Varizig (varicella-zoster immune globulin/maltose)
Varicella-Zoster Immune Globulin Intramuscular Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Varicella zoster immune globulin (VZIG) is a specific immune globulin (hyperimmune globulin). VZIG contains immune globulin G (IgG) prepared from plasma of donors selected for high titers of antibodies to varicella zoster virus (anti-VZV) and is used to provide temporary passive immunity to VZV.
Varicella zoster immune globulin (VZIG) is a lyophilized preparation of purified immune globulin G (IgG) fraction containing antibodies to varicella zoster virus (anti-VZV) prepared from plasma of healthy adults with high titers of anti-VZV. Potency of VZIG is expressed in international units by comparison to the World Health Organization (WHO) international anti-VZV immune globulin reference preparation. Each vial contains 125 units of anti-VZV.
Each 125-unit vial of VZIG contains less than 250 mg of total protein, mostly human IgG and also contains sodium chloride, glycine, and polysorbate 80; the diluent provided by the manufacturer contains 0.8% sodium chloride and sodium phosphate. The pH of reconstituted VZIG is 7. VZIG does not contain thimerosal or any other preservatives.
VZIG provides passive immunity in susceptible individuals exposed to VZV. Anti-VZV antibodies in VZIG bind to proteins on varicella virus, and may prevent or reduce severity of varicella infection if administered to susceptible individuals within 10 days after exposure. After a single VZIG dose, anti-VZV antibodies persist for at least 6 weeks, and protection against VZV may last for approximately 3 weeks.
The exact concentration of anti-VZV antibodies necessary to prevent or attenuate varicella is not known.
Following IM administration, bioavailability of VZIG is expected to be almost 100%. Anti-VZV antibodies are detected within 2-3 days and concentrations peak within 3-7 days. Following IV+ administration, peak concentrations are attained in less than 3 hours.
Although concentrations of passively-acquired antibody are higher and achieved more quickly following IV+ administration than IM administration, levels of circulating antibodies over time are expected to be similar with both routes. Anti-VZV is expected to be quickly distributed between plasma and extravascular spaces. Immune globulins are metabolized in the reticuloendothelial system.
Based on studies with other immune globulins, the elimination half-life of VZIG is expected to show interindividual variation. Half-life has been reported to be about 23-30 days following IM administration .
USES: This medication is used to help provide protection (antibodies) against a certain virus infection (varicella zoster) commonly known as chickenpox. It is used by certain people who have not been vaccinated or had the infection before and have had recent contact with someone infected with chickenpox. This medication is made from healthy human blood that has high levels of a certain substance (varicella zoster antibodies) which helps fight the infection.
Routine vaccination is usually the best way to protect against infection.
Generic name: varicella-zoster immune globulin/maltose
Pronunciation: (VAR-i-SEL-a ZOS-ter i-MUNE GLOB-ue-lin)
Drug class: Varicella-Zoster Immune Globulin
Therapeutic class: Biologicals
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Varizig
Indications
The following indications are listed for Varizig:
- Prevention Of Varicella After Exposure
Also known as: Passive Immunization Against Varicella Zoster Virus, Prevention Of Varicella After Contact With Varicella Zoster Virus, Varicella Post-Exposure Prophylaxis.
Dosing
No dosing information is available for this tab.
VZIG is labeled by the FDA for administration by IM injection only. VZIG also has been administered by IV injection+.
VZIG should not be mixed with any other drug or solution.
VZIG should not be administered concomitantly with varicella virus vaccine live. (See Live Vaccines under Drug Interactions: Vaccines.)
