2.4. Romosozumab

Final decision:

The delegate's final decision is to amend the Poisons Standard to include romosozumab in Schedule 4 as follows:

Proposed implementation date:

1 February 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:
   • Romosozumab is a humanised monoclonal antibody that binds to and inhibits sclerostin
   • Treatment with romosozumab increases bone density and prevents fractures in patients with osteoporosis
   • Risks of treatment include hypocalcaemia (prevented by monitoring and concomitant use of calcium and vitamin D), osteonecrosis of the jaw
2. the purposes for which a substance is to be used and the extent of use of a substance:
   • Romosozumab is to be used in the treatment of men and women with osteoporosis.
   • The diagnosis of osteoporosis requires an assessment by a medical officer. It is based on clinical history and examination, as well as diagnostic tests.
3. the toxicity of a substance:
   • No concerning toxicity was identified in animal studies. Pregnancy category B3
4. the dosage, formulation, labelling, packaging and presentation of a substance:
   • Romosozumab is administered as a subcutaneous injection. The formulation contains 105mg/1.17ml. The dosage is 210mg each month for 12 months
5. the potential for abuse of a substance:

   Unlikely

6. any other matters that the Secretary considers necessary to protect public health:

   Nil