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AURO-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.
Auro-Cinacalcet (cinacalcet hydrochloride) is contraindicated in patients with hypersensitivity to any of the components of this product. Auro-Cinacalcet (cinacalcet hydrochloride) 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 Auro-Cinacalcet, the dose of Auro-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.
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. 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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Page 5 of 25 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. Auro-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 Auro-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. Auro-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.
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- Page 6 of 25 treated […]