Consumer medicine information

WHAT IS IN THIS LEAFLET

This leaflet answers some of the common questions about VARILRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having VARILRIX against the expected benefits.

If you have any concerns about VARILRIX talk to your doctor, nurse or pharmacist.

Keep this leaflet with this vaccine. You may need to read it again

WHAT VARILRIX IS USED FOR

VARILRIX is a vaccine used in children aged 9 months or older, adolescents and adults to prevent chickenpox. Groups who would benefit mostly from vaccination include:

• adults not immunised (protected) against chickenpox, especially those in ‘at-risk’ occupations such as health care workers, teachers and workers in child care centres
• adults not immunised, who are parents of young children
• adults and children not immunised, who live in the same house with people who have lowered immunity and have no history of chickenpox.
• The vaccine works by causing the body to produce its own protection (antibodies) against this disease.

Chickenpox is caused by a virus called the varicella-zoster virus. VARILRIX vaccine contains a weakened form of the chickenpox (varicella-zoster) virus.

Chickenpox is a highly infectious disease, which usually causes an itchy, red rash with blisters. After about 1 week, most of the blisters have normally crusted over. The rash can appear on the face, scalp, body, or in the mouth, eyes and bottom. Other symptoms can include fever, headaches, chills, and muscle and/or joint aches and pains. Sometimes disease complications can occur such as bacterial infection of the skin (often due to itching of the rash/crusts), inflammation of the brain (varicella encephalitis), and lung infection (varicella pneumonia). Complications are not common and are mainly seen in children with lowered immunity, and sometimes in adults.

Full recovery from chickenpox generally occurs; however, later in life the virus can become active again. This condition is known as shingles or Herpes zoster.

BEFORE VACCINATION

VARILRIX SHOULD NOT BE GIVEN IF:

• you or your child has had an allergic reaction to VARILRIX, or any ingredient contained in this vaccine. The ingredients in VARILRIX are listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. VARILRIX can be used in people who have previously developed a skin rash after applying the antibiotic ‘neomycin’ to the skin.
• you or your child have previously had an allergic reaction to any vaccine against varicella
• you are or think you may be pregnant, or if you intend to become pregnant within one month of vaccination. Your doctor will discuss with you the risks of receiving VARILRIX during pregnancy.
• you or your child has severely lowered immunity. This can occur in persons:
  - with inherited (or family history of) immune deficiency conditions
  - with abnormal blood conditions or blood protein (immunoglobulin) disorders
  - with cancer
  - receiving or who have received certain drugs (ie cyclosporin, corticosteroids, and cancer medicines)
  - receiving or who have received radiation therapy
  - with Human Immunodeficiency Virus (HIV) infection
• you or your child has a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse about this before vaccination.
• the expiry (EXP) date printed on the pack has passed
• the packaging is torn or shows signs of tampering.

If you are not sure whether you or your child should have VARILRIX, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for you or your child.

BEFORE VARILRIX IS GIVEN TELL YOUR DOCTOR OR NURSE IF:

• you are breast feeding. The effect on breast fed infants of the administration of VARILRIX to their mothers has not been evaluated in clinical studies.
• you or your child has allergies to any other medicines or substances, such as dyes, foods or preservatives.
• you or your child have received another vaccine within the last month.
• You or your child has a weakened immune system. In the presence of weakened immunity, careful assessment by your doctor or your child’s doctor is necessary in order to minimise adverse reactions to the vaccine. You or your child should be closely monitored as the response to the vaccine may not be sufficient to ensure protection against the illness.
• you or your child have received a blood or plasma transfusion, or been given gamma globulin or other immunoglobulins within the last 3 months. VARILRIX may be less effective if given within 3 months of these products.
• you or your child are due to have a skin test for possible tuberculosis. If this test is done within 6 weeks after receiving Varilrix, the result may not be reliable.
• you or your child are having any prescription or OTC (over-the-counter) medicines. In particular, mention use of any medicines that suppress the immune system, such as high-dose steroids.

Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you/your child fainted with a previous injection.

Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if VARILRIX is to be given with another vaccine or medicine.

HOW VARILRIX IS GIVEN

The doctor or nurse will give VARILRIX as an injection.

If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.

HOW MUCH IS GIVEN

The dose is 0.5mL for infants (9 months or older), children, adolescents and adults.

HOW IS IT GIVEN

VARILRIX will be injected under the skin (subcutaneously) of the shoulder or thigh.

The vaccine should never be given intravenously.

WHEN IT IS GIVEN

In children from 9 months up to and including 12 years, the appropriate time and number of doses that will be given will be determined by your doctor on the basis of appropriate official recommendations. Adults and adolescents aged 13 years and older are generally given two doses at least six weeks apart. Each dose is given at a separate visit.

