Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 5% (50mg/mL) gamma globulin solution containing vaccinia virus antibodies ≥50,000 unit/vial
- 20-mL single-dose vial
Vaccinia Immunization Complications
Indications
- Eczema vaccinatum
- Progressive vaccinia
- Severe generalized vaccinia
- Vaccinia infections in individuals who have skin conditions (eg, burns, impetigo, varicella-zoster, poison ivy), or in individuals who have eczematous skin lesions because of either activity or extensiveness of such lesions
- Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard
Dose
- 6000 Units/kg IV as soon as symptoms appear and are judged to be due to severe vaccinia-related complication
- Consider repeat dosing, depending on symptom severity and response to treatment; however, clinical data on repeat doses are lacking
- Consider higher doses of 9000 Units/kg if patient unresponsive to lower dose
- Up to 24,000 units/kg administered to healthy volunteers were well tolerated in clinical trials
Dosage Modifications
Thrombosis
- Patients with risk factors for thrombosis: Not to exceed 12,000 unit/kg/day
Monkeypox (Off-label)
CDC holds an expanded access protocol that allows the use of VIGIV for treatment of orthopoxviruses (including monkeypox) in an outbreak
Data are not available on effectiveness for monkeypox virus infection
Use has no proven benefit in the treatment of monkeypox and it is unknown whether a person with severe monkeypox infection will benefit from treatment with VIG; however, healthcare providers may consider its use in severe cases
Consider prophylactic use in an exposed person with severe immunodeficiency in T-cell function for which smallpox vaccination following exposure to monkeypox virus is contraindicated
Dosing Considerations
Not effective in the treatment of postvaccinial encephalitis
Monitoring
- If signs and/or symptoms of hemolysis present after infusion, perform appropriate laboratory testing for confirmation
- If transfusion-related acute lung injury (TRALI) suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient’s serum
-
Renal function
- Periodically monitor renal function and urine output to assess if patient at increased risk of developing acute renal failure
- Assess renal function, including BUN and serum creatinine, before initial infusion and at appropriate intervals thereafter
-
Thrombosis
- Owing to increased risk of thrombosis, consider baseline assessment of blood viscosity in patients at risk for hyperviscosity
- Risk examples include those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies
<16 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (10)
- 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.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC 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.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of vaccinia immune globulin intravenous by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab 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 rozanolixizumab and using alternative therapies.
- 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.
Adverse Effects
1-10%
6000 units/kg
- Headache (54.8%)
- Rigors (22.6%)
- Dizziness (16.1%)
- Feeling cold (12.9%)
- Nausea (12.9%)
9000 units/kg
- Headache (59%)
- Nausea (28.2%)
- Rigors (17.9%)
- Dizziness (17.9%)
- Feeling cold (15.4%)
- Pain (12.8%)
1-10%
6000 units/kg
- Sweating increased (9.7%)
- Feeling hot (9.7%)
- Asthenia (6.5%)
- Pyrexia (6.5%)
- Appetite decreased (6.5%)
- Muscle spasm (6.5%)
- Back pain (6.5%)
- Paresthesia (6.5%)
- Vomiting (3.2%)
- Pain (3.2%)
- Tremor (3.2%)
- Pallor (3.2%)
9000 units/kg
- Vomiting (7.7%)
- Pallor (7.7%)
- Asthenia (5.1%)
- Fatigue (5.1%)
- Appetite decreased (5.1%)
- Muscle spasm (5.1%)
- Back pain (5.1%)
- Tremor (5.1%)
- Sweating increased (5.1%)
- Feeling hot (2.6%)
- Pyrexia (2.6%)
- Paresthesia (2.6%)
Postmarketing Reports
- Cardiovascular: Cardiac arrest, tachycardia
- Hematologic and lymphatic: Neutropenia, leukopenia, anemia, lymphadenopathy
- Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (eg, bullous dermatitis), urticaria or other skin reactions
- Gastrointestinal: Hepatic dysfunction, abdominal pain, diarrhea
- Muscular: Myalgia, arthralgia
- Neurological: Coma, loss of consciousness, seizures Renal: Acute kidney injury, osmotic nephropathy
- Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm, wheezing
- General/body as a whole: Malaise, chest discomfort
Warnings
Black Box Warnings
Blood glucose measurement in patients receiving must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV
Maltose in IGIV products may give falsely high blood glucose levels in certain types of blood glucose testing systems (eg, text based on GDH-PQQ or glucose-dye-oxidoreductase methods) resulting in inappropriate administration of insulin and life-threatening hypoglycemia
Cases of true hypoglycemia may go untreated if hypoglycemic state is masked by falsely elevated glucose readings Carefully review blood glucose testing systems, including test strips, to determine if the system is appropriate for use with maltose-containing parenteral products
Contraindications
Hypersensitivity to immunoglobulins
Presence of isolated vaccinia keratitis
