Enoxaparin
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Enoxaparin: From Pulmonary Embolism to Thrombophilia due to Protein C Deficiency
One-Sentence Summary
Enoxaparin is a low-molecular-weight heparin originally used for thromboembolic conditions such as pulmonary embolism, disseminated intravascular coagulation and purpura fulminans. The TxGNN model predicts it may be effective for thrombophilia due to protein C deficiency (autosomal recessive), but currently there are 0 clinical trials and 0 publications directly supporting this prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Pulmonary embolism, disseminated intravascular coagulation, purpura fulminans (from the knowledge graph; no approved indication text is available in the Singapore licences) |
| Predicted New Indication | Thrombophilia due to protein C deficiency, autosomal recessive |
| TxGNN Prediction Score | 99.58% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 12 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known information, enoxaparin is a low-molecular-weight heparin that inhibits factor Xa and thrombin through antithrombin. Its efficacy in thrombotic conditions is established, and mechanistically it may be applicable to protein C deficiency.
Protein C deficiency is a prothrombotic state in which the body's natural anticoagulant pathway is impaired. Anticoagulation is therefore plausible for preventing and treating thrombosis in this setting. This also resembles purpura fulminans, an existing enoxaparin-related indication that is a known complication of severe protein C deficiency.
However, no trials or literature were retrieved for this prediction. The high TxGNN score (0.996) is a model prediction only and has not been verified by clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
Twelve valid single-ingredient registrations exist. The five main ones are listed below. No approved indication text is recorded for these licences.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN07668P | CLEXANE Injection 2000 IU (20 mg)/0.2 ml | Injection | Not recorded |
| SIN14095P | CLEXANE Injection 4000 IU (40 mg)/0.4 ml | Injection | Not recorded |
| SIN14096P | CLEXANE Injection 6000 IU (60 mg)/0.6 ml | Injection | Not recorded |
| SIN16331P | INHIXA Solution for Injection 8000 Anti-Xa IU (80 mg)/0.8 ml | Injection, solution | Not recorded |
| SIN17086P | Enoxaparin Sandoz Solution for Injection in Pre-filled Syringe 6,000 IU (60 mg)/0.6 ml | Injection, solution | Not recorded |
Safety Considerations
- Contraindications suggested by the knowledge graph (not label text): liver failure, thrombocytopenia (including heparin-induced thrombocytopenia), haematologic and blood coagulation diseases, haemophilia, antithrombin III deficiency, Glanzmann thrombasthenia and other qualitative platelet defects, intracranial/intracerebral haemorrhage, placental abruption, active peptic ulcer disease, infective endocarditis, inflammatory bowel disease/ulcerative colitis, biliary tract disease/obstructive jaundice, osteoporosis, and several retinal diseases (diabetic, hypertensive retinopathy, retinitis).
- Drug Interactions: 100 interactions were identified; the sample reviewed includes these Major interactions:
- Antiplatelet and NSAID agents: acetylsalicylic acid, ketorolac, ibuprofen, abciximab
- Thrombolytic: alteplase
- Other agents: deferasirox, acalabrutinib, trastuzumab emtansine, ibritumomab tiuxetan, tositumomab (including I-131)
- Moderate interactions include fenfluramine, dexfenfluramine, sibutramine, sugammadex, aliskiren, radioactive iodide (I-123, I-131) and topical diclofenac.
Most of these combinations increase bleeding risk.
Please also refer to the package insert for full safety information, as label warnings and contraindications were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is mechanistically plausible, because anticoagulation is used in protein C deficiency. However, there are no trials or literature for it, so the evidence level is L5 (model prediction only). The label safety data were also unavailable.
Other predicted indications were reviewed and also remain at Hold. Several are mechanistically doubtful or potentially harmful, such as primary platelet release disorder, pseudo-von Willebrand disease and the retinal conditions, where bleeding risk is a concern. Thrombotic thrombocytopenic purpura and vertebral artery occlusion have only indirect case-level literature (L4).
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA, to complete safety screening
- Detailed mechanism of action data
- Clinical studies or guideline evidence on enoxaparin in protein C deficiency, including dosing and monitoring in this population
- A bleeding-risk assessment, given the major interactions and the knowledge-graph contraindications above
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.