DrugindexOnline^{2nd edition}

Pronouncation: (vax-IN-ee-ah ih-MYOON GLAH-byoo-lin)
Class: Immune globulin

Trade Names:
Vaccinia Immune Globulin Intravenous (Human)
- Solution for injection 50 mg/mL (immunoglobulin 2,500 mg/vial)

Mechanism of Action

Pharmacology

Vaccinia-specific immunoglobulin G (IgG) that directly neutralizes vaccinia virus.

Pharmacokinetics

Elimination

Serum t _½ is about 22 days.

Indications and Usage

Treatment and/or modification of aberrant infections induced by vaccinia virus (including accidental implantation in eyes, mouth, or other areas where vaccinia infection would constitute a special hazard), eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals with eczematous skin lesions. Treat complications that include vaccinia keratitis with caution.

Contraindications

Isolated vaccinia keratitis; prior severe reactions associated with parenteral use of vaccinia immune globulin IV or other human immunoglobulin preparations; people with selective IgA deficiency.

Dosage and Administration

Adults

IV 2 mL/kg (100 mg/kg) as IV infusion. Dose may be repeated, depending on severity of symptoms and response to treatment.

Higher doses (200 or 500 mg/kg) may be considered in the event the patient does not respond to the initial 100 mg/kg dose. Do not use doses greater than 400 mg/kg in patients predisposed to renal complications.

General Advice

• For IV infusion only. Not for oral, intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
• Remove tab portion of vial cap and clean rubber stopper with 70% alcohol or equivalent. Do not shake vial to avoid foaming. Withdraw prescribed dose. Administer without further dilution within 6 hr of entering the vial. Complete dose within 12 hr of entering the vial.
• Visually inspect solution before use. Do not use if particulate matter, cloudiness, or discoloration noted.
• Administer with a constant infusion pump through a dedicated IV catheter with administration set that contains an in-line filter (0.22 mcm pore size). May be piggybacked into a pre-existing catheter if the catheter contains either 0.9% sodium chloride injection or one of the following dextrose solutions (with or without sodium chloride): 2.5%, 5%, 10%, or 20% dextrose in water. Flush the line before use and do not dilute the vaccinia immune globulin IV more than 1:2 (v/v).
• Administer by IV infusion at rate of 1 mL/kg/hr for first 30 min, increased to 2 mL/kg/hr for the next 30 min, and then to 3 mL/kg/hr for the remainder of the infusion, as tolerated. Do not exceed these rates of administration.
• Monitor patient closely during and after each infusion rate change for minor (flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, wheezing) and serious (anaphylaxis, hypotension, respiratory distress) infusion-related reactions. If patient develops a minor adverse reaction, slow the rate of infusion or temporarily interrupt the infusion. For serious adverse reactions, discontinue the infusion and be prepared to treat appropriately.

Storage/Stability

Store unopened vials in refrigerator (36° to 46°F).

Drug Interactions

Live virus vaccines

To avoid interference with immune response to live virus vaccines, defer vaccination with live virus vaccines for about 6 mo after giving vaccinia immune globulin IV.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Dizziness, headache, somnolence (at least 5%).

Dermatologic

Contact dermatitis, erythema, flushing, skin lacerations, urticaria (at least 5%).

EENT

Nasal congestion, sore throat (at least 5%).

GI

Abdominal pain, nausea, toothache (at least 5%).

Local

Injection site reaction (at least 5%).

Musculoskeletal

Arthralgia, back pain (at least 5%).

Respiratory

Dyspnea, upper respiratory tract infection (at least 5%).

Precautions

Warnings Immune globulin IV (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death. Although many immune globulin IV products have been associated with renal dysfunction and acute renal failure, a disproportionate share of the cases were associated with immune globulin IV products that contained sucrose as a stabilizer and were administered at daily doses of 400 mg/kg or more. Immune globulin IV contains sucrose (5%) as a stabilizer, and the recommended dose is 100 mg/kg. Risk factors that predispose to acute renal failure include: any degree of pre-existing renal impairment, diabetes mellitus, volume depletion, sepsis, paraproteinemia, older than 65 yr of age, and concurrent treatment with nephrotoxic drugs. Immune globulin IV should be administered at the minimum concentration available and at the minimum rate of infusion practical, especially in patients predisposed to renal failure.

Monitor Monitor vital signs continuously during administration and observe for any symptoms throughout the infusion.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Safety and efficacy not established.

Hypersensitivity

Serious reactions can occur. Have epinephrine and resuscitation equipment readily available. Monitor patient for signs and symptoms of allergic reaction. Discontinue therapy immediately severe or anaphylactic reaction noted.

Renal Function

Use with caution in patients with renal impairment and patients with increased risk of developing renal insufficiency. Ensure that such patients are not volume depleted before infusion. Do not exceed recommended infusion rate.

Aseptic meningitis syndrome

Occurs infrequently and usually begins several hr to 2 days after treatment. Signs and symptoms of aseptic meningitis include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting.

Hemolysis

Immune globulin IV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Monitor patients for signs and symptoms of hemolysis (unexplained fatigue, jaundice, splenomegaly).

Transfusion-Related Acute Lung Injury (TRALI)

Noncardiogenic pulmonary edema has been reported in patients administered immune globulin IV, usually within 1 to 6 hr following infusion. Monitor patients for adverse pulmonary reactions (eg, severe respiratory distress, pulmonary edema, hypoxemia, fever, normal left ventricular function). Be prepared to provide oxygen therapy and ventilatory support. Ensure that tests for antineutrophil antibodies in the immune globulin IV and patient are performed and evaluated.

Thrombotic events

Thrombotic events have been reported in association with IGIV. Risk factors may include: history of atherosclerosis, multiple CV risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Ensure that baseline blood viscosity is assessed in patients at risk for hyperviscosity (eg, cryoglobulins, monoclonal gammopathy, fasting chylomicronemia, markedly high triglycerides). Monitor patients for signs and symptoms of thromboembolic events (eg, venous thrombophlebitis, pulmonary embolism, pulmonary infarction, stroke, arterial occlusion).

Overdosage

Symptoms

Manifestations would be related to volume overload.

Patient Information

• Explain name, action, and potential side effects of therapy.
• Review benefits of therapy and risks, including potential to transmit disease and unknown infectious agents.
• Advise patient or caregiver that medication will be prepared and administered by a health care professional in a health care setting.
• Instruct patient to immediately report any of the following to health care provider: decreased urine output, sudden weight gain, fluid retention or swelling, unexplained shortness of breath, fever, severe headache, stiff neck, unexplained drowsiness or fatigue, painful eye movements, sensitivity to bright light, persistent or worsening nausea and vomiting.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breast-feeding.
• Caution patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
• Advise patient that follow-up visits and laboratory tests may be required to monitor therapy and to keep appointments.