cinacalcet
Cinacalcet Accordpharma, Cinacalcet Viatris (previously Cinacalcet Mylan) · ATC code H05BX01
Brand names: Cinacalcet Medice, Cinacalcet Ratiopharm, Cinacalcet Stada, Cinglan, Cinacalcet Al, Cinacalcet Amarox, Cinacalcet Ascend, Cinacalcet Devatis, Cinacalcet Heumann, Cinacalcet Qilu, Cinacalcet Sigillata, Cinacalcet Tillomed, Cinacalcet Zentiva, Cineset, Cynacal …
- Key facts
- Active substance
- cinacalcet
- ATC code
- H05BX01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Cinacalcet Accordpharma 30 mg film-coated tablets / Cinacalcet Accordpharma 60 mg film-coated tablets / Cinacalcet Accordpharma 90 mg film-coated tablets
- Information as of
- 2026-10-27
Key facts
Cinacalcet is a calcimimetic that lowers parathyroid hormone secretion. It is used for secondary hyperparathyroidism on dialysis and for hypercalcaemia in parathyroid carcinoma or primary hyperparathyroidism.
What it is used for
- Secondary hyperparathyroidism in adults with end-stage renal disease on maintenance dialysis
- Secondary hyperparathyroidism in children aged 3 years and older on dialysis not adequately controlled with standard of care
- Reduction of hypercalcaemia in adults with parathyroid carcinoma
- Primary hyperparathyroidism in adults for whom parathyroidectomy is indicated but not clinically appropriate or contraindicated
Dosing
- Secondary HPT, adults: start 30 mg once daily, titrate every 2 to 4 weeks to a maximum of 180 mg once daily; target PTH in dialysis patients 150-300 pg/mL
- Measure PTH 1 to 4 weeks after starting or adjusting; serum calcium within 1 week of starting or adjusting
- Low serum calcium or hypocalcaemia symptoms: reduce or withhold dose (scheme in the full text)
- Children aged 3 years and older: starting dose up to 0.20 mg/kg once daily based on dry weight
- Parathyroid carcinoma and primary HPT: separate titration scheme in the full text
- Moderate to severe hepatic impairment: use with caution and monitor closely
Contraindications
- Hypersensitivity to the active substance or any excipient
- Hypocalcaemia
Important warnings
- Life-threatening and fatal events associated with hypocalcaemia in adults and children; monitor serum calcium carefully
- QT prolongation and ventricular arrhythmia reported; caution with other QT risk factors
- Do not start if corrected serum calcium is below the lower limit of normal
- Seizures and dizziness can occur
Side effects
- Most common: nausea and vomiting, mostly mild to moderate and transient
- Common: hypersensitivity reactions, anorexia, seizures, dizziness, paraesthesia, headache, hypotension
- Frequency not known: worsening heart failure, QT prolongation
Interactions
- Other calcium-lowering medicines increase hypocalcaemia risk; do not give with etelcalcetide
- Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, ritonavir) or inducers (rifampicin) may require dose adjustment; smoking affects clearance
- Cinacalcet is a strong CYP2D6 inhibitor: doses of e.g. flecainide, propafenone, metoprolol, desipramine may need adjustment
Pregnancy and breastfeeding
- No clinical data; use in pregnancy only if benefit justifies the risk to the foetus
- Unknown whether excreted in human milk; decide on stopping breast-feeding or treatment after benefit/risk assessment
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Cinacalcet Accordpharma · genericAccord Healthcare S.L.U. · EMEA/H/C/005236
- Cinacalcet Viatris (previously Cinacalcet Mylan) · genericMylan Pharmaceuticals Limited · EMEA/H/C/004014
Source: European Medicines Agency (EMA), product information
Austria
- Cinacalcet MediceMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
