Pronunciation:

me-NINJ-oh-kok-kal VAX-een, TET-a-nus TOX-oyd KON-joo-gate kwa-drah-VAY-lent

Brand Names:

• MenQuadfi

Dosage Forms:

• Solution
• Powder for Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Meningococcal, tetanus toxoid conjugate quadrivalent vaccine is an active immunizing agent used to prevent infection caused by certain groups of meningococcal bacteria (Neisseria meningitides). The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

This vaccine is active against Groups A, C, W, and Y meningococcal bacteria only. 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. These diseases are more likely to occur in young children and 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.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of MenQuadfi™ in children younger than 2 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of MenQuadfi™ in the elderly. However, elderly patients are less responsive to the effects of this vaccine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

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

Syncope (fainting) may occur after receiving this vaccine. Your doctor may want you to be observed after you get the injection to 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.

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

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

Side Effects of This Medicine:

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

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 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

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.