Alteplase

Evidence Level: L5

Predicted Indications: 6

Alteplase

Pharmacist Assessment Report

Alteplase: recombinant tissue plasminogen activator (thrombolytic) → Heparin cofactor 2 deficiency

One-Sentence Summary

Alteplase is a clot-dissolving (thrombolytic) injectable that is currently marketed in India under two valid licences. The TxGNN model predicts it may be useful for heparin cofactor 2 deficiency, but no clinical trials and no publications were found for this indication, so the prediction rests on the model score alone.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Heparin cofactor 2 deficiency
TxGNN Prediction Score	0.9972
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (2 of 2) – CDSCO approval status is not included in this data
Number of Listed Products	2 (valid: 2)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Alteplase belongs to the tissue plasminogen activator class. As a class, these drugs convert plasminogen to plasmin, which breaks down fibrin clots.

Heparin cofactor II deficiency is a hereditary thrombophilia, a condition that raises the risk of blood clots. In principle, alteplase could be used as a symptomatic treatment to dissolve an acute clot in such a patient. It would not correct the underlying deficiency, so it would not be disease-modifying.

No trials or literature were available for this specific condition. The case for this prediction therefore rests on mechanistic reasoning and the model score only.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
Registration No. 393	Actilyse 50mg Injection	Vial of 1 injection	Not recorded in the local data
Registration No. 1276	Actilyse 20mg Injection	Bottle of 20 ml injection	Not recorded in the local data

Both licences are for the single-ingredient product, are currently valid, and are held by Boehringer Ingelheim.

Safety Considerations

Drug Interactions: The data compiled for this report list 140 interacting drugs. The entries shown include several rated Major, mostly agents that affect clotting or bleeding:
- Abciximab
- Fondaparinux
- Apixaban
- Anisindione
- Acalabrutinib
- Deferasirox
- Ibritumomab tiuxetan
- Tositumomab
Moderate-level interactions include acetylsalicylic acid, ibuprofen, ketorolac, fluvoxamine, fosinopril, aminocaproic acid and aprotinin.

Please refer to the package insert for warnings and contraindications, as no label-based safety text was available.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has no supporting clinical trials or publications (Evidence Level L5). Even if it were valid, alteplase would only treat acute clots symptomatically and would not address the underlying deficiency. Bleeding risk and the many anticoagulant and antiplatelet interactions are further concerns.

To proceed, the following is needed:

Clinical or case-level evidence of alteplase use in patients with this deficiency
Detailed mechanism of action data
Package insert warnings and contraindications from the India licence holder
A bleeding-risk and concomitant-anticoagulant management plan
Disclaimer

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