PRODUCT MONOGRAPH

HAVRIX
hepatitis A vaccine, inactivated

Suspension for injection

Active immunizing agent

against infection by hepatitis A virus

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
Mar 16, 2021

Submission Control No:

© 2021 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

Page 1 of 24
 Table of Contents

PART I: HEALTH PROFESSIONAL INFORMATION ............................................ 3

SUMMARY PRODUCT INFORMATION ........................................................... 3
DESCRIPTION....................................................................................................... 3
INDICATIONS AND CLINICAL USE ................................................................. 4
CONTRAINDICATIONS ...................................................................................... 4
WARNINGS AND PRECAUTIONS ..................................................................... 4
ADVERSE REACTIONS....................................................................................... 5
DRUG INTERACTIONS ....................................................................................... 7
DOSAGE AND ADMINISTRATION ................................................................... 7
OVERDOSAGE ................................................................................................... 10
ACTION AND CLINICAL PHARMACOLOGY ............................................... 10
STORAGE AND STABILITY ............................................................................. 11
DOSAGE FORMS, COMPOSITION AND PACKAGING ................................ 12

PART II: SCIENTIFIC INFORMATION .................................................................. 14

PHARMACEUTICAL INFORMATION............................................................. 14
CLINICAL TRIALS ............................................................................................. 14
DETAILED PHARMACOLOGY ........................................................................ 17
MICROBIOLOGY ............................................................................................... 17
TOXICOLOGY .................................................................................................... 17
REFERENCES ..................................................................................................... 18

PART III: CONSUMER INFORMATION................................................................. 22

Page 2 of 24
 HAVRIX

Hepatitis A vaccine, inactivated

PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION

Route of Dosage Form / Nonmedicinal Ingredients

Administration Strength
Intramuscular Sterile suspension for Aluminium (as aluminium hydroxide), amino
Injection injection/ acids for injection, disodium phosphate,
HAVRIX 1440 monopotassium phosphate, polysorbate 20,
contains: 1440 ELISA potassium chloride, sodium chloride, water
units per 1 mL of for injection. Residue*: neomycin sulphate
formaldehyde-
inactivated hepatitis A
virus (HM175
hepatitis A virus
strain); HAVRIX 720
Junior contains:
720 ELISA units per
0.5 mL of
formaldehyde-
inactivated hepatitis A
virus (HM175
hepatitis A virus
strain).
*From the manufacturing process

DESCRIPTION

HAVRIX (hepatitis A vaccine, inactivated) is a sterile suspension containing

formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) adsorbed
onto aluminium hydroxide.

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INDICATIONS AND CLINICAL USE

HAVRIX (hepatitis A vaccine, inactivated) is indicated for active immunization against

disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12
months of age and older. Primary immunization should be administered at least 2 weeks
prior to anticipated exposure to HAV.

Please refer to the National Advisory Committee on Immunization (NACI) and the
Canadian Immunization Guide for recommendations of use.

CONTRAINDICATIONS

HAVRIX (hepatitis A vaccine, inactivated) should not be administered:

• to subjects with known hypersensitivity to any component of the vaccine

preparation or component of the container, or to subjects having shown signs of
hypersensitivity after previous HAVRIX administration. For a complete listing,
see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the
product monograph.

As with other vaccines, the administration of HAVRIX should be postponed in subjects

with severe febrile illness. The presence of a minor infection however, is not a
contraindication.

WARNINGS AND PRECAUTIONS

General
As with other injectable vaccines, appropriate medication (e.g. adrenaline) should be
readily available for immediate use in case of anaphylaxis or anaphylactoid reactions
following administration of the vaccine. For this reason, the vaccinee should remain
under medical supervision for 30 minutes after immunization.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic
response to the needle injection. It is important that procedures are in place to avoid
injury from faints.

Hematologic
HAVRIX (hepatitis A vaccine, inactivated) should be administered with caution to
subjects with thrombocytopenia or a bleeding disorder since bleeding may occur
following an intramuscular administration to these subjects.

Page 4 of 24
Immune
It is possible that subjects may be in the incubation period of hepatitis A infection at the
time of immunization. It is not known whether HAVRIX will prevent hepatitis A in such
cases.

Since there is a possibility that the vaccine may contain trace amounts of neomycin, the
possibility of an allergic reaction in individuals sensitive to this substance should be kept
in mind when considering the use of this vaccine (see DOSAGE FORMS,
COMPOSITION AND PACKAGING).

