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)
  • Renal impairment, diabetes mellitus, age >65 yr, volume depletion, paraproteinemia, sepsis, or exposure to nephrotoxic drugs (↑ risk of renal failure)
  • Large doses, underlying inflammatory states (↑ risk of hemolysis).

Adverse Reactions/Side Effects

CV: DEEP VEIN THROMBOSIS (DVT)

GI: nausea

GU: RENAL FAILURE

Local: infusion site reactions

MS: back pain

Neuro: aseptic meningitis syndrome, headache

Resp: PULMONARY EMBOLISM (PE), transfusion-related acute lung injury

Misc: HYPERSENSITIVITY 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 3 mo.

Route/Dosage

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

IV (Children  50–<60 kg): 6 vials (360 units) as a single dose.

IV (Children  35–<50 kg): 5 vials (300 units) as a single dose.

IV (Children  25–<35 kg): 4 vials (240 units) as a single dose.

IV (Children  18–<25 kg): 3 vials (180 units) as a single dose.

IV (Children  10–<18 kg): 2 vials (120 units) as a single dose.

IV (Children  <10 kg): 1 vial (60 units) as a single dose.

Availability

Solution for IV injection: minimum potency of ≥60 units by toxin neutralization assay/vial (contains trace amounts of IgA and maltose)

Assessment

  • Monitor for signs/symptoms of hypersensitivity reactions (rash, urticaria, pruritus, flushing, dizziness, vomiting) and angioedema (swelling of throat, lips, tongue, or face; dyspnea; stridor; wheezing; hoarseness).  If reaction occurs, discontinue immediately and provide supportive care.
  • Monitor for signs/symptoms of venous thromboembolism, such as PE (chest pain, dyspnea, tachycardia) or DVT (calf pain or tenderness, lower extremity edema, localized warmth or erythema), during and following therapy. Administer infusion at minimum rate.
  • Monitor for signs/symptoms of infusion rate reactions (chills, fever, headache, nausea vomiting) during and following infusion.  If reaction occurs, slow infusion.
  • Assess for signs/symptoms of aseptic meningitis syndrome (severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, 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 impairment. Infuse at minimum rate.  If renal function deteriorates,  consider discontinuing therapy.
  • May cause hemolysis. Monitor hemoglobin and hematocrit prior to, within approximately 36–96 hr of, and again approximately 7–10 days after infusion. If signs/symptoms of hemolysis or significant ↓ in hemoglobin or hematocrit occurs after infusion, perform confirmatory lab testing.
  • Monitor blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly ↑ triglycerides, or monoclonal gammopathies.

Implementation

IV Administration

  • Intermittent Infusion:  Thaw vials by placing frozen vials at room temperature for 1 hr followed by a water bath of 98.6°F until thawed or place vials in refrigerator until thawed (14 hr). Do not thaw in microwave or refreeze. Bring thawed vials to room temperature by allowing to sit for a few min prior to infusion. Solution should be completely thawed and 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, ↑ rate by 1 mL/min every 30 min to a max of 2 mL/min.  For children,  begin infusion at 0.01 mL/kg/min; then if tolerated, ↑ rate by 0.02 mL/kg/min every 30 min to a max of 0.04 mL/kg/min. Do not exceed adult rate at any step. If adverse reactions occur (flushing, headache, nausea, changes in HR or BP) slow rate or temporarily stop infusion.

Patient/Family Teaching

  • Explain purpose and side effects of anthrax immune globulin to patient.
  • Advise patient to notify health care provider if signs/symptoms of hypersensitivity reactions 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 revaccinated if anthrax immune globulin was received shortly after being vaccinated.
  • Rep:  Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Decreased severity and sequelae of inhalational anthrax.