KALBITOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KALBITOR (KALBITOR).
Competitive inhibition of plasma kallikrein, thereby reducing bradykinin production.
| Metabolism | Primarily hepatic via various peptidases; not significantly metabolized by CYP450 enzymes. |
| Excretion | Renal: 65–90% as unchanged drug; fecal: <5% |
| Half-life | Terminal half-life: 2.0 hours (range 1.8–2.5 h), allowing twice-daily dosing for hereditary angioedema prophylaxis |
| Protein binding | 96–98% bound to albumin (primary) and α1-acid glycoprotein |
| Volume of Distribution | 0.14 L/kg (approximate total body water), indicating limited extravascular distribution |
| Bioavailability | Subcutaneous: 100% (absolute) |
| Onset of Action | Subcutaneous: 15–30 minutes (clinical effect on acute attacks); intravenous: immediate |
| Duration of Action | Subcutaneous: 12 hours (symptom relief). Intravenous: 4–6 hours (plasma kallikrein inhibition) |
60 mg subcutaneously three times a week
| Dosage form | INJECTABLE |
| Renal impairment | No adjustment required per manufacturer; caution in severe renal impairment (GFR <30 mL/min) due to limited data. |
| Liver impairment | No adjustment required per manufacturer; caution in severe hepatic impairment (Child-Pugh class C) due to limited data. |
| Pediatric use | Safety and efficacy not established; no approved pediatric dosing. |
| Geriatric use | No specific dose adjustment; use same dosing as adults, monitor renal function due to age-related decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KALBITOR (KALBITOR).
| Breastfeeding | Unknown if excreted in human breast milk. Caution recommended. M/P ratio not available. |
| Teratogenic Risk | Limited human data; animal studies show no teratogenic effects at doses up to 10 times the human exposure. No known fetal risk in first, second, or third trimester. However, use only if clearly needed. |
| Fetal Monitoring | Monitor for hypersensitivity reactions, including anaphylaxis. No specific fetal monitoring required. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to ecallantide or any of its excipients."]
| Precautions | ["Hypersensitivity reactions including anaphylaxis have been reported.","Administer only by healthcare professional due to risk of severe hypersensitivity."] |
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| Fertility Effects | No known effects on fertility in animal studies. Human data not available. |