Cinacalcet Mylan

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

  



 

 

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1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 30 mg film-coated tablets. 

Cinacalcet Mylan 60 mg film-coated tablets. 

Cinacalcet Mylan 90 mg film-coated tablets. 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Cinacalcet Mylan 30 mg film-coated tablets 

Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride). 

 

Cinacalcet Mylan 60 mg film-coated tablets  

Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride). 

 

Cinacalcet Mylan 90 mg film-coated tablets 

Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride). 

 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet. 

 

Cinacalcet Mylan 30 mg film-coated tablets 

10.0 mm x 6.4 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one 

side of the tablet and CI30 on the other side. 

 

Cinacalcet Mylan 60 mg film-coated tablets  

12.5 mm x 8.0 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one 

side of the tablet and CI60 on the other side. 

 

Cinacalcet Mylan 90 mg film-coated tablets 

14.3 mm x 9.0 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one 

side of the tablet and CI90 on the other side. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

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 (see section 5.1).  

 

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. 

 



 

 

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4.2 Posology and method of administration 

 

Posology 

 

Secondary hyperparathyroidism: 

 

Adults and elderly (> 65 years) 

The recommended starting dose for adults is 30 mg once per day. Cinacalcet should be titrated every 2 

to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in 

dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l) in the intact PTH (iPTH) assay. PTH 

levels should be assessed at least 12 hours after dosing with cinacalcet. Reference should be made to 

current treatment guidelines.  

 

PTH should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet. PTH should be 

monitored approximately every 1-3 months during maintenance. Either the intact PTH (iPTH) or bio-
intact PTH (biPTH) may be used to measure PTH levels; treatment with cinacalcet does not alter the 

relationship between iPTH and biPTH.  

 

Dose adjustment based on serum calcium levels 

Corrected serum calcium should be measured and monitored and should be at or above the lower limit 

of the normal range prior to administration of first dose of cinacalcet (see section 4.4). The normal 

calcium range may differ depending on the methods used by your local laboratory.  

 

During dose titration, serum calcium levels should be monitored frequently, and within 1 week of 

initiation or dose adjustment of cinacalcet. Once the maintenance dose has been established, serum 

calcium should be measured approximately monthly. In the event that corrected serum calcium levels 

fall below 8.4 mg/dl (2.1 mmol/l) and/or symptoms of hypocalcaemia occur the following 

management is recommended: 

 

Corrected Serum calcium level or clinical 

symptoms of hypocalcaemia 

Recommendations 

< 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL 

(1.9 mmol/L), or in the presence of clinical 

symptoms of hypocalcaemia  

Calcium-containing phosphate binders, 

vitamin D sterols and/or adjustment of dialysis 

fluid calcium concentrations can be used to 

raise serum calcium according to clinical 

judgment.  

< 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL 

(1.9 mmol/L) or persistent symptoms of 

hypocalcaemia despite attempts to increase 

serum calcium  

Reduce or withhold dose of cinacalcet.  

Corrected Serum calcium level or clinical 

symptoms of hypocalcaemia 

Recommendations 

≤ 7.5 mg/dL (1.9 mmol/L) or persistent 

symptoms of hypocalcaemia and vitamin D 

cannot be increased  

Withhold administration of cinacalcet until 

serum calcium levels reach 8.0 mg/dL 

(2.0 mmol/L) and/or symptoms of 

hypocalcaemia have resolved.  

Treatment should be reinitiated using the next 

lowest dose of cinacalcet.  

 

Paediatric population 

Cinacalcet Mylan is not indicated for use in children and adolescents. Other pharmaceutical forms 

may be available for this population. 

 



 

 

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Parathyroid carcinoma and primary hyperparathyroidism: 

 

Adults and elderly (> 65 years) 

The recommended starting dose of Cinacalcet Mylan for adults is 30 mg twice per day. The dose of 

cinacalcet should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg 

twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum 

calcium concentration to or below the upper limit of normal. The maximum dose used in clinical trials 

was 90 mg four times daily.  

 

Serum calcium should be measured within 1 week after initiation or dose adjustment of cinacalcet. 

Once maintenance dose levels have been established, serum calcium should be measured every 2 to 

3 months. After titration to the maximum dose of cinacalcet, serum calcium should be periodically 

monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of 

cinacalcet therapy should be considered (see section 5.1).  

 

Paediatric population 

The safety and efficacy of cinacalcet in children for the treatment of parathyroid carcinoma and 

primary hyperparathyroidism have not been established. No data are available. 

 

Hepatic impairment 

No change in starting dose is necessary. Cinacalcet should be used with caution in patients with 

moderate to severe hepatic impairment and treatment should be closely monitored during dose titration 

and continued treatment (see sections 4.4 and 5.2).  

 

Method of administration 

 

For oral use. 

Tablets should be taken whole and should not be chewed, crushed or divided. 

It is recommended that Cinacalcet Mylan be taken with food or shortly after a meal, as studies have 

shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2).  

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

Hypocalcaemia (see sections 4.2 and 4.4). 

 

4.4 Special warnings and precautions for use 

 

Serum calcium 

Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult 

and paediatric patients treated with cinacalcet. Manifestations of hypocalcaemia may include 

paraesthesias, myalgias, cramping, tetany and convulsions. Decreases in serum calcium can also 

prolong the QT interval, potentially resulting in ventricular arrhythmia secondary to hypocalcaemia. 

Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with 

cinacalcet (see section 4.8). Caution is advised in patients with other risk factors for QT prolongation 

such as patients with known congenital long QT syndrome or patients receiving medicinal products 

known to cause QT prolongation.  

 

Since cinacalcet lowers serum calcium, patients should be monitored carefully for the occurrence of 

hypocalcaemia (see section 4.2). Serum calcium should be measured within 1 week after initiation or 

dose adjustment of cinacalcet. 

 

Cinacalcet treatment should not be initiated in patients with a serum calcium (corrected for albumin) 

below the lower limit of the normal range.  



 

 

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In Chronic Kidney Disease (CKD) patients receiving dialysis who were administered cinacalcet, 

approximately 30% of patients had at least one serum calcium value less than 7.5 mg/dl (1.9 mmol/l).  

 

CKD patients not on dialysis 

Cinacalcet is not indicated for CKD patients not on dialysis. Investigational studies have shown that 

CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum 

calcium levels < 8.4 mg/dl [2.1 mmol/l]) compared with cinacalcet-treated CKD patients on dialysis, 

which may be due to lower baseline calcium levels and/or the presence of residual kidney function. 

 

Seizures  

Cases of seizures have been reported in patients treated with cinacalcet (see section 4.8). The threshold 

for seizures is lowered by significant reductions in serum calcium levels. Therefore, serum calcium 

levels should be closely monitored in patients receiving cinacalcet, particularly in patients with a 

history of a seizure disorder. 

 

Hypotension and/or worsening heart failure  

Cases of hypotension and/or worsening heart failure have been reported in patients with impaired 

cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and 

may be mediated by reductions in serum calcium levels (see section 4.8). 

 

Co-administration with other medicinal products 

Administer cinacalcet with caution in patients receiving any other medicinal products known to lower 

serum calcium. Closely monitor serum calcium (see section 4.5). 

 

Patients receiving cinacalcet should not be given etelcalcetide. Concurrent administration may result 

in severe hypocalcaemia. 

 

General  

Adynamic bone disease may develop if PTH levels are chronically suppressed below approximately 

1.5 times the upper limit of normal with the iPTH assay. If PTH levels decrease below the 

recommended target range in patients treated with cinacalcet, the dose of cinacalcet and/or vitamin D 

sterols should be reduced or therapy discontinued.  

 

Testosterone levels  

Testosterone levels are often below the normal range in patients with end-stage renal disease. In a 

clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in 

the cinacalcet-treated patients and by 16.3% in the placebo-treated patients after 6 months of 

treatment. An open-label extension of this study showed no further reductions in free and total 

testosterone concentrations over a period of 3 years in cinacalcet-treated patients. The clinical 

significance of these reductions in serum testosterone is unknown.  

 

Hepatic impairment  

Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to 

severe hepatic impairment (Child-Pugh classification), cinacalcet should be used with caution in these 

patients and treatment should be closely monitored (see sections 4.2 and 5.2).   

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Medicinal products known to reduce serum calcium  

Concurrent administration of other medicinal products known to reduce serum calcium and cinacalcet 

may result in an increased risk of hypocalcaemia (see section 4.4). Patients receiving cinacalcet should 

not be given etelcalcetide (see section 4.4). 

 

Effect of other medicines on cinacalcet  



 

 

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Cinacalcet is metabolised in part by the enzyme CYP3A4. Co-administration of 200 mg, twice daily 

ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet 

levels. Dose adjustment of cinacalcet may be required if a patient receiving cinacalcet initiates or 

discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, 

voriconazole, ritonavir) or inducer (e.g. rifampicin) of this enzyme.  

 

In vitro data indicate that cinacalcet is in part metabolised by CYP1A2. Smoking induces CYP1A2; 

the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers. The 

effect of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not 

been studied. Dose adjustment may be necessary if a patient starts or stops smoking or when 

concomitant treatment with strong CYP1A2 inhibitors is initiated or discontinued.  

 

Calcium carbonate: Co-administration of calcium carbonate (single 1,500 mg dose) did not alter the 

pharmacokinetics of cinacalcet.  

 

Sevelamer: Co-administration of sevelamer (2,400 mg, three times a day) did not affect the 

pharmacokinetics of cinacalcet.  

 

Pantoprazole: Co-administration of pantoprazole (80 mg, once daily) did not alter the 

pharmacokinetics of cinacalcet.  

 

Effect of cinacalcet on other medicines  

Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): cinacalcet is a strong inhibitor 

of CYP2D6. Dose adjustments of concomitant medicinal products may be required when cinacalcet is 

administered with individually titrated, narrow therapeutic index substances that are predominantly 

metabolised by CYP2D6 (e.g. flecainide, propafenone, metoprolol, desipramine, nortriptyline, 

clomipramine).  

 

Desipramine: Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a 

tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine 

exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers.  

 

Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg 

dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers. 

 

Warfarin: Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics 

(as measured by prothrombin time and clotting factor VII) of warfarin.  

 

The lack of effect of cinacalcet on the pharmacokinetics of R-and S-warfarin and the absence of auto-

induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, 

CYP1A2 or CYP2C9 in humans.  

