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TEVA-CINACALCET is a brand name for Cinacalcet, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE......................................................................................... 3 CONTRAINDICATIONS .............................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Studies were conducted in patients with secondary hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD) receiving dialysis, parathyroid carcinoma or primary HPT. Cinacalcet hydrochloride was safe and generally well tolerated.
Hypocalcemia Cinacalcet hydrochloride lowers serum calcium, and therefore patients should be carefully monitored for the occurrence of hypocalcemia (see Monitoring and Laboratory Tests). Potential manifestations of hypocalcemia include paresthesias, myalgias, cramping, tetany, and convulsions.
Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia secondary to hypocalcemia have been reported in patients treated with cinacalcet hydrochloride.
Caution is advised in patients with other risk factors for QT prolongation such as patients with known congenital long QT syndrome or patients receiving drugs known to cause QT prolongation or lower serum calcium. (see WARNINGS AND PRECAUTIONS).
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Secondary Hyperparathyroidism in Patients with CKD Receiving Dialysis In three double-blind placebo-controlled clinical trials, 1126 CKD patients receiving dialysis received study drug (656 cinacalcet hydrochloride, 470 placebo) for up to six months.
Adverse events reported during the studies were typical for the dialysis patient population. The most frequently reported adverse events (incidence of at least 5% in the cinacalcet hydrochloride-treated group) are provided in Table 1.
The most frequently reported events in the cinacalcet hydrochloride group were nausea and vomiting which were generally mild to moderate in severity, brief in duration, and infrequently led to discontinuation of study drug. 9 Table 1.
Adverse Event Incidence (≥ 5%) in Patients Receiving Dialysis Preferred Term Placebo (n = 470) % C inacalcet hydrochloride (n = 656) % Nausea 19 31 Vomiting 15 27 Diarrhea 20 21 Headache 17 16 Myalgia 14 15 Pain Abdominal 14 12 Infection Upper Respiratory 13 12 Dizziness 8 10 Dyspnea 9 9 Pain Limb 10 9 Dyspepsia 8 8 Arthralgia 9 7 Fever 10 7 Fatigue 7 7 Hypertension 5 7 Hypotension 12 7 Edema Peripheral 7 7 Asthenia 4 7 Cough 7 6 Pruritus 7 6 Anorexia 4 6 Thrombosis Vascular Access 7 6 Pain Chest, Non-Cardiac 4 6 Access Infection 4 5 The incidence of serious adverse events (29% vs 31%) and deaths (2% vs 3%) was similar in the cinacalcet hydrochloride and placebo groups, respectively.
TEVA-CINACALCET is contraindicated in patients with hypersensitivity to any of the components of this product. TEVA-CINACALCET should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
For a complete listing of the nonmedicinal ingredients see DOSAGE FORMS, COMPOSITION AND PACKAGING section. 0 pmol/L. 0 pmol/L in patients receiving dialysis treated with TEVA-CINACALCET, the dose of TEVA-CINACALCET and/or vitamin D sterols should be reduced or therapy discontinued.
Carcinogenesis and Mutagenesis Cinacalcet hydrochloride, administered orally for 104 weeks, showed no evidence of carcinogenic potential in mice and rats. Doses administered to mice and rats resulted in total systemic exposure (AUCs) 2 times the exposures observed in humans.
The nature, incidence, and distribution of tumours in rats and mice of both sexes did not indicate any cinacalcet hydrochloride-induced carcinogenesis. A decreased incidence of thyroid C-cell adenomas was observed in rats treated with cinacalcet hydrochloride.
Cinacalcet hydrochloride was negative in the Ames assay, chromosomal aberration assay, Chinese Hamster Ovary HGPRT forward mutation assay, and in the mouse micronucleus assay. These tests indicate that cinacalcet hydrochloride has no genetic toxicity either with respect to DNA damage, including gene mutations, large scale chromosomal damage, recombinations or numerical changes.
