A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Twinrix Side Effects, and Drug Interactions - Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
Twinrix Side Effects, and Drug Interactions - Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
SIDE EFFECTS
In clinical trials involving the administration of 6,594 doses
to 2,164 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 one dose of Twinrix
and 384 received at least one 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
|
Twinrix
|
Engerix-B
|
Havrix
|
|
Event
|
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
|
37
|
35
|
41
|
41
|
25
|
30
|
53
|
47
|
|
Redness
|
8
|
9
|
11
|
6
|
7
|
9
|
7
|
9
|
|
Swelling
|
4
|
4
|
6
|
3
|
5
|
5
|
5
|
5
|
|
Adverse
|
Twinrix
|
Engerix-B and Havrix
|
|
Event
|
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
|
22
|
15
|
13
|
19
|
12
|
14
|
|
Fatigue
|
14
|
13
|
11
|
14
|
9
|
10
|
|
Diarrhea
|
5
|
4
|
6
|
5
|
3
|
3
|
|
Nausea
|
4
|
3
|
2
|
7
|
3
|
5
|
|
Fever
|
4
|
3
|
2
|
4
|
2
|
4
|
|
Vomiting
|
1
|
1
|
0
|
1
|
1
|
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 [Hepatitis
A Inactivated & Hepatitis B (Recombinant) Vaccine].
Most events reported were considered by the subjects as mild
and self-limiting and did not last more than 48 hours.
Among 2,164 subjects in fourteen 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
Local reactions at injection site: Induration.
Respiratory system: Upper respiratory tract infections.
Incidence <1% of injections
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.
Potential adverse effects
The following additional adverse effects have been reported
with either Engerix-B or Havrix in clinical trials and/or during marketed use.
Incidence <1% of injections, seen in clinical trials with
monovalent hepatitis A and/or hepatitis B vaccines
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
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 INTERACTIONS
No specific information available
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