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Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018

Scheduling medicines and poisons

28 September 2018

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1.3 Fluticasone

Part A: Amendments to the Poisons Standard referred to an expert advisory committee

1. Advisory Committee on Medicines Scheduling (ACMS #23)

1.3 Fluticasone

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Schedule 2 entry for fluticasone and the index to reflect this change in the Poisons Standard as follows:

Schedule 2 - Amend Entry

FLUTICASONE PROPIONATE (excluding derivatives) in aqueous nasal sprays delivering 50 micrograms or less of fluticasone propionate per actuation when the maximum recommended daily dose is no greater than 400 micrograms, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

Index - Amend Entries

FLUTICASONE

cross reference: FLUTICASONE PROPIONATE, FLUTICASONE FUROATE

Schedule 4

FLUTICASONE FUROATE

cross reference FLUTICASONE

FLUTICASONE PROPIONATE

Schedule 4

Schedule 2

Implementation date: 1 October 2018
Reasons:

The delegate has confirmed that the reasons for the final decision are identical to the interim decision. Additional reasons for the final decision are the following:

  • The Schedule 2 entry should be specific to fluticasone propionate and exclude derivatives, including the more potent analogue, fluticasone furoate.
    • Fluticasone furoate is a more potent analogue of fluticasone propionate available in an aqueous nasal spray for allergic perennial rhinitis, and in formulations used for asthma / COPD[2] containing fluticasone furoate in combination with long acting bronchodilators. Due to the following reasons, fluticasone furoate should remain a Schedule 4 substance, captured under the Schedule 4 entry for 'FLUTICASONE':
      • Fluticasone propionate and fluticasone furoate are distinct drug substances with distinct properties.
      • Fluticasone propionate and fluticasone furoate do not have the same active principle and share no common metabolites (neither are metabolised to fluticasone).
      • Fluticasone furoate is more potent with almost twice the receptor binding compared to fluticasone propionate and thus is generally given at lower doses:[3,4]
  • There are 6 products containing fluticasone furoate on the Australian Register of Therapeutic Goods (ATRG), all of which are Prescription-Only Medicines (Schedule 4).
Public submissions on the interim decision

No public submissions were received before the second closing date in response to an invitation published on 7 June 2018 under regulation 42ZCKP of the Regulations.

Interim decision

The interim decision for fluticasone was published on the TGA website on 7 June 2018 at Publication of interim decisions amending, or not amending, the current Poisons Standard, June 2018 - 1.3 Fluticasone.

Scheduling proposal

The pre-meeting scheduling proposal for fluticasone was published on the TGA website on 21 December 2017 at Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018.


Footnotes

  1. Chronic obstructive pulmonary disease
  2. Derendorf, H and Meltzer, EO (2008), 'Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications', Allergy, 63, 1292-1300.
  3. Schafer, T et al (2011) 'Therapeutic Index (TIX) for intranasal corticosteroids in the treatment of allergic rhinitis', Rhinology 49: 272-280

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