Meningococcal polysaccharide vaccine, diphtheria conjugate (Intramuscular)

Meningococcal polysaccharide diphtheria conjugate vaccine is a medicine used to help prevent infections from certain groups of meningococcal bacteria. It works by helping your body create its own defenses (antibodies) against these bacteria.

The information below is specific to the meningococcal vaccine that protects against meningococcal bacteria 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 against infections caused by other meningococcal bacteria groups, such as Group B.

Meningococcal infection can lead to severe illnesses, such as meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. Some people with meningococcal meningitis and/or meningococcemia may die. The rates of these diseases are highest in teenagers and young adults and are more common in individuals with certain diseases or conditions that make them more likely to get a meningococcal infection or to develop serious complications from it.

Vaccination against meningococcal disease is advised for individuals 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.

Menveo® is recommended for children 2 months of age and older and adults younger than 55 years of age. Menactra® is recommended for children 9 months of age and older and adults younger than 55 years of age.

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 any unwanted effects.

Contact your doctor right away if you or your child experience sudden weakness or are unable to move your arms or legs. This could be a sign of a serious condition called Guillain-Barré syndrome (GBS).

Check with your doctor immediately 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, skin rash, tightness in the chest, unusual tiredness or weakness, or wheezing. These could be signs of an allergic reaction to the vaccine.

Syncope (fainting) may happen after receiving this vaccine. Your doctor may want you or your child to be observed for 15 minutes after the injection to prevent and manage fainting.

This vaccine may cause apnea (breathing stops for short periods) in some premature infants. Talk with your child's doctor if you are worried about this.

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

Make sure your doctor knows if you are taking medicines that weaken your immune system, such as cancer medicines, radiation treatment, or steroids.

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 need to consider the risks of taking the vaccine against the benefits it will provide. This is a choice you will make with your doctor. For this vaccine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know 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 done on how age affects the effects of Menveo® in children younger than 2 months of age, and Menactra® in children younger than 9 months of age. Safety and effectiveness have not been established in these age groups.

Geriatric

Appropriate studies have not been done on how age affects the effects of meningococcal polysaccharide diphtheria conjugate vaccine in adults older than 55 years of age. 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.

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 happen. In these situations, your doctor may want to adjust 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.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain 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 problems may affect the use of this vaccine. Make sure to inform your doctor if you have any other medical issues, especially:

• Guillain-Barré syndrome (GBS, a nerve disease that causes paralysis), history of—This may increase the risk of developing GBS after receiving the vaccine.

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

Along with its necessary effects, this medicine may cause some unwanted effects. Not everyone will experience these side effects, but if they do happen, they might need medical attention.

Contact your doctor or nurse right away if you notice any of these side effects:

More common

• Chills
• Fever
• General feeling of discomfort or illness
• Unusual tiredness or weakness

Incidence not known

• Sudden and severe back pain
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Confusion
• Cough
• Trouble swallowing
• Dizziness
• Feeling faint or lightheaded when standing 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
• Sudden and progressing muscle weakness
• 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to help prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Crying
• Diarrhea
• Difficulty moving
• Drowsiness
• Irritability
• Loss of appetite
• Muscle pain or stiffness
• Joint pain
• Pain, redness, swelling, or tenderness at the injection site
• Vomiting

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Menactra

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

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.