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Raxibacumab

Also known as: Raxibacumab

Anthrax Protective Antigen-directed AntibodyAnthrax Protective Antigen-directed Antibody Interactions

Route: Intravenous

2 interactions on record⛔ Black Box Warning

Raxibacumab has 2 known drug interactions based on U.S. FDA drug labeling data. Patients taking Raxibacumab should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Minor: 2

Minor (2)

Raxibacumab + Anthrax Vaccine Adsorbed (Ava)— Co-administration of raxibacumab with AVA did not affect the immunogenicity of the vaccine.
Raxibacumab + Ciprofloxacin— Co-administration of raxibacumab with ciprofloxacin did not alter the pharmacokinetics of either drug.

Raxibacumab + Anthrax Vaccine Adsorbed (Ava)🟢Minor

Co-administration of raxibacumab with AVA did not affect the immunogenicity of the vaccine.

Raxibacumab + Ciprofloxacin🟢Minor

Co-administration of raxibacumab with ciprofloxacin did not alter the pharmacokinetics of either drug.

⛔ FDA Black Box Warning

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 )] . • 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 [see Warnings and Precautions ( 2.3 , 5.1 )] . WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning • Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion ( 5.1 ). • 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 ( 2.3 , 5.1 ).

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy & Breastfeeding

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. general population, the estimated background rate of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Limited data in the form of case reports of anthrax infection in pregnant women indicate that maternal infection is associated with a high risk of maternal, fetal, and neonatal deaths, particularly in the absence of treatment. Data Animal Data: A study was conducted in pregnant, healthy New Zealand White rabbits administered intravenous raxibacumab at dose levels of 40 or 120 mg/kg on Gestation Days 7 and 14. No teratogenicity or other adverse developmental outcomes were observed in pregnant rabbits at 3 times the human maximum plasma concentrations at the maximum recommended adult dose of 40 mg/kg. Maternal toxicity was observed at both doses (reduced body weight gain late in gestation, but no difference in mean total weight gain).

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.