As with other vaccines, subjects with an impaired immune system may not obtain
adequate antibody titres after the primary immunization course. Such patients may
require administration of additional doses of HAVRIX. However, no specific dosing
recommendations can be made at this time.

Renal
As with other vaccines, hemodialysis patients may not obtain adequate antibody titres
after the primary immunization course. Such patients may require administration of
additional doses of HAVRIX. However, no specific dosing recommendations can be
made at this time.

Special Populations

Pregnant Women:
Animal reproduction studies and adequate human data on use during pregnancy are not
available. However, as with all inactivated viral vaccines, the risks to the fetus are
considered to be negligible. HAVRIX should be used during pregnancy only when
clearly needed.

Nursing Women:
Animal reproduction studies and adequate human data on use during lactation are not
available. Therefore, caution should be exercised if HAVRIX is to be administered to
breast feeding women.

ADVERSE REACTIONS

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse
reaction rates observed in the clinical trials may not reflect the rates observed in
practice and should not be compared to the rates in the clinical trials of another
drug. Adverse drug reaction information from clinical trials is useful for
identifying drug-related adverse events and for approximating rates.

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The safety profile presented below is based on data from more than 5,300 subjects.

Frequency of doses Adverse Event System/Organ Class

Very Common: Irritability Psychiatric disorders
≥ 10% Headache Nervous system disorders
Pain and redness at the injection site, General disorders and administration site
fatigue conditions
Common: Appetite loss Metabolism and nutrition disorders
≥ 1% and < 10% Drowsiness Nervous system disorders
Gastrointestinal symptoms (such as Gastrointestinal disorders
nausea, vomiting, diarrhea)
Malaise, injection site reaction (such General disorders and administration site
as swelling or induration), fever conditions
(≥ 37.5°C)
Uncommon: Upper respiratory tract infection, Infections and infestations
≥ 0.1% and < 1% rhinitis
Dizziness Nervous system disorders
Rash Skin and subcutaneous tissue disorders
Myalgia, musculoskeletal stiffness Musculoskeletal and connective tissue
disorders
Influenza-like illness General disorders and administration site
conditions
Rare: Hypoaesthesia, paraesthesia Nervous system disorders
≥ 0.01% and < 0.1% Pruritus Skin and subcutaneous tissue disorders
Chills General disorders and administration site
conditions

Administration of HAVRIX with measles-mumps-rubella (MMR) and varicella (V)

vaccines
In a co-administration study (HAV 231) evaluating immune response in toddlers
receiving HAVRIX 720 Junior (N=324) or HAVRIX 720 Junior plus measles-mumps-
rubella (MMR) plus varicella vaccines (N=462) or MMR plus varicella plus HAVRIX
720 Junior (N=455), the primary analysis of safety (N=1,241) demonstrated that all the
three vaccines, HAVRIX, MMR and varicella, whether co-administered or administered
alone, were well tolerated. Reactogenicity and safety of HAVRIX when co-administered
with MMR/V vaccines is consistent with the known safety profile of HAVRIX.

Post-Market Adverse Drug Reactions

The following adverse reactions have been reported with HAVRIX.

Immune system disorders Anaphylaxis, allergic reactions including anaphylactoid

reactions and mimicking serum sickness
Nervous system disorders Convulsions
Vascular disorders Vasculitis
Skin and subcutaneous tissue disorders Angioneurotic oedema, urticaria, erythema multiforme
Musculoskeletal and connective tissue disorders Arthralgia

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DRUG INTERACTIONS

Overview
Since HAVRIX is an inactivated vaccine, its concomitant use with other inactivated
vaccines is unlikely to result in interference with immune responses. When concomitant
administration of other vaccines is considered necessary, the vaccines must be given with
different syringes and at different injection sites.

Clinical experiences with the concomitant administration of HAVRIX and the

recombinant hepatitis B virus vaccine, ENGERIX-B, has been satisfactory. No
interference in the respective immune responses to both antigens has been observed.

HAVRIX can be given concomitantly with any of the following vaccines: typhoid, yellow
fever, cholera (injectable), tetanus, or with monovalent and combination vaccines
comprised of measles, mumps, rubella and varicella. See also Clinical Trials section.

HAVRIX must not be mixed with other vaccines.

