botulism immune globulin

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botulism immune globulin

(botyoo-lism im-yoonglob-yoo-lin) ,

BabyBIG

(trade name)

Classification

Therapeutic: vaccines immunizing agents
Pharmacologic: immune globulins
Pregnancy Category: UK

Indications

Infant botulism caused by type A or B toxin in children <1 yr.

Action

Contains antibodies capable of neutralizing neurotoxins type A and B.

Therapeutic effects

Decreased sequelae of infant botulism.

Pharmacokinetics

Absorption: IV administration results in complete bioavailabilty.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 28 days (infants).

Time/action profile (presence of neutralizing antibodies)

ROUTEONSETPEAKDURATION
IV rapidend of instionup to 6 mos

Contraindications/Precautions

Contraindicated in: History of severe reactions to other immunoglobulins; Selective immunoglobulin A deficiency.
Use Cautiously in: Pre-existing renal impairment, diabetes mellitus, volume depletion, sepsis, paraproteinemia, concurrent nephrotoxic agents (↑ risk of adverse renal reactions; use lowest concentration and slowest infusion rate).

Adverse Reactions/Side Effects

Dermatologic

  • rash

Miscellaneous

  • infusion reactions

Interactions

Drug-Drug interaction

May interfere with immune response to live-virus vaccines ; defer for at least 5 mo.

Route/Dosage

Intravenous (Children <1 yr) 1 mL/kg (50 mg/kg) as a single infusion.

Availability

Lyophilized powder for injection (requires reconstitution): 100 mg/vial

Nursing implications

Nursing assessment

  • Monitor vital signs continuously during infusion. If minor side effects occur, slow infusion rate. If anaphylaxis or hypotension occur, discontinue infusion and administer epinephrine.
  • Monitor urine output during therapy.
  • Monitor for signs of aseptic meningitis syndrome (AMS) (severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, vomiting). May occur within several hours to 2 days of infusion. Cerebrospinal fluid is frequently positive for pleocytosis and elevated protein levels. More frequent with high total doses (2g/kg) and may resolve with discontinuation of therapy.
  • Lab Test Considerations: Monitor renal function (BUN, serum creatinine) prior to and periodically during therapy.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Do not confuse BabyBIG with HBIG.
  • Correct volume depletion prior to therapy.
  • Intravenous Administration
  • Reconstitute lyophilized powder with 2 mL of sterile water for injection. Use a double-ended transfer needle or large syringe. If double-ended transfer needle used, insert one end first into vial of sterile water. Lyophilized powder is supplied in an evacuated vial and water should transfer via suction (aim jet of water to side of vial). After water is transferred into vial, release residual vacuum to hasten dissolution. Rotate container gently to wet all powder. Do not shake vial; will cause foaming. Concentration: 50 mg/mL. Solution is colorless; do not administer if discolored or contains particulate matter. After reconstitution, enter vial only once for administration. Begin infusion within 2 hr and complete within 4 hr of reconstitution.
  • Rate: Use an in-line or syringe-tip disposable filter (18 micron) during administration. Begin infusion slowly at 0.5 cc/kg/hr (25 mg/kg/hr). If no untoward reactions occur after 15 min, may increase rate to 1.0 cc/kg/hr (50 mg/kg/hr). Do not exceed 1 mL/kg/hr (50 mg/kg/hr). Monitor patient closely after each rate change. Infusion should take 67.5 minutes total.
  • Y-Site Compatibility: Administer through separate IV line or piggyback in lines containing 0.9% NaCl, D5W, D10W, D2.5W. D20W, D5/0.9% NaCl, or D5/0.45% NaCl. If administered through a pre-existing line, do not dilute more than 1:2.
  • Additive Incompatibility: Do not admix with other medications

Patient/Family Teaching

  • Inform parents of purpose of medication.
  • Caution parents to avoid live vaccinations shortly before or within 5 mo of administration.

Evaluation/Desired Outcomes

  • Decreased sequelae of infant botulism.
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