Twinrix

Twinrix Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Twinrix (hepatitis A inactivated and hepatitis B [recombinant]) Vaccine is indicated for active immunization of persons 18 years of age and older against disease caused by hepatitis A virus, and infection by all known subtypes of hepatitis B virus. As with any vaccine, vaccination with Twinrix may not protect 100% of recipients. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by vaccination with Twinrix. Some of the side effects of Twinrix may include but are not limited to fever, sore throat, and headache.

Twinrix contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein per ml. Twinrix should be administered by intramuscular injection. Do no inject intravenously or intradermal. In adults, the injection should be given in the deltoid region. Twinrix should not be administered in the gluteal region; such injections may result in a suboptimal response. When concomitant administration of other vaccines or immunoglobulin (IG) is required, they should be given with different syringes and at different injection sites. There have been rare reports of anaphylaxis/anaphylactoid reactions following routine clinical use of Twinrix. Twinrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Twinrix should be given to a pregnant woman only if clearly indicated. Because many drugs are excreted in human milk, caution should be exercised when Twinrix is administered to a woman who is breastfeeding. Safety and effectiveness of Twinrix has not been established in the pediatric population.

Our Twinrix (hepatitis A inactivated and hepatitis B [recombinant]) Vaccine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Twinrix in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • fast or pounding heartbeats; or
  • easy bruising or bleeding.

Less serious side effects include:

  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;
  • headache, tired feeling;
  • mild fever;
  • runny or stuffy nose, sore throat, other cold symptoms; or
  • nausea, vomiting, loss of appetite, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Twinrix (Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Twinrix Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, tiredness, headache, nausea, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Report all side effects to your doctor before you receive the next injection.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Twinrix (Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Twinrix FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Twinrix (Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine) »

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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.


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