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Drug overview for VARIZIG (varicella-zoster immune globulin/maltose):
Generic name: varicella-zoster immune globulin/maltose (VAR-i-SEL-a ZOS-ter i-MUNE GLOB-ue-lin)
Drug class: Varicella-Zoster Immune Globulin
Therapeutic class: Biologicals
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.
No enhanced Uses information available for this drug.
Generic name: varicella-zoster immune globulin/maltose (VAR-i-SEL-a ZOS-ter i-MUNE GLOB-ue-lin)
Drug class: Varicella-Zoster Immune Globulin
Therapeutic class: Biologicals
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.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for VARIZIG (varicella-zoster immune globulin/maltose) have been approved by the FDA:
Indications:
Prevention of varicella after exposure
Professional Synonyms:
Passive immunization against varicella zoster virus
Prevention of varicella after contact with varicella zoster virus
Varicella post-exposure prophylaxis
Indications:
Prevention of varicella after exposure
Professional Synonyms:
Passive immunization against varicella zoster virus
Prevention of varicella after contact with varicella zoster virus
Varicella post-exposure prophylaxis
The following dosing information is available for VARIZIG (varicella-zoster immune globulin/maltose):
No enhanced Dosing information available for this drug.
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.)
VZIG should not be administered concomitantly with varicella virus vaccine live. (See Live Vaccines under Drug Interactions: Vaccines.)
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for VARIZIG (varicella-zoster immune globulin/maltose):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Selected Live Viral Vaccines/Selected Immunoglobulins 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 Australian, Canadian, and US manufacturers of human immunoglobulin state that live viral vaccines should be postponed for three 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) |
ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, DENGVAXIA, M-M-R II VACCINE, PRIORIX, PROQUAD, STAMARIL, VARIVAX VACCINE, YF-VAX |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
VYVGART, VYVGART HYTRULO |
| 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) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
RYSTIGGO |
The following contraindication information is available for VARIZIG (varicella-zoster immune globulin/maltose):
Drug contraindication overview.
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.)
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 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| IgA deficiency |
There are 0 moderate contraindications.
The following adverse reaction information is available for VARIZIG (varicella-zoster immune globulin/maltose):
Adverse reaction overview.
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%).
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%).
There are 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Thrombotic disorder |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Headache disorder Injection site sequelae |
Chills Fatigue Nausea Skin rash |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for VARIZIG (varicella-zoster immune globulin/maltose):
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.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
The following prioritized warning is available for VARIZIG (varicella-zoster immune globulin/maltose):
WARNING: This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for giving medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk.
Before receiving this medication, if you have any of these conditions report them to your doctor or pharmacist. To decrease the risk of serious blood clots, drink enough fluids to make sure you are not dehydrated before receiving this medication. Get medical help right away if any of these symptoms occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, or sudden vision changes.
WARNING: This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for giving medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk.
Before receiving this medication, if you have any of these conditions report them to your doctor or pharmacist. To decrease the risk of serious blood clots, drink enough fluids to make sure you are not dehydrated before receiving this medication. Get medical help right away if any of these symptoms occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, or sudden vision changes.
The following icd codes are available for VARIZIG (varicella-zoster immune globulin/maltose)'s list of indications:
| Prevention of varicella after exposure | |
| Z20.820 | Contact with and (suspected) exposure to varicella |
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