MenQuadfi (Intramuscular, Subcutaneous)

Meningococcal vaccine is a medicine 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 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 die. These diseases are more likely to happen in young children and in people with certain health issues that make them more vulnerable to a meningococcal infection or more likely to have severe complications from one.

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

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

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

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

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

Be sure to let your doctor know 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 needs 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 receive 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 who are sensitive to latex.

It is important that your doctor knows 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 need to consider the risks of the vaccine compared to the benefits it offers. This is a decision you will make with your doctor. For this vaccine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

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

Breast Feeding

Studies suggest that this medication 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 medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. It is particularly important that your healthcare professional knows if you are taking any of the following medicines while receiving this vaccine. The following interactions have been chosen based on their potential significance and are not necessarily 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 together, your doctor may change 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 taken around mealtime or with certain foods, as interactions may occur. Using alcohol or tobacco with certain 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 how this vaccine works. Make sure to tell your doctor if you have any other medical issues, especially:

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

• Severe illness with fever—The symptoms of the condition may be mistaken for the 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 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 lessen 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.

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.