Raxibacumab

Indications

Raxibacumab is used for: Inhalational Anthrax

Adult Dose

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

Child Dose

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

Renal Dose

Administration

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

Contra Indications

Hypersensitivity

Precautions

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

Pregnancy-Lactation

Pregnancy There are no data on pregnant women to inform on drug-associated risk; in pregnant rabbits, intravenous administration of raxibacumab was not associated with teratogenicity or other adverse developmental outcomes at 3 times human maximum plasma concentrations at maximum recommended adult dose Limited data in the form of case reports of anthrax infection in pregnant women indicate that maternal infection is associated with high risk of maternal, fetal, and neonatal deaths, particularly in absence of treatment Lactation There is no information available on presence of drug in human milk, effects on breastfed child, or on milk production; maternal IgG is known to be present in human milk; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for raxibacumab and any potential adverse effects on breastfed child from drug or from underlying maternal condition

Interactions

Adverse Effects

Side effects of Raxibacumab : 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

Mechanism of Action

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