Trumenba (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 protection (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 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 problems from a meningococcal infection.

Vaccination against meningococcal disease is recommended 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 problems 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 use in patients 2 years of age and older.

Bexsero® and Trumenba® are recommended for use in 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. Inform 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 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 taking the vaccine compared to the benefits it may provide.

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction 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, carefully read the label or package ingredients.

Pediatric

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

There have not been appropriate studies on the effects of Bexsero® and Trumenba® in children younger than 10 years old. Safety and effectiveness have not been established.

Geriatric

There have not been appropriate studies on the effects of the meningococcal vaccine in adults older than 65 years old. Safety and effectiveness have not been established.

Breast Feeding

Studies in women suggest 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 infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. It's especially important for your healthcare professional to know if you are taking any of the medicines listed below when receiving this vaccine. The following interactions are based on their potential significance and are not necessarily all-inclusive.

It is usually not recommended to receive this vaccine with any of the following medicines, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of 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 the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this vaccine. Make sure to inform your doctor about any other medical problems, especially:

• Immune system problems—Use with caution. This may reduce the effectiveness of the 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, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need 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 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 reduce 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.