The need for booster doses is uncertain at present.

IF A DOSE IS MISSED

If a scheduled dose is missed, talk to your doctor or nurse and arrange another visit as soon as possible.

OVERDOSAGE

Cases of accidental administration of more than the recommended dose of Varilrix have been reported. Amongst these cases, the following adverse events were reported: lethargy and convulsions. In the other cases reported as overdose there were no associated adverse events.

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

WHILE USING VARILRIX

THINGS YOU MUST NOT DO:

Do not become pregnant for one month after receiving VARILRIX vaccination. Talk to your doctor as soon as possible, if you do become pregnant within this time.

THINGS YOU MUST DO:

• Tell your doctor that you or your child has received VARILRIX if another vaccine is to be given within 1 month after vaccination.
• Tell your doctor if you or your child develops a rash within 4 weeks after vaccination. Some individuals develop symptoms of mild chickenpox several weeks after vaccination with VARILRIX. While the rash lasts, you or your child should avoid contact with people who have low immunity.
• Where possible, avoid contact with people who have lowered immunity for up to 6 weeks. The disease may be more serious in these people.
• Tell your doctor if you or your child are to have a tuberculin skin test for tuberculosis within 4-6 weeks after vaccination. The vaccine may affect the results of the tuberculin skin test.
• Tell your doctor if you or your child are to have another vaccine within 1 month after vaccination.

THINGS TO BE CAREFUL OF:

Be careful driving or operating machinery until you know how VARILRIX affects you. VARILRIX should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or lightheadedness. Make sure you know how you react to VARILRIX before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or lightheaded.

It is advised to remain in the clinic for about 15 minutes after receiving the injection. There is a rare risk of allergic reactions. These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. These reactions will usually occur before leaving the doctor’s surgery. If these symptoms occur, you should contact a doctor immediately.

SIDE EFFECTS

Tell your doctor or nurse as soon as possible if you or your child have troublesome symptoms after having had a dose of VARILRIX.

VARILRIX helps protect most people from chickenpox, but it may have unwanted side effects in a few people. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Most unwanted effects with VARILRIX are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site. However, some children develop symptoms of mild chickenpox several weeks after vaccination with VARILRIX.

Side effects that occurred during clinical trials with VARILRIX were as follows:

Very common (these may occur with more than 1 in 10 doses of the vaccine):

• pain, redness and swelling at the injection site
• headache
• fever
• upper respiratory tract infection

Common (these may occur with up to 1 in 10 doses of the vaccine):

• rash (spots and/or blisters)
• itching
• vomiting
• diarrhoea
• stomach pain or discomfort
• toothache
• nervousness
• cough
• runny or blocked nose, sneezing (rhinitis)
• sore throat and discomfort when swallowing
• discharge with itching of the eyes and crusty eyelids (conjunctivitis)
• infection of the middle ear
• tiredness (fatigue)
• chest pain
• generally feeling unwell
• nausea
• dizziness
• migraine
• sleepiness
• swollen glands in the neck, armpit or groin
• painful, swollen joints
• aching muscles, muscle tenderness or weakness, not caused by exercise

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

• irritability
• chickenpox-like rash
• fever greater than 39°C
• earache
• indigestion

Rare (these may occur with up to 1 in 1,000 doses of the vaccine):

• hives (urticaria)

After commercialisation, the following additional side effects have been rarely reported in people vaccinated with VARILRIX:

• shingles (herpes zoster)
• fits or seizures
• temporary lumpy rash that may affect the skin, mouth and other parts of the body
• bleeding or bruising more easily than normal which may be associated with skin rashes/peeling or fever
• infection or inflammation of the nervous system resulting in temporary loss of control of bodily movements, walking or sensation changes

Other side effects not listed above, can also occur during or soon after a dose of VARILRIX.

Check with your doctor or nurse if you or your child has any other effects.

STORAGE

VARILRIX is usually stored at the doctor’s clinic or surgery, or at the pharmacy. But if you need to store VARILRIX always:

• Keep VARILRIX in the refrigerator stored between 2°C and 8°C. Do not store it in the bathroom, near the sink, or leave it in the car on hot days. Avoid exposing the vaccine to sunlight. The water diluent can be kept in a refrigerator or at room temperature. It must not be frozen.
• Keep the vaccine out of the reach of children.
• Keep VARILRIX in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over VARILRIX that has expired or has not been used.

PRODUCT DESCRIPTION

WHAT IT LOOKS LIKE

VARILRIX comes as a slightly cream to yellowish or pinkish coloured powder in a glass vial. The clear sterile water diluent comes in prefilled syringes or ampoules. It is made into a clear peach to pink coloured liquid, before being injected by the doctor or nurse.

