What is Cinacalcet Mylan and what is it used for?
Cinacalcet Mylan is a medicine used in adult and elderly patients:
- for the treatment of secondary hyperparathyroidism in patients with severe kidney disease who have to undergo dialysis to purify their 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 result in elevated calcium levels in the blood and cause bone and joint pain as well as deformation of the arms and legs. "Secondary" means that hyperparathyroidism is caused by another pathology. Cinacalcet Mylan can be used as part of a therapeutic regimen that includes phosphate or vitamin D binding substances;
- for the reduction of hypercalcaemia (high levels of calcium in the blood) in patients suffering from parathyroid carcinoma (tumor of the parathyroid glands) or from primary hyperparathyroidism in which surgical removal of the parathyroid glands is not possible or, in the opinion of the physician, is not appropriate. "Primary" means that hyperparathyroidism is not caused by another disease.
Cinacalcet Mylan contains the active substance cinacalcet and is a "generic medicine". This means that Cinacalcet Mylan is similar to a 'reference medicine' already authorized in the European Union (EU). The reference medicine for Cinacalcet Mylan is Mimpara.
For more information on generic medicines, see the questions and answers by clicking here.
How is Cinacalcet Mylan used?
Cinacalcet Mylan is available in tablets of 30, 60 and 90 mg. In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day. The dose is adjusted every 2-4 weeks, depending on the patient's PTH levels, up to a maximum dose 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 Cinacalcet Mylan. Blood calcium levels should be measured frequently and within one week of each dose adjustment of Cinacalcet Mylan. 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 Cinacalcet Mylan for adults is 30 mg twice a day. The dose 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.
Cinacalcet Mylan should be taken with food or shortly after a meal. The medicine can only be obtained with a prescription.
How does Cinacalcet Mylan work?
The active substance in Cinacalcet Mylan, cinacalcet, works by increasing 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.
How has Cinacalcet Mylan been studied?
Because Cinacalcet Mylan is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Mimpara. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Cinacalcet Mylan?
Because Cinacalcet Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Cinacalcet Mylan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Cinacalcet Mylan has been shown to have comparable quality and to be bioequivalent to Mimpara. Therefore, the CHMP considered that, as in the case of Mimpara, the benefits outweigh the identified risks and recommended to approve the use of Cinacalcet Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Cinacalcet Mylan?
A risk management plan has been developed to ensure that Cinacalcet Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cinacalcet Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Cinacalcet Mylan
For more information on Cinacalcet Mylan therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website.