 

Midazolam: Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a 

CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam. These data suggest 

that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are 

metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including ciclosporin 

and tacrolimus.  

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

There are no clinical data from the use of cinacalcet in pregnant women. Animal studies do not 

indicate direct harmful effects with respect to pregnancy, parturition or postnatal development. No 

embryonal/foetal toxicities were seen in studies in pregnant rats and rabbits with the exception of 

decreased foetal body weights in rats at doses associated with maternal toxicities (see section 5.3). 



 

 

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Cinacalcet Mylan should be used during pregnancy only if the potential benefit justifies the potential 

risk to the foetus. 

 

Breast-feeding 

It is not known whether cinacalcet is excreted in human milk. Cinacalcet is excreted in the milk of 

lactating rats with a high milk to plasma ratio. Following careful benefit/risk assessment, a decision 

should be made to discontinue either breast-feeding or treatment with Cinacalcet Mylan. 

 

Fertility 

There are no clinical data relating to the effect of cinacalcet on fertility. There were no effects on 

fertility in animal studies. 

 

4.7 Effects on ability to drive and use machines 

 

Dizziness and seizures, which may have major influence on the ability to drive and use machines, have 

been reported by patients taking cinacalcet (see section 4.4). 

 

4.8 Undesirable effects 
 

a) Summary of the safety profile 
 

Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism 

Based on available data from patients receiving cinacalcet in placebo controlled studies and single-arm 

studies the most commonly reported adverse reactions were nausea and vomiting. Nausea and 

vomiting were mild to moderate in severity and transient in nature in the majority of patients. 

Discontinuation of therapy as a result of undesirable effects was mainly due to nausea and vomiting. 

 

b) Tabulated list of adverse reactions 
 
Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo 

controlled studies and single-arm studies based on best-evidence assessment of causality are listed 

below using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); 

uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known 

(cannot be estimated from the available data). 

 

Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: 

 
System organ class Very Common Common Not known 

Immune system disorders  Hypersensitivity reactions*  

Metabolism and nutrition 

disorders 

 Anorexia 

Decreased appetite 

 

Nervous system disorders  Seizures†  

Dizziness 

Paraesthesia 

Headache 

 

Cardiac disorders   Worsening heart failure* † 

QT prolongation and 

ventricular arrhythmia 

secondary to 

hypocalcaemia* † 

Vascular disorders  Hypotension  

Respiratory, thoracic and 

mediastinal disorders 

 Upper respiratory infection 

Dyspnoea 

Cough 

 

Gastrointestinal disorders Nausea 

Vomiting 

Dyspepsia 

Diarrhoea 

Abdominal pain 

 



 

 

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Abdominal pain - upper 

Constipation 

Skin and subcutaneous 

tissue disorders 

 Rash  

Musculoskeletal and 

connective tissue disorders 

 Myalgia 

Muscle spasms 

Back pain 

 

General disorders and 

administration site 

conditions 

 Asthenia  

Investigations  Hypocalcaemia† 

Hyperkalaemia 

Reduced testosterone 

levels† 

 

* see section c)  
† see section 4.4 

 

c) Description of selected adverse reactions  
 

Hypersensitivity reactions 

Hypersensitivity reactions including angioedema and urticaria have been identified during post-

marketing use of cinacalcet. The frequencies of the individual preferred terms including angioedema 

and urticaria cannot be estimated from available data.  

 

Hypotension and/or worsening heart failure 

There have been reports of idiosyncratic cases of hypotension and/or worsening heart failure in 

cinacalcet-treated patients with impaired cardiac function in post-marketing safety surveillance, the 

frequencies of which cannot be estimated from available data.  

 

QT prolongation and ventricular arrhythmia secondary to hypocalcaemia 

QT prolongation and ventricular arrhythmia secondary to hypocalcaemia have been identified during 

post-marketing use of cinacalcet, the frequencies of which cannot be estimated from available data 

(see section 4.4).  

 

d) Paediatric population  

 

Cinacalcet Mylan is not indicated for use in paediatric patients. The safety and efficacy of cinacalcet 

in the paediatric population have not been established. A fatal outcome was reported in a paediatric 

clinical trial patient with severe hypocalcaemia (see section 4.4). 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V.  

 

4.9 Overdose 
 

Doses titrated up to 300 mg once daily have been administered to patients receiving dialysis without 

adverse outcome. 

 

Overdose of cinacalcet may lead to hypocalcaemia. In the event of overdose, patients should be 

monitored for signs and symptoms of hypocalcaemia, and treatment should be symptomatic and 

supportive. Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for 

overdose. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

 

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5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents, ATC code: H05BX01 

 

Mechanism of action 

The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal 

regulator of PTH secretion. Cinacalcet is a calcimimetic agent which directly lowers PTH levels by 

increasing the sensitivity of the calcium sensing receptor to extracellular calcium. The reduction in 

PTH is associated with a concomitant decrease in serum calcium levels. 

 

Reductions in PTH levels correlate with cinacalcet concentration. 

 

After steady state is reached, serum calcium concentrations remain constant over the dosing interval. 

