Standard Care | Low Risk

Agalsidase Beta (FABRAZYME agalsidase beta-rch 35mg powder for injection vial)

Agalsidase Beta risk profile, scheduling, and guidance for claims professionals and care workers . Also known as FABRAZYME agalsidase beta-rch 35mg powder for injection vial, FABRAZYME agalsidase beta - rch 5.5mg powder for injection vial.

Source: TGA Updated April 2026

Agalsidase Beta (brand names: FABRAZYME agalsidase beta-rch 35mg powder for injection vial, FABRAZYME agalsidase beta - rch 5.5mg powder for injection vial) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. Enzyme replacement therapy for Fabry disease with minimal direct workplace safety impact.

Key Takeaways

  • TGA Schedule: S4 in Australia
  • Risk level: Low (1 points)

Scheduling and Classification

Jurisdiction Classification Status
Australia (TGA) S4 Not PBS listed

Risk Profile

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

Enzyme replacement therapy for Fabry disease with minimal direct workplace safety impact.

Regulatory and Compliance Guidance

When Agalsidase Beta appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.

Australia TGA / PBS / State Schemes

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

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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.