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Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

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2.14. Sodium zirconium cyclosilicate

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.14. Sodium zirconium cyclosilicate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of sodium zirconium cyclosilicate, a NCE for a human therapeutic medicine.

Substance summary

Sodium zirconium cyclosilicate is a highly selective cation exchanger that entraps potassium in the intestinal tract in exchange for sodium and hydrogen.

Sodium zirconium cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients.

AAN – sodium zirconium cyclosilicate

Scheduling status

Sodium zirconium cyclosilicate is not specifically scheduled and is not captured by any entry in the current Poisons Standard.

International regulations

Sodium zirconium cyclosilicate is not classified in New Zealand.

Delegate's consideration

The delegate made a delegate-only decision; hence the Advisory Committee on Medicines Scheduling was not consulted.

The delegate considered the following in regards to this application for scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2015) scheduling factors;
  • The TGA evaluation report; and
  • The new drug application.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate's final decision

The delegate has made a final decision to amend the Poisons Standard to include sodium zirconium cyclosilicate in Schedule 4, with an implementation date of 1 February 2017.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 – New Entry

SODIUM ZIRCONIUM CYCLOSILICATE.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse.

The delegate decided that the reasons for the final decision comprise the following:

  • It is a NCE with no clinical/marketing experience in Australia;
  • The intended use is the treatment of hyperkaelemia;
  • This medicine is not absorbed, it acts locally in the gastrointestinal tract; and
  • The potential for abuse of sodium zirconium cyclosilicate is unlikely.

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