IGA deficiency
Cautions
Severe, immediate hypersensitivity reactions to plasma-derived products may occur; administer in setting where appropriate equipment and personnel trained in management of acute anaphylaxis are available; discontinue immediately if hypotension, allergic, or anaphylactic reaction occurs
Renal dysfunction, acute renal failure, osmotic nephropathy, proximal tubular nephropathy, and death may occur with us of IGIV products; caution with renal insufficiency (including, but not limited to those with diabetes mellitus, age ≥65 yr, volume depletion, paraproteinemia, sepsis, coadministration of nephrotoxic drugs); contains 5% sucrose
Some types of blood glucose testing systems (eg, test based on glucose dehydrogenase pyrroloquinolinequinone [GDH-PQQ] or glucose-dye-oxidoreductase methods) could falsely interpret the maltose contained in VIGIV as glucose; and therefore, result in falsely elevated glucose readings and unnecessary administration of insulin
Thrombotic events may occur; caution in patients at risk including history of cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, history of arterial or venous thrombosis, estrogen use, indwelling central vascular catheters, and/or known or suspected hyperviscosity
May contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immune globulin, causing a positive direct antiglobulin reaction and hemolysis
Aseptic meningitis syndrome (AMS) may occur; AMS usually begins within several hours to 2 days following IGIV treatment; discontinuation of treatment has resulted in remission of AMS within several days without sequelae
Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur; TRALI characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever reported within 1-6 hr after transfusion
Derived from human plasma, small risk of viral transmission (eg, Creutzfeldt-Jakob disease) through administration
Drug interaction overview
- Defer immunization with live virus vaccine ~3 months after administration of VIGIV
- Revaccinate people (after 3 months) who received VIGIV shortly after a live virus vaccine
- Immune globulin may impair efficacy of live attenuated vaccines (eg, measles, rubella, mumps and varicella)
Pregnancy & Lactation
Pregnancy
There are no data on the use in pregnant females to inform on drug-associated risk
Animal reproduction studies have not been conducted
Lactation
Data are not available to assess presence or absence of VIGIV in human milk, effects on breastfed children, or effects on milk production/excretion
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.Pharmacology
Mechanism of Action
Provides passive immunity for individuals with complications to vaccinia virus vaccination
Derived from human immune globulins from donors who received booster shots of vaccinia virus
Absorption
Peak plasma time: ≤2 hr
Peak plasma concentration: 161 units/mL (6000 units/kg); 232 units/mL (9000 units/kg)
AUC, 1-4 hr: 49,405 units⋅hr/mL (6000 units/kg); 71,541 units⋅hr/mL (9000 units/kg)
AUC, 0-inf: 58,521 units⋅hr/mL (6000 units/kg); 78,401 units⋅hr/mL (9000 units/kg)
Distribution
Vd: 6630 L
Elimination
Half-Life: 30 days (range of 13-67 days)
Administration
IV Compatibilities
0.9% NaCl
IV Preparation
Bring vials to room temperature
- If frozen, thaw vial in refrigerator at 36-46ºF (2-8ºC) until contents are thawed for ~14 hr
- Can be thawed rapidly by placing at room temperature for 1 hr followed by water bath at 98.6ºF (37ºC) until thawed
- Do not thaw in microwave oven
- Do not refreeze the vial
Do NOT shake vial; shaking may cause foaming
Withdraw entire vial contents to obtain dose; if partial vials are required for dose calculation, withdraw entire vial contents to ensure accurate dosage calculation
If pre-existing catheter used, flush line with 0.9% NaCl before use
May be administered either undiluted or diluted no more than 1:2 (v/v)
Vial is for single use only; do not reuse or save VIGIV for future use
Contains no preservatives; discard partially used vials
Inspect solution before use; do not use if cloudy, discolored, or contains particulates
IV Administration
Administer IV through dedicated line
Begin IV infusion within 4 hr after first vial puncture
Infusion rate and monitoring
- Not to exceed 2 mL/min
- Weight <50 kg: Not to exceed 0.04 mL/kg minute (133.3 units/kg/minute)
- Adverse drug reactions may be related to infusion rate; slower infusion rate may be needed for patients who develop minor adverse reaction (eg, flushing) or patient with risk factors for thrombosis/thromboembolism
- Do not exceed recommended infusion rate in patients with pre-existing renal insufficiency, or at increased risk of acute kidney injury, thrombosis, or volume overload
- Closely monitor and carefully observe vital signs for any symptoms throughout infusion and immediately following
Storage
May be stored frozen at ≤5ºF (≤ -15ºC) or refrigerated at 36-46ºF (2-8ºC)
If product is received frozen, use within 60 days of thawing at 36-46ºF (2-8ºC)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| GamaSTAN S/D intramuscular - | 15-18 % range vial |  | |
| GamaSTAN S/D intramuscular - | 15-18 % range vial |  |
Copyright © 2010 First DataBank, Inc.
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