Vaccine Information: TWINRIX

TWINRIX- hepatitis a virus strain hm175 antigen (formaldehyde inactivated) and hepatitis b virus subtype adw2 hbsag surface protein antigen injection, suspension
A-S Medication Solutions

1 INDICATIONS AND USAGE

TWINRIX is 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.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

The vaccine should be re-suspended before use. When re-suspended, the vaccine will have a uniform hazy white appearance.

Upon storage, a fine white deposit with a clear colorless layer above may be present. Re-suspend the vaccine following the steps below.

1. Hold the syringe upright in a closed hand.

2. Shake the syringe by tipping it upside down and back upright again.

3. Repeat this action vigorously for at least 15 seconds.

4. Inspect the vaccine again:

If the vaccine appears as a uniform hazy white suspension, it is ready to use – the appearance should not be clear.
If the vaccine still does not appear as a uniform hazy white suspension, tip upside down and back upright again for at least another 15 seconds then inspect again.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Attach a sterile needle to the prefilled syringe and administer intramuscularly.

2.2 Administration

TWINRIX should be administered by intramuscular injection only as a 1-mL dose. Administer in the deltoid region. Do not administer in the gluteal region; such injections may result in a suboptimal response.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.3 Recommended Dose and Schedule

Standard dosing schedule consists of 3 doses (1-mL each), given intramuscularly at 0, 1, and 6 months. Alternatively, an accelerated schedule of 4 doses (1-mL each), given intramuscularly on Days 0, 7, and 21 to 30 followed by a booster dose at Month 12 may be used.

3 DOSAGE FORMS AND STRENGTHS

Suspension for injection available in 1-mL prefilled TIP-LOK syringes [see Description (11), How Supplied/Storage and Handling (16)].

4 CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing or hepatitis B-containing vaccine, or to any component of TWINRIX, including yeast and neomycin, is a contraindication to administration of TWINRIX [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Latex

The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

5.2 Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including TWINRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

5.3 Preventing and Managing Allergic Vaccine Reactions

Prior to immunization, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. [See Contraindications (4).]

5.4 Moderate or Severe Acute Illness

To avoid diagnostic confusion between manifestations of an acute illness and possible vaccine adverse effects, vaccination with TWINRIX should be postponed in persons with moderate or severe acute febrile illness unless they are at immediate risk of hepatitis A or hepatitis B infection.

5.5 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to TWINRIX.

5.6 Multiple Sclerosis

Results from 2 clinical studies indicate that there is no association between hepatitis B vaccination and the development of multiple sclerosis,1 and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis.2

5.7 Limitations of Vaccine Effectiveness

Hepatitis A and hepatitis B have relatively long incubation periods. The vaccine may not prevent hepatitis A or hepatitis B infection in individuals who have an unrecognized hepatitis A or hepatitis B infection at the time of vaccination. Additionally, vaccination with TWINRIX may not protect all individuals.

6 ADVERSE REACTIONS

6.1 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 with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

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 reactions 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 U.S. study, 773 subjects (aged 18 to 70 years) 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 reactions 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 Reactions within 4 Days of Vaccinationa with TWINRIXb or ENGERIX-B and HAVRIXc

Local

TWINRIX

ENGERIX-B

HAVRIX

Dose 1

Dose 2

Dose 3

Dose 1

Dose 2

Dose 3

Dose 1

Dose 2

(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

Systemic

TWINRIX

ENGERIX-B and HAVRIX

Dose 1

Dose 2

Dose 3

Dose 1d

Dose 2e

Dose 3d

(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

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 reactions 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 reactions 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 reactions 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 reactions within 30 days of vaccination in the U.S. 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.

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