MenQuadfi (Intramuscular)

Meningococcal, tetanus toxoid conjugate quadrivalent vaccine is a medicine that helps prevent infections caused by specific types of meningococcal bacteria (Neisseria meningitides). It works by helping your body create its own defenses (antibodies) against the disease.

This vaccine protects against Groups A, C, W, and Y meningococcal bacteria only. It will not protect against infections caused by other groups of meningococcal bacteria, such as Group B.

Meningococcal infections can lead to serious illnesses, like meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. Some people with meningococcal meningitis and/or meningococcemia may also die. These diseases are more likely to affect young children and individuals with certain health issues that make them more vulnerable to a meningococcal infection or more likely to have severe complications from it.

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

Be sure to tell your doctor about any side effects you experience after getting this vaccine.

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

Fainting (syncope) may happen after receiving this vaccine. Your doctor may want to watch you for a while after the injection to help prevent and manage fainting.

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

Inform your doctor if you are using any medicine or treatment that weakens your immune system (for example, eculizumab). This vaccine may not work as effectively if you are taking these medicines.

It is important for your doctor to know about all other vaccines you or your child have received recently.

In deciding to use a vaccine, you need to consider the risks of the vaccine against the benefits it may provide. This is a choice you will make with your doctor. For this vaccine, you should think about the following:

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 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 MenQuadfi™ in children younger than 2 years. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems for elderly patients that would limit the use of MenQuadfi™ in older adults. However, older patients may not respond to the effects of this vaccine as well as younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while 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 need to adjust the dose, or take other precautions. Inform 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 meal times, or with certain types of food, 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

Having other medical problems may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, especially:

• Guillain-Barré syndrome (GBS, a severe nerve and muscle issue), history of—Use with caution. May cause symptoms of this condition to come back.

• Immune system problems due to a disease or medication—May not work as well in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require 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
• troubled breathing or swallowing

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 be able to suggest ways to prevent or lessen 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

• Difficulty in 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.