vaccinia immune globulin intravenous (Rx)

Brand and Other Names:VIGIV
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50mg/mL

Vaccinia Infection

6000 Units/kg IV; may require additional dose of 9000 Units/kg if patient unresponsive to lower dose

Renal Impairment

Use caution; administer at minimum rate of infusion; discontinue if renal deterioration worsens

Safety and efficacy not established

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Interactions

Interaction Checker

and vaccinia immune globulin intravenous

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (6)

              • axicabtagene ciloleucel

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

              • brexucabtagene autoleucel

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

              • ciltacabtagene autoleucel

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

              • idecabtagene vicleucel

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

              • lisocabtagene maraleucel

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

              • tisagenlecleucel

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

              Monitor Closely (8)

              • adenovirus types 4 and 7 live, oral

                vaccinia immune globulin intravenous decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

              • BCG vaccine live

                vaccinia immune globulin intravenous decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

              • efgartigimod alfa

                efgartigimod alfa will decrease the level or effect of vaccinia immune globulin intravenous 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.

              • measles mumps and rubella vaccine, live

                vaccinia immune globulin intravenous decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

              • measles, mumps, rubella and varicella vaccine, live

                vaccinia immune globulin intravenous decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

              • rubella vaccine

                vaccinia immune globulin intravenous decreases effects of rubella vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

              • smallpox (vaccinia) vaccine, live

                vaccinia immune globulin intravenous decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

              • varicella virus vaccine live

                vaccinia immune globulin intravenous decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

              Minor (1)

              • protein a column

                protein a column decreases levels of vaccinia immune globulin intravenous 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%

              Abdominal pain

              Arthalgia

              Dizziness

              Headache

              Inj site reactions

              Nausea

              Dyspnea

              URI

              Contact dermatitis

              Erythema

              Flushing

              Skin lacerations

              Urticaria

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              Warnings

              Black Box Warnings

              Associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death

              Administer IV at minimum concentration available and minimum rate of infusion in patients predisposed to acute renal failure; IVIG products containing sucrose as a stabilizer or at daily doses >400 mg/kg account for a disproportionate share of case reports involving renal failure

              Maltose in vaccinia immune globulin can interact with glucose monitoring and cause unncessary use of insulin

              Patients predisposed to acute renal failure

              • Any degree of preexisting renal insufficiency
              • Diabetes mellitus
              • Age >65 years
              • Volume depletion
              • Sepsis
              • Paraproteinemia
              • Currently taking nephrotoxic drugs

              Contraindications

              Hypersensitivity to immunoglobulins

              Presence of isolated vaccinia keratitis

              IGA deficiency

              Cautions

              Contains 5% sucrose as preservative. Immunoglobulins with sucrose preservative have been associated with ARF, renal dysfunction, osmotic nephrosis, proximal tubular nephropathy, & death

              Not effective against postvaccinial encephalitis

              Renal impairment & conditions that incr risk of renal impairment

              Vaccination with live viruses should be deferred for at least 6 mth postadministration

              Maltose in vaccinia immune globulin can cause false readings in glucose monitoring systems

              Derived from human plasma, small risk of viral transmission through admin

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              Pregnancy & Lactation

              Pregnancy Category: C

              Lactation: use caution

              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

              Human immune globulins from donors who received booster shots of vaccinia virus (Dryvax)

              Pharmacokinetics

              Half-Life: 13-67 days

              Peak plasma time: ≤ 2 hr

              Vd: 6630 L

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              Administration

              IV Administration

              Begin infusion within 6 hr of entering vial & complete within 12 hr of entering vial

              Infuse at 1 mL/kg/hr for first 30 min, THEN 2 mL/kg/hr for next 30 min, THEN 3 mL/kg/hr for the remainder

              Predilution not recommended

              Through dedicated IV catheter with in-line 0.22 micron filter OR

              IVPB into preexisting catheter if the catheter contains NS, D2.5W, D5W, D10W or D20W

              If using preexisting catheter flush catheter before use, and do not dilute VIGIV more than 1:2

              Adverse Event Management

              Reduce infusion rate or interrupt if minor

              In case of anaphylactoid reactions, may use epinephrine with or without diphenhydramine

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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
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.