Vaccinia immune globulin vaccine is prepared from human plasma who were infected with smallpox.

• It is used in the treatment and/or modification of the following conditions:

  • Aberrant infections caused by vaccinia virus that include its accidental implantation in eyes, mouth, or other areas where vaccinia infection would constitute a special hazard.
  • - Eczema vaccinatum
  • - Progressive vaccinia
  • - Severe generalized vaccinia
  • -vaccination-related illnesses in people who have burns, impetigo, varicella-zoster, poison ivy, or who have eczematous skin lesions due to the activity or severity of such conditions

  • Use is mainly recommended for:

    • - Inadvertent inoculation
    • - Eczema vaccinatum
    • - Progressive vaccinia

  • Use might  be considered for:

    • -severe eye problems other than a single case of keratitis

  • Use is not advised for:

    • - Inadvertent inoculation that is not severe
    • - Mild or limited generalized vaccinia
    • Stevens-Johnson syndrome
    • - Postvaccinial encephalitis or encephalomyelitis
    • Nonspecific rashes, erythema multiforme,

Vaccinia immune globulin Dose in Adults

Dose in the treatment of Vaccinia conditions:

• IV:
  • 6,000 units/kg given as soon as symptoms arise; depending on the severity of the symptoms and how well they respond to treatment, it might be repeated.
  • If the patient doesn't respond to the first dose, 9,000 units/kg can be taken into account.

•  Maximum dose for patients with risk factors for thrombosis is  12,000 units/kg/day.

Vaccinia immune globulin Dose in Childrens

Dose in the treatment of Vaccinia modification:

• Adolescents ≥16 years:
  • Refer to adult dosing.

Pregnancy Risk Factor C

• Studies on animal reproduction have not been conducted.
• After 30 weeks of gestation, immunoglobulins cross the placenta mainly in higher amounts.
• Pregnant women are not subject to adequate, well-controlled studies.
• Vaccinia Immune Globulin cannot currently be used by anyone who have a contraindication to the smallpox vaccine.
• Inadvertent exposure should be reported, especially for high-risk groups (eg pregnant women).

VIGV dose in kidney disease:

• There are no dosage adjustments given in the manufacturer’s labeling
• use cautiously.
• Reduce the rate of infusion and solution concentration in patients who are at risk for renal impairment.
• Ensure adequate hydration
• stop if renal function deteriorates.

Vaccinia immune globulin Dose in Liver Disease:

• There are no dosage adjustments given in the manufacturer’s labeling.

• IV:

  • For IV infusion only.
  • Before administering VIGIV, flush with NS if a dedicated line is not available.
  • Do not exceed recommended rates of infusion.

• Patients ≥50 kg:

  • Infuse @ ≤2 mL/minute

• Patients <50 kg:

  • Infuse @ ≤0.04 mL/kg/minute.
  • 4 mL/minute is the maximum rate of infusion.
  • Reduce the rate of infusion in patients experiencing mild side effects (such as flushing) and in patients with renal insufficiency and/or thrombosis/thromboembolism risk factors.

Side effects:

Frequency of side effects of VIGV not defined.

• Cardiovascular:

  • Peripheral Edema

• Central Nervous System:

  • Headache
  • Fatigue
  • Rigors
  • Feeling Hot
  • Pain
  • Sensation Of Cold
  • Paresthesia
  • Dizziness

• Dermatologic:

  • Pallor
  • Erythema
  • Diaphoresis

• Gastrointestinal:

  • Vomiting
  • Nausea
  • Decreased Appetite

• Local:

  • Injection Site Reaction

• Neuromuscular & Skeletal:

  • Tremor
  • Muscle Spasm
  • Weakness
  • Back Pain

• Miscellaneous:

  • Fever

Contraindication to Vaccinia immune globulin Include:

Isolated vaccinia Keratitis

• prior to parenteral administration, a history of anaphylaxis or a severe systemic reaction to VIGIV or any other human immune globulin formulations
• IgA-deficient individuals who both have IgA antibodies and a history of IgA hypersensitivity

