Meningococcal Group B Vaccine (4 strain) suspension for injection

What is this medication?

MENINGOCOCCAL GROUP B VACCINE, RECOMBINANT (muh ning goh KOK kal vak SEEN) is a vaccine to protect from bacterial meningitis. This vaccine does not contain live bacteria. It will not cause a meningitis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TRUMENBA

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

•fever or infection

•immune system problems

•an unusual or allergic reaction to meningococcal vaccine, other medicines, foods, dyes, or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I use this medication?

This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.

A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 10 years of age for selected conditions, precautions do apply.

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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

•certain medicines that treat or prevent blood clots

•medicines that lower your chance of fighting infection

•other 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 are worrisome to your doctor right away.

This vaccine may not protect from all meningitis infections.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•breathing problems

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

•chills

•diarrhea

•fever

•headache

•joint pain

•muscle pain

•pain, redness, or irritation at site where injected

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.

Where should I keep my medication?

This vaccine is given in a hospital or clinic and 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.