Initial U.S. Approval: 2001
TWINRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus.
TWINRIX is approved for use in persons 18 years of age or older.
Incidence <1% of Injections
– Respiratory tract illnesses.
– Anorexia.
– Agitation, insomnia.
– Dizziness, migraine, paresthesia, somnolence, syncope.
– Vertigo.
– Flushing.
– Abdominal pain, vomiting.
– Erythema, petechiae, rash, sweating, urticaria.
– Arthralgia, back pain, myalgia.
– Injection site ecchymosis, injection site pruritus, influenza-like symptoms, irritability, weakness.
– Lymphadenopathy.
– Dysgeusia, hypertonia, tingling.
– Photophobia.
– Hypotension.
– Constipation.
– Creatine phosphokinase increased
Postmarketing Experience
– Herpes zoster, meningitis.
– Thrombocytopenia, thrombocytopenic purpura.
– Allergic reaction, anaphylactoid reaction, anaphylaxis, serum sickness–like syndrome days to weeks after vaccination (including arthralgia/arthritis, usually transient; fever; urticaria; erythema multiforme; ecchymoses; and erythema nodosum).
– Bell’s palsy, convulsions, encephalitis, encephalopathy, Guillain-Barré syndrome, hypoesthesia, myelitis, multiple sclerosis, neuritis, neuropathy, optic neuritis, paralysis, paresis, transverse myelitis.
– Conjunctivitis, visual disturbances.
– Earache, tinnitus.
– Palpitations, tachycardia.
– Vasculitis.
– Bronchospasm, including asthma-like symptoms; dyspnea.
– Dyspepsia.
– Hepatitis, jaundice.
– Alopecia, angioedema, eczema, erythema multiforme, erythema nodosum, hyperhidrosis, lichen planus.
– Arthritis, muscular weakness.
– Chills; immediate injection site pain,
stinging, and burning sensation; injection site reaction; malaise.
– Abnormal liver function tests.
– Keratitis.
– Stevens-Johnson syndrome.
– Congenital abnormality.
TWINRIX… s a bivalent vaccine containing the antigenic components used in producing HAVRIX… and ENGERIX-B…
The hepatitis A virus is propagated in MRC-5 human diploid cells…
One dose of vaccine… contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants…
From the manufacturing process, each 1-mL dose of TWINRIX also contains… MRC-5 cellular proteins…
TWINRIX has not been evaluated for its carcinogenic or mutagenic potential, or for impairment of male fertility in animals.