Varilrix: Uses, Side Effects and Dosage

What VARILRIX is used for:

VARILRIX is a vaccine against chicken pox (varicella).

How VARILRIX works:

VARILRIX protects you against chicken pox (varicella) virus. It works by helping the body to make its own antibodies which protect you against the disease.

The ingredients in VARILRIX are:

Medicinal ingredient(s): Each 0.5 mL dose of VARILRIX contains as active ingredient no less than 10^3.3 plaque-forming units (PFU) of the live attenuated Oka-strain of varicella-zoster virus.

Non-medicinal ingredients: The reconstituted vaccine contains the following nonmedicinal ingredients: amino acids, lactose, mannitol, sorbitol and water for injection. Residues: Neomycin sulphate.

VARILRIX comes in the following dosage form(s):

VARILRIX is presented as a powder and diluent for solution for injection.

The vaccine is provided as slightly cream to yellowish or pinkish coloured powder in a monodose glass vial.

The sterile diluent (0.5 mL) is clear and colourless and presented in prefilled syringes.

The colour of the reconstituted vaccine may vary from clear peach to pink coloured solution.

Do not use VARILRIX if:

You should not receive VARILRIX if:

• you have previously had an allergic reaction to VARILRIX, neomycin (an antibiotic), or any component contained in this vaccine. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• you have previously had an allergic reaction to any other vaccine against chicken pox (varicella).
• you have any severe illness that weakens the immune system (such as blood disorders, leukemia or infections) (See the To help avoid side effects and ensure proper use section below).
• you have recently received or are still taking treatment that weakens the immune system (including high dose corticosteroids).

• you are pregnant. Furthermore, pregnancy should be avoided for one month after vaccination. During this time you should use an effective method of birth control to avoid pregnancy.

• you have active untreated tuberculosis.

You should inform your doctor about the above conditions. Your doctor may decide if the vaccine can be given, if the allergy to neomycin is limited to a skin reaction (contact dermatitis) or the low white blood cell count is not evidence of inadequate immune response.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive VARILRIX. Talk about any health conditions or problems you may have, including if you:

• have a history or family history of allergies.
• have a weakened immune system or will be starting a medicine that weakens the immune system. You should be closely monitored as the responses to the vaccine may not be sufficient to ensure a protection against the illness.
• 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.
• have a severe infection with a high temperature (over 38°C). It might be necessary to postpone the vaccination until recovery. In healthy individuals, the presence of minor infection such as a cold should not be a problem, but talk to your doctor first.
• are taking any other medicine or have recently received any other vaccine.
• are breastfeeding.

Other warnings you should know about:

VARILRIX can be administered at the same time as any other vaccine. Different injectable vaccines should be administered at different injection sites.

Inactivated vaccines can be administered at any time in relationship to VARILRIX.

If a measles vaccine cannot be administered at the same time as VARILRIX, it is recommended that at least one month be allowed between the administration of the two vaccines as it is recognized that measles vaccination could affect the effectiveness of VARILRIX.

Different injectable vaccines should always be administered at different injection sites.

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

High risk patients: VARILRIX should not be administered at the same time as other live attenuated vaccines. Inactivated vaccines may be administered at any time in relationship to VARILRIX given that no specific contraindication has been established.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with VARILRIX:

In individuals who have received immune globulins or a blood transfusion, vaccination should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired varicella antibodies.

You or your child should not take any aspirin or aspirin-like products (also known as salicylates) for 6 weeks after vaccination with VARILRIX as this may cause a serious disease called Reye’s Syndrome which can affect all your body organs.

How to take VARILRIX:

The vaccine must be administered by a healthcare professional.

VARILRIX should not be mixed with any other vaccine in the same syringe.

Make sure you finish the complete vaccination course. If not you may not be fully protected against infection.

Usual dose:

VARILRIX will be injected under your skin (subcutaneously).

The upper arm (deltoid region) is the preferred site of injection. Your doctor may wipe the skin with alcohol or other disinfecting agents and will let the skin dry before the injection. VARILRIX must not be administered into your blood vessels (intravascularly) or into your skin (intradermally).

The doctor or nurse will inject the recommended dose of vaccine. The appropriate number of injections that will be given to children from the age of 12 months up to and including 12 years of age will be determined by your doctor or nurse on the basis of appropriate official recommendations. Adolescents and adults from 13 years up should receive 2 doses with an interval of at least 6 weeks between each dose. In high risk patients additional doses of vaccine might be required.

It is important to follow the instructions from the doctor/nurse so that you complete the course of injections.

Overdose:

If you think you, or a person you are caring for, have taken too much VARILRIX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you forget to go back to the doctor/nurse at the scheduled time, ask the doctor/nurse for advice.

Possible side effects from using VARILRIX:

These are not all the possible side effects you may have when taking VARILRIX. If you experience any side effects not listed here, tell your healthcare professional.

Like all vaccines, VARILRIX may occasionally cause unwanted effects.

As with all injectable vaccines, there is a risk of allergic reactions. The signs of allergy may include local or widespread skin rash that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing which may lead to collapse. These reactions will usually occur before leaving the doctor’s office. However, you should seek immediate treatment in any event.

Inflammation of the brain (encephalitis) has been observed following vaccination with live attenuated varicella vaccines including VARILRIX. Fatal cases have been observed, especially in people with weakened immune systems. If you develop any of the following symptoms, contact your doctor urgently and inform them that you have received VARILRIX:

• loss or reduced levels of consciousness, convulsions or loss of control of bodily movements, accompanied by fever and headache.

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

Very common

• Pain and redness at the injection site

Common

• Rash (spots and/or blisters)
• Swelling at the injection site
• Fever of 38^oC or more (rectal)

Uncommon

• Nose and throat infection
• Sore throat and discomfort when swallowing
• Swollen glands in the neck, armpit or groin
• Irritability
• Headache
• Sleepiness
• Cough, runny or blocked nose, sneezing (rhinitis)
• Nausea, vomiting
• Chickenpox-like rash
• Itching
• Painful, swollen joints
• Aching muscles, muscle tenderness or weakness, not caused by exercise
• Fever greater than 39.5^oC (rectal)
• Tiredness (fatigue)
• Generally feeling unwell

Rare

• Discharge with itching of the eyes and crusty eyelids (conjunctivitis)
• Stomach pain or discomfort
• Diarrhea
• Hives (urticaria)

After the marketing of VARILRIX, the following additional side effects have been reported rarely:

• allergic reactions
• infection or inflammation of the brain, spinal cord and peripheral nerves resulting in temporary difficulty when walking (unsteadiness) and/or temporary loss of control of bodily movements
• damage to the brain caused by an interruption to its blood supply (stroke)
• fits or seizures
• Shingles (herpes zoster)
• bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets
• narrowing or blockage of blood vessels. This may include unusual bleeding or bruising under the skin (Henoch Schonlein purpura) or fever which lasts for more than five days, associated with a rash on the trunk sometimes followed by a peeling of the skin on the hands and fingers, red eyes, lips, throat and tongue (Kawasaki disease)
• severe condition of the skin that may affect the mouth and other parts of the body

If these discomforts continue or become severe, tell the doctor or nurse.

If you develop any other symptom within days following the vaccination, tell the doctor as soon as possible.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting suspected side effects for vaccines

For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional.

Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada (PHAC), Health Canada (HC), and GlaxoSmithKline Inc. cannot provide medical advice.

For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (Reporting Adverse Events Following Immunization (AEFI) in Canada) and send it to your local Health Unit.

Storage:

VARILRIX should be stored in a refrigerator at 2 to 8°C.

The reconstituted vaccine may be kept for up to 90 minutes at room temperature (25°C) and 8 hours in the refrigerator (2 to 8°C). If not used within these timeframes, the reconstituted vaccine must be discarded.

The expiry date is shown on the label and packaging. The vaccine should not be used after this date.

Keep out of reach and sight of children.

If you want more information about VARILRIX:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.gsk.ca; or by calling 1-800-387-7374.

Date of Authorization: 2026-03-02

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