Cinacalcet Viatris (previously Cinacalcet Mylan)
Authorised
This medicine is authorised for use in the European Union
cinacalcet
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Cinacalcet Viatris is a medicine used to:
- treat secondary hyperparathyroidism (overactive parathyroid glands) in adults with serious kidney disease who need dialysis (to clear their blood of waste products);
- reduce hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands or with primary hyperparathyroidism when the parathyroid glands cannot be removed.
In hyperparathyroidism, the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of blood calcium, bone and joint pain and deformities of the arms and legs. ‘Secondary’ means that it is caused by another condition (serious kidney disease) while ‘primary’ means there is no other cause.
Cinacalcet Viatris contains the active substance cinacalcet and is a ‘generic medicine’. This means that Cinacalcet Viatris is similar to a ‘reference medicine’ already authorised in the European Union (EU). The reference medicine for Cinacalcet Viatris is Mimpara.
For more information on generic medicines, see the question-and-answer document here.
Cinacalcet Viatris is available as tablets, to be taken with food or shortly after a meal.
In patients with secondary hyperparathyroidism, the medicine is taken once a day and the dose is adjusted according to the patient’s PTH and calcium levels.
In patients with hypercalcaemia who also have parathyroid gland cancer or primary hyperparathyroidism, the medicine is taken twice a day. The dose is increased and taken up to 3 or 4 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 Viatris, see the package leaflet or contact your doctor or pharmacist.
The active substance in Cinacalcet Viatris, cinacalcet, is a calcimimetic agent. This means that it mimics the action of calcium in the body. 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 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 Viatris.
As for every medicine, the company provided studies on the quality of Cinacalcet Viatris. The company also carried out studies 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 Viatris is a generic medicine and is bioequivalent to the reference medicine, Mimpara, 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 Viatris 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 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 Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Mimpara also apply to Cinacalcet Viatris where appropriate.
As for all medicines, data on the use of Cinacalcet Viatris are continuously monitored. Suspected side effects reported with Cinacalcet Viatris are carefully evaluated and any necessary action taken to protect patients.
Cinacalcet Mylan received a marketing authorisation valid throughout the EU on 19 November 2015.
The name of the medicine was changed to Cinacalcet Viatris on 15 October 2024.
Product information
Latest procedure affecting product information:
IG1772
15/10/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Cinacalcet Viatris (previously Cinacalcet Mylan)
- Active substance
- cinacalcet hydrochloride
- International non-proprietary name (INN) or common name
- cinacalcet
- Therapeutic area (MeSH)
- Hyperparathyroidism, Secondary
- Hypercalcemia
- Anatomical therapeutic chemical (ATC) code
- H05BX01
Pharmacotherapeutic group
Calcium homeostasisTherapeutic indication
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.
Reduction of hypercalcaemia in patients with:
- parathyroid carcinoma
- primary HPT for whom parathyroidectomy
would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
News on Cinacalcet Viatris (previously Cinacalcet Mylan)
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