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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis
In three double-blind, placebo-controlled clinical trials, 1126 patients with CKD on dialysis received study drug (656 Sensipar (cinacalcet) , 470 placebo) for up to 6 months. The most frequently reported adverse reactions (incidence of at least 5% in the Sensipar (cinacalcet) group and greater than placebo) are provided in Table 1. The most frequently reported adverse reactions in the Sensipar (cinacalcet) group were nausea, vomiting, and diarrhea.
Table 1: Adverse Reaction Incidence ( ≥ 5%) in Patients
(n = 470)
(n = 656)
|Pain Chest, Non-Cardiac||4||6|
|*Included are events that were reported at a greater incidence in the Sensipar group than in the placebo group.|
The incidence of serious adverse reactions was similar in the Sensipar (cinacalcet) and placebo groups (29% vs. 31%, respectively).
12-Month Experience with Sensipar (cinacalcet) in Secondary Hyperparathyroidism
Two hundred sixty-six patients from two of the phase 3 studies in patients with CKD on dialysis continued to receive Sensipar (cinacalcet) or placebo treatment in a 6-month, double-blind extension study (12-month total treatment duration). The incidence and nature of adverse reactions in this long term extension study were comparable to those observed in the original phase 3 studies.
Parathyroid Carcinoma and Primary Hyperparathyroidism
The safety profile of Sensipar (cinacalcet) in these patient populations is generally consistent with that seen in patients with CKD on dialysis. Forty six patients were treated with cinacalcet in a single arm study, 29 with Parathyroid Carcinoma and 17 with intractable PHPT. Nine (20%) of the patients withdrew from the study due to adverse events. The most frequent adverse reactions and the most frequent cause of withdrawal in these patient populations were nausea and vomiting. Severe or prolonged cases of nausea and vomiting can lead to dehydration and worsening hypercalcemia so careful monitoring of electrolytes is recommended in patients with these symptoms.
Eight patients died while on study, 7 with parathyroid carcinoma (24%) and 1 (6%) with intractable PHPT. Causes of death were cardiovascular (5 patients), multi-organ failure (1 patient), gastrointestinal hemorrhage (1 patient) and metastatic carcinoma (1 patient). Adverse events of hypocalcemia were reported in three patients (7%).
Table 2: Adverse Reactions Occurring in ≥ 10% of Total
|n (%)||n (%)||n (%)|
|Number of Subjects Reporting Adverse Events||28 (97)||17 (100)||45 (98)|
|Nausea||19 (66)||10 (59)||29 (63)|
|Vomiting||15 (52)||6 (35)||21 (46)|
|Paresthesia||4 (14)||5 (29)||9 (20)|
|Fatigue||6 (21)||2 (12)||8 (17)|
|Fracture||6 (21)||2 (12)||8 (17)|
|Hypercalcemia||6 (21)||2 (12)||8 (17)|
|Anorexia||6 (21)||1 (6)||7 (15)|
|Asthenia||5 (17)||2 (12)||7 (15)|
|Dehydration||7 (24)||0 (0)||7 (15)|
|Anemia||5 (17)||1 (6)||6 (13)|
|Arthralgia||5 (17)||1 (6)||6 (13)|
|Constipation||3 (10)||3 (18)||6 (13)|
|Depression||3 (10)||3 (18)||6 (13)|
|Headache||6 (21)||0 (0)||6 (13)|
|Infection Upper Respiratory||3 (10)||2 (12)||5 (11)|
|Pain Limb||3 (10)||2 (12)||5 (11)|
|N=Number of subjects receiving at least one dose of study drug.|
Postmarketing Experience with Sensipar (cinacalcet)
The following adverse reactions have been identified during postapproval use of Sensipar (cinacalcet) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Rash, hypersensitivity reactions (including angioedema and urticaria), diarrhea, and myalgia have been identified as adverse reactions during postapproval use of Sensipar (cinacalcet) . Isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in Sensipar (cinacalcet) -treated patients with impaired cardiac function in postmarketing safety surveillance.
Read the Sensipar (cinacalcet) Side Effects Center for a complete guide to possible side effects
Strong CYP3A4 Inhibitors
Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of Sensipar (cinacalcet) may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). The iPTH and serum calcium concentrations should be closely monitored in these patients [see CLINICAL PHARMACOLOGY].
Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants) [see CLINICAL PHARMACOLOGY].
Read the Sensipar Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/19/2011
This monograph has been modified to include the generic and brand name in many instances.
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