Drug-Drug Interactions
The concomitant administration of HAVRIX (hepatitis A vaccine, inactivated) and
immune globulin (human) does not influence the seroconversion rate, but may result in a
relatively lower anti-HAV antibody titre than when the vaccine is given alone. HAVRIX
and immune globulin (human) should be administered at separate injection sites.

Drug-Food Interactions
Interactions with food have not been established.

Drug-Herb Interactions
Interactions with herbal products have not been established.

Drug-Laboratory Interactions
Interactions with laboratory tests have not been established.

DOSAGE AND ADMINISTRATION

Recommended Dose and Dosage Adjustment

Primary Immunization

Adults from 19 years onwards

A single dose of HAVRIX 1440 (hepatitis A vaccine, inactivated) (1 mL suspension) is
used for primary immunization.

Page 7 of 24
Children and adolescents from 1 year up to and including 18 years of age
A single dose of HAVRIX 720 Junior (0.5 mL suspension) is used for primary
immunization.

Booster Dose
A booster dose is recommended at any time between 6 and 12 months after a single dose
of HAVRIX 1440 or HAVRIX 720 Junior in order to ensure long-term protection.

Long-term persistence of serum antibodies to hepatitis A virus after vaccination with

HAVRIX is under evaluation. Nevertheless, data available after 5 years show persistence
of antibodies which is consistent with a projected 20 years persistence (based on
mathematical calculations).

Concomitant administration with immune globulin (human)

Concomitant administration of HAVRIX and immune globulin (human) may be
considered when a subject is at risk of being exposed to hepatitis A before adequate anti-
HAV antibody titres can be reached.

Administration
HAVRIX should be injected intramuscularly in the deltoid region in adults and
children, in the antero-lateral part of the thigh in young children up to 2 years of age. The
vaccine should not be administered intramuscularly in the gluteal region or
subcutaneously/intradermally since administration by these routes may result in a less
than optimal anti-HAV antibody response.

As with all parenterals, vaccine products should be inspected visually for any foreign
particulate matter and/or discolouration prior to administration. Before use of HAVRIX,
the syringe should be well shaken to obtain a slightly opaque, white suspension. Discard
the vaccine if the contents of the syringe appear otherwise.

The vaccine must be used as supplied.

Page 8 of 24
Syringe Instructions

To attach the needle to the syringe, refer to the drawing below

1. Holding the syringe barrel in one Needle protector

hand (avoid holding the syringe
plunger), unscrew the syringe cap Needle
by twisting it anticlockwise.

Syringe
Syringe plunger
Syringe barrel
Syringe cap

2. To attach the needle to the syringe,

twist the needle clockwise into the
syringe until you feel it lock (see
drawing).

Needle protector
3. Remove the needle protector, which
on occasion can be a little stiff.

4. Administer the vaccine.

Note: The syringe provided with HAVRIX might be slightly different (without screw
thread) than the syringe in the above drawing. In that case, the needle should be attached
following the below instructions.

Do not remove the white back-stop from the syringe. Prior to administration, ensure
that the plunger rod is firmly attached to the rubber stopper by turning the plunger
clockwise until slight resistance is felt. Do not over tighten. Remove syringe LUER
Tip-cap and needle cap. Attach needle by pressing and twisting in a clockwise rotation
until secured to the syringe.

Page 9 of 24
HAVRIX should never be administered intravenously.

OVERDOSAGE

For management of a suspected drug overdose, contact your regional Poison Control
Centre.

Cases of overdose have been reported during post-marketing surveillance. Adverse

events reported following overdosage were similar to those reported with normal vaccine
administration.

ACTION AND CLINICAL PHARMACOLOGY

Mechanism of Action
HAVRIX (hepatitis A vaccine, inactivated) confers immunity against hepatitis A virus
(HAV) infection by inducing the production of specific anti-HAV antibodies.

Immune response
In clinical studies involving subjects of 18 – 50 years of age, specific humoral antibodies
against HAV were detected in more than 88% of vaccinees at day 15 and 99% at month 1
following administration of a single dose of HAVRIX 1440 (hepatitis A vaccine,
inactivated).

In clinical studies involving subjects of 1 – 18 years of age, specific humoral antibodies

against HAV were detected in more than 93% of vaccinees at day 15 and 99% of
vaccinees one month following administration of HAVRIX 720 Junior.

