Meningococcal vaccine (Intramuscular)

Meningococcal vaccine is a type of vaccine that helps prevent infections from certain groups (A, B, C, W, and Y) of meningococcal bacteria (Neisseria meningitides). The vaccine helps your body make its own defense (antibodies) against the disease.

Meningococcal infections can lead to serious illnesses, such as meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. These diseases are more common in young children and in people with certain health issues or conditions that make them more likely to get a meningococcal infection or to have serious complications from it.

Getting immunized against meningococcal disease is advised for people who are at risk of the disease because:

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

This vaccine is recommended for people aged 10 to 25 years.

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 requires immediate medical attention. Inform your doctor right away if you experience a rash, itching, a fast heartbeat, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

Fainting may happen after you receive this vaccine. Your doctor may want to monitor you after you get the injection to prevent and manage fainting.

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 the vaccine compared to the benefits it may provide. This is a decision you will make with your doctor. For this vaccine, the following points should be taken into account:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the effects of Penbraya™ vaccine in children younger than 10 years old. Safety and effectiveness have not been established.

Geriatric

Appropriate studies have not been performed on the effects of Penbraya™ vaccine in older adults. 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 the infant 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 in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may adjust the dose or take other precautions. When you are receiving this vaccine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been identified based on their potential significance and are not necessarily all-inclusive.

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 frequency of use for 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 the time of eating food or specific types of food due to possible interactions. 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

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

• Immune system problems—This condition may reduce the effectiveness of the vaccine.

• Nerve problem (e.g., Guillain-Barré syndrome), history of—Use with caution. May worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, skin rash
• inability to move arms and legs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sudden numbness and weakness in the arms and legs
• trouble breathing
• unusual tiredness or weakness

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 may 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

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• chills
• diarrhea
• fever
• headache
• joint pain
• muscle pain
• vomiting

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
• MenQuadfi
• Menveo
• Trumenba

Available Dosage Forms:

• Suspension
• Kit
• Solution

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

This vaccine is given in 2 doses at least 6 months apart.