INFANRIX hexa™

Product Overview:

• Brand Name: INFANRIX hexa™
• Type: Combined Diphtheria and Tetanus Toxoids, Acellular Pertussis, Hepatitis B (recombinant), Inactivated Poliomyelitis, and Adsorbed Conjugated Haemophilus influenzae type b Vaccine
• Form: Sterile suspension for injection
• Manufacturer: GlaxoSmithKline Inc.

Indications and Clinical Use:

• Indication: Active primary immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and disease caused by Haemophilus influenzae type b in infants and children aged 6 weeks to 2 years.
• Booster Vaccination: Can be used for booster doses provided the infant has received a full primary vaccination course of each antigen.

Dosage and Administration:

• Primary Immunization:
  • 3-dose schedule: Administer 0.5 mL doses intramuscularly at 2, 4, and 6 months.
  • 2-dose schedule: Administer 0.5 mL doses intramuscularly at 2 and 4 months.
• Booster Dose: Given at 12-23 months of age.
• Administration: Intramuscular injection, preferably in the anterolateral aspect of the thigh or the deltoid muscle of the upper arm.

Contraindications:

• Hypersensitivity to any component of the vaccine.
• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any vaccine containing diphtheria, tetanus, pertussis, hepatitis B, poliovirus, or Haemophilus influenzae type b.
• Contraindicated in persons aged 7 years or older due to severe local and febrile reactions.
• Encephalopathy of unknown etiology within 7 days following previous pertussis vaccination.

Warnings and Precautions:

• General:
  • Do not administer intravascularly or intradermally.
  • Medical treatment should be available for anaphylactic reactions.
  • Review medical history and clinical examination before vaccination.
  • Vaccination should be postponed in case of moderate or severe acute febrile illness.
  • Syncope (fainting) can occur; procedures should be in place to prevent injury.
• Hematologic: Administer with caution to subjects with thrombocytopenia or a bleeding disorder.
• Immune: Hepatitis B vaccination may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. Not contraindicated in HIV-infected individuals.
• Neurologic: Defer pertussis immunization in children with progressive neurological disorders until the condition is stable.

Adverse Reactions:

• Very Common (≥10%): Appetite loss, irritability, abnormal crying, restlessness, pain, redness, local swelling at the injection site, fever ≥ 38°C, fatigue.
• Common (1-10%): Nervousness, vomiting, diarrhea, large local swelling at the injection site, fever >39.5°C, pruritis, injection site reactions.
• Uncommon (0.1-1%): Upper respiratory tract infection, somnolence, cough, diffuse swelling of the injected limb.
• Rare (0.01-0.1%): Bronchitis, rash.
• Very Rare (<0.01%): Convulsions (with or without fever), dermatitis, bronchospasm, urticaria, anaphylactic reactions.

Drug Interactions:

• General: Should not be mixed with any other vaccine in the same syringe or vial.
• Concomitant Vaccines: Can be given with pneumococcal conjugate, MenC conjugate, MenACWY conjugate, rotavirus, measles, mumps, rubella, and varicella vaccines. Increased rate of febrile reactions when co-administered with pneumococcal conjugate vaccine.

Storage and Stability:

• Storage: Store at 2°C to 8°C. Do not freeze. Protect from light.
• Stability: Stable for 8 hours at 21°C after reconstitution.