 

Secondary Hyperparathyroidism 

  

Three, 6 month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients 

with uncontrolled secondary HPT receiving dialysis (n=1,136). Demographic and baseline 

characteristics were representative of the dialysis patient population with secondary HPT. Mean 

baseline iPTH concentrations across the 3 studies were 733 and 683 pg/ml (77.8 and 72.4 pmol/l) for 

the cinacalcet and placebo groups, respectively. 66% of patients were receiving vitamin D sterols at 

study entry, and > 90% were receiving phosphate binders. Significant reductions in iPTH, serum 

calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet 

treated patients compared with placebo-treated patients receiving standard care, and the results were 

consistent across the 3 studies. In each of the studies, the primary endpoint (proportion of patients with 

an iPTH ≤ 250 pg/ml (≤ 26.5 pmol/l)) was achieved by 41%, 46%, and 35% of patients receiving 

cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo. Approximately 60% of 

cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent 

across the spectrum of baseline iPTH levels. The mean reductions in serum Ca x P, calcium, and 

phosphorus were 14%, 7% and 8%, respectively.  

 

Reductions in iPTH and Ca x P were maintained for up to 12 months of treatment. Cinacalcet 

decreased iPTH and Ca x P, calcium and phosphorus levels regardless of baseline iPTH or Ca x P 

level, dialysis modality (PD versus HD), duration of dialysis, and whether or not vitamin D sterols 

were administered. 

 

Reductions in PTH were associated with non-significant reductions of bone metabolism markers (bone 

specific alkaline phosphatase, N-telopeptide, bone turnover and bone fibrosis). In post-hoc analyses of 

pooled data from 6 and 12 months clinical studies, Kaplan-Meier estimates of bone fracture and 

parathyroidectomy were lower in the cinacalcet group compared with the control group. 

 

Investigational studies in patients with CKD and secondary HPT not undergoing dialysis indicated that 

cinacalcet reduced PTH levels to a similar extent as in patients with ESRD and secondary HPT 

receiving dialysis. However, efficacy, safety, optimal doses and treatment targets have not been 

established in treatment of predialytic renal failure patients. These studies show that CKD patients not 

undergoing dialysis treated with cinacalcet have an increased risk for hypocalcaemia compared with 

cinacalcet-treated ESRD patients receiving dialysis, which may be due to lower baseline calcium 

levels and/or the presence of residual kidney function. 

 

EVOLVE (EValuation Of Cinacalcet Therapy to Lower CardioVascular Events) was a randomised, 

double-blind clinical study evaluating cinacalcet versus placebo for the reduction of the risk of all-

cause mortality and cardiovascular events in 3,883 patients with secondary HPT and CKD receiving 

dialysis. The study did not meet its primary objective of demonstrating a reduction in risk of all-cause 



 

 

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mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, 

heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112). After adjusting for 

baseline characteristics in a secondary analysis, the HR for the primary composite endpoint was 0.88; 

95% CI: 0.79, 0.97. 

 

Parathyroid carcinoma and Primary Hyperparathyroidism  

In one study, 46 adult patients (29 with parathyroid carcinoma and 17 with primary HPT and severe 

hypercalcaemia (who had failed or had contraindications to parathyroidectomy) received cinacalcet for 

up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for 

patients with primary HPT). Cinacalcet was administered at doses ranging from 30 mg twice daily to 

90 mg four times daily. The primary endpoint of the study was a reduction of serum calcium of ≥ 

1 mg/dl (≥ 0.25 mmol/l). In patients with parathyroid carcinoma, mean serum calcium declined from 

14.1 mg/dl to 12.4 mg/dl (3.5 mmol/l to 3.1 mmol/l), while in patients with primary HPT, serum 

calcium levels declined from 12.7 mg/dl to 10.4 mg/dl (3.2 mmol/l to 2.6 mmol/l). Eighteen (18) of 29 

patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with primary HPT achieved a 

reduction in serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).  

 

In a 28 week placebo-controlled study, 67 adult patients with primary HPT who met criteria for 
parathyroidectomy on the basis of corrected total serum calcium (> 11.3 mg/dl (2.82 mmol/l) but ≤ 

12.5 mg/dl (3.12 mmol/l), but who were unable to undergo parathyroidectomy were included. 

Cinacalcet was initiated at a dose of 30 mg twice daily and titrated to maintain a corrected total serum 

calcium concentration within the normal range. A significantly higher percentage of cinacalcet treated 

patients achieved mean corrected total serum calcium concentration ≤ 10.3 mg/dl (2.57 mmol/l) and ≥ 

1 mg/dl (0.25 mmol/l) decrease from baseline in mean corrected total serum calcium concentration, 

when compared with the placebo treated patients (75.8% versus 0% and 84.8% versus 5.9% 

respectively). 
 

5.2 Pharmacokinetic properties 

 

Absorption 

After oral administration of cinacalcet, maximum plasma cinacalcet concentration is achieved in 

approximately 2 to 6 hours. Based on between-study comparisons, the absolute bioavailability of 

cinacalcet in fasted subjects has been estimated to be about 20-25%. Administration of cinacalcet with 

food results in an approximate 50-80% increase in cinacalcet bioavailability. Increases in plasma 

cinacalcet concentration are similar, regardless of the fat content of the meal.  

 

At doses above 200 mg, the absorption was saturated probably due to poor solubility.  

 

Distribution  

The volume of distribution is high (approximately 1,000 litres), indicating extensive distribution. 

Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood 

cells.  

 

After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of 

approximately 6 hours and a terminal half-life of 30 to 40 hours. Steady state levels of cinacalcet are 

achieved within 7 days with minimal accumulation. The pharmacokinetics of cinacalcet does not 

change over time.  

 

Biotransformation  

Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the 

contribution of CYP1A2 has not been characterised clinically). The major circulating metabolites are 

inactive.  

 



 

 

11 
 

Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other 

CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, 

CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.  

 

Elimination  

After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and 

extensively metabolised by oxidation followed by conjugation. Renal excretion of metabolites was the 

prevalent route of elimination of radioactivity. Approximately 80% of the dose was recovered in the 

urine and 15% in the faeces.  

 

Linearity/non-linearity  

The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg 

once daily.  

 

Pharmacokinetic/pharmacodynamic relationships  

Soon after dosing, PTH begins to decrease until a nadir at approximately 2 to 6 hours post dose, 

corresponding with cinacalcet Cmax. Thereafter, as cinacalcet levels begin to decline, PTH levels 

increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the 
end of the once-daily dosing interval. PTH levels in cinacalcet clinical trials were measured at the end 

of the dosing interval. 

 

Special populations 

 

Elderly 

There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet. 

 

Renal insufficiency 

The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal 

insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy 

volunteers. 

 

Hepatic insufficiency 

Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet. Compared to 

subjects with normal liver function, average AUC of cinacalcet was approximately 2-fold higher in 

subjects with moderate impairment and approximately 4-fold higher in subjects with severe 

impairment. The mean half-life of cinacalcet is prolonged by 33% and 70% in patients with moderate 

and severe hepatic impairment, respectively. Protein binding of cinacalcet is not affected by impaired 

hepatic function. Because doses are titrated for each subject based on safety and efficacy parameters, 

no additional dose adjustment is necessary for subjects with hepatic impairment (see sections 4.2 and 

4.4). 

 

Gender  

Clearance of cinacalcet may be lower in women than in men. Because doses are titrated for each 

subject, no additional dose adjustment is necessary based on gender. 

 

Paediatric population 

The pharmacokinetics of cinacalcet was studied in paediatric patients with ESRD receiving dialysis 

aged 3 to 17 years of age. After single and multiple once daily oral doses of cinacalcet, plasma 

cinacalcet concentrations (Cmax and AUC values after normalisation by dose and weight) were similar 

to those observed in adult patients.  

 

A population pharmacokinetic analysis was performed to evaluate the effects of demographic 

characteristics. This analysis showed no significant impact of age, sex, race, body surface area, and 

body weight on cinacalcet pharmacokinetics. 

 



 

 

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Smoking  

Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2-

mediated metabolism. If a patient stops or starts smoking, cinacalcet plasma levels may change and 

dose adjustment may be necessary. 

 

5.3 Preclinical safety data 

 

Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the 

maximum human dose for secondary HPT (180 mg daily). The non-teratogenic dose in rats was 4.4 

times, on an AUC basis, the maximum dose for secondary HPT. There were no effects on fertility in 

males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small 

population of patients administered a maximum clinical dose of 360 mg daily would be approximately 

half those given above).  

 

In pregnant rats, there were slight decreases in body weight and food consumption at the highest dose. 

Decreased foetal weights were seen in rats at doses where dams had severe hypocalcaemia. Cinacalcet 

has been shown to cross the placental barrier in rabbits.  

 

Cinacalcet did not show any genotoxic or carcinogenic potential. Safety margins from the toxicology 

studies are small due to the dose-limiting hypocalcaemia observed in the animal models. Cataracts and 

lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were 

not observed in dogs or monkeys or in clinical studies where cataract formation was monitored. 

Cataracts are known to occur in rodents as a result of hypocalcaemia.  

 

In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 

12 fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same 

experimental conditions. The clinical relevance is unknown, however, the potential for cinacalcet to 

act on these secondary targets cannot be fully excluded. 

 

In toxicity studies in juvenile dogs, tremors secondary to decreased serum calcium, emesis, decreased 

body weight and body weight gain, decreased red cell mass, slight decreases in bone densitometry 

parameters, reversible widening of the growth plates of long bones, and histological lymphoid changes 

(restricted to the thoracic cavity and attributed to chronic emesis) were observed. All of these effects 

were seen at a systemic exposure, on an AUC basis, approximately equivalent to the exposure in 

patients at the maximum dose for secondary HPT. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core: 

Cellulose, microcrystalline  

Silica, colloidal anhydrous  

Povidone 

Crospovidone 

Magnesium stearate 

 

Film-coat: 

Hypromellose  

Titanium dioxide (E171)  

Triacetin  

Indigo carmine aluminium lake (E132)  

Iron oxide yellow (E172) 



 

 

13 
 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

2 years 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions.  

 

6.5 Nature and contents of container 

 

Cinacalcet Mylan 30 mg, 60 mg and 90 mg film-coated tablets 

PVC/PVdC/Alu blisters of 28 tablets and perforated unit dose blisters of 28 x 1, 30 x 1 and 84 x 1 

tablets. 
 

