raxibacumab [IV]

Adult Dosing

Inhalational anthrax due to bacillus anthracis

40 mg/kg IV as a single dose infused over 2 hours 15 minutes
Premedicate with diphenhydramine 25-25 mg PO or IV within 1 hour prior to infusion

Pediatric Dosing

Inhalational anthrax due to bacillus anthracis

<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 hours 15 minutes
Premedicate with diphenhydramine within 1 hour prior to infusion

Note:Safety and effectiveness in children <16 years of age not studied. There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using a population PK approach.

Indications ⬆ ⬇

Inhalational anthrax due to bacillus anthracis

Used in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment (Based on CrCl)

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

Therapy may lead to infusion reactions such as rash, urticaria, pruritus. If these reactions occur slow or interrupt infusion and administer treatment based on severity of the reaction
Premedicate with diphenhydramine within 1 hour prior to administering raxibacumab to reduce the risk of infusion reactions

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:B

Breastfeeding: 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, however caution should be exercised when administered to a nursing woman

Adverse Reactions ⬆ ⬇

CNS:Vertigo, fatigue, insomnia, syncope vasovagal, somnolence
GU: Urticaria
GI: Dyspnea
DERM: Rash, pruritus
MUSC: Back pain, muscle spasms, pain in extremity
HEMA: Anemia, leukopenia, lymphadenopathy
CV: Palpitations, hypertension
LAB TESTS: Blood amylase increased, blood creatine phosphokinase increased, prothombin time prolonged
HYPERSENSITIVITY: Infusion site pain, peripheral edema

Clinical Pharmacology ⬆ ⬇

Recombinant monoclonal antibody; binds to the protective antigen PA of B. anthracis
Metabolism: Unknown
Excretion: Minimally in urine
Half-life: Unknown

Brands and Availability ⬆ ⬇

US Trade Name(s)

Only generic available

US Availability

raxibacumab (generic)

PWDR for INJ: 50 mg/mL

Canadian Trade Name(s)

Canadian Availability

UK Trade Name(s)

UK Availability

Australian Trade Name(s)

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Use and Dosing ⬇