Do not use Sensipar® (cinacalcet) if you have low calcium levels. Ask your healthcare provider about the normal ranges.
Low calcium levels: Sensipar® lowers calcium and can lead to low calcium levels in your blood. Tell your healthcare provider if you have spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth; or seizures. Life threatening events and fatal outcomes associated with low calcium levels have been reported in patients treated with Sensipar®, including in children. The safety and effectiveness of Sensipar® have not been established in children.
Low calcium levels may potentially result in abnormal heart rhythms, known as ventricular arrhythmia, and have been reported in patients taking Sensipar®. Tell your healthcare provider if you experience unusually fast or pounding heartbeat, if you have or have had heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems while receiving Sensipar®.
Before starting Sensipar®, tell your healthcare provider if you are taking medication to prevent seizures or have had seizures in the past. Report any seizure episodes while on Sensipar®.
Use of Sensipar® with other medicines that lower calcium, including Parsabiv™ (etelcalcetide), could result in severe low calcium levels. Do not take Sensipar® with Parsabiv™. Tell your healthcare provider if you are taking Parsabiv™ or other medicines that lower calcium.
While on Sensipar®, your healthcare provider should perform repeated blood tests to monitor calcium, phosphorus, and intact parathyroid hormone (iPTH) levels.
Upper Gastrointestinal Bleeding: Gastrointestinal (GI) bleeding, mostly upper GI bleeding, has happened in patients using Sensipar®. The exact cause of GI bleeding is unknown. Tell your healthcare provider if you have stomach pain, bloody or black stool, or if you vomit bloody or black material. Also tell your healthcare provider if you have nausea or vomiting that is getting worse.
Low Blood Pressure, Worsening Heart Failure and/or Abnormal Heart Rhythm: 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®.
Adynamic Bone Disease: Very low levels of PTH should be avoided to help maintain bone health.
Side Effects: 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 healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (332-1088).
Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
Sensipar® should not be used in patients with CKD who are not on dialysis because of an increased risk of low calcium levels.