TERROSA

What it is

TERROSA is teriparatide (rbe) solution for injection supplied as a pre-filled pen. TERROSA is a biosimilar medicine to FORTEO solution for injection. TERROSA contains 250 micrograms per mL of teriparatide. Teriparatide (rbe) is produced in E. coli using recombinant DNA technology and is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone.

Approved indications

— Treatment of osteoporosis in postmenopausal women and treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. — Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Dosing overview

The recommended dose of TERROSA is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen. Treatment with teriparatide is recommended for a lifetime duration of 24 months treatment. Calcium and vitamin D supplements are advised in patients with a low dietary intake of these nutrients.

Key safety warnings

In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumour) that was dependent on dose and treatment duration, observed at systemic exposures ranging from 3 to 60 times the exposure in humans given a 20 micrograms dose. However, no increased risk was identified in a study in which 30 monkeys were treated with teriparatide for 18 months and then observed for a further 3 years, and post marketing data in humans has not identified an increased risk. Patients should be made aware that teriparatide caused osteosarcoma in rats and that the clinical relevance of these findings is unknown. In normocalcaemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection, reaching a maximum between 4 and 6 hours and returning to baseline by 16 to 24 hours after each dose. Routine calcium monitoring during therapy is not required. In short-term clinical studies with teriparatide isolated episodes of transient orthostatic hypotension were observed, typically beginning within 4 hours of dosing and spontaneously resolving within a few minutes to a few hours; when it occurred it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment.

Contraindications

TERROSA should not be given to patients with hypersensitivity to teriparatide or any of its excipients, those who are pregnant or breast-feeding, those with pre-existing hypercalcaemia, severe renal impairment, metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, or those with skeletal malignancies or bone metastases.

PBS listing

TERROSA injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen is listed on the PBS with 2 items under streamlined restriction at an ex-manufacturer price of A$149.55, with latest schedule dated 2026-05-01.

Regulatory history

TERROSA teriparatide (rbe) 250 microgram/mL solution for injection in a pre-filled pen was first registered on the Australian Register of Therapeutic Goods on 16 May 2023. In March 2021, the PBAC recommended TERROSA for treatment of severe established osteoporosis.