Brand Name
Raxibacumab
View Brand InformationFDA approval date: December 14, 2012
Classification: Anthrax Protective Antigen-directed Antibody
Form: Injection
What is Raxibacumab?
Raxibacumab is indicated for the treatment of adult and pediatric patients with 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.
Approved To Treat
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Brand Information
Raxibacumab (raxibacumab)
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
- Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion
- Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available
1DOSAGE FORMS AND STRENGTHS
Injection: 1,700 mg/34 mL (50 mg/mL) solution in a single-use vial.
2CONTRAINDICATIONS
None.
3OVERDOSAGE
There is no clinical experience with overdosage of raxibacumab. In case of overdosage, monitor patients for any signs or symptoms of adverse effects.
4DESCRIPTION
Raxibacumab is a human IgG1λ monoclonal antibody that binds the PA component of
Raxibacumab is supplied as a sterile, preservative-free, clear to opalescent, colorless to pale yellow liquid formulation in single-use vials for intravenous infusion. Each vial contains 1,700 mg/34 mL (50 mg/mL) raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), sucrose (10 mg/mL), and Water for Injection, with a pH of 6.5.
5CLINICAL STUDIES
Because it is not feasible or ethical to conduct controlled clinical trials in humans with inhalational anthrax, the effectiveness of raxibacumab for therapeutic treatment of inhalational anthrax is based on efficacy studies in rabbits and monkeys. Raxibacumab effectiveness has not been studied in humans. Because the animal efficacy studies are conducted under widely varying conditions, the survival rates observed in the animal studies cannot be directly compared between studies and may not reflect the rates observed in clinical practice.
The efficacy of raxibacumab for treatment of inhalational anthrax was studied in a monkey model (Study 2) and a rabbit model (Studies 3 and 4) of inhalational anthrax disease. These 3 studies tested raxibacumab efficacy compared with placebo. Another study in a rabbit model (Study 1) evaluated the efficacy of raxibacumab in combination with an antibacterial drug relative to the antibacterial drug alone. Studies were randomized and blinded.
The animals were challenged with aerosolized
5.1Treatment of Inhalational Anthrax in Combination with Antibacterial Drug
The efficacy of raxibacumab administered with levofloxacin as treatment of animals with systemic anthrax disease (84 hours after spore challenge) was evaluated in New Zealand White rabbits (Study 1). The dose of levofloxacin was chosen to yield a comparable exposure to that achieved by the recommended doses in humans. Levofloxacin and raxibacumab PK in this study were unaffected by product co-administration. Forty-two percent of challenged animals survived to treatment. Treatment with antibacterial drug plus raxibacumab resulted in 82% survival compared with 65% survival in rabbits treated with antibacterial drug alone,
5.2Post-Exposure Prophylaxis/Early Treatment of Inhalational Anthrax
Monkey Study 2 and rabbit Studies 3 and 4 evaluated treatment with raxibacumab alone at an earlier time point after exposure than rabbit Study 1. Treatment with raxibacumab alone resulted in a statistically significant dose-dependent improvement in survival relative to placebo when administered at the time of initial manifestations of anthrax disease in the rabbit and monkey infection models (
In other animal studies evaluating antibacterial drug alone and raxibacumab-antibacterial drug combination, the efficacy of an antibacterial drug alone (levofloxacin in rabbits and ciprofloxacin in monkeys) was very high (95% to 100%) when given at the initial manifestations of inhalational anthrax disease. The timing of treatment was similar to that reported for Studies 2, 3, and 4 above.
In another study, rabbits were exposed to 100 times LD
6HOW SUPPLIED/STORAGE AND HANDLING
Raxibacumab is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution supplied in single-use vials containing 1,700 mg/34 mL (50 mg/mL) raxibacumab and is available in the following packaging configuration:
Single Unit Carton: Contains one single-use vial of raxibacumab 1,700 mg/34 mL (NDC 71655-103-01).
Raxibacumab must be refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Protect the 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.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).