TWINRIX is a combined vaccine indicated for active immunization against hepatitis A virus (HAV) and hepatitis B virus (HBV).
Recommended for individuals at risk of both hepatitis A and B infections.
Suitable for use in individuals aged 1 year and older.
Dosage and Administration:
Standard Schedule for Adults: Three doses at 0, 1, and 6 months.
Accelerated Schedule for Adults: Four doses at 0, 7, 21-30 days, and a booster at 12 months.
Pediatric Schedule: Two doses at 0 and 6-12 months for children aged 1-15 years.
Administered via intramuscular injection, preferably in the deltoid region.
Adverse Reactions:
Common Reactions: Pain at the injection site, headache, fatigue, and gastrointestinal symptoms like nausea.
Less Common Reactions: Fever, malaise, dizziness, and reactions at the injection site such as redness and swelling.
Rare Reactions: Allergic reactions including rash, pruritus, and urticaria.
Warnings and Precautions:
General Warnings: TWINRIX should not be administered to individuals with hypersensitivity to any component of the vaccine or those who have had an allergic reaction to a previous dose.
Special Populations:
Pregnant Women: Use only if clearly needed.
Nursing Women: Caution is advised.
Pediatrics: Safety and efficacy have been established for children aged 1-15 years.
Action and Clinical Pharmacology:
Mechanism of Action: Induces active immunity by stimulating the production of antibodies against HAV and HBV.
Pharmacodynamics: Provides protection against hepatitis A and B by eliciting an immune response.
Duration of Protection: Long-term protection against hepatitis A and B has been demonstrated, though periodic booster doses may be required based on individual risk factors and antibody levels.
Storage and Stability:
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze.
Stability: The vaccine should be protected from light and should not be used after the expiration date.
Clinical Trials:
Efficacy: Clinical studies have shown that TWINRIX is effective in producing antibodies against both HAV and HBV.
Safety: The safety profile is consistent with that observed for monovalent hepatitis A and hepatitis B vaccines.
