Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).
Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Reduction of hypercalcaemia in adult patients with:
The recommended starting dose for adults is 30 mg once per day. Mimpara 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 Mimpara. Reference should be made to current treatment guidelines.
PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara. 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 Mimpara does not alter the relationship between iPTH and biPTH.
Corrected serum calcium should be measured and monitored and should be at or above the lower limit of the normal range prior to administration of first dose of Mimpara (see section 4.4). The normal calcium range may differ depending on the methods used by your local laboratory.
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Mimpara. Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
In the event that corrected serum calcium levels fall below 8.4 mg/dL (2.1 mmol/L) and/or symptoms of hypocalcaemia occur the following management is recommended:
| Corrected Serum calcium level or clinical symptoms of hypocalcaemia | Recommendations |
|---|---|
| 8.4 mg/dL (2.1 mmol/L) and >7.5 mg/dL (1.9 mmol/L), or in the presence of clinical symptoms of hypocalcaemia | Calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium according to clinical judgment. |
| 8.4 mg/dL (2.1 mmol/L) and >7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia despite attempts to increase serum calcium | Reduce or withhold dose of Mimpara. |
| ≤7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia and Vitamin D cannot be increased | Withhold administration of Mimpara until serum calcium levels reach 8.0 mg/dL (2.0 mmol/L) and/or symptoms of hypocalcaemia have resolved. Treatment should be reinitiated using the next lowest dose of Mimpara. |
Corrected serum calcium should be in the upper range of, or above, the age-specified reference interval prior to administration of first dose of Mimpara, and closely monitored (see section 4.4). The normal calcium range differs depending on the methods used by your local laboratory and the age of the child/patient.
The recommended starting dose for children aged ≥3 years to <18 years is ≤0.20 mg/kg once daily based on the patient’s dry weight (see table 1).
The dose can be increased to achieve a desired target iPTH range. The dose should be increased sequentially through available dose levels (see table 1) no more frequently than every 4 weeks. The dose can be increased up to a maximum dose of 2.5 mg/kg/day, not to exceed a total daily dose of 180 mg.
Table 1. Mimpara daily dose in paediatric patients:
| Patient dry weight (kg) | Starting dose (mg) | Available sequential dose levels (mg) |
|---|---|---|
| 10 to <12.5 | 1 | 1, 2.5, 5, 7.5, 10 and 15 |
| ≥12.5 to <25 | 2.5 | 2.5, 5, 7.5, 10, 15, and 30 |
| ≥25 to <36 | 5 | 5, 10, 15, 30, and 60 |
| ≥36 to <50 | 5, 10, 15, 30, 60, and 90 | |
| ≥50 to <75 | 10 | 10, 15, 30, 60, 90, and 120 |
| ≥75 | 15 | 15, 30, 60, 90, 120, and 180 |
PTH levels should be assessed at least 12 hours after dosing with Mimpara and iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
The dose should be adjusted based on iPTH as shown below:
Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Once the maintenance dose has been established, weekly measurement of serum calcium is recommended. Serum calcium levels in paediatric patients should be maintained within the normal range. If serum calcium levels decrease below the normal range or symptoms of hypocalcaemia occur, appropriate dose adjustment steps should be taken as shown in table 2 below:
Table 2. Dose adjustment in paediatric patients ≥3 to <18 years of age:
| Corrected Serum calcium value or clinical symptoms of hypocalcaemia | Dosing recommendations |
|---|---|
| Corrected serum calcium is at or below age-specified lower limit of normal or if symptoms of hypocalcaemia occur, regardless of calcium level. | Stop treatment with Mimpara.* Administer calcium supplements, calcium-containing phosphate binders and/or vitamin D sterols, as clinically indicated. |
| Corrected total serum calcium is above age-specified lower limit of normal, and Symptoms of hypocalcaemia have resolved. | Restart at the next lower dose. If Mimpara treatment has been stopped for more than 14 days, restart at the recommended starting dose. If patient was receiving the lowest dose (1 mg/day) prior to discontinuation, restart at the same dose (1 mg/day). |
* If the dose has been stopped, corrected serum calcium should be measured within 5 to 7 days.
The safety and efficacy of Mimpara in children aged less than 3 years for the treatment of secondary hyperparathyroidism have not been established. Insufficient data are available.
The recommended starting dose of Mimpara for adults is 30 mg twice per day. The dose of Mimpara 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 Mimpara. Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months. After titration to the maximum dose of Mimpara, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Mimpara therapy should be considered (see section 5.1).
The safety and efficacy of Mimpara in children for the treatment of parathyroid carcinoma and primary hyperparathyroidism have not been established. No data are available.
No change in starting dose is necessary. Mimpara 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).
For oral use.
Tablets should be taken whole and should not be chewed, crushed or divided.
It is recommended that Mimpara 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).
Mimpara is also available as granules for paediatric use. Children who require doses lower than 30 mg, or who are unable to swallow tablets should receive Mimpara granules.
Doses titrated up to 300 mg once daily have been administered to adult patients receiving dialysis without adverse outcome. A daily dose of 3.9 mg/kg was prescribed to a paediatric patient receiving dialysis in a clinical study with subsequent mild stomach ache, nausea and vomiting.
Overdose of Mimpara may lead to hypocalcaemia. In the event of overdose, patients should be monitored for signs and symptoms of hypocalcaemia, and treatment should be symptomatic and supportive. Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdose.
Blister: 5 years.
Bottle: 5 years.
This medicinal product does not require any special storage conditions.
Aclar/PVC/PVAc/Aluminium blister containing 14 tablets. Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
High Density Polyethylene (HDPE) bottle with a cotton coil, and a child-resistant polypropylene cap with an induction seal, packed into a carton. Each bottle contains 30 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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