IPRIVASK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IPRIVASK (IPRIVASK).
Direct thrombin inhibitor; binds reversibly to the active site of free and clot-bound thrombin, inhibiting fibrin formation and activation of coagulation factors V, VIII, and XIII.
| Metabolism | Primarily renal excretion as unchanged drug; minor hepatic metabolism via hydrolysis and oxidation. |
| Excretion | Renal: 70% as unchanged drug; biliary/fecal: 30% (metabolites and unchanged drug). |
| Half-life | Terminal elimination half-life: 1.5-2.5 hours (prolonged in renal impairment; up to 6 hours in severe impairment). |
| Protein binding | 98-99% bound to antithrombin III and albumin. |
| Volume of Distribution | 0.3-0.5 L/kg (confined to intravascular space; does not cross placenta). |
| Bioavailability | Subcutaneous: 100%. |
| Onset of Action | Subcutaneous: 2-4 hours; Intravenous: immediate (within minutes). |
| Duration of Action | Subcutaneous: 12-24 hours (dose-dependent); Intravenous: 8-12 hours. |
Adults: 1 mg/kg intravenously twice daily.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-50 mL/min: 0.5 mg/kg IV twice daily; GFR <30 mL/min: avoid use. |
| Liver impairment | Child-Pugh A/B: no adjustment; Child-Pugh C: 0.5 mg/kg IV twice daily. |
| Pediatric use | Children: 1 mg/kg (max 50 mg) IV twice daily. |
| Geriatric use | No specific adjustment, but monitor renal function; consider reduced dose 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 IPRIVASK (IPRIVASK).
| Breastfeeding | It is unknown if fondaparinux is excreted in human breast milk. Studies in lactating rats show excretion in milk. M/P ratio not established in humans. Due to potential for serious adverse reactions in nursing infants (bleeding), a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | IPRIVASK (fondaparinux) is a factor Xa inhibitor. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown no evidence of teratogenicity or fetotoxicity at clinically relevant doses. In humans, risk cannot be ruled out. First trimester: limited data, theoretical risk of bleeding. Second and third trimesters: increased risk of hemorrhage, especially during delivery. Use only if clearly needed. |
■ FDA Black Box Warning
Epidural or spinal hematomas may occur in patients anticoagulated with desirudin who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
| Serious Effects |
Active major bleeding; hypersensitivity to desirudin; severe renal impairment (creatinine clearance < 30 mL/min); uncontrolled hypertension; history of intracranial hemorrhage; spinal puncture or neuraxial anesthesia within 24 hours.
| Precautions | Increased risk of bleeding, especially with neuraxial anesthesia; renal impairment (dose adjustment required); elderly patients; history of bleeding disorders; concurrent use of anticoagulants or antiplatelet agents. |
Loading safety data…
| Fetal Monitoring | Monitor maternal bleeding signs, vital signs, and complete blood counts (hemoglobin, hematocrit) periodically. Assess for signs of bleeding or thrombosis. In pregnancy, monitor fetal growth and well-being via ultrasound and antenatal testing as clinically indicated. Monitor coagulation parameters (anti-Xa activity) if needed to assess fondaparinux exposure, though routine monitoring is not typically required. |
| Fertility Effects | No human studies on fertility. In animal studies, there was no effect on fertility or reproductive performance. Theoretical risk: anticoagulant use may affect implantation or placental development due to bleeding risk. |