Preotact

The recommended dose is 100 micrograms of parathyroid hormone administered once-daily Posology Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. 4). 1). Renal impairment Special populations No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).

There is no data available in patients with severe renal impairment. 3). Hepatic impairment No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale). There is no data available in patients with severe hepatic impairment.

3). Paediatric population The safety and efficacy of Preotact in patients under 18 years have not been studied. 2). Method of administration The dose is administered as a subcutaneous injection into the abdomen. 6). A user manual is included in the box to instruct patients on the correct use of the pen.

6.

The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2,642 postmenopausal osteoporotic women of whom 1,341 received parathyroid hormone. 4% of the patients on parathyroid hormone reported at least one ADR.

Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney, and the bone. 3% of patients treated with Preotact. Hypercalcemia was transient and was reported most frequently in the first 3 months of treatment.

1). The only other very commonly reported ADR was nausea. 5% higher in the parathyroid hormone group compared to placebo. 9 Preotact increases serum uric acid concentrations. 4%). Although gout, arthralgia and nephrolithiasis were reported as ADRs, the relationship to elevations in uric acid due to Preotact administration has not been fully established.

2% of women receiving placebo. In these women with a positive titre, there was no evidence of hypersensitivity reactions, allergic reactions, effects on bone mineral density response, or effects on serum calcium.

Patients initiated on Preotact therapy should be monitored at months 1, 3 and 6 for elevated levels of serum and/or urinary calcium. Monitoring beyond 6 months is not recommended for patients whose total serum calcium is within the normal limits at 6 months.

Monitoring of patients during treatment Elevated serum calcium was observed during Preotact treatment. Serum calcium concentrations reach a maximum between 6 and 8 hours post dose and normally return to baseline by 20 to 24 hours after each administration of parathyroid hormone.

Therefore if any blood samples are taken from a patient for monitoring of calcium levels, this should be done at least 20 hours after the most recent injection. g. hyperparathyroidism). If no underlying condition is found, the following management procedures should be followed: Management of elevated serum calcium • Calcium and vitamin D supplementation should be withdrawn • The frequency of Preotact dosing should be changed to 100 micrograms every other day • If elevated levels continue, Preotact therapy should be stopped and the patient monitored until the abnormal values have reverted to normal Patients with pre-existing hypercalciuria Caution should be exercised in Preotact has been studied in patients with pre-existing hypercalciuria.

In these patients, Preotact treatment was more likely to exacerbate their underlying hypercalciuria. Patients with urolithiasis Preotact has not been studied in patients with active urolithiasis. 5). 3). The occurrence of osteosarcoma only occurred at doses that produced systemic exposures > 27-times higher than that observed in humans at the 100 micrograms dose.

Until further clinical data becomes available the recommended treatment time of 24 months should not be exceeded. Duration of treatment

1) • who are receiving or who has previously received radiation therapy to the skeleton • with skeletal malignancies or bone metastases. • with pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism • with metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget’s disease of the bone) • with unexplained elevations of bone-specific alkaline phosphatase • with severe renal impairment • with severe hepatic impairment