OCL
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 361.35 |
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 | No adequate studies in humans; animal studies show adverse effects. Use only if potential benefit justifies potential risk to fetus. |
| 2nd trimester | May cause fetal harm; avoid use unless no safer alternative. |
| 3rd trimester | May cause neonatal toxicity; avoid use near term. |
Clinical note
Comprehensive clinical and safety monograph for OCL (OCL).
| Placental transfer | Crosses placenta; concentration in fetal plasma approximately 50-80% of maternal levels. |
| Breastfeeding | Not recommended; may cause adverse effects in nursing infant. Use alternative therapy. |
| Lactation Rating | L5 - Contraindicated |
| 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. |
| 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. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to drug or excipientsBreastfeedingPregnancy
| 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. |
| Food/Dietary | No significant food interactions. Grapefruit juice may slightly increase estrogen levels but is not a contraindication. Avoid St. John's wort, which can reduce contraceptive efficacy. |
| Clinical Pearls | OCL (oral contraceptive levonorgestrel/ethinyl estradiol) is a combined hormonal contraceptive. Monitor for thromboembolic events, especially in smokers over 35. Counsel on breakthrough bleeding and missed pill management. Advise use of backup contraception during first 7 days of initiation. |
| Patient Advice | Take one pill daily at the same time, preferably in the evening to minimize nausea. · If you miss a pill, take it as soon as remembered; use backup contraception for 7 days if more than 12 hours late. · Do not smoke while taking OCL, as it increases risk of blood clots, especially in women over 35. · Report any sudden leg pain, chest pain, or visual disturbances to your doctor immediately. · OCL does not protect against sexually transmitted infections. |
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