FLUCELVAX Trivalent is a vaccine containing the inactivated active ingredient influenza virus hemagglutinin (HA) derived from three virus strains. It is a trivalent subunit influenza vaccine manufactured using MDCK cells and comes as a sterile injectable suspension. The vaccine is available in pre-filled syringes without preservatives or in multi-dose vials containing thimerosal as a preservative. Inactive ingredients include cetyltrimethylammonium bromide and β-propiolactone. FLUCELVAX Trivalent is intended to help protect against influenza for the 2024-2025 season.

How should I use this medication?

This vaccine is injected into a muscle or under the skin. It is given by your care team.

A copy of Vaccine Information Statements will be given before each vaccination. Be sure to read this sheet carefully each time. This sheet may change often.

Talk to your care team to see which vaccines are right for you. Some vaccines should not be used in all age groups.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

Where should I keep my medication?

The vaccine is only given by your care team. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Chills
• Fatigue
• Headache
• Joint pain
• Loss of appetite
• Muscle pain
• Nausea
• Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder like hemophilia
• Fever or infection
• Guillain-Barre syndrome or other neurological problems
• Immune system problems
• Infection with the human immunodeficiency virus (HIV) or AIDS
• Low blood platelet counts
• Multiple sclerosis
• An unusual or allergic reaction to influenza virus vaccine, latex, other medications, foods, dyes, or preservatives. Different brands of vaccines contain different allergens. Some may contain latex or eggs. Talk to your care team about your allergies to make sure that you get the right vaccine.
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Certain medications that lower your immune system, such as etanercept, anakinra, infliximab, adalimumab
• Certain medications that prevent or treat blood clots, such as warfarin
• Chemotherapy or radiation therapy
• Phenytoin
• Steroid medications, such as prednisone or cortisone
• Theophylline
• Vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Report any side effects that do not go away with your care team. Call your care team if any unusual symptoms occur within 6 weeks of receiving this vaccine.

You may still catch the flu, but the illness is not usually as bad. You cannot get the flu from the vaccine. The vaccine will not protect against colds or other illnesses that may cause fever. The vaccine is needed every year.