Pronunciation:

hee-MOF-i-lus B KON-joo-gate VAX-een, hep-a-TYE-tis B VAX-een re-KOM-bin-ant

Brand Names:

• Comvax

Uses of This Medicine:

Haemophilus b conjugate vaccine and hepatitis B vaccine is a combination immunizing agent that is used to prevent infection caused by the Haemophilus influenzae type b (Hib) bacteria and hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Infections with Haemophilus influenza type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis (a brain disease), epiglottitis (a throat disease that can cause suffocation), pericarditis (a heart disease), pneumonia (a lung disease), and septic arthritis (a bone and joint disease). Hib meningitis may cause death or leave the child with serious and permanent damage, such as mental retardation, deafness, epilepsy, or partial blindness.

HBV infection is a major cause of serious liver diseases, such as hepatitis and cirrhosis, and a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women who have hepatitis B infection or are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease.

Immunization against hepatitis B disease is recommended for all newborn babies, infants, and young children.

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 Comvax® vaccine in infants younger than 6 weeks and older than 15 months of age. Safety and efficacy have not been established.

Older adults—

Comvax® vaccine is not recommended for adult or geriatric patients.

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. 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.

• Elivaldogene Autotemcel
• 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:

• Allergy to yeast—Should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. May have an increased risk of bleeding at the injection site.

• Severe illness with a fever—Your child's dose may need to be given at a later time.

• Weak immune system from a disease or medicine (e.g., those who are receiving a steroid, chemotherapy for cancer, or who have HIV infection)—May not work as well in patients with this condition.

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 one of your child's muscles, usually in the thighs.

This vaccine is usually given as 3 doses. It is usually given at 2, 4, and 12 to 15 months of age, unless your child's doctor tells you otherwise.

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

Precautions While Using This Medicine:

It is very important that your child return to your doctor’s office at the right time for the second and third dose. Be sure to notify your child's doctor of any unwanted effects that occur after he or she receives the vaccine.

If your child develops a skin rash, hives, or any allergic reaction after receiving this vaccine, tell your child's doctor right away.

Tell your child's doctor right away if your child is allergic to latex rubber. The vaccine vials may contain dry natural latex rubber. This may cause an allergic reaction in patients who are sensitive to latex.

Before your child have any medical tests, tell the medical doctor in charge that your child is receiving this vaccine. The results of some tests may be affected by this vaccine.

This vaccine may not protect your child against diseases caused by haemophilus influenzae type b or hepatitis B infection if your child is already infected with the virus at the time he or she receives the shot.

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 more than 103 degrees F

Less common

Body aches or pain

chills

cough

difficulty with breathing

ear congestion

fever

headache

loss of voice

nasal congestion

runny nose

sneezing

sore throat

unusual tiredness or weakness

Incidence not known

Black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

convulsions

diarrhea

difficulty with swallowing

dizziness

fast heartbeat

hives

itching

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

pinpoint red spots on the skin

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

red, irritated eyes

shortness of breath

skin rash

sores, ulcers, or white spots in the mouth or on the lips

tightness in the chest

unusual bleeding or bruising

wheezing

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

Hard lumps, pain, redness, soreness, swelling, or warmth at the injection site

irritability

sleepiness or unusual drowsiness

unusual, high-pitched crying

Less common

Earache

loss of appetite

redness or swelling in the ear

vomiting

weight loss

Rare

Sore mouth or tongue

white patches in the mouth or throat or on the tongue

white patches with diaper rash

Incidence not known

Hives or welts

redness of the skin

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.