Abemaciclib

Evidence Level: N/A Predicted Indications: 0

Table of Contents

  1. Abemaciclib
    1. Pharmacist Assessment Report
    2. Abemaciclib: Known uses and market status in India
    3. Summary
    4. Quick overview
    5. Known uses recorded for this drug
      1. Approved (supported by a licence or label)
      2. Related to an approved indication (same disease category)
      3. Relations recorded in the knowledge graph (no approval found)
    6. India Market Information
    7. Cytotoxicity
    8. Safety Considerations
    9. Disclaimer

Pharmacist Assessment Report

Abemaciclib: Known uses and market status in India

Summary

The TxGNN model has no candidate with a score of 0.99 or higher for Abemaciclib, so there is currently no new predicted indication. The drug’s recorded uses are listed below.

Quick overview

Item Content
New predicted indications None (no model candidate scored 0.99 or higher)
Known uses recorded for this drug 1
Evidence level Not applicable
India Market Status Listed in a compiled Indian medicine price dataset (4 of 4) – CDSCO approval status is not included in this data
Number of Listed Products 4 (valid: 4)

Known uses recorded for this drug

Approved (supported by a licence or label)

Indication Source
breast neoplasms licence in another country
Indication Approved category
none none

Relations recorded in the knowledge graph (no approval found)

Indication
none

India Market Information

Licence Product Dosage form Status
187040 Ramiven 200mg Tablet strip of 14 tablets Valid
187031 Ramiven 100mg Tablet strip of 7 tablets Valid
190816 Ramiven 200mg Tablet strip of 7 tablets Valid
184868 Ramiven 150mg Tablet strip of 7 tablets Valid

Cytotoxicity

Item Content
Cytotoxicity Classification Targeted therapy (CDK4/6 kinase inhibitor), not a conventional cytotoxic
Myelosuppression Risk Please refer to the package insert warnings and precautions
Emetogenicity Classification Please refer to the package insert warnings and precautions
Monitoring Items Please refer to the package insert warnings and precautions. Literature also points to cardiovascular monitoring (QTc, thromboembolism, arrhythmia) and renal function.
Handling Protection Please refer to the package insert warnings and precautions

Safety Considerations

  • Drug Interactions: 210 interactions were recorded, and the 19 listed in the compiled data are mostly Moderate.
    • Major: clarithromycin, cobicistat, deferiprone, samarium (153Sm) lexidronam, lumacaftor.
    • Moderate (examples): aprepitant, dexamethasone, metformin, fluconazole, erythromycin, ticagrelor, roflumilast, chloramphenicol.
  • Literature safety signals (not label text): cardiovascular toxicity of CDK4/6 inhibitors, including thromboembolic events with abemaciclib, QTc prolongation, atrial arrhythmia and kidney injury in pharmacovigilance data. These are relevant to any use in a non-oncology population.

Package insert warnings and contraindications were not available for this report. Please refer to the package insert for full safety information.

Disclaimer

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