Menveo (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 create its own defenses (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 common in young children and in people with certain diseases or conditions that make them more likely to get a meningococcal infection or to develop serious issues from it.

Vaccination against meningococcal disease is advised for people 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 complications from it.
• They live in, work in, or visit areas where there is a high chance of catching 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 your doctor or under their supervision.

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 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 to monitor you after 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 recently received, 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 take a vaccine, you and your doctor need to weigh the risks against 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 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, 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 may be vaccinated.

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

Breast Feeding

Studies in women suggest that this medication is minimally risky for 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 not be used together at all, while others may be used together even if an interaction could happen. In those cases, your doctor might change the dose or take other precautions. 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 are 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 adjust the dose or how often you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime or with certain foods because interactions may occur. Using alcohol or tobacco with certain medicines may also cause 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 inform 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—The symptoms of this condition may be mistaken for possible side effects of the vaccine.

Along with its necessary effects, a medicine can cause some unwanted effects. Not everyone will experience these side effects, but if they do occur, they may need medical attention.

Contact your doctor or nurse right away if you notice any of the following side effects:

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 as your body adjusts to the medicine. Your health care professional might be able to provide ways to prevent or lessen some of these side effects. Talk to 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, consult 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.