The mean titre of anti-HAV antibodies induced by HAVRIX is at least 3 times higher
than the maximum observed after passive immunization using immune globulin (human).
In a randomly selected subset of subjects, vaccine induced anti-HAV antibodies were

Page 10 of 24
shown to be qualitatively indistinguishable from immune globulin (human) anti-HAV
antibodies.

To obtain long-term immunity a booster dose is recommended at any time between 6 and
12 months after primary vaccination with HAVRIX 1440 Adult or HAVRIX 720 Junior,
to induce long-term antibody titres.

Long-term persistence of serum antibodies to hepatitis A virus after vaccination with

HAVRIX is under evaluation. Nevertheless, data available after 5 years show persistence
of antibodies which is consistent with a projected 20 years persistence (based on
mathematical calculations).

Primates exposed to the virulent heterologous hepatitis A strain were vaccinated 2 days
after exposure. This post exposure vaccination resulted in total protection of the animals.

Efficacy of HAVRIX for outbreak control

Results of hepatitis A outbreak control program showed a substantial drop in
symptomatic cases in 4,930 vaccinees within 3 weeks of receiving 1 dose of hepatitis A
vaccine. In villages where more than 70% of estimated susceptible individuals were
vaccinated, a dramatic drop in the number of symptomatic cases of disease was observed
within 8 weeks of vaccination.

Immunization Recommendations (see also Canadian Immunization Guide)

Active immunization with HAVRIX is indicated for the following individuals: Armed
Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor
have an increased risk of HAV infection, close contacts of infected persons since virus
shedding of infected persons may occur for a prolonged period, individuals with chronic
liver disease or who are at risk of developing chronic liver disease such as hepatitis B
(HB) and hepatitis C (HC) chronic carriers and alcohol abusers and susceptible
individuals in areas of intermediate to high prevalence of hepatitis A.

Immunization with HAVRIX is particularly recommended in subjects who are, or will be,
at increased risk of infection such as: travellers (i.e., to areas where the prevalence of
hepatitis A is high), persons for whom hepatitis A is an occupational hazard (i.e.,
employees in day-care centres, nursing, medical and paramedical personnel in hospitals
and institutions, especially gastroenterology and pediatric units, sewage workers, and
food handlers), persons for whom there is an increased risk of transmission of Hepatitis A
(i.e., homosexuals, persons with multiple sexual partners, abusers of injectable drugs,
hemophiliac patients), specific population groups known to have higher incidence of
Hepatitis A (i.e., North American Indians, Inuits, recognized community-wide HAV
epidemics).

STORAGE AND STABILITY

The vaccine should not be used beyond the expiry date stamped on the syringe.

Page 11 of 24
Store HAVRIX (hepatitis A vaccine, inactivated) in the original package in order to
protect from light. The vaccine must be stored at 2 to 8°C.

Do not freeze; discard if vaccine has been frozen.

Stability data indicate that HAVRIX is stable at temperatures up to 25°C for 3 days.
These data are intended to guide healthcare professionals in case of temporary
temperature excursion only.

DOSAGE FORMS, COMPOSITION AND PACKAGING

Dosage Forms
HAVRIX (hepatitis A vaccine, inactivated) is available as HAVRIX 1440 (1440 ELISA
Units/mL) and HAVRIX 720 Junior (720 ELISA Units/0.5 mL) suspension for injection.

Composition
HAVRIX is a sterile suspension containing formaldehyde-inactivated hepatitis A virus
(HM175 hepatitis A virus strain) adsorbed onto aluminium hydroxide.

The virus is propagated in MRC5 human diploid cells. Before viral extraction, the cells
are extensively washed to remove culture medium constituents. A virus suspension is
then obtained by lysis of the cells followed by purification using ultrafiltration techniques
and gel chromatography. Inactivation of the virus is assured by treatment with formalin.
The viral antigen content of HAVRIX is determined by an ELISA test. Each dose is
standardized to ensure a viral antigen content of not less than:

ELISA Units Dose Volume

HAVRIX 1440 1440 1 mL
HAVRIX 720 Junior 720 0.5 mL

The virus is adsorbed on aluminium (0.5 mg/1 mL adult dose, 0.25 mg/0.5 mL pediatric
dose) in the form of aluminium hydroxide. Excipients: aluminium (as aluminium
hydroxide), amino acids for injection, disodium phosphate, monopotassium phosphate,
polysorbate 20, potassium chloride, sodium chloride, water for injection. Residue from
the manufacturing process: neomycin sulphate (less than 10 ng for HAVRIX 720 Junior;
less than 20 ng for HAVRIX 1440).

