Nivolumab

Evidence Level: N/A

Predicted Indications: 0

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Table of Contents

1. Nivolumab
   1. Pharmacist Assessment Report
   2. Nivolumab: Known uses and market status in Australia
   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. Australia Market Information
   7. Cytotoxicity
   8. Safety Considerations
   9. Disclaimer

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Pharmacist Assessment Report

Nivolumab: Known uses and market status in Australia

Summary

The TxGNN model has no candidate with a score of 0.99 or higher for Nivolumab, so there is currently no new predicted indication. The drug’s recorded uses are listed below. They are the drug’s own recorded uses, not model candidates.

Quick overview

Item	Content
New predicted indications	None (no model candidate scored 0.99 or higher)
Known uses recorded for this drug	13
Evidence level	Not applicable
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)

Known uses recorded for this drug

Approved (supported by a licence or label)

Indication	Source
colorectal neoplasms	licence in another country
hodgkin disease	licence in another country
melanoma	licence in another country
mesothelioma	licence in another country
non-small-cell lung carcinoma	licence in another country
renal cell carcinoma	licence in another country
squamous cell carcinoma of head and neck	licence in another country
transitional cell carcinoma	licence in another country
urologic neoplasms	licence in another country

Related to an approved indication (same disease category)

Indication	Approved category
none	none

Relations recorded in the knowledge graph (no approval found)

Indication
lung cancer
metastatic melanoma
non-small cell lung carcinoma
squamous cell lung carcinoma

Australia Market Information

Licence	Product	Dosage form	Status
11900H	Opdivo	Injection concentrate for I.V. infusion	Valid

Cytotoxicity

Item	Content
Cytotoxicity Classification	Immunotherapy (anti-PD-1 monoclonal antibody), not a conventional cytotoxic agent
Myelosuppression Risk	Low. Please refer to the Product Information (PI) warnings and precautions
Emetogenicity Classification	Low
Monitoring Items	Please refer to the PI. Immune-related adverse events are the main concern, so liver, thyroid and renal function, blood glucose and clinical review of organ symptoms are typically monitored
Handling Protection	Please refer to the PI and local institutional policy

Safety Considerations

Warnings and contraindications from the TGA-approved Product Information were not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for full safety information.

Literature in the data compiled for this report describes immune-related adverse events with nivolumab, including fulminant myocarditis with rhabdomyolysis, capillary leak syndrome, bullous pemphigoid, colitis and pulmonary sarcoid-like granulomatosis.

Drug interactions (14 recorded):

• Major: lenalidomide, pomalidomide, thalidomide
• Moderate: systemic corticosteroids (hydrocortisone, triamcinolone, dexamethasone, betamethasone, budesonide, prednisolone, prednisone, methylprednisolone, deflazacort) and idelalisib

Corticosteroids are commonly needed to manage immune-related adverse events, so the interaction with nivolumab should be considered in clinical context.

Disclaimer

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

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