Macitentan

Evidence Level: N/A

Predicted Indications: 0

---

Table of Contents

1. Macitentan
   1. Pharmacist Assessment Report
   2. Macitentan: 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

---

Pharmacist Assessment Report

Macitentan: Known uses and market status in Australia

Summary

The TxGNN deep-learning model has no candidate with a score of 0.99 or higher for Macitentan, so there is currently no new predicted indication. The uses recorded for this drug 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	2
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
pulmonary arterial hypertension	licence in another country
pulmonary hypertension	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
10134J	Opsumit	Tablet 10 mg	Valid

Safety Considerations

Specific warnings and contraindications from the product label are not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for full safety information.

Drug Interactions: 58 interactions are listed. Major interactions include:

• Clarithromycin
• Erythromycin
• Ketoconazole
• Cobicistat
• Lumacaftor

Moderate interactions include aprepitant, dexamethasone, cimetidine, fluconazole, ticagrelor and others. Many of these involve CYP3A4 inhibitors or inducers.

Class-related considerations to review against the PI: embryo-fetal toxicity (contraception and pregnancy testing), hepatotoxicity and anaemia monitoring, and caution in Eisenmenger patients with right-to-left shunts.

Disclaimer

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

---