Cinacalcet Accordpharma

Cinacalcet Accordpharma is available as 30, 60 and 90 mg tablets, to be taken with food or shortly after a meal.

In patients with secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day, while in children the daily starting dose depends on the child’s weight. The dose is adjusted, according to the patient’s PTH and calcium levels. In younger patients requiring less than 30 mg once a day, other cinacalcet products should be used that allow a lower dose to be given.

In patients with hypercalcaemia who also have parathyroid gland cancer or primary hyperparathyroidism, the recommended starting dose of Cinacalcet Accordpharma in adults is 30 mg twice a day. The dose should be increased every 2 to 4 weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.

The medicine can only be obtained with a prescription. For more information about using Cinacalcet Accordpharma, see the package leaflet or contact your doctor or pharmacist.

The active substance in Cinacalcet Accordpharma, cinacalcet, works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands. The reduction in PTH levels also leads to a decrease in blood calcium levels.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Mimpara, and do not need to be repeated for Cinacalcet Accordpharma.  

As for every medicine, the company provided studies on the quality of Cinacalcet Accordpharma. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Cinacalcet Accordpharma 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.

The European Medicines Agency concluded that, in accordance with EU requirements, Cinacalcet Accordpharma has been shown to have comparable quality and to be bioequivalent to Mimpara. Therefore, the Agency’s view was that, as for Mimpara, the benefits of Cinacalcet Accordpharma outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinacalcet Accordpharma have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Cinacalcet Accordpharma are continuously monitored. Side effects reported with Cinacalcet Accordpharma are carefully evaluated and any necessary action taken to protect patients.

Cinacalcet Accordpharma received a marketing authorisation valid throughout the EU on 3 April 2020.

Information on the reference medicine can also be found on the Agency’s website.