Raxibacumab
Generic Name: raxibacumab
Brand Names:
Raxibacumab
11 DESCRIPTION Raxibacumab is a human IgG1λ monoclonal antibody that binds the PA component of B. anthracis toxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system. Raxibacumab is supplied as a sterile, preservative-free, clear to opalescent, colorless to pale yellow liquid formulation in single-use vials for intravenous infusion.
Overview
11 DESCRIPTION Raxibacumab is a human IgG1λ monoclonal antibody that binds the PA component of B. anthracis toxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system. Raxibacumab is supplied as a sterile, preservative-free, clear to opalescent, colorless to pale yellow liquid formulation in single-use vials for intravenous infusion.
Uses
1 INDICATIONS AND USAGE 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. ( 1.1 ) Limitations of Use: The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. ( 1.2 , 14.1 ) There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. ( 1.2 , 8.4 ) Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis.
Dosage
2 DOSAGE AND ADMINISTRATION Premedicate with diphenhydramine. ( 2.1 , 2.2 , 5.1 ) Dilute and administer as an intravenous infusion over 2 hours and 15 minutes. ( 2.3 ) - Adults: 40 mg/kg raxibacumab. ( 2.1 ) - Pediatrics greater than 40 kg: 40 mg/kg raxibacumab. ( 2.2 ) - Pediatrics greater than 10 kg to 40 kg: 60 mg/kg raxibacumab. ( 2.2 ) - Pediatrics 10 kg or less: 80 mg/kg raxibacumab. ( 2.2 ) 2.1 Dose and Schedule for Adults Administer raxibacumab as a single dose of 40 mg/kg intravenously over 2 hours and 15 minutes after dilution in 0.9% Sodium Chloride Injection, USP (normal saline) to a final volume of 250 mL. Administer 25 to 50 mg diphenhydramine within 1 hour prior to the raxibacumab infusion to reduce the risk of occurrence and/or the severity of an infusion reaction.
Side Effects
6 ADVERSE REACTIONS Common adverse reactions in healthy adult subjects (≥1.5%) were injection site reaction, erythema and pain, headache, rash, pain in extremity, pruritus, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of raxibacumab has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax.
Interactions
7 DRUG INTERACTIONS 7.1 Ciprofloxacin Co-administration of 40 mg/kg raxibacumab intravenously with intravenous or oral ciprofloxacin in human subjects did not alter the PK of either ciprofloxacin or raxibacumab [see Clinical Pharmacology ( 12.3 )] . 7.2 Anthrax Vaccine Adsorbed (AVA) Co-administration of 40 mg/kg raxibacumab intravenously (Day 1) with a SC AVA regimen (Days 1, 15, and 29) did not affect the immunogenicity of AVA [see Clinical Pharmacology ( 12.3 )].
Warnings
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . 5 WARNINGS AND PRECAUTIONS Hypersensitivity and Anaphylaxis: ( Boxed Warning , 2.1 , 2.3 , 5.1 , 6.1 ) 5.1 Hypersensitivity and Anaphylaxis Hypersensitivity reactions including rash, urticaria, pruritus, chills, chest and throat tightness, lip and throat swelling, and hypotension were reported in 27 (4.5%) of 606 healthy subjects during or after the administration of raxibacumab in clinical trials. Two subjects experienced anaphylaxis during the raxibacumab infusion [see Adverse Reactions ( 6.1 )] . Some subjects with hypersensitivity or anaphylaxis required interruption or discontinuation of the raxibacumab infusion as well as additional appropriate treatment that included steroids, diphenhydramine, H2 blockers, and/or intravenous fluids [see Adverse Reactions ( 6.1 )] . 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no data on the use of raxibacumab in 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 the human maximum plasma concentrations at the maximum recommended adult dose (see Data) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
Storage
16 HOW 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).
Frequently Asked Questions
What is Raxibacumab used for?▼
1 INDICATIONS AND USAGE 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. ( 1.1 ) Limitations of Use: The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. ( 1.2 , 14.1 ) There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. ( 1.2 , 8.4 ) Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis.
What are the side effects of Raxibacumab?▼
6 ADVERSE REACTIONS Common adverse reactions in healthy adult subjects (≥1.5%) were injection site reaction, erythema and pain, headache, rash, pain in extremity, pruritus, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of raxibacumab has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax.
Can I take Raxibacumab during pregnancy?▼
8.1 Pregnancy Risk Summary There are no data on the use of raxibacumab in 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 the human maximum plasma concentrations at the maximum recommended adult dose (see Data) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
What are the important warnings for Raxibacumab?▼
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . 5 WARNINGS AND PRECAUTIONS Hypersensitivity and Anaphylaxis: ( Boxed Warning , 2.1 , 2.3 , 5.1 , 6.1 ) 5.1 Hypersensitivity and Anaphylaxis Hypersensitivity reactions including rash, urticaria, pruritus, chills, chest and throat tightness, lip and throat swelling, and hypotension were reported in 27 (4.5%) of 606 healthy subjects during or after the administration of raxibacumab in clinical trials. Two subjects experienced anaphylaxis during the raxibacumab infusion [see Adverse Reactions ( 6.1 )] . Some subjects with hypersensitivity or anaphylaxis required interruption or discontinuation of the raxibacumab infusion as well as additional appropriate treatment that included steroids, diphenhydramine, H2 blockers, and/or intravenous fluids [see Adverse Reactions ( 6.1 )] . 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.