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Twinrix (Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In clinical trials involving the administration of 6,543 doses to 2,299 individuals and during routine clinical use of the vaccine outside the United States, TWINRIX has been generally well tolerated.

Of 773 volunteers who participated in the comparative trial conducted in the United States, 389 subjects received at least 1 dose of TWINRIX and 384 received at least 1 dose each of ENGERIX-B and HAVRIX as separate but simultaneous injections. Solicited adverse events reported following the administration of TWINRIX are shown in Table 5, compared with adverse events reported after administration of ENGERIX-B and HAVRIX.

Table 5. Rate of Adverse Events Reported After Administration of TWINRIX or ENGERIX-B and HAVRIX

Adverse Event TWINRIX ENGERIX-B HAVRIX
Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3 Dose 1 Dose 2
Local (N = 385) % (N = 382) % (N = 374) % (N = 382) % (N = 376) % (N = 369) % (N = 382) % (N = 369) %
Soreness
Redness
Swelling
37
8
4
35
9
4
41
11
6
41
6
3
25
7
5
30
9
5
53
7
5
47
9
5

Adverse Event TWINRIX ENGERIX-B and HAVRIX
Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3
General (N = 385) % (N = 382) % (N = 374) % (N = 382) % (N = 376) % (N = 369) %
Headache
Fatigue
Diarrhea
Nausea
Fever
Vomiting
22
14
5
4
4
1
15
13
4
3
3
1
13
11
6
2
2
0
19
14
5
7
4
1
12
9
3
3
2
1
14
10
3
5
4
1

Adverse reactions seen with TWINRIX were similar to those observed after vaccination with the monovalent components. The frequency of solicited adverse events did not increase with successive doses of TWINRIX. Most events reported were considered by the subjects as mild and self-limiting and did not last more than 48 hours.

Among 2,299 subjects in 14 clinical trials, the following adverse experiences were reported to occur within 30 days following vaccination with the frequency shown below.

Incidence 1% to 10% of Injections, Seen in Clinical Trials With TWINRIX:

Local Reactions at Injection Site: Induration.

Respiratory System: Upper respiratory tract infections.

Incidence <1% of Injections, Seen in Clinical Trials With TWINRIX:

Local Reactions at Injection Site: Pruritus, ecchymoses.

Body as a Whole: Sweating, weakness, flushing, influenza-like symptoms.

Cardiovascular System: Syncope.

Gastrointestinal System: Abdominal pain, anorexia, vomiting.

Musculoskeletal System: Arthralgia, myalgia, back pain.

Nervous System: Migraine, paresthesia, vertigo, somnolence, insomnia, irritability, agitation, dizziness.

Respiratory System: Respiratory tract illnesses.

Skin and Appendages: Rash, urticaria, petechiae, erythema.

As with any vaccine, it is possible that expanded routine clinical use of the vaccine could reveal rare adverse events.

Incidence <1% of Injections, Seen in Clinical Trials With HAVRIXa and/or ENERGIX-B b :

Body as a Whole: Tingling. b

Cardiovascular System: Hypotension. b

Gastrointestinal: Constipation,b dysgeusia. a

Hematologic/lymphatic: Lymphadenopathy. a+b

Musculoskeletal System: Elevation of creatine phosphokinase. a

Nervous System: Hypertonic episode,a photophobia. a

Post-marketing Reports With HAVRIX and/or ENERGIX-B: Since market introduction, more than 61 million doses of HAVRIX and more than 600 million doses of ENGERIX-B have been distributed worldwide (circa 2000). 27 Voluntary reports of adverse events in people receiving either ENGERIX-B or HAVRIX that have been reported since market introduction of the vaccines include the following:

Body as a Whole: Anaphylaxis/anaphylactoid reactions and allergic reactions. a

Hypersensitivity: Erythema multiforme including Stevens-Johnson syndrome, b angioedema, b arthritis, b serum sickness-like syndrome days to weeks after vaccination including arthralgia/arthritis (usually transient), fever, urticaria, erythema multiforme, ecchymoses and erythema nodosum. b

Cardiovascular System: Tachycardia/palpitations. b

Skin and Appendages: Erythema multiforme, a hyperhydrosis, a angioedema, a eczema, b herpes zoster, b erythema nodosum, b alopecia. b

Gastrointestinal System: Jaundice, a hepatitis, a abnormal liver function tests, b dyspepsia. b

Hematologic/lymphatic: Thrombocytopenia. b

Nervous System: Convulsions, a paresis, b encephalopathy, a neuropathy, a+b myelitis, a Guillain-Barré syndrome, a+b multiple sclerosis, a+b Bell's palsy, b transverse myelitis, b optic neuritis. b

Respiratory System: Dyspnea, a bronchospasm including asthma-like symptoms. b

Special Senses: Conjunctivitis, b keratitis, b visual disturbances, b tinnitus, b earache. b

Other: Congenital abnormality. a


a Following HAVRIX.

b Following ENGERIX-B.

a+b Following either HAVRIX or ENGERIX-B.

Drug label data at the top of this Page last updated: 2006-08-08

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