Pronunciation:

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

Brand Names:

• Bexsero
• Menactra
• MenQuadfi
• Menveo
• Trumenba

Dosage Forms:

• Suspension
• Kit
• Solution
• Powder for Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

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

Meningococcal infection can cause life-threatening illnesses, including meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. 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.

This vaccine 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 Penbraya™ vaccine 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 Penbraya™ vaccine in geriatric patients. 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—This condition may decrease the useful effects of the vaccine.

• Nerve problem (eg, Guillain-Barré syndrome), history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

This vaccine is given in 2 doses at least 6 months apart.

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 after you receive this vaccine. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.

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:

Incidence not known

Chest tightness

cough

difficulty swallowing

dizziness

fainting

fast heartbeat

hives, itching, skin rash

inability to move arms and legs

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

sudden numbness and weakness in the arms and legs

trouble breathing

unusual tiredness or weakness

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

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

chills

diarrhea

fever

headache

joint pain

muscle pain

vomiting

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.