ActHIB

Name: ActHIB

What is ActHIB (haemophilus b conjugate (PRP-T) vaccine)?

Haemophilus influenzae type B (Hib) is a bacteria that can cause serious illness, including breathing problems or meningitis. Hib infection usually affects children and can be fatal.

Haemophilus B conjugate (PRP-T) vaccine is used to prevent this disease in children, and is sometimes combined with vaccines to protect against other diseases. This vaccine is given to children between the ages of 2 months and 18 months old.

The vaccine works by exposing your child to a small amount of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body, and will not protect against other types of influenza.

Haemophilus B conjugate vaccine is not for use in children younger than 6 weeks. When used in combination with certain diphtheria vaccines, this vaccine may not be used in children younger than 15 months.

Like any vaccine, haemophilus B conjugate vaccine may not provide protection from disease in every person.

How should I take this vaccine?

This vaccine is injected into a muscle. Your child will receive this injection in a doctor's office or clinic setting.

This vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months and 6 months of age, and again at 15 to 18 months of age. In some cases, a 5th booster dose is given at 4 to 6 years of age.

Your child's individual booster schedule may be different from these guidelines, especially if the child does not start this series of shots before 7 months of age. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What other drugs will affect this vaccine?

Before your child receives this vaccine, tell the doctor about all other vaccines your child has recently received.

Other drugs may interact with haemophilus b conjugate vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell the doctor about all medications and treatments your child has recently received. Not all possible interactions are listed in this medication guide.

Uses For ActHIB

Haemophilus b conjugate vaccine 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 using a different schedule.

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 (i.e., 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 ActHIB

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of the haemophilus b conjugate vaccine 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.

Geriatric

The haemophilus b conjugate vaccine is not recommended for adult or geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 (nervous system disorder that causes paralysis), history of after a vaccine with tetanus—Your doctor will decide if you should receive this vaccine.
  • Weakened immune system—May not work as well in patients with this condition.

How do I store and/or throw out ActHIB?

  • If you need to store ActHIB at home, talk with your doctor, nurse, or pharmacist about how to store it.

Side effects

More than 7,000 infants and young children ( ≤ 2 years of age) have received at least one dose of ActHIB vaccine during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who received ActHIB vaccine alone reported no serious or life threatening adverse reactions.

Adverse reactions commonly associated with a first ActHIB vaccine immunization of children 12 to 15 months of age who were previously unimmunized with any Haemophilus b conjugate vaccine, include local pain, redness, and swelling at the injection site. Systemic reactions include fever, irritability, and lethargy.4,10

Adverse reactions associated with ActHIB vaccine generally subsided after 24 hours and usually do not persist beyond 48 hours after immunization.

In a US trial, safety of TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, in 110 children aged 15 to 20 months was compared to ActHIB vaccine given with Tripedia vaccine at separate sites to 110 children. All children received three doses of Haemophilus b conjugate vaccine (ActHIB vaccine or HibTITER) and three doses of whole-cell DTP at approximately 2, 4, and 6 months of age.

Table 5: Local and Systemic Reactions at 6, 24, and 48 Hours Following Immunization with ActHIB and Tripedia Vaccines Given Concomitantly at Separate Sites Compared to TriHIBita Vaccine in Children 15- to 20-months-old10

Adverse Event 6 Hrs. Post-dose 24 Hrs. Post-dose 48 Hrs. Post-dose
Separate Injectionsb
N = 110
TriHIBit vaccine
N = 110
Separate Injectionsb
N = 110
TriHIBit vaccine
N = 110
Separate Injectionsb
N = 110
TriHIBit vaccine
N = 110
Local (%)
Tenderness 17.3/20.0 19.1 8.2/8.2 10.0 1.8/0.9 1.8
Erythema > 1” 0.9/0.0 3.6 2.7/0.9 3.6 0.9/0.0 1.8
Indurationc 3.6/5.5 2.7 2.7/3.6 8.2 4.5/0.9 3.6
Swelling 3.6/3.6 3.6 2.7/1.8 5.5 0.9/0.0 4.5
Systemic (%) N = 103-110 N = 102-109 N = 105-110 N = 103-108 N = 104-110 N = 103-109
Fever > 102.2°F (39.0°C) 0 2.0 1.0 1.9 1.9 0
Irritability 27.3 22.9 20.9 17.6 12.7 10.1
Drowsiness 36.4 30.3 17.3 13.9 12.7 11.0
Anorexia 12.7 9.2 10.0 6.5 6.4 2.8
Vomiting 0.9 1.8 0.9 1.9 0.9 2.8
Persistent Cry 0 0 0 0 0 0
Unusual Cry 0 0 0 0 0 0.9
a TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution
b Tripedia vaccine injection site/ActHIB vaccine injection site
c Induration is defined as hardness with or without swelling

TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, was administered to approximately 850 children, aged 15 to 20 months. All children received three doses of a Haemophilus b conjugate vaccine (ActHIB vaccine or HibTITER) and three doses of whole-cell DTP at approximately 2, 4, and 6 months of age. Local reactions were typically mild and usually resolved within the 24 to 48 hour period after immunization. The most common local reactions were pain and tenderness at the injection site. Systemic reactions occurring were usually mild and resolved within 72 hours of immunization. The reaction rates were similar to those observed in TABLE 5 when TriHIBit vaccine, ActHIB vaccine reconstituted with Tripedia vaccine, was administered and when Tripedia vaccine was administered alone as a booster.10

The number of subjects studied with TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, was inadequate to detect rare serious adverse events.

Reporting of Adverse Events

Reporting by the parent or guardian of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a tollfree number 1-800-822-7967.15,16,18

Health-care providers also should report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of ActHIB. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

  • Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
  • Nervous System Disorders: Convulsions
  • General Disorders and Administration Site Conditions: Extensive limb swelling, peripheral edema, pruritus, and rash

ActHIB Drug Class

ActHIB is part of the drug class:

  • Hemophilus influenzae B vaccines

Other Comments

Administration advice:
-Inject IM into the anterolateral aspect of the thigh or deltoid.
-Do not administer intravenously, intradermally, or subcutaneously.

Storage requirements:
-Refrigerate; do not freeze.
-Protect from light.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-Do not mix with other products.

Haemophilus b conjugate (prp-t) vaccine Pregnancy Warnings

Animal studies have not been conducted. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended. AU TGA pregnancy category: B2 US FDA pregnancy category: C

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