varicella zoster immune globulin, human (Rx)

Brand and Other Names:VariZIG
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intramuscular injection

  • 125 IU/vial (lyophilized powder)
  • 100 IU/mL (after reconstitution)

Varicella, Postexposure Prophylaxis

Indicated for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals after exposure

625 units IM within 10 days after exposure (ideally within 4 days [96 hr])

Consider a second full dose for high risk patients who have additional exposures to varicella >3 weeks after initial administration

Dosing Considerations

High risk groups include

  • Immunocompromised patients without evidence of immunity
  • Pregnant women without evidence of immunity

Reduces severity only

  • There is no convincing evidence that varicella zoster immune globulin (VZIG) reduces the incidence of chickenpox infection after exposure to VZV
  • There is no convincing evidence that established infections with VZV can be modified by VZIG administration
  • There is no indication for the prophylactic use of VZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation

Administration

Inject IM into the deltoid muscle or the anterolateral aspects of the upper thigh

Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site; if gluteal region is used, only use the upper, outer quadrant

Depending on patient size, divide the IM dose and administer in 2 or more injection sites; not to exceed 3 mL/injection site

Dosage Forms & Strengths

intramuscular injection

  • 125 IU/vial (lyophilized powder)
  • 100 IU/mL (after reconstitution)

Varicella, Postexposure Prophylaxis

Indicated for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals after exposure

125 IU/10kg IM; not to exceed 625 IU/dose

Administer within 10 days after exposure (ideally within 4 days [96 hr])

<2 kg: 62.5 IU IM

2.1-10 kg: 125 IU IM

10.1-20 kg: 250 IU IM

20.1-30 kg: 375 IU IM

30.1-40 kg: 500 IU IM

>40 kg: 625 IU IM

Consider a second full dose for high risk patients who have additional exposures to varicella >3 weeks after initial administration

Dosing Considerations

High risk groups include

  • Immunocompromised patients without evidence of immunity
  • Newborn infants whose mothers have signs and symptoms of varicella around the time of delivery (ie, 5 days before to 2 days after)
  • Hospitalized premature infants born at 28 weeks of gestation or greater whose mothers do not have evidence of immunity to varicella
  • Hospitalized premature infants born at <28 weeks of gestation or who weigh 1 kg or less at birth, regardless of their mothers' evidence of immunity to varicella

Reduces severity

  • There is no convincing evidence that varicella zoster immune globulin (VZIG) reduces the incidence of chickenpox infection after exposure to VZV
  • There is no convincing evidence that established infections with VZV can be modified by VZIG administration
  • There is no indication for the prophylactic use of VZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation

Administration

For IM use only

Depending on patient size, divide the IM dose and administer in 2 or more injection sites; not to exceed 3 mL/injection site

Inject IM into the deltoid muscle or the anterolateral aspects of the upper thigh

Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site; if gluteal region is used, only use the upper, outer quadrant

Infants/small children: Administer IM in anterolateral aspect of thigh

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Interactions

Interaction Checker

and varicella zoster immune globulin, human

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     activity indicator 
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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (6)

              • axicabtagene ciloleucel

                varicella zoster immune globulin, human, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • brexucabtagene autoleucel

                varicella zoster immune globulin, human, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • ciltacabtagene autoleucel

                varicella zoster immune globulin, human, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • idecabtagene vicleucel

                varicella zoster immune globulin, human, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • lisocabtagene maraleucel

                varicella zoster immune globulin, human, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tisagenlecleucel

                varicella zoster immune globulin, human, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (1)

              • efgartigimod alfa

                efgartigimod alfa will decrease the level or effect of varicella zoster immune globulin, human by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

              Minor (1)

              • protein a column

                protein a column decreases levels of varicella zoster immune globulin, human by Other (see comment). Minor/Significance Unknown. Comment: Since Prosorba binds IgG, it could theoretically interfere with the levels and/or effects of pharmacologic immune globulins.

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              Adverse Effects

              1-10%

              Injection site pain (2%)

              Headache (2%)

              Frequency Not Defined

              Chills

              Fatigue

              Rash

              Nausea

              Thrombosis

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              Warnings

              Contraindications

              Anaphylactic or hypersensitivity reactions to human immune globulin preparations

              IgA-deficient patients with antibodies against IgA and a history of hypersensitivity may have an anaphylactoid reaction; contains <40 mcg/mL of IgA

              Cautions

              Thrombotic events reported during or following treatment with immune globulin products; individuals at risk include those with history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity

              For IM administration only; patients with severe thrombocytopenia or any coagulation disorder that would contraindicate IM injections, only administer if the expected benefits outweigh the potential risks

              Made from human plasma, may carry risk of transmitting infectious agents (eg, viruses, variant Creutzfeldt-Jakob disease [vCJD] agent)

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              Pregnancy & Lactation

              Pregnancy Category: C

              Lactation: Unknown whether distributed in breast milk

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Solvent/detergent-treated sterile lyophilized preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus

              Provides passive immunization for nonimmune individuals exposed to varicella zoster virus, thereby reducing the severity of varicella infections

              Absorption

              Peak plasma time: 4.5 days

              Peak plasma concentration: 136 mIU/mL

              AUC: 2472-4087 mIU•day/mL (24-84 days)

              Elimination

              Half-life: 26.2 days

              Total body clearance: 0.204 mL/day

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              Administration

              IM Preparation

              Only use the accompanying sterile diluent when reconstituting lyophilized powder

              To reconstitute

              • Remove caps from the sterile diluent provided and VZIG vials
              • Wipe exposed central portion of each rubber stopper with suitable disinfectant
              • Withdraw 1.25 mL of the sterile diluent using a suitable syringe and needle
              • Inject diluent slowly into the VZIG vial at an angle so that the liquid is directed onto the inside glass wall of the vial containing the freeze-dried pellet
              • Wet pellet by gently tilting and inverting the vial to avoid frothing; gently swirl upright vial until dissolved (<10 minutes); DO NOT SHAKE

              Inspect visually for particulate matter and discoloration prior to administration

              Do not use if turbid and/or discoloration is observed

              IM Administration

              For IM use only

              Depending on patient size, divide the IM dose and administer in 2 or more injection sites; not to exceed 3 mL/injection site

              Inject IM into the deltoid muscle or the anterolateral aspects of the upper thigh

              Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site; if gluteal region is used, only use the upper, outer quadrant

              Infants/small children: Administer IM in anterolateral aspect of thigh

              Storage

              Unopened vials: Store refrigerated between 2-8°C (36-46°F); do not freeze

              Reconstituted vials: Use within 12 hr of reconstitution if stored at 2-8°C; contains no preservative

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              Images

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.