Phylloquinone
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Phylloquinone: Renal tubular acidosis
One-Sentence Summary
Phylloquinone (vitamin K1) was originally used for conditions involving bone and mineral metabolism and for vitamin K-dependent clotting deficiency (for example, congenital prothrombin deficiency). The TxGNN model predicts it may be effective for renal tubular acidosis, but there are currently 0 clinical trials and 0 publications supporting this prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Renal tubular acidosis |
| TxGNN Prediction Score | 0.9994 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available in the data compiled for this report. Based on known pharmacology, phylloquinone is a cofactor for gamma-glutamyl carboxylase, which activates vitamin K-dependent proteins such as osteocalcin and matrix Gla protein (MGP). These proteins are involved in bone mineralisation and in preventing soft-tissue calcification.
Renal tubular acidosis is commonly associated with nephrocalcinosis, bone demineralisation and altered calcium and phosphate handling. These features overlap with the drug’s original indications (osteoporosis, nephrocalcinosis, hypercalcaemia). This gives a plausible but speculative link.
However, no direct mechanistic link is established. Phylloquinone does not address the primary defect in renal tubular acidosis, which is impaired tubular acid-base transport. The high TxGNN score is not backed by clinical trials or published studies.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10213M | Konakion MM | Injection 10 mg in 1 mL | Not available in the data compiled |
Safety Considerations
- Disease associations flagged in the knowledge graph (not label text): The knowledge graph links phylloquinone to contraindication-type relationships with several conditions. These include kidney disease, nephrolithiasis, nephrocalcinosis, hyperparathyroidism, hypercalcaemia, hyperphosphataemia, sarcoidosis, diabetes mellitus, diabetic ketoacidosis, hypervitaminosis, constipation, and several cancers (breast, prostate, cervical, endometrial). These are model-derived associations and should be verified against the official Product Information.
- Drug Interactions: 100 interactions were identified in total. The main ones listed are:
- Minor: mineral oil, orlistat (both reduce absorption of fat-soluble vitamins).
- Severity not classified: pantoprazole, omeprazole, lansoprazole, famotidine, sucralfate, morphine, epinephrine, amphotericin B, hydrocortisone, prednisone, loperamide, ondansetron, metronidazole, aspirin, vancomycin, lactulose, simvastatin, nystatin.
Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the TxGNN model (deep learning) score (Evidence Level L5). There are no registered trials or publications, and there is no established mechanism by which vitamin K1 would correct the tubular transport defect in renal tubular acidosis. The score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence, so it calls for caution.
To proceed, the following is needed:
- Mechanism of action data and a clear mechanistic rationale linking vitamin K-dependent proteins to renal tubular acidosis
- Preclinical or observational evidence, such as vitamin K status and vascular or renal calcification outcomes in renal tubular acidosis
- The TGA-approved Product Information, including indications, warnings and contraindications for Konakion MM
- Assessment of route compatibility (the only Australian product is an injection) and of the knowledge-graph contraindication flags in renal disease
- A comparison against standard care (alkali therapy) to define any plausible added benefit
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.