raxibacumab


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raxibacumab

(rax-ee-bak-ue-mab) ,

ABthrax

(trade name)

Classification

Therapeutic: antidotes
Pharmacologic: temporary class
Pregnancy Category: B

Indications

Treatment of inhalational anthrax in combination with anti-infective agents.Prevention of inhalational anthrax when other agents cannot be used or are unavailable.

Action

A monoclonal anti-toxin, blocks the activity of toxin produced by Bacillus anthracisThe toxin is a primary cause of disease progression.

Therapeutic effects

Decreased morbidity and mortality associated with inhalational anthrax exposure and disease.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability
Distribution: Some tissue distribution
Metabolism and Excretion: No renal clearance
Half-life:

Time/action profile (levels)

ROUTEONSETPEAKDURATION
IVrapidend of infusionunknown

Contraindications/Precautions

Contraindicated in: No contraindications noted.
Use Cautiously in: Infusion reactions (premedication with diphenhyramine is recommended) Obstetric: Effects in pregnant women are not know Lactation: Use cautiously Pediatric: Safe and effective use in children >16 yr has not been studied

Adverse Reactions/Side Effects

Central nervous system

  • drowsiness

Dermatologic

  • pruritus
  • rash

Musculoskeletal

  • extremity pain

Miscellaneous

  • infusion reactions (rash/urticaria/pruritus)

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Pretreatment with diphenhydramine is recommended.
Intravenous (Adults and Children > 50 kg) 40 mg/kg single dose
Intravenous (Children >15 kg-50 kg) 60 mg/kg single dose
Intravenous (Children ≤15 kg) 80 mg/kg single dose

Availability

Solution for IV infusion (requires further dilution): 1700 mg/34 mL (50 mg/mL) vial

Nursing implications

Nursing assessment

  • Monitor for infusion-related reactions (rash, urticaria, pruritus). Slow or interrupt infusion if these occur.

Potential Nursing Diagnoses

Risk for infection (Indications)
Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)

Implementation

  • Premedicate within 1 hr of infusion with 25 to 50 mg PO or IV depending on proximity of raxibacumab infusion.
  • Intermittent Infusion: Diluent: Dilute in 0.9% NaCl or 0.45% NaCl for patients up to 15 kg and 0.9% NaCl for patients >15 kg to a final volume of 250 mL or to a volume based on child's weight for either syringe or infusion bag preparation. For syringe preparation, use volume of 7 mL for patients ≤1 kg, 15 mL for patients 1.1–2 kg, 20 mL for patients 2.1–3 kg, 25 mL for patients 3.1–4.9 kg, 50 kg for patients 5–10 kg. Gently mix solution; do not shake. For infusion bag preparation, use volume of 100 mL for patients 16–30 kg, 250 mL for patients 31–40 kg, 250 mL for patients 41 to 50 kg or greater. Gently invert infusion bag; do not shake. Solution is clear to opalescent, colorless to pale yellow; do not administer solutions that are discolored or contain particulate matter. Stable for 8 hr at room temperature.
  • Rate: Infuse over up to 2 hr and 15 min based on patient weight. For patients ≤1 kg, first 20 min infuse at 0.5 mL/hr and remaining infusion over 3.5 mL/hr, patients 1.1–2 kg, first 20 min infuse at 1 mL/hr and remaining infusion over 7 mL/hr, patients 2.1–3 kg, first 20 min infuse at 1.2 mL/hr and remaining infusion over 10 mL/hr, patients 3.1–4.9 kg, first 20 min infuse at 1.5 mL/hr and remaining infusion over 12 mL/hr, patients 5–10 kg, first 20 min infuse at 3 mL/hr and remaining infusion over 25 mL/hr, patients 11–30 kg, first 20 min infuse at 6 mL/hr and remaining infusion over 50 mL/hr, patients 31–50 kg or more, first 20 min infuse at 15 mL/hr and remaining infusion over 125 mL/hr. Rate may be slowed or discontinued if symptoms of adverse reactions or infusion-related reactions occur.

Patient/Family Teaching

  • Explain purpose of raxibacumab to patient or parents.
  • Advise patient to notify health care professional immediately if rash, hives, or itching occur during infusion.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decreased morbidity and mortality associated with inhalational anthrax exposure and disease.
References in periodicals archive ?
As per the contract, Glaxo will be offering 60,000 doses of its raxibacumab medicine over four years to combat the deadly disease.
1 million recognized from sales and deliveries of raxibacumab to the U.
Also in late-stage development is raxibacumab (ABthrax(TM)) for the treatment of inhalation anthrax (Biologics License Application currently pending with the U.
The drug, a human monoclonal antibody called raxibacumab, improved survival rates for monkeys by 64%, researchers said in an article published in the New England Journal of Medicine.
London, July 10 (ANI): An experimental drug called raxibacumab has been found to be effective in treating anthrax poisoning, say researchers.
Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for raxibacumab, a treatment for inhalational anthrax, and has established December 15, 2012 as the Prescription Drug User Fee Act (PDUFA) action date.
GlaxoSmithKline (GSK) plc today announced a new four year contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), for the provision of its inhalation anthrax treatment, raxibacumab.
These forward- looking statements include those regarding our expectations for BENLYSTA, darapladib, albiglutide and raxibacumab, among others.
Government exercised its option to purchase 45,000 additional doses of raxibacumab for the U.
GlaxoSmithKline announced today that the Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) voted 16 to 1 in support of the clinical benefit of raxibacumab for the treatment of inhalational anthrax, with one abstention.
Two of the approved NME's in 2012, choline C-11 and raxibacumab, were approved with the non-proprietary name in place of a proprietary name.
Government exercised its option to purchase 45,000 additional doses of raxibacumab for the Stockpile for emergency use in treating inhalation anthrax, with delivery to be completed over a three-year period.