Pronunciation:

hee-MOF-i-lus B KON-joo-gate VAX-een

Brand Names:

• ActHIB
• Hibtiter
• Pedvaxhib

Dosage Forms:

• Powder for Solution
• Powder for Suspension
• Solution

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Haemophilus b conjugate vaccine (tetanus toxoid conjugate) is an active immunizing agent that is used to prevent infection caused by the Haemophilus influenza type b (Hib) bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Haemophilus b conjugate vaccine is prepared by adding a diphtheria, meningococcal, or tetanus-related substance to the process. However, this vaccine does not take the place of the regular vaccines for diphtheria, tetanus, or meningococcus that children and adults should receive. All of the haemophilus b conjugate vaccines work the same way, but they may be given at different ages or different schedules.

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.

Haemophilus b conjugate vaccine is recommended for all children 2 months to 5 years of age (up to the 6th birthday).

The Hiberix® vaccine is used as a booster dose for children who have already received the primary series with a haemophilus b conjugate vaccine. The vaccine will "boost" or increase the protection that the child had from an earlier dose.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ActHIB®, HibTITER®, or PedvaxHIB® in children 2 months to 5 years of age. However, safety and efficacy have not been established in children 6 years of age and older and children younger than 2 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of the Hiberix® vaccine in children 15 months to 4 years of age. However, safety and efficacy have not been established in children 5 years of age and older and children younger than 15 months of age.

Older adults—

The haemophilus b conjugate vaccine (tetanus toxoid conjugate) is not for use in adult or 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.

• 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:

• Guillain-Barré syndrome (severe nerve and muscle problem), history of after a vaccine with tetanus toxoid—Your doctor will decide if you should receive this vaccine.

• Weakened immune system—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 in a medical facility. It is given as a shot into a muscle.

The exact schedule for your child's vaccines will vary depending on the brand of medicine used and your child's age at the time of the first dose. In general, your child will receive the first dose at 2 to 6 months of age, followed by 2 more doses at least 8 weeks apart. Your child will usually receive a booster dose at 15 to 18 months of age, although he or she can receive this medicine up until the age of 5 years.

It is important that your child receive all of the doses of the 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.

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 unwanted effects that occur after your child receives this 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 the 1 to 2 weeks after the vaccine is given.

The vaccine syringe and vial stopper may contain dry natural rubber(a derivative of latex), which may cause an allergic reaction in patients who are sensitive to latex. Tell your doctor if your child has a latex allergy before receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Diarrhea

loss of appetite

vomiting

Less common

Earache

redness or swelling in the ear

Rare

Chest pain

chills

cough

fever over 102 degrees F (39 degrees C)

lack or loss of strength

seizures

sneezing

sore throat

tightness in the chest

troubled breathing

Incidence not known

Bloating or swelling of the face, arms, hands, lower legs, or feet

bluish lips or skin

dizziness

fast heartbeat

hives or welts, skin rash

itching (especially of the feet or hands)

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

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

rapid weight gain

reddening of the skin (especially around the ears)

swelling of the eyes, face, or inside of the nose

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tingling of the hands or feet

unusual tiredness or weakness (sudden and severe)

unusual weight gain or loss

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

Fever less than 102 degrees F (39 degrees C)

irritability

redness, pain, swelling, tenderness, or warm feeling at the injection site

reduced physical activity

restlessness

sleepiness

Less common

Prolonged crying lasting more than 4 hours

unusual high-pitched crying

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.