Flublok

What is Flublok?

• Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine.

What are the uses of this medicine?

• Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza B viruses contained in the vaccine.

How does this medicine work?

• Flublok Quadrivalent contains recombinant HA proteins of the four strains of influenza virus specified by health authorities for inclusion in the annual seasonal vaccine. These proteins function as antigens which induce a humoral immune response, measured by hemagglutination inhibition (HI) antibody.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.

What drug interactions can this medicine cause?

• Data evaluating the concomitant administration of Flublok Quadrivalent with other vaccines are not available.

Is this medicine FDA approved?

• Initial U.S. Approval: 2013

How should this medicine be used?

Recommended Dosage:

• For intramuscular (IM) injection only (0.5 mL)

Administration

• Invert the prefilled syringe containing Flublok Quadrivalent gently prior to affixing the appropriate size needle for intramuscular 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.
• The preferred site for injection is the deltoid muscle. Flublok Quadrivalent should not be mixed in the same syringe with any other vaccine.

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

This medicine is available in fallowing doasage form:

• As a sterile solution for injection supplied in 0.5 mL single dose prefilled syringes.

This medicine is available in fallowing brand namesː

• Flublok

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection-site reactions
• headache
• fatigue
• myalgia
• arthralgia

What special precautions should I follow?

• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
• The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré Syndrome (GBS). If Guillain Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give Flublok Quadrivalent should be based on careful consideration of potential benefits and risks.
• If Flublok Quadrivalent is administered to immunocompromised individuals, including persons receiving immunosuppressive therapy, the immune response may be diminished.
• Vaccination with Flublok Quadrivalent may not protect all vaccine recipients.

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?

• Pregnancy outcomes in women exposed to Flublok Quadrivalent during pregnancy are being monitored. Contact: Sanofi Pasteur Inc. by calling 1-800-822-2463.

Can this medicine be used in children?

• Safety and effectiveness of Flublok Quadrivalent have not been established in children 3 years to less than 18 years of age.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN
• INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN
• INFLUENZA B VIRUS B/WASHINGTON/02/2019 RECOMBINANT HEMAGGLUTININ ANTIGEN
• INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN

Inactive ingredients:

• SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
• SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
• SODIUM CHLORIDE
• POLYSORBATE 20
• OCTOXYNOL-9
• WATER

Who manufactures and distributes this medicine?

Manufactured by Protein Sciences Corporation (Meriden, CT).

• U.S. license No. 1795.

Distributed by Sanofi Pasteur Inc.

• Flublok is a registered trademark of Protein Sciences Corporation.

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

• Store refrigerated between 2°C and 8°C (36°F and 46°F).
• Do not freeze. Discard if product has been frozen.
• Protect syringes from light.
• Do not use after expiration date shown on the label.

• Dailymed label info on Flublok
• FDA Flublok

Flublok Resources
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