Cardiovascular Hypotension and/or Worsening Heart Failure In post-marketing safety surveillance, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet hydrochloride could not be completely excluded and may be mediated by reductions in serum calcium levels.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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7% (5/641) of placebo-treated patients across all completed placebo-controlled trials. 4% (2/470) of placebo-treated patients in the three double-blind placebo-controlled clinical trials in CKD patients receiving dialysis (see WARNINGS AND PRECAUTIONS).
12-Month Experience with Cinacalcet hydrochloride in Secondary Hyperparathyroidism Two hundred sixty-six patients from the two pivotal phase 3 studies continued to receive cinacalcet hydrochloride or placebo treatment in a 6-month double-blind extension study (12-month total treatment duration).
The incidence and nature of adverse events in this study were similar in the two treatment groups, and comparable to those observed in the pivotal phase 3 studies. 5 years. The safety profile of cinacalcet hydrochloride in these patient populations is generally consistent with that seen in patients with CKD receiving dialysis.
The most frequent adverse drug reactions in these patient populations were nausea and vomiting. 7% (1/140) of cinacalcet hydrochloride-treated patients and 0% (0/46) of placebo-treated patients in the clinical trials in patients with primary HPT or parathyroid carcinoma (see WARNINGS AND PRECAUTIONS).
Laboratory Values Serum calcium levels should be monitored in patients receiving TEVA-CINACALCET (see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION). 88 mmol/L. 88 mmol/L within the first 6 months and overall, respectively. Post-Market Adverse Drug Reactions Additional adverse events have been identified during post-marketing use of cinacalcet hydrochloride.
These adverse events include, but are not limited to, the following (listed by body system): Cardiac disorders: hypotension, worsening heart failure, QT prolongation and ventricular arrhythmia secondary to hypocalcemia Gastrointestinal disorders: abdominal pain upper, constipation Immune system disorders: hypersensitivity reactions (including angioedema and urticaria), severe hypersensitivity reaction Metabolism and nutrition disorders: hypocalcemia (some cases with fatal outcomes), hyperkalemia Musculoskeletal and connective back pain, muscle spasms, calcium […]
Clinical trial data showed hypotension occurred in 7% of cinacalcet hydrochloride-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving cinacalcet hydrochloride or placebo. 5 QT Prolongation and Ventricular Arrhythmias Cases of QT prolongation and ventricular arrhythmia secondary to hypocalcemia have been reported in patients treated with cinacalcet hydrochloride (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia).
Endocrine and Metabolism Hypocalcemia Life-threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with cinacalcet hydrochloride including pediatric patients. TEVA-CINACALCET is not indicated for use in pediatric patients (see WARNINGS and PRECAUTIONS, Special Populations, Pediatrics).
Cinacalcet hydrochloride lowers serum calcium, and therefore patients should be carefully monitored for the occurrence of hypocalcemia (see Monitoring and Laboratory Tests). Potential manifestations of hypocalcemia include paresthesias, myalgias, cramping, tetany, and convulsions.
Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia secondary to hypocalcemia have been reported in patients treated with cinacalcet hydrochloride.
Caution is advised in patients with other risk factors for QT prolongation such as patients with known congenital long QT syndrome or patients receiving drugs known to cause QT prolongation or lower serum calcium. 1 mmol/L. 88 mmol/L or if symptoms of hypocalcemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium.
If hypocalcemia or symptoms of QT prolongation/ventricular arrhythmia persist, reduce the dose or discontinue administration of TEVA-CINACALCET (see DOSAGE AND ADMINISTRATION). 88 mmol/L. 88 mmol/L within the first 6 months and overall, respectively (see ADVERSE REACTIONS).
1% in the placebo group permanently discontinued study drug due to hypocalcemia. TEVA-CINACALCET is not indicated for CKD patients not receiving dialysis. 1 mmol/L) compared with cinacalcet hydrochloride-treated CKD patients receiving dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
6 Testosterone Levels Testosterone levels are often below the normal range in patients with end stage renal disease. 3% in the placebo-treated patients after 6 months of treatment. The clinical significance of these reductions in serum testosterone is unknown.
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 hydrochloride-treated patients. Hepatic Due to the potential for 2- to 4-fold higher plasma levels of […]