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Selected Immunoglobulins/Selected Live Viral Vaccines
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Immune globulin(IG) products may prevent the immune system from properly responding to the vaccine.(1-19)
CLINICAL EFFECTS: Administration of selected live viral vaccines after immunoglobulins may impair the efficacy of the vaccine.(1-19) Administration of immunoglobulins within 2-4 weeks after selected live viral vaccines impair the efficacy of the vaccine.(1-4,15)
PREDISPOSING FACTORS: The amount of antigen-specific antibody present in the administered immunoglobulin product determines the duration of this interaction.(15)
PATIENT MANAGEMENT: The recommendations regarding this interaction are conflicting. The Centers for Disease Control and Prevention(CDC) immunization recommendations for spacing of live vaccines and antibody-containing products include the following(15): - Live attenuated influenza vaccine, rotavirus, zoster and Ty21a typhoid vaccines may be given any time before, concurrent, with, or after administration of any immune globulin. Yellow fever vaccine may also be given in areas where donor blood products are unlikely to contain a substantial quantity of yellow fever antibody. - Administration of measles or varicella containing vaccines should be postponed for the following intervals after immunoglobulin therapy: Hepatitis B IG, Tetanus IG - 3 months Rabies IG - 4 months Varicella IG - 5 months Measles prophylaxis IG - 6 months if nonimmunocompromised Botulinum IG Intravenous, CMV IG Intravenous, Hepatitis A IG - 6 months Intravenous Immune Globulin(IVIG) - 8 to 11 months depending upon the dose Monoclonal antibody to RSV F protein (palivizumab) - none - Administration of antibody-containing products should be delayed 2 weeks after administration of live vaccines, except for influenza, rotavirus, zoster and typhoid vaccines as noted above. CDC guidelines state that in circumstances where there is high-risk of vaccine-preventable disease, it is acceptable to administer a dose of vaccine prior to completion of these intervals.(16) Manufacturer recommendations are as follows: Administration of a live viral vaccine should be postponed for at least three months in patients who have received the following immunoglobulin therapy: anthrax immunoglobulin,(19) cytomegalovirus immunoglobulin,(1) hepatitis B immunoglobulin,(5,6) rabies immunoglobulin,(7) tetanus immunoglobulin,(8-11) vaccinia immunoglobulin,(18) and zoster immunoglobulin.(2) Administration of a live viral vaccine should be postponed for at least six months in patients who have received the following immunoglobulin therapy: botulinum neurotoxin a/b immune globulin.(17) The US manufacturer of human immunoglobulin states that live viral vaccines should be postponed for three months in patients who have received human immunoglobulin. The Australian and Canadian manufacturers of human immunoglobulin advise postponing live viral vaccines for 3-6 months in patients who have received human immunoglobulin.(6,12,13,18) The UK manufacturer states that vaccines may be compromised for one year and vaccines should be postponed in children for at least seven months.(14) The US manufacturer of immune globulin-hyaluronidase states that immune response to live attenuated vaccines may be impaired for up to 6 months, or for a year or more in the case of measles vaccine.(15) Cytomegalovirus immunoglobulin(1) or human immunoglobulin(3) should not be administered to patients who have received a live vaccine in the previous two weeks. If a live viral vaccine is given within two weeks of zoster immunoglobulin,(1) repetition of the vaccination three months after the completion of immunoglobulin should be considered.
DISCUSSION: CDC Immunization Recommendations(15)provide discussion, charts, and further details regarding appropriate use and timing of vaccine therapy.(16)
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
History of anaphylactic or severe systemic (hypersensitivity) reactions to any human immune globulin preparation.
IgA deficiency with antibodies against IgA and history of hypersensitivity reaction. (See IgA Deficiency under Warnings/Precautions: Sensitivity Reactions, in Cautions.)
There are no contraindication contraindications for this drug.
- IgA deficiency
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects reported with VZIG in clinical trials in pregnant women, infants, and immunocompromised adults and children were injection site pain (2%), headache (2%), chills, fatigue, rash, and nausea. The highest incidence of adverse effect occurred in pregnant women and included injection site pain (9%), headache (4%), chills (2%), and fatigue (2%).
Rare or Very Rare
- Anaphylaxis
- Thrombotic disorder
More Frequent
- Headache disorder
- Injection site sequelae
Less Frequent
- Chills
- Fatigue
- Nausea
- Skin rash
Precautions
No enhanced messaging available.
Safety and efficacy of VZIG have been evaluated for postexposure prophylaxis of varicella in pediatric patients, including preterm neonates and infants, term neonates and infants, children, and adolescents. (See Uses.)
Category C. (See Users Guide)
VZIG should be used during pregnancy only when clearly needed. (See Pregnant Women under Uses: Postexposure Prophylaxis of Varicella.)
The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that there are no known risks for the fetus from use of immune globulin preparations for passive immunization in pregnant women.
It is not known whether VZIG is distributed into milk. The immune globulin should be used with caution in nursing women.
Clinical studies of VZIG for postexposure prophylaxis of varicella did not include sufficient numbers of individuals 65 years of age or older to determine whether geriatric individuals respond differently than younger adults.
VZIG should be used with caution in individuals 65 years of age and older who are at increased risk of thrombotic events. (See Thrombotic Events under Cautions: Warnings/Precautions.)
When used in geriatric individuals, VZIG should only be administered IM and the recommended dosage should not be exceeded.
ICD codes
| Code | Type | Description |
|---|---|---|
| Prevention of varicella after exposure | ||
| Z20.820 | ICD10CM | Contact with and (suspected) exposure to varicella |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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