Cinacalcet Mylan 30 mg film-coated tablets 

HDPE bottle with polypropylene (PP) screw cap closure with induction sealing liner containing 100 

tablets. 
 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal  

 

No special requirements for disposal. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allee des Parcs 

69 800 Saint Priest 

France 

 

 

8. MARKETING AUTHORISATION NUMBERS  

 

EU/1/15/1054/001 

EU/1/15/1054/002 

EU/1/15/1054/003 

EU/1/15/1054/004 

EU/1/15/1054/005 

EU/1/15/1054/006 

EU/1/15/1054/007 

EU/1/15/1054/008 

EU/1/15/1054/009 

EU/1/15/1054/010 

EU/1/15/1054/011 

EU/1/15/1054/012 



 

 

14 
 

EU/1/15/1054/013 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 19 November 2015 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

 

  

http://www.ema.europa.eu./


 

 

15 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH 

RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 



 

 

16 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturers responsible for batch release 

 

Mylan Hungary Kft 

H-2900 Komárom, Mylan utca 1 

Hungary 

 

McDermott Laboratories Limited trading as Gerard Laboratories 

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 

Ireland 

 

Mylan Germany GmbH 

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 

Bad Homburg v. d. Hoehe 

Hessen, 61352,  

Germany 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  

 

Medicinal product subject to medical prescription. 

 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic Safety Update Reports 
 

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   

 

• Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in 

the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 

subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 



 

 

17 
 

 

  



 

 

18 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 

 

 

 

  



 

 

19 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

 

 

 

 

 

 

  



 

 

20 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON (BLISTERS AND BOTTLES) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 30 mg film-coated tablets 

cinacalcet  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 

28 Film-coated tablets 

28 x 1 Film-coated tablets 

30 x 1 Film-coated tablets 

84 x 1 Film-coated tablets  

100 Film-coated tablets 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

 

21 
 

9. SPECIAL STORAGE CONDITIONS 

 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allee des Parcs 

69 800 Saint Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBERS  

 

EU/1/15/1054/001  

EU/1/15/1054/002  

EU/1/15/1054/003  

EU/1/15/1054/004 

EU/1/15/1054/011 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Cinacalcet Mylan 30 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 



 

 

22 
 

SN: 

NN:  



 

 

23 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

 

LABEL (BOTTLES) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 30 mg film-coated tablets 

cinacalcet  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets  

 

100 Film-coated tablets 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

 

24 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allee des Parcs 

69 800 Saint Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBERS  

 

EU/1/15/1054/002  

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Cinacalcet Mylan 30 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN:  



 

 

25 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 30 mg film-coated tablets 

cinacalcet  

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



 

 

26 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 60 mg film-coated tablets 

cinacalcet  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 

28 Film-coated tablets 

28 x 1 Film-coated tablets 

30 x 1 Film-coated tablets 

84 x 1 Film-coated tablets 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 



 

 

27 
 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allee des Parcs 

69 800 Saint Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBERS  

 

EU/1/15/1054/005  

EU/1/15/1054/006  

EU/1/15/1054/007  

EU/1/15/1054/012 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Cinacalcet Mylan 60 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



 

 

28 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 60 mg film-coated tablets 

cinacalcet  

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



 

 

29 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 90 mg film-coated tablets 

cinacalcet  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride). 

 

 

3. LIST OF EXCIPIENTS 

 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Film-coated tablets 

 

28 Film-coated tablets 

28 x 1 Film-coated tablets 

30 x 1 Film-coated tablets 

84 x 1 Film-coated tablets 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Oral use. 

 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 



 

 

30 
 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117 Allee des Parcs 

69 800 Saint Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBERS  

 

EU/1/15/1054/008  

EU/1/15/1054/009  

EU/1/15/1054/010 

EU/1/15/1054/013 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

Cinacalcet Mylan 90 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



 

 

31 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Cinacalcet Mylan 90 mg film-coated tablets 

cinacalcet  

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

 

  



 

 

32 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

  



 

 

33 
 

Package leaflet: Information for the patient 

 

Cinacalcet Mylan 30 mg film-coated tablets 

Cinacalcet Mylan 60 mg film-coated tablets 

Cinacalcet Mylan 90 mg film-coated tablets 

cinacalcet  

 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What Cinacalcet Mylan is and what it is used for 

2. What you need to know before you take Cinacalcet Mylan  

3. How to take Cinacalcet Mylan 

4. Possible side effects 

5. How to store Cinacalcet Mylan  

6. Contents of the pack and other information 

 

 

1. What Cinacalcet Mylan is and what it is used for 
 

Cinacalcet Mylan contains the active ingredient cinacalcet, which works by controlling the levels of 

parathyroid hormone (PTH), calcium and phosphorous in your body. It is used to treat problems with 

organs called parathyroid glands. The parathyroids are four small glands in the neck, near the thyroid 

gland, that produce parathyroid hormone (PTH).  

 

Cinacalcet Mylan is used:  

• to treat secondary hyperparathyroidism in patients with serious kidney disease who need 
dialysis to clear their blood of waste products  

• to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid 
cancer  

• to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary 
hyperparathyroidism when removal of the parathyroid gland is not possible.  

 

In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid glands. 

“Primary” means that the hyperparathyroidism is not caused by any other condition and “secondary” 

means that the hyperparathyroidism is caused by another condition, e.g. kidney disease. Both primary 

and secondary hyperparathyroidism can cause loss of calcium in the bones, which can lead to bone 

pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma. 

