ORGARAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ORGARAN (ORGARAN).
Danaparoid is a low molecular weight heparinoid that exerts its anticoagulant effect by inhibiting factor Xa and, to a lesser extent, factor IIa (thrombin) through binding to antithrombin III and heparin cofactor II.
| Metabolism | Primarily renal excretion; partially metabolized by desulfation and depolymerization. Enzyme involvement is not well characterized. |
| Excretion | Renal: 40-50% as unchanged drug; biliary/fecal: minimal; small amount metabolized via desulfation and N-acetylation. |
| Half-life | Terminal elimination half-life: 18-25 hours (mean ~19 hours) in patients with normal renal function; prolonged in renal impairment (up to 30-40 hours in severe renal failure, CrCl <30 mL/min). |
| Protein binding | Highly bound (>95%) primarily to antithrombin III (ATIII) and to a lesser extent to other plasma proteins; binding is rapid and reversible. |
| Volume of Distribution | 0.2-0.4 L/kg; low Vd indicates limited extravascular distribution, mainly confined to plasma volume. |
| Bioavailability | Subcutaneous: approximately 95-100% (nearly complete) after SC administration; intravenous: 100%. |
| Onset of Action | Subcutaneous: 2-4 hours for anti-Xa activity; intravenous: immediate for therapeutic anticoagulation. |
| Duration of Action | Subcutaneous: 12-16 hours; duration of anticoagulant effect correlates with anti-Xa activity; monitoring recommended in renal impairment due to accumulation. |
Adults: Initial intravenous bolus of 2500 IU (anti-Xa), followed by continuous intravenous infusion of 400 IU/h for 2 hours, then 300 IU/h for 2 hours, then 200 IU/h for 5 days; or subcutaneous injection of 750 IU twice daily. Dose adjusted to maintain anti-Xa levels of 0.5-1.0 IU/mL.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: Contraindicated. GFR 30-50 mL/min: Reduce dose by 25-50% and monitor anti-Xa levels. GFR >50 mL/min: No adjustment required. |
| Liver impairment | Child-Pugh Class B or C: Caution, reduce initial dose by 25-50% and monitor anti-Xa levels. No specific data for Class A. |
| Pediatric use | Safety and efficacy not established; use not recommended under 18 years of age. |
| Geriatric use | Elderly patients (≥65 years) may have increased risk of bleeding; consider dose reduction by 25% and monitor anti-Xa levels closely, especially those with renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ORGARAN (ORGARAN).
| Breastfeeding | It is not known whether danaparoid is excreted in human milk. M/P ratio not available. Because many drugs are excreted in milk, caution should be exercised when administered to a nursing woman. |
| Teratogenic Risk | Danaparoid (ORGARAN) is a low molecular weight heparinoid. Animal studies have not demonstrated teratogenic effects, and there are no adequate well-controlled studies in pregnant women. However, it should be used during pregnancy only if clearly needed. First trimester: no evidence of increased risk. Second and third trimesters: exposure may be associated with maternal bleeding risks but not specific fetal malformations. |
■ FDA Black Box Warning
Risk of spinal/epidural hematoma in patients receiving neuraxial anesthesia or spinal puncture, which can result in long-term or permanent paralysis.
| Serious Effects |
["Active major bleeding","History of heparin-induced thrombocytopenia (HIT) or hypersensitivity to danaparoid or pork products","Severe hemorrhagic diathesis","Concurrent neuraxial anesthesia without consideration of risk"]
| Precautions | ["Increased risk of bleeding with recent surgery, trauma, or hemorrhagic conditions","Do not use interchangeably with heparin or low molecular weight heparins","Monitor renal function; dose adjustment required in severe renal impairment","May cause hypersensitivity reactions including anaphylaxis"] |
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| Fetal Monitoring | Monitor maternal signs of bleeding (e.g., hemoglobin, hematocrit, occult blood). Monitor platelet count periodically due to potential for thrombocytopenia. Fetal monitoring should include standard prenatal assessments; growth and wellbeing monitoring if maternal condition warrants. |
| Fertility Effects | There are no data on the effects of danaparoid on human fertility. Animal studies have not revealed impaired fertility. |