KALBITOR
KALBITOR (ecallantide) is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE). The medication is approved for use in adult and pediatric patients 12 years of age and older. It serves as a therapeutic intervention to manage the localized swelling, inflammation, and pain that characterize acute episodic attacks of this genetic condition.
How KALBITOR Works
In patients with hereditary angioedema, unregulated plasma kallikrein activity results in the excessive generation of bradykinin, a vasodilator responsible for localized swelling and pain. KALBITOR functions as a selective and reversible inhibitor that binds to plasma kallikrein and blocks its binding site. This action prevents the protease from converting high molecular weight (HMW) kininogen into bradykinin. By directly inhibiting this process, the drug reduces bradykinin levels to treat symptoms during acute episodic attacks.
Details
- Status
- Prescription
- First Approved
- 2009-12-01
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KALBITOR Approval History
What KALBITOR Treats
1 indicationsKALBITOR is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hereditary Angioedema
KALBITOR Boxed Warning
ANAPHYLAXIS Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hyperse...
WARNING: ANAPHYLAXIS Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR. [ see Contraindications (4) , Warnings and Precautions (5.1) , and Adverse Reactions (6) ] WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning Anaphylaxis has been reported after administration of KALBITOR ® . Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR [ see Contraindications (4) , Warnings and Precautions (5.1) , and Adverse Reactions (6) ].
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KALBITOR FDA Label Details
ProIndications & Usage
FDA Label (PDF)KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
WARNING: ANAPHYLAXIS Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.