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Indications for PEDIARIX, INFANRIX, and KINRIX

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years of age (prior to 7th birthday).

A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.

Indication for HIBERIX

HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).

Indication for ENGERIX-B

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

Important Safety Information for PEDIARIX, INFANRIX, and KINRIX

  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine or to any component of INFANRIX is a contraindication for INFANRIX
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, or poliovirus-containing vaccine or to any component of KINRIX, including neomycin and polymyxin B, is a contraindication for KINRIX
  • Additional contraindications for PEDIARIX, INFANRIX, and KINRIX are: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders
  • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines
  • The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (ie, temperature ≥105°F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions
  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX or INFANRIX should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
  • In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever, and loss of appetite
  • Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients

Important Safety Information for HIBERIX

  • Contraindications for HIBERIX: severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b-­ or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of HIBERIX
  • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including HIBERIX, should be based on careful consideration of the potential benefits and possible risks
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination
  • Prior to administration, the healthcare provider should review the patient's immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur
  • Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained
  • Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of an H. influenzae type b-containing vaccine, including HIBERIX
  • Immunization with HIBERIX does not substitute for routine tetanus immunization
  • Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, sleepiness, fussiness, and restlessness
  • Vaccination with HIBERIX may not result in protection in all vaccine recipients

Important Safety Information for ENGERIX-B

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PDRWCNT210009 April 2021