Dalteparin

Evidence Level: L5

Predicted Indications: 5

Dalteparin

Pharmacist Assessment Report

Dalteparin: low-molecular-weight heparin (factor Xa inhibitor) → thrombophilia due to protein C deficiency, autosomal recessive

One-Sentence Summary

Dalteparin is a low-molecular-weight heparin that potentiates antithrombin and inhibits factor Xa. The TxGNN model predicts it may be relevant to thrombophilia due to protein C deficiency, autosomal recessive, with a score of 0.9988. No clinical trials or publications directly studying this disease are available, so the support is model prediction only.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Thrombophilia due to protein C deficiency, autosomal recessive
TxGNN Prediction Score	0.9988
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (10 of 10) – CDSCO approval status is not included in this data
Number of Listed Products	10 (valid: 10)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Dalteparin is known as a low-molecular-weight heparin: it enhances antithrombin activity and inhibits factor Xa, which reduces clot formation.

Protein C deficiency removes an important natural brake on coagulation and produces a prothrombotic state. An anticoagulant is therefore biologically plausible in this setting, particularly in the severe homozygous form, which can cause purpura fulminans.

This is still only a plausible link. Standard management relies on protein C replacement together with anticoagulation, so any role for dalteparin would need to be defined by a dedicated review. The score is a model output, not clinical proof.

Clinical Trial Evidence

Currently no related clinical trials registered for this disease.

Literature Evidence

Currently no related literature available.

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
62004	Daltehep 5000IU Injection	Vial of 2 ml injection	Not recorded
67971	Daltepin 2500IU Injection	Vial of 1 ml injection	Not recorded
67675	Dalpin 2500IU Injection	Vial of 1 ml injection	Not recorded
65716	Daltepin 10000IU Injection	Vial of 1 ml injection	Not recorded
84330	Fragmin 5000IU Injection	Prefilled syringe of 0.2 ml solution for injection	Not recorded

All 10 licences are single-ingredient products and currently valid; the table lists the first 5.

Safety Considerations

Drug Interactions: 174 interactions are recorded. Major-level examples include acetylsalicylic acid, ibuprofen, ketorolac, fondaparinux, abciximab, acalabrutinib, deferasirox and trastuzumab emtansine. These mostly reflect additive bleeding risk. Moderate-level examples include fluvoxamine, fosinopril, sibutramine and sugammadex.

Package insert warnings and contraindications were not available in the compiled data. Please refer to the package insert for these.

Conclusion and Next Steps

Decision: Hold

Rationale: The mechanism is plausible, but there are no trials or publications for protein C deficiency, so the evidence is limited to model prediction (L5). Established treatment (protein C replacement plus anticoagulation) already exists.

To proceed, the following is needed:

A focused literature review of LMWH use in severe congenital protein C deficiency
Mechanism of action data and package insert warnings and contraindications
Defined dosing and safety considerations for bleeding risk and for patients with renal impairment
Disclaimer

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