HAVRIX meets the World Health Organization requirement for biological substances
including those for final vaccine residual bovine serum albumin.

Page 12 of 24
Packaging

HAVRIX 1440:
Single Dose 1 mL Prefilled Syringes: In packages of 1 prefilled syringe.

HAVRIX 720 Junior:

Single Dose 0.5 mL Prefilled Syringes: In packages of 1 prefilled syringe.

Page 13 of 24
 PART II: SCIENTIFIC INFORMATION

PHARMACEUTICAL INFORMATION

Drug Substance

Proper name: hepatitis A vaccine, inactivated

Product Characteristics
HAVRIX (hepatitis A vaccine, inactivated) is a sterile suspension containing
formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) adsorbed
onto aluminium hydroxide.

CLINICAL TRIALS

Clinical studies have been conducted in Asia, Europe, Latin America, USA and Canada
to evaluate the immunogenicity and reactogenicity of HAVRIX.

Summary of Study Demographics, Trial Design and Efficacy Results

Study No. Trial design Dosage and route of administration No. of subjects Patient Immunogenicity Results1
Demographics
SC Rate GMT
(%) (mIU/ml)

HAV-104 Double- Intramuscular injection (into deltoid Enrolled: 150 Healthy adults 97.62 5772
blind, region) aged 18 to 50
randomized, years
1440 EL.U/1 mL dose
multi-
country, 0, 6 month dosing schedule
multi-centre

HAV-107 Double- Intramuscular injection (into deltoid Enrolled: 150 Healthy adults 99.32 4902
blind, region) aged 18 to 40
randomized, years
1440 EL.U/1 mL dose
multi-
country, 0, 6 month dosing schedule
multi-centre

HAV-112 Double- Intramuscular injection (into deltoid Enrolled: 194 Healthy adults 99.43 3873
blind, region) aged 21 to 40
randomized, years
1440 EL.U/1 mL dose
multi-
country, 0, 12 month dosing schedule
multi-centre

Page 14 of 24
Study No. Trial design Dosage and route of administration No. of subjects Patient Immunogenicity Results1
Demographics
SC Rate GMT
(%) (mIU/ml)

HAV-115 Open Intramuscular injection (into deltoid Enrolled: 202 Healthy Group 1: Group 1:
randomized, region) adolescents 99.0 249
multi- aged 12 to 19 Group 2: Group 2:
Group 1: 720 EL.U/0.5 mL dose years 100 349
country,
multi-centre Group 2: 1440 EL.U/1 mL dose

0, 6 month dosing schedule

HAV-117B Open study, Intramuscular injection (into deltoid Enrolled: 60 Healthy 100 305
multi- region) children aged 2
country, to 13 years
720 EL.U/0.5 mL dose
multi-centre
0, 6 month dosing schedule

HAV-118 Open Intramuscular injection (into deltoid Enrolled: 54 Healthy 95.5 184
prospective region, and sometimes the thigh children aged 2
study, multi- muscle) to 11 years
country,
720 EL.U/0.5 mL dose
multi-centre
0, 12 month dosing schedule

HAV-122 Open Intramuscular injection (into deltoid Enrolled: 81 Healthy 96.8 194
randomized region) children aged 2
study, multi- to 15 years
720 EL.U/0.5 mL dose
country,
multi-centre 0, 6 month dosing schedule

HAV-129 Open study, Intramuscular injection (into deltoid Enrolled: 120 Healthy 100 256
multi- region) adolescents
country, aged 9 to 18
720 EL.U/0.5 mL dose years
multi-centre
0, 6 month dosing schedule

Alaskan Independent Children/teenagers received dose Enrolled: 4,930 Mean age 924 Children /
Outbreak study, multi- level of 720 EL.U/0.5 mL (±standard teenagers:
Control country, deviation): 2695
Adults received dose level of 16.47 ± 14.9
Programme multi-centre
1440 EL.U/1 mL years
Adults:
Male: 51% 2546
Female: 49%
Toddlers 15 months of age Enrolled: 1474 Mean age Group 1: Group 1:
HAV-231 Open
randomized (±standard 99 1390
Group 1: HAVRIX 720 EL.U/0.5 mL
study, USA, deviation): 15 Group 2: Group 2:
dose
multi-centre 0, 6 month dosing schedule months ± 0.21 99.7 1895
months Group 3: Group 3:
Group 2: HAVRIX 720 EL.U/0.5 mL 100 1770
+ MMR + varicella vaccines Male: 53%.
0, 6-9 month dosing schedule Female: 47% (SC rates (GMCs
post-dose post-dose
Group 3: MMR + varicella vaccines + 2)7 2)8
HAVRIX 720 EL.U/0.5 mL

