VariZIG™

Product Information

• Name: VariZIG™
• Type: Varicella Zoster Immune Globulin (Human)
• Form: Powder for Injection, 125 IU/vial
• Manufacturer: Cangene Corporation

Indications and Clinical Use

• Indications:
  • Prevention or reduction in severity of maternal varicella infections within 4 days of exposure to the varicella-zoster virus (VZV).
  • Recommended for susceptible pregnant women exposed to varicella.

Dosage and Administration

• Recommended Dose: 125 IU/10 kg body weight, up to a maximum of 625 IU.
• Administration:
  • Intravenous (IV) or Intramuscular (IM): Administer within 96 hours of exposure, preferably as soon as possible.
• Reconstitution:
  • Use only the accompanying sterile diluent.
  • Administer reconstituted product immediately; if not, store at 2-8°C and use within 12 hours.
  • Do not use the gluteal region for IM injection due to the risk of sciatic nerve injury.

Contraindications

• Known immunity to varicella-zoster virus.
• IgA deficiency with the potential for anaphylactic reactions.
• History of severe systemic reactions to immune globulins.
• Hypersensitivity to any component of the formulation.

Warnings and Precautions

• General:
  • VariZIG™ is derived from human plasma and may carry a risk of transmitting infectious agents, despite measures taken to inactivate and remove viruses.
  • Serious hypersensitivity reactions are rare but possible.
  • Patients should be observed for at least 20 minutes post-administration.
• Special Populations:
  • Pregnant Women: Should be administered only if clearly needed.
  • Nursing Women: Unknown if excreted in human milk.
  • Pediatrics and Geriatrics: Safety and effectiveness not established.
• Thrombosis: Rare thrombotic events have been reported with immune globulin products.
• Renal and Respiratory Complications: Careful monitoring required for at-risk individuals.

Adverse Reactions

• Common: Injection site pain, headache, rash.
• Less Common: Myalgia, rigors, fatigue, nausea, flushing.
• Serious: Anaphylactic reactions, allergic reactions.

Drug Interactions

• Live Attenuated Vaccines: May impair the efficacy of vaccines like measles, rubella, mumps, and varicella for a period of 3 months or more. Vaccination should be deferred accordingly.

Storage and Stability

• Unreconstituted Vaccine: Store at 2-8°C. Do not freeze.
• Reconstituted Vaccine: Use immediately or store at 2-8°C for up to 12 hours.

Clinical Trials and Efficacy

• Study VZ-006: Evaluated the safety and efficacy of VariZIG™ compared to VZIG in pregnant women exposed to varicella.
• Results: VariZIG™ showed similar effectiveness to VZIG in reducing the incidence and severity of varicella infections.
• Infection Rates: Lower incidence of varicella in patients treated with VariZIG™ compared to those treated with VZIG, though not statistically significant.

Mechanism of Action

• Mechanism: Anti-VZV antibodies in VariZIG™ bind to proteins on the varicella virus, preventing or reducing the severity of infections.