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raxibacumab (Rx)Brand and Other Names:

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravenous solution

  • 50mg/mL (1700mg/34mL single-dose vial)
  • Available from CDC
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Inhalational Anthrax

Indicated for treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate

40 mg/kg IV as a single dose infused over 2.25 hr

Premedicate with diphenhydramine within 1 hr before infusion

Dosing Considerations

Effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax

Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis; should be used in combination with appropriate antibacterial drugs

Dosage Forms & Strengths

intravenous solution

  • 50mg/mL (1700mg/34mL single-dose vial)
  • Available from CDC
more...

Inhalational Anthrax

Indicated for treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate

<15 kg: 80 mg/kg IV

≥15 to 50 kg: 60 mg/kg IV

>50 kg: 40 mg/kg IV Administer as a one-time single IV infusion over 2.25 hr

Premedicate with diphenhydramine within 1 hr before infusion

Dosing Considerations

Effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax

There have been no studies of raxibacumab in the pediatric population; dosing in pediatric patients was derived using a population PK approach

Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis; should be used in combination with appropriate antibacterial drugs

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Adverse Effects

1-10%

Rash (3.2%)

Pain in extremity (2.5%)

Pruritus (2.5%)

Somnolence (1.4%)

<1%

Reported at rates higher than placebo

Blood and lymphatic system: Anemia, leukopenia, lymphadenopathy

Cardiac disorders: Palpitations

Ear and labyrinth: Vertigo

General disorders and administration site: Fatigue, infusion site pain, peripheral edema

Investigations: Blood amylase increased, blood creatine phosphokinase increased, prothrombin time prolonged

Musculoskeletal and connective tissue: Back pain, muscle spasms

Nervous system: Syncope vasovagal

Psychiatric: Insomnia

Vascular: Flushing, hypertension

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Warnings

Contraindications

None

Cautions

Infusion reactions (eg, rash, urticaria, pruritus) reported in clinical trials; premedicate with diphenhydramine; slow or interrupt IV infusion and administer treatment based on severity of the reaction

Does not cross the blood-brain barrier and does not prevent or treat meningitis; use in combination with appropriate antibacterial drugs

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Human immunoglobulins are excreted in human milk, published data suggest that neonatal consumption of human milk does not result in substantial absorption of these maternal immunoglobulins into circulation; exposure to breastfeeding infant unknown

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Recombinant human IgG1-gamma monoclonal antibody directed at the protective antigen of Bacillus anthracis

Absorption

Peak Plasma Concentration: 1020.3 mcg/mL

AUC: 15,845.8 mcg•h/mL

Distribution

Vd: 72.92 mL/kg (steady-state); suggests some tissue distribution

Elimination

Half-life: 1.76 days (alpha phase); ~22 days (beta [terminal] phase)

Renal clearance: 2.49 mL/day/kg

Excretion: Minimal in urine

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Administration

IV Compatibilities

0.45% NaCl

0.9% NaCl

IV Preparation

Further dilution required before administering

  • Gently invert the bag/syringe to mix the solution; do not shake
  • Dilute with 0.9% or 0.45% NaCl to final volume of 250 mL for adults and children >31 kg
  • For children, the final infusion volume is weight-based as described below:
  • <1 kg: 7 m
  • 1.1-2 kg: 15 mL
  • 2.1-3 kg: 20 mL
  • 3.1-4.9 kg: 25 mL
  • 5-10 kg: 50 mL
  • 11-30 kg: 100 mL

IV Administration

Infusion rate

  • Adults and children >31 kg: 15 mL/hr IV over initial 20 min, then increase to 125 mL/hr
  • For children, the final infusion rate is weight-based as described below:
  • <1 kg: 7 mL total volume; 0.5 mL/hr IV over initial 20 min, then increase to 3.5 mL/hr
  • 1.1-2 kg: 15 mL total volume; 1 mL/hr IV over initial 20 min, then increase to 7 mL/hr
  • 2.1-3 kg: 20 mL total volume; 1.2 mL/hr IV over initial 20 min, then increase to 10 mL/hr
  • 3.1-4.9 kg: 25 mL total volume; 1.5 mL/hr IV over initial 20 min, then increase to 12 mL/hr
  • 5-10 kg: 50 mL total volume; 3 mL/hr IV over initial 20 min, then increase to 25 mL/hr
  • 11-30 kg: 100 mL total volume; 6 mL/hr IV over initial 20 min, then increase to 50 mL/hr
  • Infusion rate may be slowed or interrupted if signs of adverse reactions, including infusion-associated symptoms occur

Storage

Unopened vials

  • Refrigerate at 2-8°C (36-46°F); DO NOT FREEZE
  • Contains no preservative
  • Protect vial from exposure to light prior to use; brief exposure to light, as with normal use, is acceptable
  • Store vial in original carton until time of use

Diluted to final volume

  • Prepared solution is stable for 3 hr at room temperature
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Formulary

FormularyPatient Discounts

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  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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