Apremilast

Evidence Level: N/A

Predicted Indications: 0

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Table of Contents

1. Apremilast
   1. Pharmacist Assessment Report
   2. Apremilast: 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. Safety Considerations
   8. Disclaimer

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Pharmacist Assessment Report

Apremilast: Known uses and market status in Australia

Summary

The TxGNN deep-learning model has no candidate indication with a score of 0.99 or higher for Apremilast, 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	4
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
Behcet syndrome	licence in another country
Oral ulcer	licence in another country
Psoriasis	licence in another country
Psoriatic arthritis	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
none

Australia Market Information

Licence	Product	Dosage form	Status
12218C	Otezla	Pack containing 4 tablets 10 mg, 4 table	Valid

Safety Considerations

• Drug Interactions: 75 interactions were identified in the interaction database, with the following examples:
  • Major: lumacaftor, fosphenytoin, apalutamide. These are likely strong enzyme inducers that may reduce apremilast exposure.
  • Moderate: dexamethasone, griseofulvin, bosentan, bexarotene, deferasirox, among others.
  • Minor: armodafinil.
• Headache is a known adverse effect of apremilast (noted in the pharmacovigilance literature), which is relevant to any migraine application.

Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.

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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