the purposes for which a substance is to be used and the extent of use of a substance:
Abemaciclib is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy (MONARCH-2,3).
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
the toxicity of a substance:
the dosage, formulation, labelling, packaging and presentation of a substance:
the potential for abuse of a substance:
any other matters that the Secretary considers necessary to protect public health:
The delegate of the Secretary proposed to amend the Poisons Standard with respect to abemaciclib, a new chemical entity (NCE) for a human therapeutic medicine.
Abemaciclib is not specifically scheduled and is not captured by any entry in the Poisons Standard.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.