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.
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|
|≥ 40.1||≥ 88.1||625||5||6.0|
|*Volume of VARIZIG to be administered after reconstitution.|
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.
Reconstitute VARIZIG according to Table 2. Only use the accompanying Sterile Diluent with aseptic technique throughout. Reconstitute shortly before use.
Table 2 : Recommendations for Reconstitution of
|Route of Administration||Number of VARIZIG Vials||Volume of Sterile Diluent||Concentration of Reconstituted VARIZIG|
|Intramuscular||1 vial (125 IU)||1.25 milliliters||100 IU/milliliter|
- Remove caps from the Sterile Diluent and VARIZIG vials.
- Wipe exposed central portion of each rubber stopper with suitable disinfectant.
- Withdraw 1.25 milliliter of the Sterile Diluent using a suitable syringe and needle.
- Inject diluent slowly into the VARIZIG vial at an angle so that the liquid is directed onto the inside glass wall of the vial containing the freeze-dried pellet.
- Wet pellet by gently tilting and inverting the vial. Avoid frothing. Gently swirl upright vial until dissolved (less than ten minutes). Do not shake.
- Inspect VARIZIG visually for particulate matter and discoloration prior to administration.
- Do not use if turbid and/or discoloration is observed.
- Reconstituted product can be stored for up to 12 hours at 2 to 8°C (36 to 46°F) prior to use.
- Do not freeze. Solutions that have been frozen should not be used.
VARIZIG is for single use only. Partially used vials, including the remaining Sterile Diluent, should be discarded.
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.
Dosage Forms And Strengths
VARIZIG is supplied as a sterile lyophilized powder for solution for intramuscular injection and is available in a single-use vial of 125 IU. VARIZIG is accompanied by a vial containing 8.5 milliliters of Sterile Diluent for reconstitution. Each 125 IU vial of VARIZIG contains less than 250 milligrams of total protein, mostly human immunoglobulin G (IgG). VARIZIG contains no preservative and is intended for single use only. VARIZIG does not contain mercury.
NDC XXXXX-XXXX-X: VARIZIG [Varicella Zoster Immune Globulin (Human)] is supplied as a kit in a carton box containing approximately 125 IU of anti-VZV supplied freeze-dried in a 6 mL type 1 glass tubing vial fitted with a 20 mm rubber lyophilization stopper and a 20 mm flip-off seal, one single dose vial of Sterile Diluent, non-pyrogenic for reconstitution of VARIZIG 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. Use the product within 12 hours of reconstitution if stored at 2 to 8°C.
Manufactured by: Cangene Corporation, Winnipeg, Canada R3T 5Y3. Revised: 12/2012
Last reviewed on RxList: 2/19/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional VariZIG Information
Report Problems to the Food and Drug Administration
Find out what women really need.