Menactra (Intramuscular, Subcutaneous)

Meningococcal vaccine is a type of vaccine that helps protect against infections caused by certain groups of meningococcal bacteria (Neisseria meningitides). It works by prompting your body to make 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 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 die. These diseases are more likely to occur in young children and in people with certain diseases or conditions that make them more vulnerable to a meningococcal infection or more likely to have severe complications from a meningococcal infection.

Vaccination against meningococcal disease is recommended for those who are at risk of getting the disease because:

• They have certain diseases or conditions that make them more vulnerable to a meningococcal infection or more likely to have severe complications from a meningococcal infection.
• They are living in, working in, or visiting an area where there is a high chance of contracting meningococcal disease.

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

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

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

Be sure to tell your doctor about any side effects you experience after getting 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 notice a rash, itching, a fast heartbeat, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth after getting the vaccine.

Fainting can happen while you are getting this vaccine. Your doctor may want to observe you after the injection to help 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 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 receives it. It will not treat symptoms of meningococcal infection if you already have the disease.

In deciding to use a vaccine, you need to consider the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this vaccine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, check the label or package ingredients closely.

Pediatric

There have not been appropriate studies on how Menomune® affects children younger than 2 years. However, in some cases, children as young as 3 months may receive the vaccine.

There have not been appropriate studies on how Bexsero® and Trumenba® affect children younger than 10 years. Safety and effectiveness have not been established.

Geriatric

There have not been appropriate studies on how the meningococcal vaccine affects adults older than 65 years. Safety and effectiveness have not been established.

Breast Feeding

Studies in women suggest that this medicine poses minimal risk to infants when used during breastfeeding.

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Weigh the possible benefits against the possible risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there could be an interaction. In these situations, your doctor may want to adjust the dose, or other precautions might be necessary. When receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their possible importance and are not necessarily a complete list.

Getting this vaccine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are given together, your doctor may adjust the dose or how often you take one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around meal times or with certain foods as interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Immune system problems—Use with caution. May reduce the effectiveness of this vaccine.

• Severe illness with fever—Symptoms may be mistaken for possible side effects of the vaccine.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or lessen 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.