Pedvaxhib (Intramuscular)

Haemophilus b conjugate vaccine (tetanus toxoid conjugate) is a vaccine that helps protect against infections caused by the Haemophilus influenza type b (Hib) bacteria. It prompts your body to create its own defense (antibodies) against the disease.

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

Infections caused by Haemophilus influenza type b (Hib) bacteria can lead to severe illnesses, including meningitis (a brain condition), epiglottitis (a throat condition that can cause suffocation), pericarditis (a heart condition), pneumonia (a lung condition), and septic arthritis (a bone and joint condition). Hib meningitis can be fatal or may result in significant and permanent damage, such as intellectual disability, deafness, epilepsy, or partial blindness.

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

The Hiberix® vaccine is given as a booster dose for children who have already completed the initial series with a haemophilus b conjugate vaccine. This vaccine will "boost" or enhance the protection that the child received from an earlier dose.

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

It is very important that your child returns to your doctor’s office at the right time for each dose. Be sure to tell your doctor about any unwanted effects that happen after your child receives this vaccine.

This vaccine may affect lab tests that check for Hib disease. Make sure your doctor knows that your child received the vaccine if a severe infection occurs within 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.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare 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.

Pediatric

Studies so far have not shown any specific problems that would limit the use of ActHIB®, HibTITER®, or PedvaxHIB® in children aged 2 months to 5 years. However, safety and effectiveness have not been established in children 6 years and older or in children younger than 2 months.

Studies so far have not shown any specific problems that would limit the use of the Hiberix® vaccine in children aged 15 months to 4 years. However, safety and effectiveness have not been established in children 5 years and older or in children younger than 15 months.

Geriatric

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.

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 might happen. In these situations, your doctor may need to adjust the dose or take other precautions. When you receive this vaccine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to 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. Make sure to tell your doctor if you have any other medical issues, especially:

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

• Weakened immune system—This vaccine may not work as well in patients with this condition.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• ActHIB
• Hibtiter
• Pedvaxhib

Available Dosage Forms:

• Powder for Solution
• Powder for Suspension
• Solution

Therapeutic Class: Vaccine

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.