May 5, 2016
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VariZIG

Indications
Dosage
How Supplied

INDICATIONS

VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated 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.

  • 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.

DOSAGE AND ADMINISTRATION

For intramuscular use only.

Preparation And Handling

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.

Dosing of VARIZIG is based on body weight. Administer a single dose of VARIZIG intramuscularly as recommended in Table 1.

The minimum dose is 62.5 International Units (IU) for small infants under two kilograms body weight; the maximum dose of 625 IU should be administered for all patients greater than 40 kilograms in weight.

Table 1 : VARIZIG Dose and Volume of Administration

Weight of Patient VARIZIG Dose Volume to Administer* (milliliters)
Kilograms Pounds IU Number of Vials
≤ 2.0 ≤ 4.4 62.5 0.5 0.6
2.1-10.0 4.5-22.0 125 1 1.2
10.1-20.0 22.1-44.0 250 2 2.4
20.1-30.0 44.1-66.0 375 3 3.6
30.1-40.0 66.1-88.0 500 4 4.8
≥ 40.1 ≥ 88.1 625 5 6.0
* Extractable volumes are confirmed using a 21 gauge needle as per USP General Chapters < 1 > Injections.

Consider a second full dose of VARIZIG for high risk patients who have additional exposures to varicella greater than three weeks after initial VARIZIG administration.

Administration

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.

HOW SUPPLIED

Dosage Forms And Strengths

VARIZIG is supplied as a sterile solution for intramuscular injection and is available in a single-use vial of 125 IU. Each 125 IU vial of VARIZIG contains less than 156 milligrams of total protein, mostly human immune globulin G (IgG). VARIZIG contains no preservative and is intended for single use only. VARIZIG does not contain mercury.

NDC 53270-0126-2: VARIZIG [Varicella Zoster Immune Globulin (Human)] is supplied as a sterile liquid approximately 125 IU of anti-VZV in a 3 mL type 1 glass tubing vial fitted with a 13 mm rubber stopper and a 13 mm flip-off seal, and a package insert.

Storage And Handling

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

Manufactured by: Cangene Corporation, a subsidiary of Emergent BioSolutions Inc., Winnipeg, Canada R3T 5Y3. Distributed by: Cangene bioPharma, Inc., a subsidiary of Emergent BioSolutions Inc., Baltimore, MD. Revised Apr 2015.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/14/2016

Indications
Dosage
How Supplied

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