Menomune-A/C/Y/W-135 (Intramuscular, Subcutaneous)

Meningococcal vaccine is a type of vaccine that helps protect against infections caused by certain types of meningococcal bacteria (Neisseria meningitides). The vaccine helps your body 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, like meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. Some people with meningococcal meningitis and/or meningococcemia may die. These illnesses are more likely to happen 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 serious complications from one.

Getting vaccinated against meningococcal disease is recommended for people who are at higher risk of getting the disease because:

• They have specific diseases or conditions that make them more susceptible to a meningococcal infection or more likely to have serious complications from a meningococcal infection.
• 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 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 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. 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 getting the vaccine.

Fainting may happen while you are getting this vaccine. Your doctor may want you to be watched after you get the injection to prevent and manage fainting.

The tip caps of Bexsero® prefilled syringes have dry natural rubber (a type 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 recently received, 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 must consider the risks of the vaccine against the benefits it may provide. Here are some important points to consider:

Allergies

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

Pediatric

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

There have not been enough studies on how Bexsero® and Trumenba® affect children younger than 10 years old. Safety and effectiveness have not been established for this age group.

Geriatric

There have not been enough studies on how the meningococcal vaccine affects adults older than 65 years old. Safety and effectiveness have not been established for this age group.

Breast Feeding

Research suggests that this vaccine poses minimal risk to infants when used during breastfeeding.

There are no sufficient studies to determine the risk to infants when this vaccine is used during breastfeeding. Consider the potential benefits and risks before using this vaccine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there might be an interaction. In these situations, your doctor may adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the following medicines when receiving this vaccine. The following interactions have been highlighted based on their potential importance and may not be a complete list.

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 change the dose or the frequency of use for one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using this vaccine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this vaccine works. Make sure to inform your doctor if you have any other medical conditions, especially:

• Immune system problems—Use with caution. This may reduce the effectiveness of the vaccine.

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

Along with its necessary effects, a medicine can 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 happen:

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 might 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, 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can 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.