 

 

2. What you need to know before you take Cinacalcet Mylan 
 

Do not take Cinacalcet Mylan if you are allergic to cinacalcet or any of the other ingredients of this 

medicine (listed in section 6). 

 



 

 

34 
 

Do not take Cinacalcet Mylan if you have low levels of calcium in your blood. Your doctor will 

monitor your blood calcium levels. 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking Cinacalcet Mylan. 

Before you start taking Cinacalcet Mylan, tell your doctor if you have or have ever had:  

• seizures (fits or convulsions). The risk of having seizures is higher if you have had them before;  

• liver problems; 

• heart failure.  
 

Cinacalcet Mylan reduces calcium levels. Life threatening events and fatal outcomes associated with 

low calcium levels (hypocalcaemia) have been reported in patients treated with cinacalcet.  

 

Please tell your doctor if you experience any of the following which may be signs of low calcium 

levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or 

around your mouth or seizures, confusion or loss of consciousness while being treated with Cinacalcet 

Mylan. 

 

Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an 

unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines 

known to cause heart rhythm problems, while taking Cinacalcet Mylan.  

 

For additional information see section 4. 

 

During treatment with Cinacalcet Mylan, tell your doctor:  

• if you start or stop smoking, as this may affect the way Cinacalcet Mylan works.  
 

Children and adolescents 

Children under the age of 18 must not take Cinacalcet Mylan. 

 

If you are being treated for secondary hyperparathyroidism, your doctor should monitor your calcium 

levels before starting treatment with Cinacalcet Mylan and during treatment with Cinacalcet Mylan. 

You should inform your doctor if you experience any of the signs of low calcium levels as described 

above.    

  

It is important that you take your dose of Cinacalcet Mylan as advised by your doctor. 

 

Other medicines and Cinacalcet Mylan  

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines 
particularly etelcalcetide or any other medicines that lower the level of calcium in your blood. 

 

You should not take Cinacalcet Mylan together with etelcalcetide. 

 

Tell your doctor if you are taking the following medicines. 

Medicines such as these can affect how Cinacalcet Mylan works: 

• medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole) 

• medicines used to treat bacterial infections (telithromycin, rifampicin and ciprofloxacin)  

• a medicine used to treat HIV infection and AIDS (ritonavir)  

• a medicine used to treat depression (fluvoxamine).  
 

Cinacalcet Mylan may affect how medicines such as the following work:  

• medicines used to treat depression (amitriptyline, desipramine, nortriptyline and clomipramine) 

• a medicine used to relieve cough (dextromethorphan) 

• medicines used to treat changes in heart rate (flecainide and propafenone)  

• a medicine used to treat high blood pressure (metoprolol).  



 

 

35 
 

 

Cinacalcet Mylan with food and drink 

Cinacalcet Mylan should be taken with or shortly after food. 

 

Pregnancy, breast-feeding and fertility 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before taking this medicine. 

 

Cinacalcet has not been tested in pregnant women. In case of pregnancy, your doctor may decide to 

modify your treatment, as cinacalcet might harm the unborn baby. 

 

It is not known whether cinacalcet is excreted in human milk. Your doctor will discuss with you if you 

should discontinue either breast-feeding or treatment with Cinacalcet Mylan. 

 

Driving and using machines 

Dizziness and seizures have been reported by patients taking cinacalcet. If you experience these side 

effects do not drive or operate machines. 

 

 

3. How to take Cinacalcet Mylan 
 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet Mylan you must take.  

 

Cinacalcet Mylan must be taken orally, with or shortly after food. The tablets must be taken whole and 

are not to be chewed, crushed or divided.  

 

Your doctor will take regular blood samples during treatment to monitor your progress and will adjust 

your dose if necessary.  

 

If you are being treated for secondary hyperparathyroidism  

The recommended starting dose for Cinacalcet Mylan is 30 mg (one tablet) once per day.  

 

If you are being treated for parathyroid cancer or primary hyperparathyroidism  

The recommended starting dose for Cinacalcet Mylan is 30 mg (one tablet) twice per day. 

 

If you take more Cinacalcet Mylan than you should 

If you take more Cinacalcet Mylan than you should you must contact your doctor immediately. 

Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps 

and seizures.  

 

If you forget to take Cinacalcet Mylan 

Do not take a double dose to make up for a forgotten dose.  

 

If you have forgotten a dose of Cinacalcet Mylan, you should take your next dose as normal.  

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Please tell your doctor immediately: 

 



 

 

36 
 

• If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures. 
These may be signs that your calcium levels are too low (hypocalcaemia). 

• If you experience swelling of the face, lips, mouth, tongue or throat which may cause difficulty 
in swallowing or breathing (angioedema). 

 

Other possible side effects: 

 

Very common: may affect more than 1 in 10 people 

• nausea and vomiting, these side effects are normally quite mild and do not last for long. 
 

