TWINRIX

Indications and Clinical Use:

TWINRIX is indicated for active immunization against hepatitis A and hepatitis B virus infection in adults, adolescents, children and infants.

Contraindications:

• Should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administration of TWINRIX, or monovalent hepatitis A or hepatitis B vaccines.
• Should not be used in subjects with known hypersensitivity to neomycin.
• Should be postponed in subjects suffering from acute severe febrile illness.

Relevant Warnings and Precautions:

• The vaccine will not protect against infection caused by other agents such as hepatitis C, hepatitis E and other pathogens known to infect the liver. It can be expected that hepatitis D will also be prevented by immunization with TWINRIX as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
  
• Should never be administered intravascularly.
• Appropriate supervision and medication should be available in case of anaphylaxis.
  
• Syncope (fainting) can occur as a psychogenic response to the needle injection.
• Can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders. Subcutaneous injection may result in a less than optimal antibody response.
• It is not known whether TWINRIX will prevent hepatitis A and hepatitis B if subjects are in the incubation period of hepatitis A or hepatitis B infection at the time of immunization.
  
• As with other vaccines, persons with an impaired immune system or hemodialysis patients may not obtain adequate anti-HAV and anti-HBs antibody titres after the primary immunization course and additional doses might be required.
• Should be used during pregnancy only when clearly needed and when the possible advantages outweigh the possible risks for the fetus.
• Should be used with caution in breastfeeding mothers.
  

Adverse Events:

Adults: Side effects that occurred during clinical trials with the standard (3-dose) and rapid (4-dose) TWINRIX vaccination schedule were as follows:‡

Very common (more than 10% of doses): headache, pain and redness at the injection site, and fatigue.

Common (1%-10% of doses): diarrhea, nausea, vomiting, swelling at the injection site, injection site reaction, and malaise.

Uncommon (0.1%-1% of doses): upper respiratory tract infection, dizziness, myalgia, fever (≥37.5°C).

Rare (0.01%-0.1% of doses): lymphadenopathy, decreased appetite, hypoesthesia, paresthesia, hypotension, rash, pruritus, arthralgia, influenza-like illness, chills.

Very Rare (<0.01% of doses): urticaria.

Pediatrics: Side effects that occurred during clinical trials with the standard (3-dose) TWINRIX Junior vaccination schedule were as follows:

Very common (more than 10% of doses): pain and redness at the injection site.

Common (1%-10% of doses): appetite loss, irritability, drowsiness, headache, nausea, diarrhea‡, vomiting, swelling at the injection site, injection site reaction, fatigue, malaise, and fever (≥37.5˚C).

Uncommon (0.1%-1% of doses): rash.

Rare (0.01%-0.1% of doses): lymphadenopathy, dizziness, urticaria. 

Very Rare (<0.01% of doses)*: paresthesia‡, hypoesthesia‡, hypotension‡, pruritus‡, myalgia‡, arthralgia‡, influenza-like illness‡, chills‡.

For More Information:

Please consult the Product Monograph at www.gsk.ca/twinrix/pm for important information relating to adverse reactions, drug interactions, dosing and administration information which has not been discussed in this piece. To request a Product Monograph, or to report an adverse event please call 1‑800-387-7374.

* TWINRIX is not indicated to treat the clinical features or prevent the consequences of hepatitis A and B.
† TWINRIX is not indicated to reduce transmission of hepatitis A and B.
‡ Observed in clinical trials with TWINRIX.