Sanofi Pasteur 01 May 2015 v0.2 271/371 Fluzone® LE6746

Sanofi Pasteur 271/371 Fluzone?

01 May 2015 v0.2 LE6746

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

Fluzone (Influenza Vaccine) Suspension for Intramuscular Injection 2015-2016 Formula Initial US Approval 1980

----------------------------INDICATIONS AND USAGE--------------------------------Fluzone 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 is approved for use in persons 6 months of age and older. (1)

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

Age

Dose

Schedule

6 months through 35 One or two doses a, 0.25 mL If 2 doses, administer at

months

each

least 1 month apart

36 months through 8 One or two doses a, 0.5 mL If 2 doses, administer at

years

each

least 1 month apart

9 years and older

One dose, 0.5 mL

-

a1 or 2 doses depends on vaccination history as per Advisory Committee on

Immunization Practices annual recommendations on prevention and control of

influenza with vaccines

"-" Indicates information is not applicable

----------------------------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 of

previous influenza vaccination, the decision to give Fluzone should be based on careful consideration of the potential benefits and risks. (5.1)

-----------------------------ADVERSE REACTIONS------------------------------? In children 6 months through 8 years of age, the most common injection-

site reactions were pain or tenderness (>50%) and redness (>25%); the most common solicited systemic adverse events were irritability and drowsiness (>25% of children 6 months through 35 months) and myalgia (>20% of children 3 years through 8 years). (6.1) ? In adults 18 through 64 years of age, the most common injection-site reaction was pain (>50%); the most common solicited systemic adverse events were headache and myalgia (>30%). (6.1) ? In adults >65 years of age, the most common injection-site reaction was pain (>20%); the most common solicited systemic adverse events were headache, myalgia, and malaise (>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..

-------------------------USE IN SPECIFIC POPULATIONS-----------------? Safety and effectiveness of Fluzone has not been established in pregnant

women. (8.1) ? Antibody responses to Fluzone are lower in persons >65 years of age

than in younger adults. (8.5)

----------------------------DOSAGE FORMS AND STRENGTHS--------------------Suspension for injection supplied in multi-dose vial, 5 mL. (3)

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

Revised: XXXX XXXX

_______________________________________________________________________________________________________________________________________

FULL PRESCRIBING INFORMATION: CONTENTS*

8 USE IN SPECIFIC POPULATIONS

1 INDICATIONS AND USAGE

8.1 Pregnancy

2 DOSAGE AND ADMINISTRATION

8.3 Nursing Mothers

2.1 Dose and Schedule

8.4 Pediatric Use

2.2 Administration

8.5 Geriatric Use

3 DOSAGE FORMS AND STRENGTHS

11 DESCRIPTION

4 CONTRAINDICATIONS

12 CLINICAL PHARMACOLOGY

5 WARNINGS AND PRECAUTIONS

12.1 Mechanism of Action

5.1 Guillain-Barr? Syndrome

13 NON-CLINICAL TOXICOLOGY

5.2 Preventing and Managing Allergic Reactions

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

5.3 Altered Immunocompetence

14 CLINICAL STUDIES

5.4 Limitations of Vaccine Effectiveness

14.1 Efficacy of Fluzone in Children 6 through 24 Months of Age

6 ADVERSE REACTIONS

14.2 Efficacy of Fluzone in Adults

6.1 Clinical Trials Experience

14.3 Immunogenicity of Fluzone in Children 6 Months through 8 Years

6.2 Post-Marketing Experience

of Age

7 DRUG INTERACTIONS

14.4 Immunogenicity of Fluzone in Adults

14.5 Immunogenicity of Fluzone in Geriatric Adults

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

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

listed.

Sanofi Pasteur 271/371 Fluzone?

01 May 2015 v0.2 LE6746

1 FULL PRESCRIBING INFORMATION: 2 1 INDICATIONS AND USAGE

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

8 2 DOSAGE AND ADMINISTRATION

9 ? For intramuscular use only 10 2.1 Dose and Schedule

11 The dose and schedule for Fluzone are presented in Table 1.

12 Table 1: Dose and Schedule for Fluzone

Age 6 months through 35 months

Dose

Schedule

One or two dosesa , 0.25 mL each If 2 doses, administer at least

36 months through 8 years

One or two dosesa , 0.5 mL each

1 month apart If 2 doses, administer at least

1 month apart

9 years and older

One dose, 0.5 mL

-

13 a1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual 14 recommendations on prevention and control of influenza with vaccines

15 "-" Indicates information is not applicable

16

17 2.2 Administration

18 Inspect Fluzone visually for particulate matter and/or discoloration prior to administration. If 19 either of these conditions exist, the vaccine should not be administered. 20

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Sanofi Pasteur 271/371 Fluzone?

01 May 2015 v0.2 LE6746

21 Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial. Withdraw a 22 single dose of vaccine using a sterile needle and syringe. Use a separate sterile needle and syringe 23 for each dose withdrawn from the multi-dose vial. 24 25 The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 26 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if 27 muscle mass is adequate) in persons 12 months through 35 months of age, or the deltoid muscle 28 in persons >36 months of age. The vaccine should not be injected into the gluteal area or areas 29 where there may be a major nerve trunk. 30 31 Do not administer this product intravenously or subcutaneously. 32 33 Fluzone should not be combined through reconstitution or mixed with any other vaccine. 34

35 3 DOSAGE FORMS AND STRENGTHS

36 Fluzone is a suspension for injection. 37 38 Fluzone is supplied in 1 presentation: 39 1) Multi-dose vial, 5 mL, for persons 6 months of age and older. 40

41 4 CONTRAINDICATIONS

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Sanofi Pasteur 271/371 Fluzone?

01 May 2015 v0.2 LE6746

42 A severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description 43 (11)], including egg protein, or to a previous dose of any influenza vaccine is a contraindication to 44 administration of Fluzone. 45

46 5 WARNINGS AND PRECAUTIONS

47 5.1 Guillain-Barr? Syndrome

48 The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barr? 49 syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is 50 inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 51 million persons vaccinated. (1) If GBS has occurred within 6 weeks following previous influenza 52 vaccination, the decision to give Fluzone should be based on careful consideration of the potential 53 benefits and risks. 54 55 5.2 Preventing and Managing Allergic Reactions

56 Appropriate medical treatment and supervision must be available to manage possible anaphylactic 57 reactions following administration of the vaccine. 58 59 5.3 Altered Immunocompetence

60 If Fluzone is administered to immunocompromised persons, including those receiving 61 immunosuppressive therapy, the expected immune response may not be obtained. 62 63 5.4 Limitations of Vaccine Effectiveness

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Sanofi Pasteur 271/371 Fluzone?

01 May 2015 v0.2 LE6746

64 Vaccination with Fluzone may not protect all recipients. 65

66 6 ADVERSE REACTIONS

67 6.1 Clinical Trials Experience

68 Because clinical trials are conducted under widely varying conditions, adverse event rates 69 observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical 70 trial(s) of another vaccine and may not reflect the rates observed in practice. 71 72 Children 6 Months through 8 Years of Age 73 In a multi-center study conducted in the US, children 6 months through 35 months of age received 74 two 0.25 mL doses of Fluzone, and children 3 years through 8 years of age received two 0.5 mL 75 doses of Fluzone, irrespective of previous influenza vaccination history. The two doses (200676 2007 formulation) were administered 26 to 30 days apart. The safety analysis set included 97 77 children 6 months through 35 months of age and 163 children 3 years through 8 years of age. 78 Table 2 and Table 3 summarize solicited injection site reactions and systemic adverse events 79 reported within 7 days post-vaccination via diary cards.

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