Enoxaparin

Evidence Level: L5 Predicted Indications: 1

Table of Contents

  1. Enoxaparin
  2. Enoxaparin: From Pulmonary Embolism and Related Coagulation Disorders to Protein C Deficiency Thrombophilia
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. New Zealand Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Enoxaparin: From Pulmonary Embolism and Related Coagulation Disorders to Protein C Deficiency Thrombophilia

One-Sentence Summary

Enoxaparin is a low-molecular-weight heparin, originally used for 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 there are currently 0 clinical trials and 0 publications supporting this direction, so the prediction rests on the model score and mechanistic reasoning alone.

Quick Overview

Item Content
Original Indication Pulmonary embolism, disseminated intravascular coagulation, purpura fulminans (from the knowledge graph; no approved indication text is available from New Zealand licences)
Predicted New Indication Thrombophilia due to protein C deficiency, autosomal recessive
TxGNN Prediction Score 99.58%
Evidence Level L5
New Zealand Market Status Cancelled only (all licences cancelled)
Number of Authorizations 7 (0 currently valid)
Recommended Decision Hold

Why is This Prediction Reasonable?

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 potentiates antithrombin and mainly inhibits factor Xa (and, to a lesser degree, thrombin). Its target interaction recorded here is with antithrombin (SERPINC1).

Severe congenital protein C deficiency causes uncontrolled thrombin generation, leading to thrombosis and purpura fulminans. Enoxaparin's existing graph-based indications (purpura fulminans and disseminated intravascular coagulation) share this pathophysiology, so anticoagulation is biologically plausible.

This link is inferred only from mechanism and the model prediction. Standard care for this condition is generally protein C replacement (concentrate or plasma) plus anticoagulation. Any role for enoxaparin would therefore likely be adjunctive or for long-term prophylaxis, which the available data cannot confirm.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

New Zealand Market Information

All seven licences are cancelled; none is currently valid. Approved indication text is not available for any of them.

Authorization Number Product Name Dosage Form Status
2581922 Clexane Forte Inj 150 mg in 1 ml syringe Cancelled
2581892 Clexane Inj 80 mg in 0.8 ml syringe Cancelled
2581906 Clexane Inj 100 mg in 1 ml syringe Cancelled
2581876 Clexane Inj 40 mg in 0.4 ml syringe Cancelled
2581884 Clexane Inj 60 mg in 0.6 ml syringe Cancelled

Two further cancelled licences (Clexane 20 mg in 0.2 ml, 2581868; Clexane Forte 120 mg in 0.8 ml, 2581914) are not listed above.

Safety Considerations

  • Contraindications (from the knowledge graph, not label text): The graph links enoxaparin to the following conditions as contraindications:
    • Bleeding and coagulation: intracranial or intracerebral hemorrhage, placental abruption, hemophilia, blood coagulation disease, Glanzmann thrombasthenia, qualitative platelet defect
    • Platelet and haematological: thrombocytopenia, heparin-induced thrombocytopenia, hematologic disease, antithrombin III deficiency
    • Hepatic and gastrointestinal: liver failure, active peptic ulcer disease, ulcerative colitis, inflammatory bowel disease, biliary tract disease, obstructive jaundice
    • Eye and cardiovascular: retinal disease, retinitis, diabetic retinopathy, diabetic cataract, hypertensive retinopathy, infective endocarditis (including subacute bacterial endocarditis), arteriosclerosis obliterans
    • Bone: osteoporosis, postmenopausal osteoporosis
  • Drug Interactions: The only recorded interaction is pharmacological, with the target serpin family C member 1 (antithrombin, SERPINC1). No drug-drug interaction data are available.

Please refer to the package insert for authoritative warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction score is high (99.58%) and the mechanism is plausible, but there are no clinical trials or literature for this indication (Evidence Level L5). Standard care is protein C replacement, and all New Zealand licences are cancelled, which limits feasibility.

To proceed, the following is needed:

  • Literature and trial searches specific to enoxaparin in congenital protein C deficiency (case series, registries, guidelines)
  • Detailed mechanism of action data
  • Package insert warnings and contraindications from Medsafe, which are required for safety screening
  • Clarification of the cancelled licence status and whether a supply route exists in New Zealand
  • Assessment of enoxaparin's role relative to, or alongside, protein C replacement therapy

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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