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Scheduling delegates' final decisions: NCEs, May 2018

Scheduling medicines and poisons

19 June 2018

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1.12 Nivolumab

New Chemical Entities - medicines for human therapeutic use

1.12 Nivolumab

Delegate's final decision
Final decision:

The delegate's final decision is to amend the Poisons Standard to include nivolumab in Schedule 4 as follows:

Schedule 4 - New Entry


Implementation date: 1 June 2018

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

  1. the risks and benefits of the use of a substance
    • Nivolumab is an active chemical substance which has significant risks in terms of immunomodulation. The risk-benefit balance for an individual patient, including explanation of the risks in order for the balance to be understood, requires the input of a medical practitioner.
  2. the toxicity of a substance
    • Nivolumab can cause significant, potentially fatal toxicity.
Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to nivolumab.

Scheduling status

Nivolumab is not specifically scheduled in the Poisons Standard, but as a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:

Schedule 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.
Delegate's consideration

The delegate considered the following in regards to this scheduling:

  • Advice on the place in therapy of this medicine;
  • Scheduling Policy Framework (SPF 2018); and
  • Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; and (c) the toxicity of a substance.

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