Infanrix Hexa – GSK

Indication and Usage –

• Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.

Dosage and Administration –

• Infanrix hexa is for deep intramuscular injection, preferably at alternating sites for subsequent injections.
• The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
• Where a dose of hepatitis B vaccine is given at birth, Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.

Contraindications –

• Hypersensitivity to the active substances or to any of the excipients like formaldehyde, neomycin and polymyxin.
• Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.
• Infanrix hexa is contraindicated if the infant or toddlers has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines.
• As with other vaccines, administration of Infanrix hexa should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.

Adverse reactions –

• Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
• If any of the following events are known to have occurred in temporal relation to receipt of pertussis containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:

1. Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable cause;
2. Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination;
3. Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;
4. Convulsions with or without fever, occurring within 3 days of vaccination. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.

Drug interactions and other interactions –

• As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
• When Infanrix hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2, 6 pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference.