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

Safety information 1

Twinrix Adult 1

The Twinrix Adult safety profile is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21-day schedule (n=320). The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6-month schedule are pain and redness occurring in a per-dose frequency of 37.6% and 17.0% respectively. 1

In the 2 clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined below. After a fourth dose given at month 12, the incidence of systemic and local adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days. 1

In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines. 1

Tabulated list of adverse reactions for Twinrix Adult: 1

Frequencies are reported as:
Very common: ≥1/10
Common: ≥1/100 – <1/10
Uncommon: ≥1/1,000 – <1/100
Rare: ≥1/10,000 – <1/1,000
Very rare: <1/10,000

Frequency Reactions
Very common Headache, pain and redness at the injection site, fatigue
Common Gastrointestinal symptoms, diarrhoea, nausea, swelling at the injection site, injection-site reactions (such as haematoma, pruritus and bruising), malaise
Uncommon Upper respiratory tract infection, dizziness, vomiting, abdominal pain*, myalgia, fever (≥37.5°C)
Rare Lymphadenopathy, decreased appetite, hypoaesthesia, paraesthesia, hypotension, rash, pruritus, arthralgia, influenza- like illness, chills

* Refers to adverse reactions observed in clinical trials performed with the paediatric formulation

 

Twinrix Paediatric 2

The Twinrix Paediatric safety profile is based on data from approximately 800 subjects. The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively.

Tabulated list of adverse reactions for Twinrix Paediatric

Frequencies are reported as:
Very common: ≥1/10
Common: ≥1/100 – <1/10
Uncommon: ≥1/1,000 – <1/100
Rare: ≥1/10,000 – <1/1,000
Very rare: <1/10,000

Frequency Reactions 
Very common Pain and redness at the injection site
Common Appetite loss, irritability, drowsiness, headache, gastrointestinal symptoms, nausea, swelling at the injection site, injection-site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
Uncommon Upper respiratory tract infection*, diarrhoea, vomiting, abdominal pain, rash, myalgia*
Rare Lymphadenopathy, hypoaesthesia*, paraesthesia*, dizziness, hypotension*, urticaria, pruritus*, arthralgia*, influenza-like illness*, chills*

* Refers to adverse reactions observed in clinical trials performed with the adult formulation.

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