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VARIZIG
Overview
What is VARIZIG?
VARIZIG [Varicella Zoster Immune Globulin (Human)] is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). VZV is the causative agent of chickenpox. VARIZIG is prepared from plasma donated by healthy, screened donors with high titers of antibodies to VZV, which is purified by an anion-exchange column chromatography manufacturing method. This donor selection process includes donors with high anti-VZV titers due to recent natural infection by VZV, or due to recurrent zoster infection (shingles).
VARIZIG is intended for single use and should be administered intramuscularly [see ].
The product potency is expressed in IU by comparison to the World Health Organization (WHO) international reference preparation for anti-VZV immune globulin. Each vial contains 125 IU of anti-VZV. VARIZIG is formulated with 10% maltose and 0.03% polysorbate 80. VARIZIG has a pH of 5.0 – 6.5 and contains no preservative.
The presence of anti-Protein S antibodies has been reported to arise transiently in patients after VZV infection (4). Low levels of anti-Protein S antibodies have been reported in VARIZIG.
The source plasma used in the manufacture of this product was tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) and found to be negative. Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 10 IU of B19 DNA per milliliter.
The manufacturing process contains two steps implemented specifically for virus clearance. The solvent/detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV-1. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses.
The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in . The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general.
What does VARIZIG look like?
What are the available doses of VARIZIG?
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 ().
What should I talk to my health care provider before I take VARIZIG?
How should I use VARIZIG?
VARIZIG [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include:
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.
For intramuscular use only.
What interacts with VARIZIG?
Sorry No Records found
What are the warnings of VARIZIG?
Sorry No Records found
What are the precautions of VARIZIG?
Sorry No Records found
What are the side effects of VARIZIG?
Sorry No records found
What should I look out for while using VARIZIG?
History of anaphylactic or severe systemic reactions to human immune globulins ().
IgA-deficient patients with antibodies against IgA and a history of hypersensitivity ().
What might happen if I take too much VARIZIG?
Manifestations of an overdose of VARIZIG administered intramuscularly are expected to be pain and tenderness at the injection site.
How should I store and handle VARIZIG?
Store VARIZIG at 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
VARIZIG provides passive immunization for non-immune individuals exposed to VZV, reducing the severity of varicella infections (5).
Non-Clinical Toxicology
History of anaphylactic or severe systemic reactions to human immune globulins ().IgA-deficient patients with antibodies against IgA and a history of hypersensitivity ().
Thrombotic events may occur during or following treatment with immune globulin products (1, 2, 3). Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.
The most serious adverse drug reactions observed in clinical trials for all subjects and patients (n=601) include pyrexia, nausea, and vomiting.
The most common adverse drug reactions (reported by ≥ 1% of subjects) observed in clinical trials for all subjects and patients (n=601) are the following:
All other adverse drug reactions occurred in less than 1%.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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