RUBY-FILL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RUBY-FILL (RUBY-FILL).
RUBY-FILL is a direct-acting anticoagulant that inhibits thrombin (Factor IIa) via reversible, competitive binding to the active site, thereby preventing fibrin formation and clot propagation.
| Metabolism | Primarily metabolized via CYP3A4 and CYP2D6, with minor contribution from CYP2C19 and CYP2C9. Undergoes glucuronidation and renal excretion of unchanged drug. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 30-40% of elimination; biliary/fecal elimination accounts for 50-60%, with the remainder metabolized. |
| Half-life | Terminal elimination half-life is 12-18 hours in patients with normal renal and hepatic function; may be prolonged in renal impairment (up to 30 hours) or hepatic dysfunction. |
| Protein binding | Approximately 90-95% bound to serum albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8-1.2 L/kg, indicating extensive extravascular distribution and tissue binding. |
| Bioavailability | Oral: 60-75% due to first-pass metabolism; Intravenous: 100%. |
| Onset of Action | Oral: 1-2 hours; Intravenous: within 5-10 minutes. |
| Duration of Action | Oral: 8-12 hours; Intravenous: 4-6 hours. Duration may be extended in patients with impaired clearance. |
100 mg orally twice daily, with or without food.
| Dosage form | SOLUTION |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59 mL/min: reduce to 100 mg once daily; GFR <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce to 100 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | 2 mg/kg orally twice daily, maximum 100 mg per dose; not established for children <2 years. |
| Geriatric use | No specific adjustment; monitor renal function due to age-related decline; consider starting at 100 mg once daily if GFR <60 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RUBY-FILL (RUBY-FILL).
| Breastfeeding | RubY-FILL is excreted in human milk; M/P ratio is 0.3. Infant exposure is estimated at 2% of maternal weight-adjusted dose. Caution advised; monitor infant for diarrhea, rash, and growth. |
| Teratogenic Risk | No data available on teratogenic risk for RUBY-FILL in pregnant women. Based on animal studies, potential for fetal harm cannot be ruled out. Avoid use in first trimester unless benefit outweighs risk. Second and third trimester exposure may affect fetal growth and development. |
| Fetal Monitoring |
■ FDA Black Box Warning
WARNING: EPIDURAL OR SPINAL HEMATOMAS. Risk of spinal/epidural hematoma with neuraxial anesthesia or spinal puncture, resulting in long-term or permanent paralysis. Monitor for signs/symptoms of neurological impairment.
| Serious Effects |
Active major bleeding; history of heparin-induced thrombocytopenia; hypersensitivity to RUBY-FILL; severe renal impairment (CrCl < 15 mL/min); concomitant use with strong CYP3A4 and CYP2D6 inhibitors; pregnancy and lactation (relative).
| Precautions | Risk of bleeding; discontinue prior to surgery or invasive procedures; monitor renal function; caution with concomitant antiplatelet agents/NSAIDs; increased risk in elderly patients; use with caution in hepatic impairment; avoid in severe renal impairment (CrCl < 15 mL/min). |
Loading safety data…
| Monitor maternal blood pressure, renal function, and liver enzymes every 4 weeks. Fetal ultrasound for growth and amniotic fluid volume every 4-6 weeks. Non-stress test starting at 32 weeks gestation. |
| Fertility Effects | RubY-FILL may reduce fertility in females and males based on animal studies. Reversible after discontinuation. Clinical relevance in humans unknown. |