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

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                Monitor Closely (7)

                • 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.

                • 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.