Page 15 of 24
 Study No. Trial design Dosage and route of administration No. of subjects Patient Immunogenicity Results1
Demographics
SC Rate GMT
(%) (mIU/ml)
0, day 42 (1st dose HAVRIX 720
EL.U/0.5 mL), month 7.5-10.5 (2nd
dose HAVRIX 720 EL.U/0.5 mL)
1. Results at 1 month after initial dose
2. Average of 3 lots
3. Average of 2 lots
4. Results at 3-4 weeks after initial dose
5. Average for 3 different age groups (1-2 years, 3-9 years and 10-19 years)
6. 20-40 years age group
7. Seroconversion rates for anti-HAV antibodies
8. GMCs for anti-HAV antibodies

Efficacy
Clinical studies performed in Europe (HAV 104, 107, 112) evaluated immune response in
adults to primary vaccination with HAVRIX 1440. Antibodies were measured at
screening, day 15, and at month 1 and 6.

In an overall analysis of immunogenicity following vaccination the seroconversion rate

was 98.9% at month 1 and the Geometric Mean Titre was 466 mIU/mL.

Clinical studies performed in Asia, Europe, Latin America, and Alaska (HAV 115, 117B,
118, 122, 129 and Alaskan outbreak program) evaluated immune response in subjects
between 2 and 18 years receiving 720 EL.U.

The overall analysis of immunogenicity following vaccination showed that the

seroconversion rate was 99.3% at month 1 and the Geometric Mean Titre was
253 mIU/mL.

Administration of HAVRIX with measles-mumps-rubella (MMR) and varicella (V)

vaccines
A co-administration study (HAV 231) evaluated immune response in toddlers receiving
HAVRIX 720 Junior (group 1) or HAVRIX 720 Junior + MMR + V vaccines (group 2)
or MMR + V + HAVRIX 720 Junior (group 3). Study HAV 231 demonstrated non-
inferiority of anti-HAV immune response 31 days after the 2nd dose of HAVRIX when
the 1st dose had been co-administered with MMR + V compared to HAVRIX alone (1st
co-primary objective). HAV 231 also demonstrated non-inferiority of the MMR + V
immune responses 42 days after the first dose of MMR co-administered with varicella
and HAVRIX vaccines compared to MMR + V alone (2nd co-primary objective). All
antigens in study HAV 231, including anti-measles, anti-rubella and anti-varicella
antibodies, had similar immune responses in the co-administration group
(HAV+MMR+V) and control groups (HAV Group and the MMR+V – HAV group).
Thus, co-administration of HAVRIX with MMR and varicella vaccines does not impact
the immunogenicity of either of these vaccines.

Page 16 of 24
Safety
For safety information please refer to the Adverse Reactions Section, Part I.

DETAILED PHARMACOLOGY

Not applicable.

MICROBIOLOGY

Not applicable.

TOXICOLOGY

Not applicable.

Page 17 of 24
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23. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia N et al.

Transmission of hepatitis A to patients with hemophilia by factor VIII concentrates
treated with organic solvent and detergent to inactivate viruses. The Italian
Collaborative Group. Ann Intern Med. 1994;120(1):1-7.

24. McFarlane ES, Embil JA, Manuel FR, Thiebaux HJ. Antibodies to hepatitis A antigen
in relation to the number of lifetime sexual partners in patients attending an STD
clinic. Br J Vener Dis. 1981;57(1):58-61.

25. NACI, 2016. National Advisory Committee on Immunization (NACI) Update on the
Recommended use of Hepatitis A Vaccine. 2016. Published by the Public Health
Agency of Canada. Accessed March 29, 2017. https://www.canada.ca/en/public-
health/services/publications/healthy-living/update-recommended-use-hepatitis-
vaccine.html.

