What is Mimpara?
Mimpara is a medicine that contains the active substance cinacalcet. It is found in the form of light green oval tablets (30, 60 and 90 mg).
What is Mimpara used for?
Mimpara is used for the treatment of adult and elderly patients in the following cases:
- for the treatment of secondary hyperparathyroidism in patients with severe kidney disease, who must undergo dialysis to clean the blood from waste products. Hyperparathyroidism is a disease in which the parathyroid glands located in the neck produce too much parathyroid hormone (PTH), which can cause bone and joint pain and deformation of the arms and legs. "Secondary" means that it is caused by another pathology. Mimpara can be used in the context of a therapy that includes phosphate binders or vitamin D sterols;
- to reduce hypercalcemia (high levels of calcium in the blood) in patients suffering from parathyroid carcinoma (tumor of the parathyroid glands) or from primary hyperparathyroidism that cannot undergo parathyroid gland removal or if the doctor believes that such removal is not appropriate . "Primary" means that hyperparathyroidism is not caused by another disease.
The medicine can only be obtained with a prescription.
How is Mimpara used?
In cases of secondary hyperparathyroidism, the recommended starting dose in the adult is 30 mg once a day. The dose should be adjusted every two to four weeks, depending on the patient's PTH levels, up to a maximum of 180 mg once a day. PTH levels should be evaluated at least 12 hours after dosing and one to four weeks after each dose adjustment of Mimpara. Blood calcium levels must be measured frequently and within one week of each Mimpara dose adjustment. Once the maintenance dose is established, calcium levels should be measured every month and PTH levels should be measured every 1-3 months.
In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Mimpara in adults is 30 mg twice a day. The dose of Mimpara should be increased every 2-4 weeks without exceeding the maximum dose of 90 mg three or four times a day, to bring the concentration of calcium back into the blood to normal levels.
Mimpara should be taken with food or shortly after a meal.
How does Mimpara work?
The active ingredient of Mimpara, cinacalcet, is a calcimimetic agent: that is it mimics the action of calcium in the body. Cinacalcet increases the sensitivity of calcium-sensitive receptors located on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet causes a reduction in PTH production by the parathyroid glands. The reduction in PTH levels also leads to a reduction in blood calcium levels.
What studies have been carried out on Mimpara?
Mimpara was compared with placebo (a dummy treatment) in three main studies involving 1 136 dialysis patients with severe kidney disease. The studies lasted six months. The main measure of effectiveness was the number of patients who, at the end of the study, had a PTH level lower than 250 micrograms per liter.
Mimpara was also examined in a study conducted on 46 patients suffering from hypercalcemia, of which 29 with parathyroid carcinoma and 17 with primary hyperparathyroidism that could not be subjected to removal of the parathyroid glands or in which such removal would not have been effective. The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels greater than 1 mg per deciliter at the time a maintenance dose was reached (between two and 16 weeks from the start of study). The study was conducted for over three years. Three other studies compared Mimpara with a placebo on a total of 136 patients with primary hyperparathyroidism for up to one year. 45 of these patients then underwent a fourth long-term study designed to examine the effectiveness of Mimpara for a total of almost six years.
What benefit has Mimpara shown during the studies?
In the case of dialysis patients suffering from severe renal disease, approximately 40% of patients treated with Mimpara had PTH levels below 250 micrograms / l at the end of the study, compared with approximately 6% of subjects treated with placebo. Mimpara resulted in a 42% reduction in PTH levels, compared to an 8% increase in placebo-treated patients.
Mimpara resulted in a reduction in blood calcium levels of more than 1 mg / dl in 62% of cancer patients (18 of 29) and in 88% of patients with primary hyperparathyroidism (15 of 17). The results of the other studies supported the use of Mimpara for hypercalcaemia in patients with primary hyperparathyroidism.
What is the risk associated with Mimpara?
The most common side effects with Mimpara in primary hyperparathyroidism (seen in more than 1 in 10 patients) are nausea and vomiting. In patients with parathyroid carcinoma or primary hyperparathyroidism, undesirable effects are similar to those seen in patients with long-standing kidney disease (the most frequent are nausea and vomiting). For the full list of all side effects reported with Mimpara, see the Package Leaflet.
Mimpara should not be used in people who may be hypersensitive (allergic) to cinacalcet or other ingredients in the medicine.
Why has Mimpara been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Mimpara outweigh its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease and undergoing dialysis maintenance therapy and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for which parathyroidectomy would be indicated based on serum calcium levels, but clinically is not appropriate or is contraindicated. The committee recommended the granting of a marketing authorization for Mimpara.
Other information about Mimpara:
On 22 October 2004, the European Commission issued a marketing authorization valid for Mimpara to Amgen Europe BV, valid throughout the European Union. The marketing authorization was renewed on 22 October 2009.
The full EPAR for Mimpara can be found here.
Last update of this summary: 10-2009.
