Influenza Virus Vaccine (Recombinant)

Use influenza virus vaccine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about influenza virus vaccine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about influenza virus vaccine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using influenza virus vaccine.

Review Date: October 4, 2017

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intramuscular [preservative free]:

Flublok: (0.5 mL) [no egg protein]

Flublok: (0.5 mL) [thimerosal free]

Solution Prefilled Syringe, Intramuscular [preservative free]:

Flublok Quadrivalent: 0.5 mL (0.5 mL) [egg free]

• Vaccine
• Vaccine, Recombinant

Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine

There are no dosage adjustments provided in the manufacturer’s labeling.

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

>10%:

Central nervous system: Headache (older adults 10% to 17%), fatigue (13% to 15%)

Local: Pain at injection site (37%, older adults 19% to 32%)

Neuromuscular & skeletal: Myalgia (8% to 11%)

1% to 10%:

Central nervous system: Chills (older adults 5%)

Gastrointestinal: Nausea (4% to 6%)

Local: Injection site reactions (3% to 7%; includes redness, swelling and firmness)

Neuromuscular & skeletal: Arthralgia (older adults 6% to 8%)

Respiratory: Cough (1% to 2%), nasal congestion (1% to 2%), nasopharyngitis (1% to 2%), pharyngolaryngeal pain (1% to 2%), rhinorrhea (1% to 2%), upper respiratory tract infection (1% to 2%)

<1% (Limited to important or life-threatening): Hypersensitivity reaction, pleuropericarditis

Adverse events were not observed in animal reproduction studies. Information specific to the use of RIV in pregnancy has not been located.

Pregnant women are at an increased risk of complications from influenza infection (Rasmussen 2008). Influenza vaccination with the inactivated influenza vaccine (IIV) is recommended for all women who are or will become pregnant during the influenza season and who do not otherwise have contraindications to the vaccine (CDC/ACIP [Grohskopf 2016]).

Pregnant women should observe the same precautions as nonpregnant women to reduce the risk of exposure to influenza and other respiratory infections (CDC/HHS 2016). When vaccine supply is limited, focus on delivering the vaccine should be given to women who are pregnant or will be pregnant during the flu season, as well as mothers of newborns and contacts or caregivers of children <5 years of age (CDC/ACIP [Grohskopf 2016]).

Health care providers are encouraged to refer women exposed to the influenza vaccine during pregnancy to the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) by contacting The Organization of Teratology Information Specialists (OTIS) at (877) 311-8972. Women exposed to this vaccine during pregnancy may also contact the Flublok pregnancy registry at 888-855-7871.