Dosing and uses of VIGIV (vaccinia immune globulin intravenous)
Adult dosage forms and 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
Pediatric dosage forms and strengths
Safety and efficacy not established
VIGIV (vaccinia immune globulin intravenous) adverse (side) effects
1-10%
Abdominal pain
Arthalgia
Dizziness
Headache
Inj site reactions
Nausea
Dyspnea
URI
Contact dermatitis
Erythema
Flushing
Skin lacerations
Urticaria
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
Pregnancy and 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.
Pharmacology of VIGIV (vaccinia immune globulin intravenous)
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
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
