Posology : מינונים

4.2    Posology and method of administration

Posology
Secondary hyperparathyroidism

Adults and elderly (> 65 years)
The recommended starting dose for adults is 30 mg once per day. Cinacalcet Teva should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l) in the intact PTH (iPTH) assay. PTH levels should be assessed at least 12 hours after dosing with Cinacalcet Teva. Reference should be made to current treatment guidelines.

PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Cinacalcet Teva. 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 Cinacalcet Teva does not alter the relationship between iPTH and biPTH.

During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Cinacalcet Teva. Once the maintenance dose has been established, serum calcium should be measured approximately monthly. If serum calcium levels decrease below the normal range, appropriate steps should be taken, including adjustment of concomitant therapy (see section 4.4).

Children and adolescents
Cinacalcet Teva is not indicated for use in children and adolescents due to a lack of data on safety and efficacy (see section 4.4).

Parathyroid carcinoma and primary hyperparathyroidism

Adults and elderly (> 65 years)
The recommended starting dose of Cinacalcet Teva for adults is 30 mg twice per day. The dose of Cinacalcet Teva 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 Cinacalcet Teva. Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months. After titration to the maximum dose of Cinacalcet Teva, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Cinacalcet Teva therapy should be considered (see section 5.1).

Children and adolescents
Cinacalcet Teva is not indicated for use in children and adolescents due to a lack of data on safety and efficacy (see section 4.4).

Hepatic impairment

No change in starting dose is necessary. Cinacalcet Teva should be used with caution in patients with moderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2).

Method of administration

For oral use. It is recommended that Cinacalcet Teva be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2). Tablets should be taken whole and not divided.