Prescription medicine

Raxibacumab

Raxibacumab is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the raxibacumab FDA label on DailyMed (effective January 22, 2026, Emergent BioDefense Operations Lansing); the BLA 125349 record on Drugs@FDA; every raxibacumab label on DailyMed.

Highlights of the record

FDA label of January 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed 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 ).

Used for

From the label: 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.

Forms and strengths

50 mg/ml

Injection.

On the market

Earliest approval on file: December 14, 2012 Raxibacumab, Human Genome Sciences Inc.; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is raxibacumab used for?

From the label: 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. […]

FDA pharmacologic class: Anthrax Protective Antigen-directed Antibody.

Source: FDA drug label (Raxibacumab), BLA125349 (Human Genome Sciences Inc.), as published by Emergent BioDefense Operations Lansing, effective January 22, 2026 (SPL set f6927e91-bb46-47b3-ab66-f9d8a9d7b12a), via openFDA; the full label on DailyMed

What does the patient leaflet for raxibacumab say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about RAXIBACUMAB?
RAXIBACUMAB can cause serious side effects, including: • Serious allergic reactions. Tell your healthcare provider right away if you have any of the following symptoms while receiving RAXIBACUMAB or after receiving RAXIBACUMAB: • rash • hives • itching • chills • chest tightness or shortness of breath • throat tightness or trouble breathing • swelling of the lips, throat, or tongue • feeling dizzy or lightheaded

Is there a generic for raxibacumab?

No generic raxibacumab is approved (Drugs@FDA, October 8, 2026).

2012 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the raxibacumab label say about other medicines?

The raxibacumab label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Ciprofloxacin	drug interactions	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 )].
Diphenhydramine	warnings and precautions	Premedicate with diphenhydramine within 1 hour prior to administering raxibacumab to reduce the risk of occurrence and/or severity of a hypersensitivity reaction [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 )].
Epinephrine	boxed warning	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 )].

Check raxibacumab against other medicines

What next?

Other anthrax protective antigen-directed antibodys: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other