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Sensipar® should not be used in adult patients with CKD who are not on dialysis because of an increased risk of low calcium levels.
Important Safety Information
- Sensipar® (cinacalcet) treatment should not be started if you have low calcium levels. Ask your doctor about the normal ranges. Life threatening events and fatal outcomes associated with low calcium levels have been reported in patients treated with Sensipar®, including in children.
- Low calcium levels may potentially result in abnormal heart rhythms, known as ventricular arrhythmia, and have been reported in patients taking Sensipar®.
- Before starting Sensipar®, tell your doctor if you are taking medication to prevent seizures or have had seizures in the past. Report any seizure episodes while on Sensipar® therapy.
- Very infrequent cases of low blood pressure, worsening heart failure, and/or abnormal heart rhythm (arrhythmia) have been reported in patients with impaired heart function taking Sensipar®.
- While on Sensipar®, your doctor should perform repeated blood tests to monitor calcium, phosphorus, and intact parathyroid hormone (iPTH) levels. Very low and very high levels of PTH should be avoided to help maintain bone health. Very low levels (iPTH < 100 pg/mL) of PTH may cause a condition your doctor may refer to as adynamic bone disease.
- Patients with moderate to severe liver impairment should be monitored throughout treatment with Sensipar®.
- Tell your doctor if you experience any muscle spasms, aches or cramping, tingling in your limbs, or seizures.
- In clinical trials, the most common side effects reported in patients were nausea, vomiting, and diarrhea.
If you have any questions about this information, be sure to discuss them with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call