Varicella Zoster Immune Globulin (Human)

What is Varicella Zoster Immune Globulin (Human)?

• VARIZIG is a Varicella Zoster Immune Globulin (Human) used in Passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella.

What are the uses of this medicine?

This medicine is used for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include:

• immunocompromised children and adults,
• newborns of mothers with varicella shortly before or after delivery,
• premature infants,
• neonates and infants less than one year of age,
• adults without evidence of immunity,
• pregnant women

• VARIZIG administration is intended to reduce the severity of varicella. Administer VARIZIG as soon as possible following varicella zoster virus (VZV) exposure, ideally within 96 hours for greatest effectiveness.

Limitation of use:

• There is no convincing evidence that VARIZIG reduces the incidence of chickenpox infection after exposure to VZV.
• There is no convincing evidence that established infections with VZV can be modified by VARIZIG administration.
• There is no indication for the prophylactic use of VARIZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation.

How does this medicine work?

• VARIZIG provides passive immunization for non-immune individuals exposed to VZV, reducing the severity of varicella infections.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive VARIZIG.
• IgA-deficient patients with antibodies against IgA and a history of hypersensitivity may have an anaphylactoid reaction.

What drug interactions can this medicine cause?

• The passive transfer of antibodies with immune globulin administration may impair the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
• Inform the immunizing physician of recent therapy with VARIZIG so that appropriate measures can be taken.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• Dosing of VARIZIG is based on body weight.

Administration:

• Each vial of VARIZIG contains a minimum potency of 125 IU in 1.2 mL.
• Bring VARIZIG to room temperature prior to use.
• Inspect VARIZIG for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.
• VARIZIG is for single use only. Discard any unused portion.
• For intramuscular use only.
• Divide the intramuscular dose and administer in two or more injection sites, depending on patient size. Do not exceed 3 milliliters per injection site.
• Inject into the deltoid muscle or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site. If the gluteal region is used, only use the upper, outer quadrant.
• To prevent the transmission of infectious agents from one person to another, use a new disposable sterile syringe and needle for each individual patient.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As VARIZIG is supplied as a sterile solution for intramuscular injection and is available in a single-use vial of 125 IU in 1.2 mL.

This medicine is available in fallowing brand namesː

• VARIZIG

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain at the injection site
• headache

What special precautions should I follow?

• Thrombotic events may occur during or following treatment with immune globulin products.
• Administer VARIZIG intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, only administer VARIZIG if the expected benefits outweigh the potential risks.
• Severe hypersensitivity reactions may occur following VARIZIG administration. Administer VARIZIG in a setting with appropriate equipment, medication and personnel trained in the management of hypersensitivity, anaphylaxis and shock. In the case of hypersensitivity, discontinue administration of VARIZIG immediately and provide appropriate treatment.
• Because VARIZIG is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The plasma donors are screened for the presence of certain infectious agents.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• pain and tenderness at the injection site.

Can this medicine be used in pregnancy?

• It also is not known whether VARIZIG can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• VARIZIG should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of VARIZIG have been evaluated for post-exposure prophylaxis in pediatric patients.
• The dosing recommendations in the treatment of pediatric patients are by body weight.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN

Inactive Ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured by:

Cangene Corporation, a subsidiary of Emergent BioSolutions Inc.
Winnipeg, Canada 

Distributed by: Cangene bioPharma, Inc., a subsidiary of Emergent BioSolutions Inc. Baltimore, MD USA

What should I know about storage and disposal of this medication?

• Store VARIZIG at 2 to 8°C (36 to 46°F).
• Do not freeze.
• Do not use after expiration date.

• Dailymed label info on Varicella Zoster Immune Globulin (Human)
• FDA Varicella Zoster Immune Globulin (Human)

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