HIGHLIGHTS OF PRESCRIBING INFORMATION …

Sanofi Pasteur 372 Fluzone? High-Dose

16 February 2016 v0.1 LE6868

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Fluzone? High-Dose safely and effectively. See full prescribing information for Fluzone High-Dose.

Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection 2016-2017 Formula Initial US Approval: 2009

----------------------------INDICATIONS AND USAGE--------------------------------Fluzone High-Dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. (1) Fluzone High-Dose is approved for use in persons 65 years of age and older. (1)

----------------------------CONTRAINDICATIONS-------------------------------Severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine. (4)

----------------------------WARNINGS AND PRECAUTIONS------------------? If Guillain-Barr? syndrome (GBS) has occurred within 6 weeks following

previous influenza vaccination, the decision to give Fluzone High-Dose should be based on careful consideration of the potential benefits and risks. (5.1) -----------------------------ADVERSE REACTIONS------------------------------? In adults >65 years of age, the most common injection-site reaction was pain (>30%); the most common solicited systemic adverse events were myalgia, malaise, and headache (>10%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or vaers..

----------------------------DOSAGE AND ADMINISTRATION-----------------------? For intramuscular use only

-------------------------USE IN SPECIFIC POPULATIONS-----------------Safety and effectiveness of Fluzone High-Dose has not been established in pregnant women. (8.1)

A single 0.5 mL dose for intramuscular injection in adults 65 years of age and older. (2.1)

See 17 PATIENT COUNSELING INFORMATION and FDA ? approved patient labeling.

Revised: XXXX XXXX

----------------------------DOSAGE FORMS AND STRENGTHS---------------------

Suspension for injection in prefilled syringe (gray plunger rod), 0.5 mL. (3)

_______________________________________________________________________________________________________________________________________

FULL PRESCRIBING INFORMATION: CONTENTS*

8 USE IN SPECIFIC POPULATIONS

1 INDICATIONS AND USAGE

8.1 Pregnancy

2 DOSAGE AND ADMINISTRATION

8.4 Pediatric Use

2.1 Dose and Schedule

8.5 Geriatric Use

2.2 Administration

11 DESCRIPTION

3 DOSAGE FORMS AND STRENGTHS

12 CLINICAL PHARMACOLOGY

4 CONTRAINDICATIONS

12.1 Mechanism of Action

5 WARNINGS AND PRECAUTIONS

13 NON-CLINICAL TOXICOLOGY

5.1 Guillain-Barr? Syndrome

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

5.2 Preventing and Managing Allergic Reactions

14 CLINICAL STUDIES

5.3 Altered Immunocompetence

14.1 Immunogenicity of Fluzone High-Dose in Geriatric Adults

5.4 Limitations of Vaccine Effectiveness

14.2 Efficacy of Fluzone High-Dose in Adults 65 Years of Age and Older

6 ADVERSE REACTIONS

15 REFERENCES

6.1 Clinical Trials Experience

16 HOW SUPPLIED/STORAGE AND HANDLING

6.2 Post-Marketing Experience

16.1 How Supplied

7 DRUG INTERACTIONS

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not

listed.

Sanofi Pasteur 372 Fluzone? High-Dose

16 February 2016 v0.1 LE6868

1 FULL PRESCRIBING INFORMATION: 2 1 INDICATIONS AND USAGE

3 Fluzone? High-Dose is a vaccine indicated for active immunization for the prevention of 4 influenza disease caused by influenza A subtype viruses and type B virus contained in the 5 vaccine. 6 7 Fluzone High-Dose is approved for use in persons 65 years of age and older. 8

9 2 DOSAGE AND ADMINISTRATION

10 ? For intramuscular use only 11 2.1 Dose and Schedule

12 Fluzone High-Dose should be administered as a single 0.5 mL injection by the intramuscular 13 route in adults 65 years of age and older. 14 15 2.2 Administration

16 Inspect Fluzone High-Dose visually for particulate matter and/or discoloration prior to 17 administration. If either of these conditions exist, the vaccine should not be administered. 18 19 Before administering a dose of vaccine, shake the prefilled syringe. 20 21 The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be 22 injected into the gluteal area or areas where there may be a major nerve trunk. 23

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Sanofi Pasteur 372 Fluzone? High-Dose

16 February 2016 v0.1 LE6868

1 Do not administer this product intravenously or subcutaneously. 2 3 Fluzone High-Dose should not be combined through reconstitution or mixed with any other 4 vaccine. 5

6 3 DOSAGE FORMS AND STRENGTHS

7 Fluzone High-Dose is a suspension for injection. 8 9 Fluzone High-Dose is supplied in prefilled syringes (gray syringe plunger rod), 0.5 mL, for adults 10 65 years of age and older. 11

12 4 CONTRAINDICATIONS

13 A severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description 14 (11)], including egg protein, or to a previous dose of any influenza vaccine is a contraindication to 15 administration of Fluzone High-Dose. 16

17 5 WARNINGS AND PRECAUTIONS

18 5.1 Guillain-Barr? Syndrome

19 If Guillain-Barr? syndrome (GBS) has occurred within 6 weeks following previous influenza 20 vaccination, the decision to give Fluzone High-Dose should be based on careful consideration of 21 the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated 22 risk of GBS. Evidence for a causal relation of GBS with other influenza vaccines is inconclusive;

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Sanofi Pasteur 372 Fluzone? High-Dose

16 February 2016 v0.1 LE6868

1 if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons 2 vaccinated. (See references 1 and 2.) 3 4 5.2 Preventing and Managing Allergic Reactions

5 Appropriate medical treatment and supervision must be available to manage possible anaphylactic 6 reactions following administration of the vaccine. 7 8 5.3 Altered Immunocompetence

9 If Fluzone High-Dose is administered to immunocompromised persons, including those receiving 10 immunosuppressive therapy, the expected immune response may not be obtained. 11 12 5.4 Limitations of Vaccine Effectiveness

13 Vaccination with Fluzone High-Dose may not protect all recipients. 14

15 6 ADVERSE REACTIONS

16 6.1 Clinical Trials Experience

17 Because clinical trials are conducted under widely varying conditions, adverse event rates 18 observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical 19 trial(s) of another vaccine and may not reflect the rates observed in practice. 20 Two clinical studies have evaluated the safety of Fluzone High-Dose. 21 Study 1 (NCT00391053, see ) was a multi-center, double-blind pre22 licensure trial conducted in the US. In this study, adults 65 years of age and older were

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Sanofi Pasteur 372 Fluzone? High-Dose

16 February 2016 v0.1 LE6868

1 randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study 2 compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. The safety 3 analysis set included 2573 Fluzone High-Dose recipients and 1260 Fluzone recipients. 4 5 Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 6 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination 7 and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and 8 systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared 9 to Fluzone. 10

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