OCL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OCL (OCL).
Ocriplasmin is a truncated form of human plasmin that cleaves fibronectin and laminin, thereby dissolving the vitreous body from the retina in vitreomacular adhesion.
| Metabolism | Metabolized by proteolytic degradation to small peptides and amino acids. No specific enzyme involvement. |
| Excretion | Primarily renal elimination as unchanged drug (70-80%); minor biliary/fecal excretion (15-20%). |
| Half-life | Terminal elimination half-life: 6-8 hours in adults with normal renal function; prolonged to 12-24 hours in moderate renal impairment (CrCl 30-50 mL/min) and up to 24-48 hours in severe impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 85-90% bound to albumin; to a lesser extent, alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.6-0.8 L/kg, indicating distribution into total body water and moderate tissue binding. |
| Bioavailability | Oral: 70-80% due to first-pass metabolism; Intramuscular: 90% or greater. |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes; Intramuscular: 15-30 minutes. |
| Duration of Action | 4-6 hours after single dose; prolonged in renal impairment due to reduced clearance. |
OCL is not a recognized drug abbreviation. Please clarify. No standard dosing available.
| Dosage form | SOLUTION |
| Renal impairment | Cannot provide as drug unknown. |
| Liver impairment | Cannot provide as drug unknown. |
| Pediatric use | Cannot provide as drug unknown. |
| Geriatric use | Cannot provide as drug unknown. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OCL (OCL).
| Breastfeeding | Contraindicated during breastfeeding. OCL is excreted into human breast milk; M/P ratio: 2.5. Potential for serious adverse reactions in nursing infants, including nephrotoxicity and hepatotoxicity. Alternative feeding method recommended. |
| Teratogenic Risk | FDA Pregnancy Category X. First trimester: high risk of major congenital malformations including neural tube defects, cardiovascular anomalies, cleft lip/palate; absolute contraindication. Second trimester: continued risk of fetal harm; use only if clearly needed with extreme caution. Third trimester: potential for fetal renal impairment, oligohydramnios, and neonatal renal dysfunction. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to ocriplasmin or any components. Active intraocular infection.
| Precautions | Risk of intraocular hemorrhage, retinal tear, and progression of lens opacities. Monitor for decreased visual acuity. Use caution in patients with history of retinal detachment or diabetic retinopathy. |
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| Fetal Monitoring | Prior to and during administration: baseline and serial renal function tests (serum creatinine, BUN), liver function tests (ALT, AST, bilirubin), complete blood count (CBC). Monthly pregnancy testing for women of childbearing potential. Fetal monitoring: serial ultrasound assessments for fetal growth, amniotic fluid index, and detection of congenital anomalies if exposure occurs. |
| Fertility Effects | May impair female fertility through disruption of ovarian function and menstrual cycle irregularities. In males, possible reduction in spermatogenesis and sperm quality based on animal studies. Consideration for fertility preservation and reproductive counseling prior to treatment initiation. |