Description
Meningococcal polysaccharide 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 bacteria.
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 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 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.
Menveo® is recommended for use in children 2 months of age and older and adults younger than 55 years of age. Menactra® is recommended for use in children 9 months of age and older and adults younger than 55 years of age.
This vaccine is to be administered only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Suspension
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 Menveo® in children younger than 2 months of age, and Menactra® in children younger than 9 months of age. Safety and efficacy have not been established in these age groups.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of meningococcal polysaccharide diphtheria conjugate vaccine in adults older than 55 years of age. Safety and efficacy have not been established.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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 (GBS, nerve disease that causes paralysis), history of—May increase risk of developing GBS after receiving the vaccine.
- 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 muscles (usually in the thighs or upper arms).
This vaccine is usually given only once. You will not need a booster dose unless the vaccine is for a patient younger than 2 years of age or your doctor tells you otherwise.
It is very important for your child to receive all of the shots for the vaccine. If your child misses a dose, call your child’s doctor for another appointment.
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.
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).
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, or wheezing. These could be symptoms of an allergic reaction to the vaccine.
Syncope (fainting) may occur after receiving this vaccine. Your doctor may want you or your child to be observed for 15 minutes after you get the injection to prevent and manage fainting.
This vaccine may cause apnea (breathing stops for short periods) in some premature infants. Discuss this with your child's doctor if you are concerned.
It is important that your doctor should know about all other vaccines you or your child have recently received, including a flu shot.
Make sure your doctor knows if you are using medicines that weaken your immune system such as cancer medicines, radiation treatment, or steroids.
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:
More common
- Chills
- fever
- general feeling of discomfort or illness
- unusual tiredness or weakness
Incidence not known
- Back pain, sudden and severe
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- confusion
- cough
- difficulty with swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast heartbeat
- flushing or redness of the skin
- hives or welts
- inability to move the arms and legs
- itching
- muscle weakness, sudden and progressing
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- shortness of breath
- skin rash
- sudden numbness and weakness in the arms and legs
- sweating
- tightness in the chest
- unusually warm skin
- wheezing
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
- Crying
- diarrhea
- difficulty with moving
- drowsiness
- irritability
- loss of appetite
- muscle pain or stiffness
- pain in the joints
- pain, redness, swelling, or tenderness at the injection site
- 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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