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 need to undergo dialysis to clear the blood of waste products. Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), the which can cause high levels of calcium in the blood and cause bone and joint pain as well as deformities of the arms and legs. "Secondary" means that the "hyperparathyroidism is caused by" another disease. Cinacalcet Mylan can be used as part of a treatment regimen that includes phosphate binding substances or vitamin D;
- for the reduction of hypercalcaemia (high levels of calcium in the blood) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or primary hyperparathyroidism in whom surgical removal of the parathyroid glands is not possible or, in the doctor's judgment, is not appropriate. "Primary" means that the "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 30, 60 and 90 mg tablets. In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once daily. 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. once daily. PTH levels should be assessed 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. Cinacalcet Mylan dose Once the maintenance dose has been established, calcium levels should be measured every month and PTH levels should be measured every 1-3 months.
In patients with parathyroid cancer or primary hyperparathyroidism, the recommended starting dose of Cinacalcet Mylan for adults is 30 mg twice daily. 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 calcium concentration in the blood back 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 the calcium-sensitive receptors on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet causes a reduction in the production of PTH by the parathyroid glands. The reduction in PTH levels also results in a reduction in blood calcium levels.
How has Cinacalcet Mylan been studied?
Since Cinacalcet Mylan is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Mimpara. Two medicines are bioequivalent when they produce the same levels of the active substance 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 taken as being the same as the reference medicine's.
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 that Cinacalcet Mylan be approved for use 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 added to the summary of product characteristics and package leaflet for Cinacalcet Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Cinacalcet Mylan
For more information about Cinacalcet Mylan therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. The full EPAR version of the reference medicine can also be found on the Agency's website.
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