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26. Rothschild C, Pol S, Mattlinger B, Reijasse D, Torchet MF, Gazengel C. Vaccination
against Hepatitis A Virus in French Hemophilic Children. Vox Sanguinis.
1995;69(1):80-81.

27. Rubertone MV, DeFraites RF, Krauss MR, Brandt CA. An outbreak of hepatitis A
during a military field training exercise. Mil Med. 1993;158(1):37-41.

28. Sjogren MH, Tanno H, Fay O, Sileoni S, Cohen BD, Burke DS et al. Hepatitis A
virus in stool during clinical relapse. Ann Intern Med. 1987;106(2):221-226.

29. Steffen R. Risk of hepatitis A in travellers. Vaccine. 1992;10 Suppl 1:S69-S72.

30. Steffen R. Hepatitis A and hepatitis B: risks compared with other vaccine preventable
diseases and immunization recommendations. Vaccine. 1993;11(5):518-520.

31. Stewart T, Crofts N. An outbreak of hepatitis A among homosexual men in

Melbourne. Med J Aust. 1993;158(8):519-521.

32. Totos G, Gizaris V, Papaevangelou G. Hepatitis A vaccine: persistence of antibodies

5 years after the first vaccination. Vaccine. 1997;15(11):1252-1253.

33. Van Damme P, Mathei C, Thoelen S, Meheus A, Safary A, Andre FE. Single dose
inactivated hepatitis A vaccine: rationale and clinical assessment of the safety and
immunogenicity. J Med Virol. 1994;44(4):435-441.

34. Van Damme P, Thoelen S, Cramm M, De Groote K, Safary A, Meheus A. Inactivated

hepatitis A vaccine: reactogenicity, immunogenicity, and long-term antibody
persistence. J Med Virol. 1994;44(4):446-451.

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among health care workers - epidemiology and prevention. In 1993;(International
Congress on Occupational Health):133-137.

36. Van Damne P, Thoelen S Meheus. Long-term immunogenicity of an inactivated

hepatitis A vaccine. IX Triennal International Symposium on Viral Hepatitis and
Liver Disease. 1996;21-25.

37. Van Damne P, Van Herck K, Thoelen S Meheus. Long-term immunogenicity of an

inactivated hepatitis A vaccine. 5th International Conference on Travel Medicine
1997;24-27.

38. Vernon AA, Schable C, Francis D. A large outbreak of hepatitis A in a day-care

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39. WHO. Prevention of foodborne hepatitis A – Considerations on the vaccination of
food handlers. WHO Tech Rep Ser. 1993;68:25-26.

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 IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION What dosage forms it comes in:

HAVRIX is presented as a suspension for injection.
HAVRIX
hepatitis A vaccine, inactivated WARNINGS AND PRECAUTIONS
BEFORE you use HAVRIX talk to your doctor or pharmacist
This leaflet is part III of a three-part "Product Monograph" if:
published for HAVRIX (hepatitis A vaccine, inactivated)
approved for sale in Canada and is designed specifically for • you or your child has a severe infection with a high
Consumers. This leaflet is a summary and will not tell you temperature (over 38°C).
everything about HAVRIX. Contact your doctor or • you or your child have any known allergies.
pharmacist if you have any questions about the vaccine. • you or your child is on dialysis for kidney disease.
• you or your child have a poor immune system due
ABOUT THIS VACCINE to illness or drug treatment.
• you are pregnant or breastfeeding.
What the vaccine is used for: • you or your child have a bleeding problem or bruise
HAVRIX is a vaccine used to prevent hepatitis A disease. easily.
Vaccination is the best way to protect against this disease.
Please tell your doctor if you are taking or have recently
HAVRIX is approved for use in persons 12 months of age taken any other medicines. You can be given other vaccines
and older. The first dose of the vaccine should be given at at the same time as HAVRIX, however these vaccines will be
least 2 weeks prior to anticipated exposure to hepatitis A given at different injection sites.
disease.
Fainting can occur following, or even before, any needle
What it does: injection; therefore, tell the doctor or nurse if you or your
The vaccine works by causing the body to produce its own child fainted with a previous injection.
protection (antibodies) against hepatitis A disease.
INTERACTIONS WITH THIS VACCINE
When it should not be used:
HAVRIX should not be used: HAVRIX and immune globulin (human) should be
administered at separate injection sites.
• if you or your child have a known allergy to any
component of the vaccine (see What the important When administration of other vaccines with HAVRIX is
medicinal ingredient is and What the important considered necessary, the vaccines must be given with
nonmedicinal ingredients are sections). different syringes and at different injection sites.
• if you or your child have shown signs of a serious
allergic reaction after a previous dose of this vaccine or PROPER USE OF THIS VACCINE
any vaccine intended to protect against hepatitis A
infection. Signs of an allergic reaction may include skin In case of drug overdose, contact a health care practitioner,
rash, shortness of breath and swelling of the face or hospital emergency department or regional Poison Control
tongue. Centre immediately, even if there are no symptoms.

