Immunosuppressant | Low Risk

Iptacopan (Fabhalta)

What to know about Iptacopan — also sold as Fabhalta: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.

Iptacopan (brand names: Fabhalta) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. Complement inhibitor with minimal occupational impairment risk.

Key Takeaways

  • TGA Schedule: S4 in Australia
  • Risk level: Low (1 points)
  • PBS listed: Subsidised under the Australian Pharmaceutical Benefits Scheme

Scheduling and Classification

Jurisdiction Classification Status
Australia (TGA) S4 PBS listed

Risk Profile

Risk Level Low
Risk Points 1
CNS Depressant No
Respiratory Risk No

Complement inhibitor with minimal occupational impairment risk.

How Iptacopan is regulated

Iptacopan is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.

Australia TGA / PBS / State Schemes

Classified as S4 under the Therapeutic Goods Administration (TGA).

Listed on the Pharmaceutical Benefits Scheme (PBS) for subsidised prescribing.

Check this medication against your full medication list

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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.