Warnings and precautions

• Anaphylaxis/hypersensitivity reactions:
  • Anaphylactic reactions and hypersensitivity are common.
  • Stop therapy immediately and start treatment (including epinephrine 1-mg/mL).
  • It contains trace amounts IgA
  • Use caution in IgA-deficient patients
  • IgA-deficient patients with IgA-specific antibodies and a history of IgA hypersensitivity should not take this medication.
• Aseptic meningitis
  • Aseptic meningitis syndrome (AMS), which can be caused by intravenous immuno globulin administration, has been reported to occur within a few hours to two days.
  • You may experience it more often if you take high total doses (2g/kg).
  • The treatment was stopped and AMS was remitted within a few days. There were no sequelae.
• Hemolysis
  • Hemolysis has been linked to IVIG
  • Monitor for hemolytic anemia.
  • Patients with non-O blood groups are more at risk for hemolysis if they receive high doses of the drug in one or multiple administrations.
  • For confirmation, perform laboratory testing if hemolysis symptoms are apparent.
• Infusion reactions
  • Infusion rate may be a factor in adverse reactions
  • Ensure that you closely monitor your patient during and immediately after infusion.
  • Follow the recommended infusion rates.
• Pulmonary edema
  • Monitor for transfusion-related acute pulmonary injury (TRALI).
  • Non-cardiogenic pulmonary embolism from intravenous immuneglobulin has been documented.
  • Infusions usually take between 1 and 6 hours.
  • If TRALI is suspected, you should do the necessary tests to see if the serum and product include antineutrophil antibodies.
• Effects on the renal system:
  • Acute renal failure, renal dysfunction, proximal tubular and osmotic kidney disease, and fatalities can all occur
  • This happens most often in patients who receive total sucrose doses >=400mg/kg (VIGIV does NOT contain sucrose).
• Thrombotic events
  • Thrombotic events have been linked to intravenous immuneglobulin administration.
  • Patients should exercise caution if they have a history of cardiovascular disease or risk factors for it, such as arterial or venous embolism, indwelling central vein catheters, advanced age, oestrogen use, impaired cardiac output, hypercoagulable conditions, prolonged periods of immobility, or known or suspected hyperviscosity.
  • Patients with cryoglobulins, fasting chylomicronemia/markedly elevated triglycerides, or monoclonal gammopathies should have their baseline blood viscosity evaluated because they are at risk for developing hyperviscosity.
  • Patients at high risk of thrombosis should be given the lowest possible dose, minimum concentration, and infusion rate.
  • Before administering, ensure that you have enough water.
• Hypovolemia:
  • Before starting therapy, patients should not have lost any volume.
• Postvaccinial Encephalitis
  • It is not recommended for post-vaccinial encephalitis.
• Renal impairment
  • Patients who have renal disease already or who are at a high risk of getting it should use caution when taking the medication.
  • Do not exceed the maximum rate of infusion
  • Before VIGIV injection, ensure patients have enough volume.
  • You must monitor your renal function and urine output.
  • Stop therapy if renal function is declining
• Vaccinia keratitis:
  • When VIGIV is used to treat patients suffering from complications caused by vaccinia vaccinations that also include concomitant vaccine keratitis, be careful.

Vaccinia immune globulin (intravenous) (United States: Availability limited to CDC distribution from strategic national stockpile in consultation with local health department): Drug Interaction

Monitor:

• Renal performance (including BUN, serum creatinine)
• Prior to the initial infusion and as clinically necessary, keep an eye on your urine output.
  basal blood viscosity in people at high risk for hyperviscosity
• As the patient receives the infusion, keep an eye out for any indications of adverse reactions, such as flushing, changes in blood pressure or heart rate, fever, chills, or respiratory trouble.
• TRALI or transfusion-related acute lung injury may occur typically 1 to 6 hours after the infusion.
• signs/symptoms of hemolysis (prior to infusion and ~36 to 96 hours post-infusion).

How to administer Vaccinia immune globulin?

• It is for IV infusion only.
• Flush with NS before giving VIGIV if a dedicated line is not available.
• Don't inject more frequently than advised.

• Patients ≥50 kg:

  • Infuse at ≤2 mL/minute

• Patients <50 kg:

  • Infuse at ≤0.04 mL/kg/minute.
  • 4 mL/minute is the maximum rate of infusion.
  • Reduce the rate of infusion in patients who begin to experience mild side effects (such as flushing) and in those who have renal insufficiency or thrombosis/thromboembolism risk factors.

Mechanism of action of Vaccinia immune globulin:

• Passive immunity is provided by these antibodies derived from combined human plasma of smallpox vaccine recipients.

Distribution: V :

• 6.6 L

Half-life elimination:

• 30 days (range: 13 to 67 days)
• Time to peak, plasma: 1.8 to 2.6 hour 

International Brands of Vaccinia immune globulin:

• CNJ-016

Vaccinia immune globulin Brands in Pakistan: 

No Brands available in Pakistan.