Pronunciation:

me-NINJ-oh-kok-kal VAX-een

Brand Names:

• Bexsero
• Menactra
• Menomune-A/C/Y/W-135
• MenQuadfi
• Menveo
• Trumenba

Dosage Forms:

• Suspension
• Kit
• Solution

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Meningococcal vaccine is an active immunizing agent used to prevent infection caused by certain groups of meningococcal bacteria (Neisseria meningitides). The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Menomune® is active against groups A, C, Y and W-135 meningococcal bacteria only.

Bexsero® and Trumenba® is active against group B meningococcal bacteria only. .

Meningococcal infection can cause life-threatening illnesses, such as meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. Some persons with meningococcal meningitis and/or meningococcemia also may die. These diseases are more likely to occur in young children and in persons with certain diseases or conditions that make them more susceptible to a meningococcal infection or more likely to develop serious problems from a meningococcal infection.

Immunization against meningococcal disease is recommended for persons who are at risk of getting the disease because:

• They have certain diseases or conditions that make them more susceptible to a meningococcal infection or more likely to develop serious problems from a meningococcal infection.
• They are living in, working in, or visiting an area where there is a strong possibility of contracting meningococcal disease.

Menomune® is recommended for use in patients 2 years of age and older.

Bexsero® and Trumenba® is recommended for use in patients 10 to 25 years of age. .

This vaccine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Menomune® in children younger than 2 years of age. However, in some cases children as young as 3 months of age may be vaccinated.

Appropriate studies have not been performed on the relationship of age to the effects of Bexsero® and Trumenba® in children younger than 10 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of meningococcal vaccine in adults older than 65 years of age. Safety and efficacy have not been established.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Measles Virus Vaccine, Live
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune system problems—Use with caution. May decrease the effects of this vaccine.

• Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine.

Proper Use of This Medicine:

A nurse or other trained health professional will give this vaccine to you or your child. It is given as a shot under your skin or into one of your muscles.

Trumenba®: An injection is given into a muscle. It is very important for you or your child to receive all of the shots for the vaccine.

• Two-dose schedule: Given at least 6 months apart (0 and 6 months). If the second dose is given earlier than 6 months after the first dose, you will receive a third dose at least 4 months after the second dose.
• Three-dose schedule: After you receive the first dose (0 month), you will receive a second dose after 1 to 2 months. The third dose is given 6 months after the first dose.

Bexsero®: An injection is given into a muscle. Two doses, each given at least 1 month apart. It is very important for you or your child to receive all of the 2 shots for the vaccine.

Menomune®: One dose injected under the skin. Usually a person needs to receive the vaccine only once. However, additional injections may be needed for young children who remain at high risk for meningococcal disease.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

Fainting may occur while you are receiving this vaccine. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.

The tip caps of Bexsero® prefilled syringes contain dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex.

It is important that your doctor should know about all other vaccines you or your child have recently received, including a flu shot.

This vaccine may not protect everyone who receives it. It will not treat symptoms of meningococcal infection if you already have the disease.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chills

Less common

Fever over 100 degrees F

general feeling of discomfort or illness

Incidence not known

Cough

difficulty with breathing or swallowing

dizziness

fainting

fast heartbeat

hives, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

reddening of the skin, especially around the ears

unusual tiredness or weakness (sudden and severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty with moving

headache

joint or muscle pain

nausea

redness, tenderness, soreness, or pain at the injection site

Less common

Hard lump at the injection site

Incidence not known

Blisters at or around the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.