Medical Editor: John P. Cunha, DO, FACOEP
What Is Hiberix?
Hiberix [haemophilus b conjugate vaccine (tetanus toxoid conjugate)] is a vaccine for active immunization as a booster dose for the prevention of diseases caused by Haemophilus influenza type b.
What Are Side Effects of Hiberix?
Common side effects of Hiberix include:
- injection site reactions (pain, redness, swelling),
- loss of appetite,
- diarrhea, and
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Hiberix
Hiberix is administered as a single dose (approximately 0.5 mL) by intramuscular injection into thigh or upper arm.
What Drugs, Substances, or Supplements Interact with Hiberix?
Hiberix may interact with other vaccines mixed in the same syringe, immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids. Tell your doctor all medications and supplements you use and all vaccines you recently received.
Hiberix During Pregnancy or Breastfeeding
During pregnancy, Hiberix should be administered only If prescribed; it is unknown if it could harm a fetus. Consult your doctor before breastfeeding.
Our Hiberix [haemophilus b conjugate vaccine (tetanus toxoid conjugate)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
Call your doctor at once if your child has:
- a seizure;
- fussiness, irritability, crying for an hour or longer; or
- high fever (within a few hours or a few days after the vaccine).
Common side effects may include:
- fussiness, irritability, crying;
- loss of appetite; or
- pain, swelling, or redness where the shot was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. There is the possibility that broad use of HIBERIX could reveal adverse reactions not observed in clinical trials.
In 7 clinical studies, 1,008 children received HIBERIX as a booster dose following primary vaccination with either HIBERIX (not approved for primary series in US, N = 530), Haemophilus b Conjugate Vaccine manufactured by Sanofi Pasteur SA (N = 235), Haemophilus b Conjugate Vaccine manufactured by Merck & Co., Inc. (N = 26), or Haemophilus b Conjugate Vaccine manufactured by Wyeth Pharmaceuticals Inc. (no longer licensed in the US, N = 217). None of the studies included a comparator group that received a booster dose with a US-licensed Haemophilus b Conjugate Vaccine. Studies were conducted in Europe, Canada, and Latin America. Across these studies, the mean age of subjects at the time of booster vaccination with HIBERIX ranged from 16 to 19 months. At the time of vaccination, 172 (17.1%) subjects were 11 to 14 months of age, 642 (63.7%) subjects were 15 to 18 months of age, and 194 (19.2%) subjects were 19 to 25 months of age. Approximately half of the subjects were male. Among subjects for whom information on race/ethnicity was available, nearly all subjects were white.
In these 7 studies, HIBERIX was administered concomitantly with non-US formulations (containing 2.5 mg 2-phenoxyethanol per dose as preservative) of one of the following US- licensed vaccines: INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) (DTaP), KINRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) (DTaP-IPV), or PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] (DTaP-HBV-IPV). In the studies, DTaP-IPV and DTaP-HBV-IPV were administered in dosing regimens not approved in the US. Some subjects received DTaP-HBV (GlaxoSmithKline Biologicals, not licensed in US) concomitantly with HIBERIX.
Solicited Adverse Events
In an open-label, multicenter study conducted in Germany, 371 children received a booster dose of HIBERIX administered concomitantly with DTaP-HBV- IPV. The mean age at the time of vaccination was 16 months. Subjects in this study had previously received a primary series with either HIBERIX (not approved for primary series in US, N = 92), Haemophilus b Conjugate Vaccine manufactured by Sanofi Pasteur SA (N = 96), or Haemophilus b Conjugate Vaccine manufactured by Wyeth Pharmaceuticals Inc. (no longer licensed in the US) (N = 183). All subjects previously received 3 doses of DTaP-HBV-IPV. Information on adverse events was collected by parents/guardians using standardized forms for 4 consecutive days following vaccination with HIBERIX (i.e., day of vaccination and the next 3 days). The reported frequencies of solicited local and general adverse events are presented in Table 1.
Table 1: Percentage of Children With Solicited Local
And General Adverse Events Within 4 Days of Vaccinationa With
HIBERIXb Coadministered With DTaP-HBV-IPVc, Intent to
Treat Cohort (N = 371)
|% Any||% Grade 3|
|Loss of appetite||22.9||0.8i|
|N = all subjects for whom safety data were available.
a Within 4 days of vaccination defined as day of vaccination and the next 3 days. b In this study, 92 subjects previously received 3 doses of HIBERIX (not approved for primary immunization in the US), 96 subjects previously received 3 doses of a US-licensed Haemophilus b Conjugate Vaccine (manufactured by Sanofi Pasteur SA), and 183 subjects previously received 3 doses of a Haemophilus
b Conjugate Vaccine that is no longer licensed in the US.
c In this study, DTaP-HBV-IPV was given to subjects who previously received 3 doses of DTaP-HBV-IPV. In the US, PEDIARIX is approved for use as a 3-dose primary series; use as a fourth consecutive dose is not approved in the US.
d Local reactions at the injection site for HIBERIX.
e Grade 3 redness or swelling defined as > 20 mm.
f Grade 3 pain defined as causing crying when limb moved.
g Fever defined as ≥ 100.4°F ( ≥ 38.0°C) rectally or ≥ 99.5°F ( ≥ 37.5°C) axillary, oral or tympanic; Grade 3 fever defined as > 103.1°F ( > 39.5°C) rectally or > 102.2°F ( > 39.0°C) axillary, oral or tympanic.
h Grade 3 fussiness defined as persistent crying and could not be comforted. i Grade 3 for these symptoms defined as preventing normal daily activity.
Serious Adverse Events
Two of 1,008 subjects reported a serious adverse event that occurred in the 31-day period following booster immunization with HIBERIX. One subject developed bilateral pneumonia 9 days post-vaccination and one subject experienced asthenia following accidental drug ingestion 18 days post-vaccination.
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for HIBERIX since market introduction (1996) of this vaccine are listed below. This list includes serious events and/or events which have a plausible causal connection to HIBERIX. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.
General Disorders and Administration Site Conditions: Extensive swelling of the vaccinated limb, injection site induration.
Immune System Disorders: Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema.
Nervous System Disorders: Convulsions (with or without fever), hypotonic- hyporesponsive episode, somnolence, syncope or vasovagal responses to injection.
Respiratory, Thoracic, and Mediastinal Disorders: Apnea.
Skin and Subcutaneous Tissue Disorders: Rash, urticaria.
Read the entire FDA prescribing information for Hiberix (Haemophilus B Conjugate Vaccine Tetanus Toxoid Conjugate for Intramuscular Injection)
© Hiberix Patient Information is supplied by Cerner Multum, Inc. and Hiberix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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