1.6 Linaclotide

The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 is to include linaclotide in the Poisons Standard as follows:

Implementation date

1 October 2019

Reasons

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

1. the risks and benefits of the use of a substance:
   • It is a new chemical entity with no clinical or marketing experience in Australia.
   • The benefits outweigh the risks.
2. the purposes for which a substance is to be used and the extent of use of a substance:
   • For the management of chronic idiopathic constipation [CIC] and irritable bowel syndrome with constipation[IBS-C].
3. the toxicity of a substance:
   • Minimal.
4. the dosage, formulation, labelling, packaging and presentation of a substance:
   • Irritable Bowel Syndrome with Constipation.
     • The recommended dosage of linaclotide is 290 mcg orally once daily.
   • Chronic Idiopathic Constipation
     • The recommended dosage of linaclotide is 145 mcg orally once daily. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability.
   • Strength/Dose Form
     • 72 μg, 145 μg and 290 μg as hard capsules for oral administration.
5. the potential for abuse of a substance:
   • Nil.
6. any other matters that the Secretary considers necessary to protect public health:
   • Nil.