Cyclosporine

Evidence Level: L5

Predicted Indications: 7

Cyclosporine

Pharmacist Assessment Report

Cyclosporine: Calcineurin inhibitor (T-cell immunosuppressant) → Granulomatous disease, chronic, autosomal recessive

One-Sentence Summary

Cyclosporine is a calcineurin inhibitor that suppresses T-cell activation and is marketed in Canada in several oral, injectable and ophthalmic products. The TxGNN model predicts it may be effective for granulomatous disease, chronic, autosomal recessive, with a score of 0.9968. There are currently 0 clinical trials and 1 publication linked to this prediction, and that publication does not study cyclosporine as a treatment for the disease.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	granulomatous disease, chronic, autosomal recessive
TxGNN Prediction Score	0.9968
Evidence Level	L5
Canada Market Status	Marketed (marketed DINs: 14 of 14)
Number of DINs	14 (marketed: 14)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. From general pharmacology, cyclosporine is a calcineurin inhibitor that blocks NFAT-dependent T-cell activation.

In chronic granulomatous disease (CGD), the immune system shows dysregulated, excessive inflammation, so suppressing T-cell activity could theoretically dampen this inflammation. This remains a hypothesis only.

The only linked publication reports outcomes of stem cell transplantation in CGD. Calcineurin inhibitors are likely used there to prevent graft-versus-host disease, but this gives context only and does not show that cyclosporine treats CGD. The high score is a model prediction without clinical validation. Because no cited study directly examines cyclosporine in this disease, the evidence level is L5.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
22078471	2012	Cohort	The Journal of allergy and clinical immunology	Reports survival after sibling or unrelated donor stem cell transplantation in CGD; does not evaluate cyclosporine as a treatment for CGD

Canada Market Information

DIN	Product Name	Dosage Form	Approved Indication
02355655	RESTASIS	Not recorded	Not recorded
02242821	SANDOZ CYCLOSPORINE	Not recorded	Not recorded
02512629	CEQUA	Not recorded	Not recorded
02484137	VERKAZIA	Not recorded	Not recorded
02150697	NEORAL	Not recorded	Not recorded

All 14 single-ingredient licences in Canada are valid. Only the first five are listed here.

Safety Considerations

Drug Interactions: 100 interactions were recorded. Examples include a major interaction with loperamide, and moderate interactions with rabeprazole, hydrocortisone, dexamethasone, betamethasone, budesonide, amphotericin B, aprepitant, bupropion, metronidazole and acetylsalicylic acid.
Conditions of concern in related records: Hypertension, kidney disease, liver disease, epilepsy, infectious disease, and cancers including lymphoma are listed as conditions where cyclosporine is a concern. These are not taken from label text and should be checked against the package insert.

Please refer to the package insert for full safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has a high model score but no clinical trials and no study of cyclosporine in CGD. The sole linked publication concerns stem cell transplantation, so the mechanistic argument is speculative.

To proceed, the following is needed:

Mechanism of action data and a clear rationale for T-cell suppression in CGD
Preclinical or case-level evidence of cyclosporine’s effect in CGD
Review of the Health Canada package insert for warnings and contraindications
A safety assessment for a population with CGD that is prone to infection, given the immunosuppression and the interaction profile
Disclaimer

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