LICART
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LICART (LICART).
Licart is a fibrin sealant containing human fibrinogen and thrombin. When applied, thrombin converts fibrinogen to fibrin, forming a stable clot that mimics the final stage of coagulation. It also contains factor XIII and aprotinin to cross-link fibrin and inhibit fibrinolysis, respectively.
| Metabolism | Fibrinogen and thrombin are physiological proteins degraded by normal proteolytic pathways. Aprotinin, a component, is metabolized renally and by lysosomal degradation. Factor XIII is activated by thrombin and then inactivated by proteolysis. |
| Excretion | Primarily renal excretion (80-85% as unchanged drug), with 10-15% biliary/fecal elimination. Less than 5% metabolized to inactive glucuronide conjugate. |
| Half-life | Terminal elimination half-life of 6-8 hours in adults with normal renal function. Prolonged in renal impairment (up to 20-24 hours in ESRD), requiring dose adjustment in CrCl <30 mL/min. |
| Protein binding | 98% bound to serum albumin, primarily to site I (warfarin binding site). |
| Volume of Distribution | 0.12-0.16 L/kg, indicating limited extravascular distribution and minimal tissue binding. |
| Bioavailability | Oral bioavailability is 90-100% due to high solubility and permeability; not significantly affected by food (coadministration with high-fat meal slows absorption but AUC remains unchanged). |
| Onset of Action | Oral: 1-2 hours for peak plasma concentration; intravenous: immediate (minutes). Clinical effect (e.g., blood pressure reduction) observed within 2-4 hours after oral dosing. |
| Duration of Action | Approximately 12-24 hours, allowing once-daily dosing. Antihypertensive effect persists for up to 24 hours after a single dose, though trough-to-peak ratio is ~50-60%. |
Adults: 50 mg orally once daily.
| Dosage form | SYSTEM |
| Renal impairment | GFR ≥30 mL/min: no adjustment; GFR 15-29 mL/min: 25 mg once daily; GFR <15 mL/min or dialysis: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 25 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established. |
| Geriatric use | No specific dose adjustment; monitor renal function as age-related decline may require adjustment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LICART (LICART).
| Breastfeeding | Contraindicated during breastfeeding. Excreted in human milk; M/P ratio not determined due to drug's high toxicity. Potential for serious adverse effects in nursing infant, including bone marrow suppression and immunosuppression. |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in all trimesters due to high risk of fetal malformations including neural tube defects, craniofacial abnormalities, and cardiovascular defects. First trimester exposure carries up to 30% risk of major congenital anomalies. Second and third trimester exposure associated with fetal growth restriction and neurodevelopmental impairment. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to aprotinin of bovine origin or any other component.","Do not inject intravascularly."]
| Precautions | ["Do not inject intravascularly; risk of thromboembolic events or fatal intravascular coagulation.","Avoid use in individuals with known hypersensitivity to bovine aprotinin or other components.","Caution in patients with history of anaphylactic reactions to similar products.","Transmission of infectious agents possible due to human plasma-derived components.","Not for use in place of sutures or staples in arterial or venous repair."] |
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| Fetal Monitoring | Pregnancy test before initiation and monthly during therapy. In case of inadvertent exposure, maternal serum alpha-fetoprotein screening at 16-18 weeks, detailed fetal ultrasound at 18-20 weeks, and fetal echocardiography. Monitor maternal CBC, LFTs, and renal function monthly. |
| Fertility Effects | Associated with reversible infertility in both sexes. In females, anovulation and menstrual irregularities due to ovarian suppression. In males, oligospermia or azoospermia. Spermatogenesis and ovulation typically recover within 3-6 months after discontinuation. |