TERIPARINTAS

What it is

Teriparatide (rbe) is the active ingredient in TERIPARINTAS. TERIPARINTAS solution for injection is a biosimilar medicine to FORTEO solution for injection. TERIPARINTAS solution for injection contains 250 micrograms/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. TERIPARINTAS is a solution for injection presented as a sterile, colourless, clear solution with a pH of 3.8–4.5.

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 TERIPARINTAS 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.

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, with the effect 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, with serum calcium concentrations reaching a maximum between 4 and 6 hours and returning to baseline by 16 to 24 hours after each dose. <cite index index="1-51">Patients with pre-existing hypercalcaemia should be excluded from treatment with teriparatide because of the possibility of exacerbating hypercalcaemia.</cite> 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, occurring within the first several doses and relieved by placing subjects in a reclining position.

Contraindications

TERIPARINTAS should not be given to patients with hypersensitivity to teriparatide or to any of its excipients. TERIPARINTAS is contraindicated in pregnancy and breast-feeding, 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, and in patients with skeletal malignancies or bone metastases.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

TERROSA (the reference teriparatide biosimilar) received its first approval on 16 May 2023. TERIPARINTAS was approved on 11 August 2025, following a comprehensive evaluation of its biosimilarity to Forteo. TERIPARINTAS teriparatide 250 micrograms/mL solution for injection pre-filled pen was first listed on the ARTG on 2 October 2025.