Introduction Contents What Do You Want From Health Care? Confident Communication Need a New Doctor? Understanding Your Health Insurance OTC Safety as Simple as 1-2-3 The Fight Against Resistance Drug Interactions Prevention is Better than Cure Hitting a Home Run 'The Herbalist Will See You Now' Healthy Eating to Boost Your Heart and Health Exercise: The Elixir of Life Back from the Brink Taking Control Up All Night Vitamins and Minerals 101 Allergies: Combating the Causes Protect Yourself From Colds and the Flu Diabetes: Assessing Your Risk Dealing with Diabetes The Cholesterol Count Getting a Grip on Hypertension Facts About CKD Banish the Burn Easing the Pain Stop the Pounding Urinary Tract Infections: Common and Preventable Skin Essentials The ABCs of COPD Impotence: Tackling the Old Taboo Taking Responsibility for Your Health Prostate Cancer Screening: Is it For You? Protecting Your Prostate Heart Disease and Women: Know the Risks Birth Control to Suit You Maneuvering Through Menopause Help for PMS Infertility: Problems Having a Baby Preventive Health: What Women Need to Know Pregnancy: Taking Care of You and Your Baby Eating for Two Postpartum Mood Disorders The Basics of Breast Milk Newborn Screening Tests: Possible Lifesavers Common Newborn Conditions Childhood Vaccines: Why They're Necessary Food Allergies: The Facts Facing Your Acne Raising Grades Staying On Your Feet Age Gracefully: Take Care of Your Bones Battling Osteoarthritis Tackling Anxiety Beating the Blues

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