Immunization should be postponed if you or your child has a

Usual dose:
severe fever or infection.
HAVRIX is injected into the muscle in your upper arm or in
the front of the thigh in young children.
What the medicinal ingredient is:
The medicinal ingredient in HAVRIX is inactivated hepatitis
Primary Immunization:
A virus. None of the components of the vaccine are The first dose of the vaccine should protect you or your child
infectious. with normal immunity from infection with hepatitis A virus
within 2-4 weeks after the injection.
What the nonmedicinal ingredients are:
Aluminium (as aluminium hydroxide), amino acids for Booster Dose:
injection, disodium phosphate, monopotassium phosphate, To ensure that you or your child is protected long-term you
polysorbate 20, potassium chloride, sodium chloride and or your child should have a second (booster) dose of the
water for injection. Residue from the manufacturing process: vaccine 6 to 12 months after the first injection.
neomycin sulphate.

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 IMPORTANT: PLEASE READ

Missed Dose:
REPORTING SUSPECTED SIDE EFFECTS
If you or your child misses a scheduled injection, talk to your
doctor to arrange another visit.
To monitor vaccine safety, the Public Health Agency of
Canada collects case reports on adverse events following
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
immunization.
Like all vaccines, HAVRIX can have side effects.
For health care professionals:
If a patient experiences an adverse event following
Side effects that may occur are the following:
immunization, please complete the appropriate Adverse
Events following Immunization (AEFI) Form and send it to
Very common (more than 10% of doses):
your local Health Unit in your province/territory.
• Irritability.
• Headache. For the General Public:
• Pain and redness at the injection site, fatigue. Should you experience an adverse event following
immunization, please ask your doctor, nurse, or pharmacist to
Common (between 1% and 10% of doses): complete the Adverse Events following Immunization (AEFI)
• Loss of appetite. Form.
• Drowsiness.
• Diarrhea, nausea, vomiting. If you have any questions or have difficulties contacting your
• Swelling or hard lump at the injection site. local health unit, please contact Vaccine Safety Section at
• Generally feeling unwell, fever. Public Health Agency of Canada:

Uncommon (between 0.1% and 1% of doses): By toll-free telephone: 866-844-0018

• Upper respiratory tract infection, runny or blocked By toll-free fax: 866-844-5931
nose. By email: caefi@phac-aspc.gc.ca
• Dizziness. At the following website:
• Rash. http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
• Aching muscles, muscular stiffness not caused by
exercise. By regular mail:
• Flu-like symptoms, such as high temperature, sore The Public Health Agency of Canada
throat, runny nose, cough and chills. Vaccine Safety Section
130 Colonnade Road
If any of the side effects get serious or if you notice any side Ottawa, Ontario
effects not mentioned above, please tell your doctor. K1A 0K9 Address Locator 6502A

This is not a complete list of side effects. For any unexpected NOTE: Should you require information related to the
effects while taking HAVRIX, contact your doctor or management of the side effect, please contact your health
pharmacist. care provider before notifying the Public Health Agency of
Canada. The Public Health Agency of Canada does not
provide medical advice.

HOW TO STORE IT

HAVRIX must be stored in a refrigerator between 2 and 8°C.

Do not freeze. Discard if the vaccine has been frozen.

Do not use after expiration date shown on the label. The date
for last use corresponds to the last day of the month
mentioned.

Store all vaccines out of the reach and sight of children.

Store in the original package in order to protect from light.

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 IMPORTANT: PLEASE READ

MORE INFORMATION

This document plus the full product monograph, prepared for

health professionals can be found at:
http://www.gsk.ca
or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374

This leaflet was prepared by GlaxoSmithKline Inc.

Last revised: Mar 16, 2021

© 2021 GSK group of companies or its licensor

Trademarks are owned by or licensed to the GSK group of
companies.

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