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MLT_GIB/OTH/0007/17m
Date of preparation: March 2018

 

Contraindications

  • Twinrix Adult and Twinrix Paediatric should not be administered to subjects with known hypersensitivity to the active substances or to any of the excipients or neomycin
  • Subjects with hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines should not be administered Twinrix
  • The administration of Twinrix Adult/Paediatric should be postponed in subjects suffering from acute severe febrile illness 12

Warnings and precautions

  • Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints 12
  • It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination. It is not known whether Twinrix Adult and Twinrix Paediatric will prevent hepatitis A and hepatitis B in such cases 12
  • The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver 12
  • Twinrix Adult and Twinrix Paediatric is not recommended for post-exposure prophylaxis (e.g. needle stick injury) 12
  • The vaccine has not been tested in patients with impaired immunity. In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.12
  • Obesity (defined as BMI ≥ 30 kg/m2) has been observed to reduce the immune response to hepatitis A vaccines. A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Twinrix Adult. Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.1
  •  As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine 12
  • Twinrix Adult and Paediatric should under no circumstances be administered intravenously 12
  • As with any vaccine, a protective immune response may not be elicited in all vaccinees.1

Interactions

Use with other vaccines

  • No data on concomitant administration of Twinrix Adult and Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated. However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres 12
  • Although the concomitant administration of Twinrix Adult and other vaccines has not specifically been studied, it is anticipated that, if different syringes and other injection sites are used, no interaction will be observed 1
  • Twinrix Paediatric can be given concomitantly with human papillomavirus (HPV) vaccine 2
  • Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs >10mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone 2
  • Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied. It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric 2

Use with systemic immunosuppressive medications

  • It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved 1

Pregnancy

  • Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix on pregnancy or on the health of the fetus/newborn child. While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection. 12
  • The effect of Twinrix Adult and Twinrix Paediatric on embryo-foetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials 12
  • The effect of Twinrix Adult and Twinrix Paediatric on embryo-foetal, peri-natal and post-natal survival and development has been assessed in rats. Such animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryo-foetal development, parturition or post-natal development 12

Lactation

  • It is unknown whether Twinrix Adult/Paediatric is excreted in human breast milk. The excretion of Twinrix Adult/Paediatric in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Twinrix Adult/Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Adult/Paediatric therapy to the woman.12

For further information, including a full list of special warnings and precautions, please consult the Twinrix Adult and Twinrix Paediatric Summary of Prescribing Information.

References:

  1. Twinrix Adult Summary of Product Characteristics, GlaxoSmithKline.
  2. Twinrix Paediatric Summary of Product Characteristics, GlaxoSmithKline. 

Twinrix is a registered trademark of the GlaxoSmithKline Group of Companies