Cyclosporine
| Evidence Level: L5 | Predicted Indications: 7 |
Table of Contents
- Cyclosporine
- Pharmacist Assessment Report
- Cyclosporine: calcineurin inhibitor immunosuppressant → granulomatous disease, chronic, autosomal recessive
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Cyclosporine: calcineurin inhibitor immunosuppressant → granulomatous disease, chronic, autosomal recessive
One-Sentence Summary
Cyclosporine is a calcineurin inhibitor that suppresses T-cell activation and is widely used as an immunosuppressant. The TxGNN model predicts it may be relevant to granulomatous disease, chronic, autosomal recessive, but the only supporting item is 1 publication (a stem cell transplantation cohort study), with no clinical trials registered.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| 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 pharmacology, cyclosporine inhibits calcineurin and thereby suppresses T-cell activation. It is used in transplant immunosuppression and prevention of graft-versus-host disease (GVHD).
The only publication linked to this prediction (PMID 22078471) concerns stem cell transplantation for chronic granulomatous disease (CGD). Cyclosporine is plausibly part of the transplant or GVHD-prophylaxis regimen in such patients, but the abstract provided does not state this. This would be an indirect, supportive-care role, not treatment of the underlying defect in the NADPH oxidase enzyme that causes CGD. No direct therapeutic mechanism against CGD has been established.
Because the cited study is about transplantation as a treatment for the disease and does not evaluate cyclosporine itself for CGD, the evidence is classed as model prediction only (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 | Matched related donor stem cell transplantation is a successful treatment for CGD; this study examines the safety and efficacy of transplantation from sibling and unrelated donors (title: excellent survival after sibling or unrelated donor transplantation). Cyclosporine is not evaluated directly. |
India Market Information
Cyclosporine is marketed in India. All 20 licence records in the data compiled for this report are valid, and the list may be partial. The records carry no approved-indication text. Main authorizations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 166958 | Oncyclo 50mg Capsule | Strip of 5 capsules | Not recorded |
| 39039 | Cyclophil ME Oral Solution | Bottle of 50 ml oral solution | Not recorded |
| 237076 | Vaktear Eye Drop | Bottle of 3 ml eye drop | Not recorded |
| 202327 | Sandimmun Injection | Ampoule of 1 ml injection | Not recorded |
| 41303 | Cyclomune 50mg Tablet | Strip of 10 tablets | Not recorded |
Available routes include oral, ophthalmic and injectable forms.
Safety Considerations
- Drug Interactions: 823 interactions were found in the data compiled for this report. Examples include:
- Major: Loperamide
- Moderate: Rabeprazole, Hydrocortisone, Amphotericin B, Bupropion, Aprepitant, Mesalazine, Triamcinolone, Acetylsalicylic acid, Dexamethasone, Betamethasone, Metronidazole, Budesonide
- Minor: Ranitidine, Doxycycline
- Conditions flagged as contraindicated in the compiled data (not label text): hypertension, epilepsy, kidney disease, liver disease, infectious disease, cancer, lymphoma and others. These should be checked against the package insert.
Package insert warnings and contraindications were not available. Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high (0.9968), but it is supported by a single transplantation cohort study that does not test cyclosporine for this disease, and no trials are registered. Cyclosporine has a significant safety burden (kidney toxicity, hypertension, infection risk), so there is no basis yet for advancing.
To proceed, the following is needed:
- Direct clinical or preclinical evidence of cyclosporine in chronic granulomatous disease (not only as transplant support)
- Detailed mechanism of action data
- Package insert warnings and contraindications for Indian products
- A risk-benefit assessment for the target patient population, given the immunosuppression and the many drug interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.