Description
Meningococcal diphtheria conjugate vaccine is an active immunizing agent used to prevent infection by certain groups of meningococcal bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.
The following information applies only to the meningococcal vaccine used for meningococcal bacteria Groups A, C, Y, and W-135. These groups cause nearly all of the meningococcal meningitis cases in the U.S. The vaccine will not protect against infection caused by other meningococcal bacteria groups, such as Group B.
Meningococcal infection can cause life-threatening illnesses, such as meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. Some persons with meningococcal meningitis and/or meningococcemia also may die. The rate of these diseases peak in adolescence and early adulthood and are more likely to occur in persons with certain diseases or conditions that make them more susceptible to a meningococcal infection or more likely to develop serious problems from a meningococcal infection.
Immunization against meningococcal disease is recommended for persons 9 months to 55 years of age 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 strong possibility of contracting meningococcal disease. .
This vaccine is to be administered only by or under the supervision of your doctor.
Before Using
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, 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 relationship of age to the effects of meningococcal diphtheria conjugate vaccine in infants younger than 9 months of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of meningococcal diphtheria conjugate vaccine in adults older than 55 years of age. Safety and efficacy have not been established.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Atidarsagene Autotemcel
- Elivaldogene Autotemcel
- Measles Virus Vaccine, Live
- Teplizumab-mzwv
- Ublituximab-xiiy
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
- Guillain-Barré syndrome (nerve disease that causes paralysis), history of—Should not be used in patients with this condition.
- Hemophilia (blood disorder with tendency to bleed uncontrollably) or
- Illness, recent or critical or
- Other bleeding problems—May make these conditions worse.
- Immunodeficiency disorder or
- Weak immune system—This vaccine may not work well in patients with these conditions.
Proper Use
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.
Precautions
It is very important that your doctor check you or your child at regular visits to make sure this vaccine is working properly and to check 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, 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, and/or wheezing. These could be symptoms of an allergic reaction to the vaccine.
Contact your doctor immediately if you or your child have sudden weakness or are not able to 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 that your doctor should know about all other vaccines you or your child have recently received, including a flu shot.
It is important to tell 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.
Side Effects
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:
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 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
- 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.
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