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Final decisions and reasons for NCEs, medicines and chemicals, November 2018
Scheduling medicines and poisons
Part B - Final decisions on matters not referred to an expert advisory committee
4. New Chemical Entities - medicines for human therapeutic use
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Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include isavuconazole in Schedule 4 as follows:
Schedule 4 - New Entry
Appendix L - New Entry
Index - New Entry
1 June 2019
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:
- the risks and benefits of the use of a substance:
Isavuconazole is a new chemical entity with no clinical or marketing experience in Australia.
- the purposes for which a substance is to be used and the extent of use of a substance:
Isavuconazole is used for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.
- the toxicity of a substance:
Safety issues include hepatotoxicity and the potential for drug-drug interactions.
- the dosage, formulation, labelling, packaging and presentation of a substance:
Isavuconazole should be prescribed by medical professionals who are familiar with the management of invasive fungal infections. Patients need to be instructed to follow the dosing regimens.
- the potential for abuse of a substance:
- any other matters that the Secretary considers necessary to protect public health:
The Australian Pregnancy Categorisation for isavuconazonium is D, as reproductive toxicity studies showed an increased incidence of bone abnormalities in rats and rabbits.
The delegate of the Secretary proposed to amend the Poisons Standard with respect to isavuconazole, a new chemical entity (NCE) for a human therapeutic medicine.
Isavuconazole is not specifically scheduled and is not captured by any entry in the Poisons Standard.
- Section 52E(1) of the Therapeutic Goods Act 1989;
- Scheduling Policy Framework (SPF 2018); and
- Advice on the place in therapy of this NCE.