Meningococcal vaccine, diphtheria conjugate (Intramuscular)

Meningococcal diphtheria conjugate vaccine is a medication that helps your body build protection against certain types of meningococcal bacteria. It works by making your body produce its own defenses (antibodies) against the disease.

The information below is specifically about the meningococcal vaccine for Groups A, C, Y, and W-135. These groups are responsible for almost all meningococcal meningitis cases in the U.S. This vaccine will not protect you from infections caused by other groups of meningococcal bacteria, such as Group B.

Meningococcal infections can lead to very 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. The incidence of these diseases is highest in teenagers and young adults, and they are more likely to occur in people with certain health issues that increase their risk of meningococcal infection or serious complications from it.

Vaccination against meningococcal disease is recommended for individuals aged 9 months to 55 years who are at risk of the disease because:

• They have certain health conditions that increase their susceptibility to meningococcal infection or their risk of serious complications from it.
• They are living in, working in, or visiting areas where there is a high chance of contracting meningococcal disease.

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

It is very important for your doctor to check you or your child at regular visits to ensure this vaccine is working properly and to look for unwanted effects.

The stopper of the vial contains dry natural latex rubber. Make sure your doctor knows if you or your child have had an allergic reaction to latex rubber.

Check with your doctor right away if you have a cough, trouble swallowing, dizziness, a fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, shortness of breath, a skin rash, tightness in the chest, unusual tiredness or weakness, and/or wheezing. These could be signs of an allergic reaction to the vaccine.

Contact your doctor immediately if you or your child have sudden weakness or cannot move your arms or legs. This could be a sign of a serious condition called Guillain-Barré syndrome (GBS).

Make sure your doctor knows if you or your child are receiving medicine or a procedure that may weaken the immune system, such as steroids, cancer medicines, or radiation.

It is important for your doctor to know about all other vaccines you or your child have recently received, including a flu shot.

It is important to inform your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.

This vaccine will not prevent diphtheria and will not treat symptoms of meningococcal infection if you already have the disease.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine against the benefits it may provide. Here are important things to think about for this vaccine:

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 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

Studies have not been done on how meningococcal diphtheria conjugate vaccine affects infants younger than 9 months of age. Safety and effectiveness are not known for this age group.

Geriatric

Studies have not been done on how meningococcal diphtheria conjugate vaccine affects adults older than 55 years of age. Safety and effectiveness are not known for this age group.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. When receiving this vaccine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The interactions listed are based on their potential importance and may not include all possible interactions.

Using 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 adjust 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 with food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may change how this vaccine can be used. Be sure to tell your doctor if you have any other medical issues, especially:

• Guillain-Barré syndrome (a nerve disease that can cause paralysis) – This vaccine should not be used in patients with this condition.

• Hemophilia (a blood disorder that causes excessive bleeding) or
• Recent serious illness or
• Other bleeding problems – These conditions may worsen with this vaccine.

• Immunodeficiency disorder or
• Weak immune system – This vaccine may not be effective in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do happen, they may require medical attention.

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

Rare

• Cough
• Difficulty with swallowing
• Dizziness
• Fast heartbeat
• Hives
• Itching
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Shortness of breath
• Skin rash
• Tightness in the chest
• Unusual tiredness or weakness
• Wheezing

Incidence not known

• Inability to move the arms and legs
• Fainting
• Sudden and progressing muscle weakness
• Sudden and severe back pain
• Sudden numbness and weakness in the arms and legs
• Weakness of the muscles in your face

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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Chills
• Diarrhea
• Difficulty with moving
• Fever
• General feeling of discomfort or illness
• Hard lump at the injection site
• Headache
• Irritability
• Loss of appetite
• Muscle pain or stiffness
• Pain in the joints
• Pain, redness, or swelling at the injection site
• Sleepiness
• Weight loss

Less common

• 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.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your or your child’s muscles.

This vaccine is usually given only once. You will not need a booster dose, unless your doctor tells you otherwise.

Vaccine information statements are given to the patient, parent, or guardian before receiving this vaccine. Read the information carefully. Ask your doctor if you have any questions.