Patient Medication Information: uses, side effects, how to take - Varizig (Cangene Corporation A Subsidiary of Emergent Biosolutions)
ABOUT THIS MEDICATION
What the medication is used for:
$ Prevention or reduction in severity of maternal varicella infections (chickenpox) in non-immune pregnant women that have been exposed to individuals with a varicella zoster virus infection (chickenpox).
What it does:
Although the exact mechanism by which VariZIG™ works is not fully known, it is believed that antibodies in VariZIG™ interact with the virus to prevent or decrease the severity of chickenpox in at-risk individuals.
If you have not had chickenpox before and become exposed to someone with chickenpox, please see your physician immediately to determine whether you should receive VariZIG™. Your physician will determine whether you require VariZIG™ based on lab tests for pre-existing immunity, the type of exposure and the time since you were exposed to someone with chickenpox.
When it should not be used:
- In patients with a history of allergic reactions to blood products.
- In patients deficient in IgA, which is a specific type of blood protein.
What the medicinal ingredient is:
- aricella Zoster Immune Globulin (Human)
What the important nonmedicinal ingredients are:
Human plasma protein
Sodium Chloride
Glycine
Polysorbate 80
VariZIG™ may contain trace amounts of tri-n-butyl phosphate and Triton X-100®.
What dosage forms it comes in:
WARNINGS AND PRECAUTIONS
G Serious Warnings and Precautions
| $ VariZIG™ is made from human plasma, which may contain the causative agents of viral disease. The risk of getting a disease from this product has been reduced by screening plasma donors, testing for the presence of certain viruses and by utilizing manufacturing steps that inactivate and remove certain viruses. However, there is still a possibility that plasma products could transmit disease. |
$ Allergic or anaphylactic reactions are rare. These reactions can occur in patients with a history of allergies to blood products or in patients lacking the IgA blood protein. BEFORE you receive VariZIG™ talk to your doctor or pharmacist if:
|
|---|
$ You have a known IgA deficiency
$ You have recently received any vaccinations.
- NTERACTIONS WITH THIS MEDICATION
Drugs that may interact with VariZIG™ have not been established.
Immune globulins like VariZIG™ may impair the effectiveness of certain live virus vaccines such as measles, rubella (i.e. German measles), mumps and varicella (i.e. chickenpox). Talk to your doctor if you have been recently vaccinated.
PROPER USE OF THIS MEDICATION
Usual dose:
| The standard dose of VariZIG is 125 IU/10 kg of body weight up to a maximum of 625 IU/patient. Your individual dose of VariZIG™ will be determined by your weight. |
Overdose:
The consequences of an overdose are not known. In case of an overdose, consult your doctor.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
VariZIG™ is provided in single use 6 mL glass vials that contain approximately 125 IU of varicella zoster antibody activity. You may be administered up to 5 vials depending on your body weight. VariZIG™ will be administered either intravenously or intramuscularly.
The most common side effects are injection site pain, chills, fever, headaches, vomiting, nausea, joint pain and rash. These side effects are usually mild, but if they require treatment ask your health care professional.
VariZIG™ Product Monograph Page 24 of 25 VariZIG™ Product Monograph Page 25 of 25
IMPORTANT: PLEASE READ
This is not a complete list of side effects. For any unexpected effects while taking VariZIG™, contact your doctor or pharmacist.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Talk with your doctor or pharmacist
Symptom / effect
| Stop taking drug and call your doctor or pharmacist | ||||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| Common | Not applicable* | |||
| Uncommon | Allergic reaction | |||
T
| T | *Serious side effects are not common. |
HOW TO STORE IT
Store VariZIG™ under refrigeration. Do not freeze. Do not use after expiration date.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789 By email: cadrmp@hc-sc.gc.ca By regular mail: National AR Centre Marketed Health Products Safety and Effectiveness Information Division Marketed Health Products Directorate Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9 NOTE: Before contacting Health Canada, you should contact your physician or pharmacist. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
| http://www.cangene.com/pdf/vz_mono_e.pdf |
or by contacting Cangene Corporation’s Pharmacovigilance Department at 1-800-768-2304 (phone) or 1-800-768-2281 (fax).