Language selection

Search

Details for: VARILRIX

Company: GLAXOSMITHKLINE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02241047VARILRIXVARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA-STRAIN); WATER1995 PFU / 0.5 ML; 0.5 MLPOWDER FOR SOLUTIONSUBCUTANEOUS
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

VARILRIX is a vaccine against chicken pox (varicella).

What it does

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.

When it should not be used

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 also Warnings and Precautions).
  • 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 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.

What the medicinal ingredient is

Each 0.5 mL dose of VARILRIX contains as active ingredient no less than 103.3 plaque-forming units (PFU) of the live attenuated Oka-strain of varicella-zoster virus.

What the non-medicinal ingredients are

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

What dosage form it comes in

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 ampoules or prefilled syringes*.

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

*Format not available in Canada

Warnings and precautions

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 effect the effectiveness of VARILRIX.

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

BEFORE you use VARILRIX talk to your doctor or pharmacist if:

  • you are or think you may be pregnant.
  • you have or think you have had an allergic reaction previously to VARILRIX or any of its constituents.
  • you have or think you have had an allergic reaction previously to another chickenpox vaccine.
  • you have a history or family history of allergies.
  • you have a weakened immune system. You should be closely monitored as the responses to the vaccine may not be sufficient to ensure a protection against the illness.
  • you 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 have a severe infection with a high temperature (over 38°C). It might be necessary to postpone the vaccination until recovery. In healthy subjects the presence of minor infection such as a cold should not be a problem, but talk to your doctor first.
  • you are taking any other medicine or have recently received any other vaccine.
  • you are breastfeeding.

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.

Interactions with this medication

In subjects 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.

Proper use of this medication

The vaccine must be administered by a health care 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.

Administration

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

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them

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.

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°C or more (rectal)

Uncommon

  • Upper respiratory tract 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°C (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:

  • Shingles (herpes zoster)
  • bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets
  • Allergic reactions
  • Fits or seizures
  • 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)
  • stroke
  • 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.

This is not a complete list of side effects. For any unexpected effects while taking VARILRIX, contact your doctor or pharmacist.

How to store

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 (25ºC) and 8 hours in the refrigerator (2 to 8ºC). If not used within these timeframes, the reconstituted vaccine must be discarded.

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

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

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

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: August 14, 2019

©2019 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.

Date modified: