Varicella-Zoster Immune Globulin (Human) - VariZIG; VZVIG
Status: BLA approved in Dec. 2012
Organizations involved:
Cangene Corp. – Manuf.; R&D; Tech.
Apotex Holdings Inc. – Parent
FFF Enterprises, Inc. – USA mark.
Cross ref: See the entry above for the formerly FDA-approved VZVIG. See the entry for Varicella Virus Vaccine Live (Oka/Merck) or Varivax entry (#564) for background information on varicella virus. See the Immune Globulin Products entry (#743).
Description: Varicella-Zoster Immune Globulin (Human) or VariZIG is a lyophilized (freeze-dried formulation of immune globulin containing high titers of varicella-zoster virus (VZV; chickenpox; herpes zoster) antibodies obtained from fractionated pooled Plasma from donors with high titers of varicella-zoster virus antibodies (having received VZV vaccination).
VariZIG is supplied in 6 ml, 125 Unit glass vials. After reconstitution, VariZIG is approximately a 5% solution of immune globulin G (IgG) for intramuscular administration. Note, this is unlike the VZVIG formerly available in the U.S. (see entry above), which is adminstered intravenously.
The dating period for Varicella Zoster Immune Globulin (Human) is 36 months from the date of manufacture when stored at 2-8 °C. The date of manufacture is defined as the date of final sterile filtration of the formulated drug product in accordance with 21 CFR 610.50. Following the final sterile filtration, no reprocessing/reworking is allowed without prior approval from the Agency. The expiration date for the packaged product, VARIZIG plus Sterile Diluent, is dependent on the shortest expiration date of any component. The product is exempt from CBER/FDA lot release requirements.
Nomenclature: Varicella-Zoster Immune Globulin/Cangene [BIO]; VariZIG [TR]; Varicella-Zoster Immune Globulin (Human) [FDA]; VZVIG [SY]
Companies.: VariZIG was developed and is manufactured by Cangene Corp., CBER/FDA lic. no. 1201 (Winnipeg, Manitoba, Canada). Cangene is majority owned by Apotex Holdings Inc., a large generic drug company. VariZIG is exclusively distributed in the U.S. by FFF Enterprises, Inc.
FDA class: Biologic BLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 20060200; IND (which allowed for U.S. patient use on an as-needed basis)
Date = 20121221, full BLA
Indications: for post-exposure prophylaxis only for patients who have been exposed to varicella and who are at increased risk for severe disease and complications [unofficial]
Status: VZVIG from Massachusetts Biological Labs. (see related entry) is no longer being manufactured and its approval had been withdrawn.
In Feb. 2006, VariZIG was granted an investigational new drug application (IND) by FDA, and became available in the U.S. through an expanded access protocol. As with any product used under IND, patients must be informed of potential risks and benefits and must give informed consent before receiving the product.
Then, until its full approval, VariZIG was available under IND to patients without evidence of immunity to varicella (i.e., without history of disease or age-appropriate vaccination) who are at high risk for severe disease and complications, who have been exposed to varicella, and from whom informed consent has been obtained. The expanded access protocol had received central institutional review board (IRB) approval. With this central IRB review and approval and its IND, FDA did not require an additional approval by the IRB at the treatment site.
Pharmacists and health-care providers who expect to have patients who will need VariZIG were allowed to participate in a program that allows them to acquire inventory in advance. Under normal circumstances, VariZIG can be delivered from FFF Enterprises within 24 hours of request.
In Nov. 2006, FDA granted VariZIG orphan designation for passive immunization of exposed, susceptible individuals who are at risk of complications from varicella.
In Dec. 2012, full BLA approval was granted. FDA had not referred this application to the Blood Products Advisory Committee because its review of the BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion. It was designated as an orphan drug by the FDA and received a priority review. Approval was granted with orphan exclusivity.
With FDA approval, product launch and termination of the U.S. Expanded Access program were planned for March 2013.
Medical: The recommended dose is 125 units/10 kg body weight, up to a maximum of 625 units (five vials). The minimum dose is 125 U. (one vial).
Companies involvement:
Full monograph
792 Varicella-Zoster Immune Globulin/Cangene
Nomenclature:
Varicella-Zoster Immune Globulin/Cangene [BIO]
VariZIG [TR]
Varicella-Zoster Immune Globulin (Human) [FDA]
VZVIG [SY]
FDA Class: Bologic BLA
Year of approval (FDA) = 2012
Date of 1st FDA approval = 20121221
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, human <!-- immunoglobulins -->
Varicella Virus Vaccine
Plasma (Human)
exempt from CBER lot release requirements
implants
orphan status
PrefGel
EU000 Not yet/Never filed with EU
UM001 Marketed Product in US
US400 Expanded/Compassionate Access
EM999 Not Available/Not Marketed in EU
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