Cinacalcet Accordpharma is a medicine used to treat: - secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products); - 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 Accordpharma contains the active substance cinacalcet and is a ‘generic medicine’. This means that Cinacalcet Accordpharma contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Mimpara.
Therapeutic Indication
### Therapeutic indication **Secondary hyperparathyroidism** Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). **Parathyroid carcinoma and primary hyperparathyroidism in adults** Reduction of hypercalcaemia in adult 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.
Therapeutic Area (MeSH)
ATC Code
H05BX01
ATC Item
cinacalcet
Pharmacotherapeutic Group
Calcium homeostasis
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| cinacalcet hydrochloride | N/A | 西那卡塞 |
EMA Name
Cinacalcet Accordpharma
Medicine Name
Cinacalcet Accordpharma
Aliases
N/A