INGREDIENTS

The active ingredient of VARILRIX is a live weakened varicella-zoster virus (Oka strain). Each 0.5 mL dose contains not less than 1,995 plaque-forming units of the varicella-zoster virus.

The inactive ingredients in the vaccine are: amino acids, lactose, mannitol and sorbitol. Neomycin sulphate is present as traces.

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

VARILRIX does not contain a preservative, sucrose, gluten, tartrazine or any other azo dyes.

FURTHER INFORMATION

VARILRIX is only available if prescribed by a doctor.

VARILRIX comes in the following:

• a glass vial with sterile water diluent (prefilled syringe) in packs of 1 or 10 - AUST R 234750. Needles may or may not be provided, subject to availability.
• a glass vial with sterile water diluents (ampoule) in packs of 1 or 10 – AUST R 234751 Needles are not provided.

Not all pack sizes may be marketed.

MANUFACTURER

GlaxoSmithKline Biologicals S.A
rue de l'Institut 89,
1330 Rixensart, Belgium.

DISTRIBUTED IN AUSTRALIA BY

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria 3067

Date of Preparation:

16 March 2017

Version 2.0

VARILRIX is a registered trade mark of the GSK group of companies.

© 2016 GSK group of companies. All rights reserved.

Published by MIMS July 2017

1 Name of Medicine

Live varicella vaccine.

2 Qualitative and Quantitative Composition

Varilrix is a lyophilised preparation of the live attenuated Oka strain of varicella-zoster virus, obtained by propagation of the virus in MRC₅ human diploid cell culture.
Each 0.5 mL dose of the reconstituted vaccine contains not less than 10^3.3 plaque forming units (PFU) of the varicella-zoster virus.
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
Varilrix meets the World Health Organisation requirements for biological substances and for varicella vaccines.

List of excipients with known effect.

3 Pharmaceutical Form

Powder and diluent for solution for injection.
Varilrix is presented as a slightly cream to yellowish or pinkish coloured powder for reconstitution with clear and colourless sterile diluent.

4 Clinical Particulars

4.1 Therapeutic Indications

Varilrix is indicated for active immunisation against varicella of healthy children and adults from 9 months of age.
Groups who would particularly benefit from vaccination include:
Nonimmune adults, especially those in at-risk occupations such as health care workers, teachers and workers in children's day care centres.
Nonimmune parents of young children.
Nonimmune household contacts, both adults and children, of immunocompromised patients with no history of the disease.

4.2 Dose and Method of Administration

Varilrix should be administered as a single dose by subcutaneous injection only. The upper arm (deltoid region) is the preferred site of injection.
Under no circumstances should Varilrix be administered intravenously. Varilrix should not be administered intradermally.

Dosage (dose and interval).

Infants and children (aged 9 months up to and including 12 years of age).

Adolescents and adults (13 years of age and over).

Interchangeability.

Method of administration.

Instructions for reconstitution of the vaccine with diluent presented in ampoules.

Instructions for reconstitution of the vaccine with diluent presented in pre-filled syringe.

4.3 Contraindications

Varilrix is contraindicated in children and adults with known hypersensitivity to neomycin or to any other component of the vaccine. A history of contact dermatitis to neomycin is not a contraindication.
Varilrix is contraindicated in children and adults having shown signs of hypersensitivity after previous administration of varicella vaccine.
Varilrix is contraindicated in pregnant women. Pregnancy should be avoided for one month after vaccination (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Varilrix is contraindicated in patients with severe humoral or cellular immunodeficiency such as:
patients with primary and acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm³;
patients presenting other evidence of lack of cellular immune competence (e.g. children and adults with leukaemias, lymphomas, blood dyscrasias, clinically manifest HIV infection);
patients receiving immunosuppressive therapy including high doses of corticosteroids (further guidance is found in the Australian Immunisation Handbook).
See Section 4.4 Special Warnings and Precautions for Use.
As with other vaccines, the administration of Varilrix should be postponed in children and adults suffering from acute severe febrile illness. In healthy children and adults, the presence of a minor infection, however, is not a contraindication to immunisation.

