Twinrix

Side Effects
Interactions

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of TWINRIX could reveal adverse events not observed in clinical trials.

Following any dose of TWINRIX, the most common ( ≥ 10%) solicited injection site reactions were injection site soreness (35% to 41%) and redness (8% to 11%); the most common solicited systemic adverse events were headache (13% to 22%) and fatigue (11% to 14%).

The safety of TWINRIX has been evaluated in clinical trials involving the administration of approximately 7,500 doses to more than 2,500 individuals.

In a US study, 773 subjects (18 to 70 years of age) were randomized 1:1 to receive TWINRIX (0-, 1-, and 6-month schedule) or concurrent administration of ENGERIX-B (0-, 1-, and 6-month schedule) and HAVRIX (0- and 6-month schedule). Solicited local adverse reactions and systemic adverse events were recorded by parents/guardians on diary cards for 4 days (days 0 to 3) after vaccination. Unsolicited adverse events were recorded for 31 days after vaccination. Solicited events reported following the administration of TWINRIX or ENGERIX-B and HAVRIX are presented in Table 1.

Table 1: Rates of Local Adverse Reactions and Systemic Adverse Events Within 4 Days of Vaccinationa With TWINRIXb or ENGERIX-B and HAVRIXc

Local TWINRIX ENGERIX-B HAVRIX  
Dose 1
(N = 385 )%
Dose 2
(N = 382) %
Dose 3
(N = 374) %
Dose 1
(N = 382) %
Dose 2
(N = 376) %
Dose 3
(N = 369) %
Dose 1
(N= 382) %
Dose 2
(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
Systemic TWINRIX ENGERIX-B and HAVRIX  
Dose 1
(N = 385)%
Dose 2
(N = 382)%
Dose 3
(N = 374)%
Dose 1d
(N = 382)%
Dose 2e
(N = 376)%
Dose 3d
(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    
a Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b 389 subjects received at least 1 dose of TWINRIX.
c 384 subjects received at least 1 dose each of ENGERIX-B and HAVRIX.
d Doses 1 and 3 included ENGERIX-B and HAVRIX in the control group receiving separate vaccinations.
e Dose 2 included only ENGERIX-B in the control group receiving separate vaccinations.

Most solicited local adverse reactions and systemic adverse events seen with TWINRIX were considered by the subjects as mild and self-limiting and did not last more than 48 hours.

In a clinical trial in which TWINRIX was given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months, solicited local adverse reactions or systemic adverse events were comparable to those seen in other clinical trials of TWINRIX given on a 0-, 1-, and 6-month schedule.

Among 2,299 subjects in 14 clinical trials, the following adverse events were reported to occur within 30 days following vaccination:

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

Infections and Infestations: Upper respiratory tract infections.

General Disorders and Administration Site Conditions: Injection site induration.

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

Infections and Infestations: Respiratory tract illnesses.

Metabolism and Nutrition Disorders: Anorexia.

Psychiatric Disorders: Agitation, insomnia.

Nervous System Disorders: Dizziness, migraine, paresthesia, somnolence, syncope.

Ear and Labyrinth Disorders: Vertigo.

Vascular Disorders: Flushing.

Gastrointestinal Disorders: Abdominal pain, vomiting.

Skin and Subcutaneous Tissue Disorders: Erythema, petechiae, rash, sweating, urticaria.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia.

General Disorders and Administration Site Conditions: Injection site ecchymosis, injection site pruritus, influenza-like symptoms, irritability, weakness.

Incidence < 1% of Injections, Seen in Clinical Trials With HAVRIX and/or ENGERIX-B:

Blood and Lymphatic System Disorders: Lymphadenopathy.a+b

Nervous System Disorders: Dysgeusia,a hypertonia,a tingling.b

Eye Disorders: Photophobia.a

Vascular Disorders: Hypotension.b

Gastrointestinal Disorders: Constipation.b

Investigations: Creatine phosphokinase increased.a

a+b Following either HAVRIX or ENGERIX-B.
a Following HAVRIX.
b Following ENGERIX-B.

Adverse events within 30 days of vaccination in the US clinical trial of TWINRIX given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months were comparable to those reported in other clinical trials.

Postmarketing Experience

The following adverse events have been identified during postapproval use of TWINRIX, HAVRIX, or ENGERIX-B. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to product exposure.

Postmarketing Experience with TWINRIX

The following list includes serious events or events which have suspected causal connection to components of TWINRIX.

Infections and Infestations: Herpes zoster, meningitis.

Blood and Lymphatic System Disorders: Thrombocytopenia, thrombocytopenic purpura.

Immune System Disorders: 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).

Nervous System Disorders: Bell's palsy, convulsions, encephalitis, encephalopathy, Guillain-Barré syndrome, hypoesthesia, myelitis, multiple sclerosis, neuritis, neuropathy, optic neuritis, paralysis, paresis, transverse myelitis.

Eye Disorders: Conjunctivitis, visual disturbances.

Ear and Labyrinth Disorders: Earache, tinnitus.

Cardiac Disorders: Palpitations, tachycardia.

Vascular Disorders: Vasculitis.

Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm including asthma-like symptoms, dyspnea.

Gastrointestinal Disorders: Dyspepsia.

Hepatobiliary Disorders: Hepatitis, jaundice.

Skin and Subcutaneous Tissue Disorders: Alopecia, angioedema, eczema, erythema multiforme, erythema nodosum, hyperhydrosis, lichen planus.

Musculoskeletal and Connective Tissue Disorders: Arthritis, muscular weakness.

General Disorders and Administration Site Conditions: Chills, immediate injection site pain, stinging, and burning sensation, injection site reaction, malaise.

Investigations: Abnormal liver function tests.

Postmarketing Experience With HAVRIX and/or ENGERIX-B

The following list includes serious events or events which have suspected causal connection to components of HAVRIX and/or ENGERIX-B, not already reported above for TWINRIX.

Eye Disorders: Keratitis.b

Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome.b

Congenital, Familial and Genetic Disorders: Congenital abnormality.a

a Following HAVRIX.
b Following ENGERIX-B.

Read the Twinrix (hepatitis a inactivated & hepatitis b (recombinant) vaccine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant Administration With Vaccines And Immune Globulin

Do not mix TWINRIX with any other vaccine or product in the same syringe or vial.

When concomitant administration of immunoglobulin is required, it should be given with a different syringe and at a different injection site.

There are no data to assess the concomitant use of TWINRIX with other vaccines.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to TWINRIX.

Read the Twinrix Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 8/29/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
A A A

Twinrix - User Reviews

Twinrix User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Twinrix sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Living Better

Find the secrets to longer life.


NIH talks about Ebola on WebMD