Description
VariZIG™ (Varicella Zoster Immune Globulin (Human) Injection) is a sterile freeze-dried gamma globulin (IgG) fraction of human plasma containing antibodies to varicella zoster virus (anti-VZV). VariZIG™ is available in a single-use 125 IU vial and is accompanied with a vial containing 8.5 mL of sterile diluent used for reconstitution of the product. VariZIG or any of the packaging components does not contain latex. VariZIG is also thimerosal free.
Dosage and Administration
Dosing of VariZIG™ is based on body weight. The recommended dose is 125 IU/10 kg body weight up to a maximum of 625 IU. The minimum dose is 125 IU and the maximum dose of 625 IU should be sufficient to prevent or modify infection in at-risk patients.
VariZIG™ is licensed for either intravenous or intramuscular administration. VariZIG™ should be administered within 96 hours of varicella exposure, preferably as soon as possible. The efficacy of varicella immune globulins in the reduction of incidence or severity of varicella infections in at-risk patients has not been demonstrated when administered more than 96 hours after exposure.
Reconstitution:
| Route of Administration |
Vial Size |
Volume of Diluent to be added to vial |
Approximate Available Volume |
Nominal Concentration per mL |
Intravenous |
6 mL |
2.5 mL |
2.4 mL |
50 IU/mL |
Intramuscular |
6 mL |
1.25 mL |
1.2 mL |
100 IU/mL |
VariZIG™ should be reconstituted only with the accompanying vial of Sterile Diluent. Use aseptic technique throughout. Reconstitute shortly before use.
To reconstitute:
- Remove caps from the diluent and product vials.
- Wipe exposed central portion of each rubber stopper with suitable disinfectant.
- Withdraw 2.5 mL of diluent for IV administration or 1.25 mL diluent for IM administration using a suitable syringe and needle.
- Inject diluent slowly 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.
Parenteral products such as VariZIG™ (Varicella Zoster Immune Globulin (Human)) should be inspected for particulate matter and discoloration prior to administration. Reconstituted product can be stored for up to 12 hours at 2-8°C prior to use.
Administration:
If VariZIG™ is administered by an intravenous (IV) route, then reconstituted drug should be infused into a suitable vein over 3-5 minutes.
If VariZIG™ is administered by an intramuscular (IM) route, it should be given as an injection into the deltoid muscle or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, the gluteal region should not be used as a routine injection site. If the gluteal region is used, use only the upper, outer quadrant.
To prevent the transmission of infectious agents from one person to another, a separate sterile disposable syringe and needle should be used for each individual patient.
There is no available data on concomitant use of VariZIG™ and other medications.
Admixtures of VariZIG™ with other drugs have not been evaluated. It is recommended that VariZIG™ be administered separately from other drugs or medications that the patient may be receiving. If a pre-existing catheter must be used for IV administration, the line should be flushed with 0.9% Sodium Chloride for injection USP before administering the product.
OVERDOSAGE
In clinical studies, 15 patients were administered a VariZIG™ dose of 50 IU/kg of body weight (IV) 1, 2, 3 . This dose is approximately four times greater than the recommended dose for the immunoprophylaxis of varicella. Related adverse events were mostly mild in nature. All of the related adverse events of chills, nausea, pain at the injection site, rash, urticaria, asthenia, headache, back pain, arthralgia, dizziness and twitch have previously been reported with the use of immune globulins and are expected adverse events. No clinically significant changes in laboratory test results or vital signs were associated with VariZIG™ infusion.
1 Zaia JA, Levin MJ, Preblud SR, Leszczynski J, Wright GG, Ellis RJ et al. Evaluation of varicella-zoster immune globulin: protection of immunosuppressed children after household exposure to varicella. J Infect Dis 1983; 147(4):737-743.
2 Unpublished data on file, VZ-001 study report. 2005.
3 Unpublished data on file, VZ-003 study report. 2005.
VariZIG™ Storage:
VariZIG™ should be stored at 2-8°C. Do not freeze.
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