Meningococcal vaccine (Intramuscular, Subcutaneous)

Meningococcal vaccine is a type of vaccine that helps protect against infections caused by certain groups of meningococcal bacteria (Neisseria meningitides). The vaccine helps your body create its own defense (antibodies) against the disease.

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

Bexsero® and Trumenba® protect against group B meningococcal bacteria only.

Meningococcal infection can lead to very serious illnesses, such as meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. Some people with meningococcal meningitis and/or meningococcemia may also die. These diseases are more likely to happen in young children and in individuals with certain health issues or conditions that make them more vulnerable to a meningococcal infection or more likely to have severe complications from it.

Vaccination against meningococcal disease is advised for individuals who are at risk of contracting the disease because:

• They have certain health issues or conditions that make them more vulnerable to a meningococcal infection or more likely to experience serious complications from it.
• They are living in, working in, or visiting an area where there is a high chance of getting meningococcal disease.

Menomune® is recommended for patients who are 2 years of age and older.

Bexsero® and Trumenba® are recommended for patients aged 10 to 25 years.

This vaccine should only be given by or under the guidance of your doctor.

Be sure to tell your doctor about any side effects that happen after you get this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical help. Contact 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 getting the vaccine.

Fainting may happen while you are receiving this vaccine. Your doctor may want to watch you 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 for your doctor to know about all other vaccines you or your child have received recently, including a flu shot.

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

In deciding to use a vaccine, you and your doctor need to think about the risks versus the benefits. Here are some important things to consider for this vaccine:

Allergies

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

Pediatric

Studies have not been done to determine the effects of Menomune® in children younger than 2 years of age. However, some children as young as 3 months may be vaccinated.

Studies have not been done to determine the effects of Bexsero® and Trumenba® in children younger than 10 years of age. Safety and effectiveness have not been established.

Geriatric

Studies have not been done to determine the effects of meningococcal vaccine in adults older than 65 years of age. Safety and effectiveness have not been established.

Breast Feeding

Research suggests that this medication poses minimal risk to the infant when used during breastfeeding.

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

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there might be an interaction. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you receive this vaccine. The following interactions are significant and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with certain foods, as interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Make sure to tell your doctor if you have any other medical issues, particularly:

• Immune system problems—Use with caution. This may decrease the effects of the vaccine.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor or nurse right away 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 require 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 how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

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

Available Dosage Forms:

• Suspension
• Kit
• Solution

Therapeutic Class: Vaccine

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.