Fluarix, Fluarix Quadrivalent

What is Fluarix, Fluarix Quadrivalent?

• Fluarix, Fluarix Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

What are the uses of this medicine?

• Fluarix, Fluarix Quadrivalent is used for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
• FLUARIX QUADRIVALENT is approved for use in persons aged 6 months and older.

How does this medicine work?

• Influenza illness and its complications follow infection with influenza viruses.
• Global surveillance of influenza identifies yearly antigenic variants.
• Since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation.
• FLUARIX (trivalent influenza vaccine) contains 2 influenza A subtype viruses and one influenza type B virus.
• Inactivated influenza vaccines are standardized to contain the hemagglutinins of influenza viruses.
• Annual revaccination is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus change from year to year.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine.

What drug interactions can this medicine cause?

• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater-than-physiologic doses), may reduce the immune response to FLUARIX QUADRIVALENT.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• One dose or 2 doses (0.5‑mL each) depending on vaccination history as per the annual Advisory Committee on Immunization Practices (ACIP) recommendation on prevention and control of seasonal influenza with vaccines.
• If 2 doses, administer each 0.5‑mL dose at least 4 weeks apart.

Administration:

• Shake well before administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• If either of these conditions exists, the vaccine should not be administered.
• Attach a sterile needle to the prefilled syringe and administer intramuscularly.
• The preferred sites for intramuscular injection are the anterolateral thigh for children aged 6 through 11 months and the deltoid muscle of the upper arm for persons aged 12 months and older if muscle mass is adequate. Do not inject in the gluteal area or areas where there may be a major nerve trunk.
• Do not administer this product intravenously, intradermally, or subcutaneously.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Suspension for injection supplied in 0.5‑mL single-dose prefilled syringes.

This medicine is available in fallowing brand namesː

• FLUARIX QUADRIVALENT

What side effects can this medication cause?

The most common side effects of this medicine include: In adults:

• pain
• muscle aches
• headache
• fatigue

In children aged 6 through 35 months:

• pain
• redness
• irritability
• loss of appetite
• drowsiness

In children aged 3 through 5 years:

• drowsiness
• irritability
• loss of appetite

In children aged 6 through 17 years:

• fatigue
• muscle aches
• headache
• arthralgia
• gastrointestinal symptoms

What special precautions should I follow?

• The 1976 swine influenza vaccine was associated with an increased frequency of GBS. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX QUADRIVALENT should be based on careful consideration of potential benefits and risks.
• Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
• Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination‑related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of FLUARIX QUADRIVALENT.
• If FLUARIX QUADRIVALENT is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
• As with other intramuscular injections, FLUARIX QUADRIVALENT should be given with caution in individuals with bleeding disorders, such as hemophilia or on anticoagulant therapy, to avoid the risk of hematoma following the injection.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are insufficient data on FLUARIX QUADRIVALENT in pregnant women to inform vaccine-associated risks.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FLUARIX QUADRIVALENT during pregnancy. Healthcare providers are encouraged to register women by calling 1-888-452-9622.

Can this medicine be used in children?

• Safety and effectiveness of FLUARIX QUADRIVALENT in children younger than 6 months have not been established.
• Safety and effectiveness of FLUARIX QUADRIVALENT in individuals aged 6 months through 17 years have been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)
• INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)
• INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)
• INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)

Inactive ingredients:

• OCTOXYNOL-9
• .ALPHA.-TOCOPHEROL SUCCINATE, D-
• POLYSORBATE 80
• POTASSIUM CHLORIDE
• SODIUM CHLORIDE
• MAGNESIUM CHLORIDE
• SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
• POTASSIUM PHOSPHATE, MONOBASIC
• WATER

Who manufactures and distributes this medicine?

• Manufactured by GlaxoSmithKline Biologicals, Dresden, Germany, a branch of SmithKline Beecham Pharma GmbH & Co. KG, Munich, Germany
• Licensed by GlaxoSmithKline Biologicals, Rixensart, Belgium
• Distributed by GlaxoSmithKline, Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• Store refrigerated between 2º and 8ºC (36º and 46ºF).
• Do not freeze.
• Discard if the vaccine has been frozen.
• Store in the original package to protect from light.

• Dailymed label info on Fluarix, Fluarix Quadrivalent
• FDA Fluarix, Fluarix Quadrivalent

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