- Cinacalcet RatiopharmTeva B.V · 1 register entry
- Cinacalcet StadaStada Arzneimittel Gmbh · 1 register entry
- CinglanG.L. Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Cinacalcet AlAliud Pharma Gmbh · 2 register entries
- Cinacalcet AmaroxAmarox Pharma Gmbh · 2 register entries
- Cinacalcet AscendAscend Gmbh · 1 register entry
- Cinacalcet DevatisDevatis Gmbh · 1 register entry
- Cinacalcet HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Cinacalcet MediceMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
- Cinacalcet QiluQilu Pharma Spain S.L. · 1 register entry
- Cinacalcet RatiopharmRatiopharm Gmbh · 1 register entry
- Cinacalcet SigillataSigillata Limited · 1 register entry
- Cinacalcet StadaStadapharm Gmbh · 2 register entries
- Cinacalcet TillomedTillomed Pharma Gmbh · 1 register entry
- Cinacalcet ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- CinesetNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- CynacalVEM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- NefrosetİLKO İLAÇ SAN.VE TİC. A.Ş. · 3 register entries
- PimaroDEVA HOLDİNG A.Ş. · 3 register entries
- ViscapABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 23 more European countries
- Belgium
- Cinacalcet Ab
- Bulgaria
- Синакалцет Тева, Синакалцет Хитън
- Croatia
- Cinakalcet
- Cyprus
- Cinacalcet (Ωσ Hydrochloride) Pharmazac, Cinacalcet Rafarm, Cinacalcet/Pharmazac
- Czechia
- Cinacalcet Heaton, Cinacalcet Stada, Cinacalcet Zentiva
- Denmark
- Cinacalcet Amarox, Cinacalcet Glenmark, Cinacalcet Orion, Cinacalcet Sigillata, Cinacalcet Stada, Cinacalcet Teva
- Finland
- Cinacalcet Accord, Cinacalcet Orion, Cinacalcet Stada, Sinafex
- France
- Cinacalcet Arrow, Cinacalcet Bgr, Cinacalcet Biogaran, Cinacalcet Cristers, Cinacalcet Eg, Cinacalcet Evolugen, Cinacalcet Qilu, Cinacalcet Sandoz, Cinacalcet Teva, Cinacalcet Zentiva
- Greece
- Calcedem, Cinacalcet Faran, Cinacalcet Genepharm, Cinacalcet Rafarm, Cinacalcet Stada, Cinacalcet Teva, Cinacalcet Ωσ Υδροχλωρική Pharmazac, Cinacalcetωσ Υδροχλωρική Pharmazac
- Hungary
- Cinacalcet Onkogen
- Iceland
- Cinacalcet Accordpharma, Cinacalcet Stada, Cinacalcet Viatris, Cinacalcet Wh
- Ireland
- Cinacalcet Clonmel, Cinacalcet Teva
- Italy
- Cinacalcet Abdi, Cinacalcet Aurobindo, Cinacalcet Eg, Cinacalcet Glenmark, Cinacalcet Qilu, Cinacalcet Tillomed
- Liechtenstein
- Cinacalcet Accordpharma, Cinacalcet Viatris
- Malta
- Cinacalcet Clonmel, Cinacalcet Heaton
- Netherlands
- Calcedem, Cinacalcet Abdi, Cinacalcet Amarox, Cinacalcet Arx, Cinacalcet Cf, Cinacalcet Devatis, Cinacalcet Doc, Cinacalcet Genepharm, Cinacalcet Genthon, Cinacalcet Glenmark, Cinacalcet Heaton, Cinacalcet Hydrochloride Aurobindo, Cinacalcet Macleods, Cinacalcet Pharmazac, Cinacalcet Rafarm, Cinacalcet Teva, Cinacalcet Will Pharma, Cinglan
- Norway
- Cinacalcet
- Poland
- Cinacalcet Aurovitas
- Portugal
- Cinacalcet Basi, Cinacalcet Generis
- Romania
- Cinacalcet Heaton
- Slovakia
- Cinacalcet Heaton, Cinacalcet Pharmsol, Cinacalcet Teva
- Spain
- Cinacalcet Abdi, Cinacalcet Aurovitas, Cinacalcet Basi, Cinacalcet Glenmark, Cinacalcet Macleods, Cinacalcet Normon, Cinacalcet Pharmsol, Cinacalcet Qilu, Cinacalcet Stada, Cinacalcet Tarbis, Cinacalcet Tillomed
- Sweden
- Cinacalcet Amarox, Cinacalcet Glenmark, Cinacalcet Orion, Cinacalcet Stada, Cinacalcet Teva
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Cinacalcet Accordpharma – EPAR, Product Information (OF THE TEXT Detailed information on this product is availabl). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/cinacalcet-accordpharma-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.