Pronunciation:

me-NINJ-oh-kok-kal VAX-een, TET-a-nus TOX-oyd KON-joo-gate bye-VAY-lent, hee-MOF-i-lus B KON-joo-gate VAX-een

Brand Names:

• Menhibrix

Uses of This Medicine:

Meningococcal polysaccharide vaccine and Haemophilus B conjugate vaccine is an active immunizing combination agent that is used to prevent infection caused by certain groups of meningococcal bacteria and Haemophilus influenza type b (Hib) bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

The following information applies only to the meningococcal vaccine used for meningococcal bacteria Groups C and Y

Menhibrix® vaccine is recommended for use in children 6 weeks to 18 months of age.

This vaccine is to be administered only by or under the direct 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 Menhibrix® vaccine in infants younger than 6 weeks of age and in children 19 months to 16 years of age. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of Menhibrix® vaccine in geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atidarsagene Autotemcel
• Elivaldogene Autotemcel
• Ocrelizumab
• Teplizumab-mzwv
• Ublituximab-xiiy

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:

• Apnea in premature babies (breathing stops for short periods)—Use with caution. Shots given into the muscle, such as this vaccine, may make this condition worse.

• Guillain-Barré syndrome (GBS, nervous system disorder that causes paralysis), history of after a vaccine with tetanus—Your doctor will decide if your child should receive this vaccine.

• Immunodeficiency disorder or
• Weak immune system—May not work as well in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into a muscle (usually in the thighs or upper arms).

The exact schedule for your child's vaccines will vary depending on your child's age at the time of the first dose. In general, your child can receive the first dose of the vaccine as early as 6 weeks to 2 months of age. This is followed by receiving the remaining three doses at 4, 6, and 12 to 15 months of age.

It is important that your child receives all of the doses of vaccine in this series. Try to keep all of your child's scheduled appointments. If your child does miss a dose of this vaccine, make another appointment as soon as possible.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Precautions While Using This Medicine:

It is very important that your child return to your doctor’s office at the right time for each dose. Be sure to notify your doctor of any side effects that occur after your child receives this vaccine.

Fainting may occur after receiving intramuscular injections, such as this vaccine. It may occur with other symptoms including: blurred vision, numbness or tingling in your arms, hands, or feet, or seizures.

Check with your doctor right away if your child has 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, or unusual tiredness or weakness. These could be symptoms of an allergic reaction to the vaccine.

This vaccine may interfere with laboratory tests that check for Hib disease. Make sure your doctor knows that your child received the vaccine if a severe infection occurs during 2 weeks after the vaccine is given.

It is important that your child's doctor should know about all other vaccines 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.

Menhibrix® vaccine is not a substitute for routine tetanus vaccination, and will not treat symptoms of meningococcal infection or flu if your child already has the disease.

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:

More common

Fever

Incidence not known

Bluish lips

cough

difficulty with swallowing

fainting

fast heartbeat

hives

itching

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

shortness of breath

skin rash

unusual tiredness or weakness

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

drowsiness

irritability

loss of appetite

pain, redness, or swelling at the injection site

Incidence not known

Hard lump at the injection site

sleepiness or unusual drowsiness

welts

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.