Parareg

For oral use. 2). Tablets should be taken whole and not divided. Hepatic impairment No change in starting dose is necessary. 2). Secondary Hyperparathyroidism Adults and elderly (> 65 years) The recommended starting dose for adults is 30 mg once per day.

8 pmol/l) in the intact PTH (iPTH) assay. PTH levels should be assessed at least 12 hours after dosing with Parareg. Reference should be made to current treatment guidelines. 2Medicinal product no longer authorised PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.

PTH should be monitored approximately every 1-3 months during maintenance. Either the intact PTH (iPTH) or bio- intact PTH (biPTH) may be used to measure PTH levels; treatment with Parareg does not alter the relationship between iPTH and biPTH.

1 During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Parareg. Once the maintenance dose has been established, serum calcium should be measured approximately monthly.

4). Concomitant therapy with phosphate binders and/or vitamin D sterols should be adjusted as appropriate. Children and adolescents Safety and efficacy have not been established in patients below the age of 18 years. Parathyroid Carcinoma and Primary Hyperparathyroidism Adults and elderly (> 65 years) The recommended starting dose of Parareg for adults is 30 mg twice per day.

The dosage of Parareg should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.

The maximum dose used in clinical trials was 90 mg four times daily. Serum calcium should be measured within 1 week after initiation or dose adjustment of Parareg. Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months.

1). Children and adolescents Safety and efficacy have not been established in patients below the age of 18 years.

Secondary Hyperparathyroidism Data presented from controlled studies include 656 patients who received Parareg and 470 patients who received placebo for up to 6 months. The most commonly reported undesirable effects were nausea and vomiting, occurring in 31% Parareg and 19% placebo treated patients, and 27% Parareg and 15% placebo treated patients, respectively.

Nausea and vomiting were mild to moderate in severity and transient in nature in the majority of patients. Discontinuation of therapy as a result of undesirable effects was mainly due to nausea (1% placebo; 5% cinacalcet) and vomiting (< 1% placebo; 4% cinacalcet).

Adverse reactions, defined as adverse events considered at least possibly attributable to cinacalcet treatment based on best-evidence assessment of causality and reported in excess of placebo in double- blind clinical studies are listed below using the following convention: very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1,000); very rare (< 1/10,000).

4) Parathyroid Carcinoma and Primary Hyperparathyroidism The safety profile of Parareg in these patient populations is generally consistent with that seen in patients with Chronic Kidney Disease. The most frequent ADRs in these patient populations were nausea and vomiting.

Post-marketing Experience There have been reports of isolated, idiosyncratic cases of hypotension and/or worsening heart failure in cinacalcet-treated patients with impaired cardiac function in post marketing safety surveillance.

Seizures In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Parareg and placebo groups reported a history of seizure disorder at baseline. 4% of placebo-treated patients.

While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels. 3Medicinal product no longer authorised Hypotension and/or worsening heart failure In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.

Clinical trial data showed hypotension occurred in 7% of cinacalcet-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving cinacalcet or placebo. Serum Calcium Parareg treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.

2). 875 mmol/l). In the event of hypocalcaemia, calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium. If hypocalcaemia persists, reduce the dose or discontinue administration of Parareg..

Potential manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions. Cinacalcet is not indicated for CKD patients not on dialysis. 1 mmol/l]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.

5 times the upper limit of normal with the iPTH assay. If PTH levels decrease below the recommended target range in patients treated with Parareg, the dose of Parareg and/or vitamin D sterols should be reduced or therapy discontinued.

Hypersensitivity to the active substance or to any of the excipients.