Common: may affect up to 1 in 10 people 

• dizziness 

• numbness or tingling sensation (paraesthesia) 

• loss (anorexia) or decrease of appetite 

• muscle pain (myalgia) 

• weakness (asthenia) 

• rash 

• reduced testosterone levels 

• high potassium levels in the blood (hyperkalaemia) 

• allergic reactions (hypersensitivity) 

• headache 

• seizures (convulsions or fits) 

• low blood pressure (hypotension) 

• upper respiratory infection 

• breathing difficulties (dyspnoea) 

• cough 

• indigestion (dyspepsia) 

• diarrhoea 

• abdominal pain, abdominal pain - upper 

• constipation 

• muscle spasms 

• back pain 

• low calcium levels in the blood (hypocalcaemia). 
 

Not known: frequency cannot be estimated from the available data 

• Hives (urticaria).  

• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or 
breathing (angioedema).  

• Unusually fast or pounding heart beat which may be associated with low levels of calcium in 
your blood (QT prolongation and ventricular arrhythmia secondary to hypocalcaemia).  

 

After taking cinacalcet a very small number of patients with heart failure had worsening of their 

condition and/or low blood pressure (hypotension). 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Cinacalcet Mylan 

 

Keep this medicine out of the sight and reach of children. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

 

37 
 

 

Do not use this medicine after the expiry date which is stated on the blister, carton or bottle after EXP. 

The expiry date refers to the last day of that month. 

 

This medicine does not require any special storage conditions. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Cinacalcet Mylan contains 

The active substance is cinacalcet. Each film-coated tablet contains 30 mg, 60 mg or 90 mg of 

cinacalcet (as hydrochloride). 

 

The other ingredients are cellulose, microcrystalline; silica, colloidal anhydrous; povidone; 

crospovidone; magnesium stearate.  

 

The tablet coating contains hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132), 

iron oxide yellow (E172). 

  

What Cinacalcet Mylan looks like and contents of the pack 

 

Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are green, oval, biconvex, bevelled edge 

tablets marked with M on one side of the tablet and CI30, CI60 or CI90 on the other side.   

 

Cinacalcet Mylan 30 mg, 60 mg, 90 mg film-coated tablets are available in blister packs of 28 tablets 

and perforated unit dose blister packs of 28 x 1, 30 x 1 and 84 x 1 tablets.  

 

Cinacalcet Mylan 30 mg film-coated tablets are available in plastic bottles of 100 tablets.  

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder  

Mylan S.A.S. 

117 Allee des Parcs 

69 800 Saint Priest 

France 

 

Manufacturers 

Mylan Hungary Kft 

H-2900 Komárom, Mylan utca 1 

Hungary 

 

McDermott Laboratories Limited trading as Gerard Laboratories 

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 

Ireland 

 

 

Mylan Germany GmbH 

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 

Bad Homburg v. d. Hoehe 

Hessen, 61352,  

Germany 



 

 

38 
 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

Lietuva 

BGP Products UAB 

Tel: + 370 5 205 1288 

 

България  

Майлан ЕООД 

Тел: +359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: + 32 (0)2 658 61 00 

(Belgique/Belgien) 

 

Česká republika 

Mylan Healthcare CZ  s.r.o. 

Tel: + 420 222 004 400 

Magyarország  

Mylan EPD Kft 

Tel: + 36 1 465 2100 

 

Danmark 

Mylan Denmark ApS 

Tel: +45  28 11 69 32 

 

 

Malta 

V.J. Salomone Pharma Ltd 

Tel: + 356 21 22 01 74 

 

Deutschland 

Mylan Healthcare GmbH 

Tel:  +49 800 0700 800 

Nederland 

Mylan BV 

Tel:  +31 (0)20 426 3300 

 

Eesti 

BGP Products Switzerland GmbH Eesti filiaal 

Tel: + 372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

 

Ελλάδα  

Generics Pharma Hellas ΕΠΕ 

Τηλ:  +30 210 993 6410  

 

Österreich 

Arcana Arzneimittel GmbH 

Tel: +43 1 416 2418 

 

España 

Mylan Pharmaceuticals, S.L. 

Tel: + 34 900 102 712 

 

Polska 

Mylan Healthcare Sp. z.o.o. 

Tel: + 48 22 546 64 00 

 

France 

Mylan S.A.S 

Tel: + 33 4 37 25 75 00 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 56 

 

Hrvatska  

Mylan Hrvatska d.o.o.  

Tel: +385 1 23 50 599 

 

Ireland 

Mylan Ireland Limited 

Tel: +353 (0) 87 1694982 

 

 

România 

BGP Products SRL 

Tel: +40 372 579 000 

 

Slovenija 

Mylan Healthcare d.o.o. 

Tel: + 386 1 23 63 180 

 

Ísland 

Icepharma hf 

Tel: +354 540 8000  

 

 

Slovenská republika 

Mylan s.r.o. 

Tel: +421 2 32 199 100 



 

 

39 
 

Italia 

Mylan Italia S.r.l. 

Tel: + 39 02 612 46921 

 

Suomi/Finland 

Mylan Finland OY 

Puh/Tel: +358 20 720 9555 

 

Κύπρος  

Varnavas Hadjipanayis Ltd   

Τηλ: +357 2220 7700  

 

 

Sverige 

Mylan AB 

Tel: + 46 855 522 750 

Latvija 

Mylan Healthcare SIA 

Tel: +371 676 055 80 

 

United Kingdom 

Generics [UK] Ltd 

Tel: +44 1707 853000 

 

 

This leaflet was last revised in {MM/YYYY}. 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET