Meningococcal vaccine, tetanus toxoid conjugate quadrivalent (Intramuscular)

Meningococcal, tetanus toxoid conjugate quadrivalent vaccine is a medicine that helps your body protect itself from certain types of meningococcal bacteria (Neisseria meningitides). It does this by prompting your body to create its own defenses (antibodies) against the disease.

This vaccine is effective against Groups A, C, W, and Y meningococcal bacteria only. It will not protect you from infections caused by other meningococcal bacteria groups, like Group B.

Meningococcal infections can lead to serious 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. These diseases are more common in young children and in individuals with certain health conditions that make them more vulnerable to meningococcal infections or more likely to experience severe complications from them.

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 receive this vaccine.

This vaccine can cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after the injection.

Syncope (fainting) may happen after getting this vaccine. Your doctor might want you to be watched after the injection to prevent and manage fainting.

MenQuadfi™ may not protect everyone who gets it. This vaccine will not prevent tetanus and will not treat symptoms of meningococcal infection if you already have the disease.

Tell your doctor if you are using a medicine or treatment that weakens your immune system (for example, eculizumab). This vaccine may not work as well if you are also using these medicines.

It is important that your doctor knows about all other vaccines you or your child have recently received.

In deciding to use a vaccine, you and your doctor will weigh the risks of the vaccine against its benefits. Here are some important things to consider:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how MenQuadfi™ affects children younger than 2 years. Safety and effectiveness have not been established for this age group.

Geriatric

Studies to date have not shown any specific problems in elderly patients that would limit the usefulness of MenQuadfi™. However, older adults may respond less effectively to this vaccine compared to younger adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there might be an interaction. In such cases, your doctor may adjust the dose or take other precautions. 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 taken around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this vaccine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. It may cause symptoms of this condition to return.

• Immune system problems from a disease or medicine—This vaccine may not work as well in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Rare

• Fainting

Incidence not known

• Fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trouble breathing or swallowing

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 how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty moving
• general feeling of discomfort or illness
• headache
• muscle pain
• pain, redness, or swelling at the injection site
• unusual tiredness or weakness

Rare

• Dizziness

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.

• MenQuadfi

Available Dosage Forms:

• Solution

Therapeutic Class: Vaccine

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

If you are 15 years of age and older who are at continued risk for meningococcal infection, you should get a booster (repeat) dose of the vaccine at least 4 years after your last dose.