raxibacumab

General

Pronunciation:
rax-ee-bak-ue-mab

Trade Name(s)

• ABthrax

Ther. Class.
antidotes

Pharm. Class.
monoclonal anti-toxins

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 Effect(s):

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)

Contraindication/Precautions

Contraindicated in:

• No contraindications noted.

Use Cautiously in:

• Infusion reactions (premedication with diphenhyramine is recommended)
• OB: Effects in pregnant women are not know
• Lactation:Use cautiously
• Pedi: Safe and effective use in children >16 yr has not been studied

Adverse Reactions/Side Effects

CNS: drowsiness

Derm: pruritus, rash

MS: extremity pain

Misc: infusion reactions (rash/urticaria/pruritus)

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

Interactions

Drug-Drug

None noted.

Route/Dosage

Pretreatment with diphenhydramine is recommended.

IV: (Adults and Children > 50 kg): 40 mg/kg single dose.

IV: (Children >15 kg-50 kg): 60 mg/kg single dose.

IV: (Children ≤15 kg): 80 mg/kg single dose.

Availability

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

Assessment

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

Potential 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.