4.4 Special Warnings and Precautions for Use

Varilrix must not be administered intravascularly or intradermally.
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 a place to avoid injury from faints.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of a vaccine.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.
Transmission of the Oka vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees with rash. Transmission of the Oka vaccine from a vaccinee who does not develop a rash to seronegative contacts cannot be excluded.
The mild nature of the rash which developed in the healthy contacts indicates that the virus remains attenuated after passage through human hosts. Vaccine recipients should attempt to avoid contact with susceptible high risk individuals for up to 6 weeks, where possible.
As for any vaccine, vaccination with Varilrix may not result in protection from subsequent infection with varicella virus in 100% of susceptible persons given the vaccine (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
As for other varicella vaccines, cases of varicella disease have been shown to occur in persons who have previously received Varilrix. These breakthrough cases are usually mild, with a fewer number of lesions and less fever as compared to cases in unvaccinated individuals.
The duration of protection from varicella infection with Varilrix is unknown. The need for and timing of booster doses is uncertain at present. In a highly vaccinated population, immunity of some individuals may wane due to lack of exposure to natural varicella as a result of shifting epidemiology.
It is not known whether Varilrix given immediately after exposure to wild varicella virus will prevent illness. Results of a small household contact study using another live varicella virus vaccine containing the same varicella strain as Varilrix suggested that some protection was provided by that vaccine when vaccination occurred within 72 hours of exposure.
There are inadequate data to assess the incidence and severity of herpes zoster (shingles) after vaccination with Varilrix.
There is limited data on the use of Varilrix in immunocompromised patients, therefore vaccination should be considered with caution and only when, in the opinion of the physician, the benefits outweigh the risks, further guidance is found in the Australian Immunisation Handbook.
Immunocompromised patients who have no contraindication for this vaccination (see Section 4.3 Contraindications) may not respond as well as immunocompetent children and adults, therefore some of these patients may acquire varicella despite appropriate vaccine administration. Immunocompromised patients should be monitored carefully for signs of varicella.
Very few reports exist on disseminated varicella with internal organ involvement following vaccination with the Oka varicella vaccine strain and these are mainly in immunocompromised patients.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Varilrix should not be mixed in the same syringe with other vaccines. Different injection sites should always be used.
There was no reduction in safety and immunogenicity when Varilrix was given concomitantly, at a separate site, using a separate syringe, with a measles-mumps-rubella vaccine and with a diphtheria-tetanus-acellular pertussis vaccine. There are no data on concomitant administration with other live or inactivated vaccines or on administration of vaccines after Varilrix has been given. If it is necessary to administer more than 1 live virus vaccine at the same time, these may be given at the same visit at different sites. If not given on the same day, the live viral vaccinations should be separated by an interval of at least 4 weeks.
If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that live viral vaccines may cause a temporary depression of tuberculin skin sensitivity. As this anergy may last up to a maximum of 6 weeks, tuberculin testing should not be performed within that period after vaccination to avoid false negative results.
Varilrix may be administered at the same time as a measles containing vaccine. If this is not possible, an interval of at least one month should elapse before the measles containing vaccine is given. Measles vaccination may lead to short lived suppression of the cell mediated immune response.
In children and adults who have received immune globulin or a blood transfusion, immunisation should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired varicella antibodies.
Salicylates should be avoided for 6 weeks after varicella vaccination as Reye's syndrome has been reported following the use of salicylates during natural varicella infection.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

Local reactions.

Body as a whole.

Blood and lymphatic system disorders.

Skin and appendages.

Gastrointestinal.

Musculoskeletal.

Central nervous system.

Respiratory.

Special senses.

Local reactions.

Body as a whole.

Skin and appendages.

Gastrointestinal.

Central nervous system.

Respiratory.

Haematologic/ lymphatic.

Musculoskeletal.

Special senses.

Post-marketing data.

Infections and infestations.

Blood and lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Vascular disorders.

Skin and subcutaneous tissue disorders.

Skin.

Reporting suspected adverse effects.

4.9 Overdose

Cases of accidental administration of more than the recommended dose of Varilrix have been reported. Amongst these cases, the following adverse events were reported: lethargy and convulsions. In the other cases reported as overdose there were no associated adverse events.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

One dose regimen in children.

Two dose regimen in children.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The vaccine also contains amino acids, lactose, mannitol and sorbitol. Varilrix does not contain a preservative. Neomycin sulphate is present as a residual from the manufacturing process.

6.2 Incompatibilities

Varilrix should not be mixed in the same syringe with other vaccines.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

The lyophilised vaccine should be stored in a refrigerator between 2°C and 8°C. The diluent can be stored in the refrigerator or at ambient temperatures. The lyophilised vaccine is not affected by freezing.
When supplies of Varilrix are distributed from a central cold store, it is necessary to arrange transport under refrigerated conditions.

6.5 Nature and Contents of Container

Varilrix is presented as a slightly cream to yellowish or pinkish coloured powder in a glass vial. The sterile diluent is clear and colourless and presented in ampoules and prefilled syringes.
Varilrix is supplied as:
a box containing 10 single dose vials of lyophilised vaccine (needles not supplied);
a box containing a single dose vial of lyophilised vaccine with a diluent syringe included (available in packs of 1 or 10; needles may or may not be included);
a box containing a single dose vial of lyophilised vaccine with diluent ampoule included (available in packs of 1 or 10; needles not supplied).
Not all pack sizes and container types may be distributed in Australia.
The ampoules, vials and prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes