anthrax immune globulin

General

Pronunciation:
an-thrax im-myoon glob-yoo-lin


Trade Name(s)

  • Anthrasil

Ther. Class.

vaccines/immunizing agents

Pharm. Class.

immune globulins

Indications

Treatment of inhalational anthrax (in combination with appropriate anti-infectives).

Action

Provides passive immunization, neutralizes anthrax toxin.

Therapeutic Effect(s):

Decreased severity and sequelae of inhalational anthrax.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 174–187 days.

TIME/ACTION PROFILE

ROUTEONSETPEAKDURATION
IVrapidunknownup to 84 days†
† Persistence of neutralizing activity.

Contraindication/Precautions

Contraindicated in:

  • History of anaphylactic/severe systemic hypersensitivity reaction to human immune globulin
  • IgA deficiency with antibodies against IgA and history of IgA hypersensitivity.

Use Cautiously in:

  • Advanced age, impaired cardiac output, hypercoagulable state, prolonged immobilization, history of venous/arterial thromboses, estrogen use, indwelling central vascular catheters or hyperviscosity (↑risk of thrombosis; maintain hydration, use lower infusion rate)
  • Renal insufficiency, diabetes mellitus, age >65 yr, volume depletion, paraproteinemia, sepsis, exposure to nephrotoxic drugs (↑ risk of renal failure; maintain hydration, use lower infusion rate and monitor renal function)
  • Large doses, underlying inflammatory states (↑ risk of hemolysis).

Adverse Reactions/Side Effects

CV: THROMBOSIS

GI: nausea

GU: RENAL FAILURE

Local: infusion site reactions

MS: back pain

Neuro: aseptic meningitis syndrome, headache

Resp: transfusion-related acute lung injury

Misc: allergic reactions including ANAPHYLAXIS, transfusion of blood-borne infectious agents.

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  •  Estrogens  may ↑ risk of thrombosis.
  • May alter the efficacy of  live attenuated vaccines including measles, mumps, rubella  and  varicella  (defer vaccination for three mo).

Route/Dosage

IV (Adults and Children ≥17 yr or ≥60 kg): 7 vials (420 units); if symptoms are severe (substantial hemorrhage) consider initial dose of 14 vials (840 units) which may be repeated depending on clinical situation.

IV (Children <1 yr- ≤16 yr): 60–420 units based on patient weight.

IV (Children 50–<60 kg): 6 vials (360 units).

IV (Children 35–<50 kg): 5 vials (300 units).

IV (Children 25–<35 kg): 4 vials (240 units).

IV (Children 18–<25 kg): 3 vials (180 units).

IV (Children 10–<18 kg): 2 vials (120 units).

IV (Children <10 kg): 1 vials (60 units).

Availability

Solution for IV injection (requires further dilution): minimum potency of ≥60 units by Toxin Neutralization Assay/vial (contains trace amounts of IgA and maltose)

Assessment

  • Monitor for signs and symptoms of hypersensitivity reaction (urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia). If severe, discontinue infusion.
  • Monitor for signs and symptoms of thrombosis (swelling in foot, ankle, or leg on one side, cramping pain in affected leg beginning in calf, pain in foot and ankle, area of skin feels warmer than skin on surrounding areas) during and following therapy. Patients at increased risk have cardiovascular risk factors, older age, impaired cardiac output, hypercoagulable disorders, immobilization, history of arterial or venous thrombosis, estrogen use, indwelling central vascular catheters, and/or known or suspected hyperviscosity. Administer infusion at minimum rate.
  • Monitor for signs and symptoms of infusion rate reactions (chills, fever, headache, nausea vomiting) during and following infusion. Slow infusion if reactions occur.
  • Assess for aseptic meningitis syndrome in patients with signs and symptoms (severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Conduct neurological exam and CSF studies to confirm.

Lab Test Considerations:

• Maltose in immune globulin products may give falsely high blood glucose levels with some blood point-of-care glucose testing systems. Measure blood glucose with a glucose-specific method (monitor and test strips).

  • Monitor renal function (BUN, serum creatinine) and urine output prior to and during therapy. May cause acute renal dysfunction. Patients at risk include pre-existing or risk of developing renal insufficiency (diabetes mellitus, age greater than 65 years, volume depletion, paraproteinemia, sepsis, patients receiving known nephrotoxic drugs). Infuse at minimum rate. If renal function deteriorates, consider discontinuing therapy.
  • May cause hemolysis. Monitor hemoglobin or hematocrit prior to, within approximately 36 to 96 hr and again approximately seven to 10 days post infusion. If signs and symptoms of hemolysis or significant drop in hemoglobin or hematocrit occur after infusion, perform confirmatory lab testing.
  • Monitor blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.

Implementation

  • Intermittent Infusion:  Bring vials to room temperature by placing frozen vials at room temperature for 1 hr followed by a water bath of 98.6° until thawed or place vials in refrigerator until thawed (14 hrs). Do not thaw in microwave or refreeze. Bring thawed vials to room temperature by allowing to sit for a few minutes prior to infusion. Solution should be completely thawed, clear or slightly opalescent; do not use solutions that are cloudy or contain particulate matter. Swirl upright gently to mix; do not shake. Dilution:  Withdraw contents of vial and transfer to bag; do not dilute. Administer as soon as possible using infusion pump. In-line filter is optional. Discard unused portion.
  • Rate: For adults,  begin infusion at 0.5 mL/min, then if tolerated, increase rate by 1 mL/min every 30 min to a maximum of 2 mL/min.  For children,  begin infusion at 0.01 mL/kg/min, then if tolerated, increase rate by 0.02 mL/kg/min every 30 min to a maximum of 0.04 mL/kg/min. Do not exceed adult rate at any step. If adverse reactions occur (flushing, headache, nausea, changes in pulse rate or BP) slow rate or temporarily stop infusion.

Patient/Family Teaching

  • Explain purpose of anthrax immune globulin to patient.
  • Advise patient to notify health care professional if signs and symptoms of hypersensitivity reactions (hives, rash, chest tightness, wheezing, shortness of breath, feeling light headed or dizzy when they stand) or if injection site pain, chills, fever, headache, nausea, vomiting, or joint pain occur.
  • Advise patient to defer live vaccinations for 3 mo following administration of anthrax immune globulin and to be re-vaccinated if anthrax immune globulin was received shortly after being vaccinated.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Decreased severity and sequelae of inhalational anthrax.