For adult patients with secondary HPT on dialysis

For adult patients with secondary HPT on dialysis,

Which three body parts can contribute to high PTH, calcium, and phosphorus levels?

Click on the body parts below to learn more.

The kidneys, parathyroid glands, and bones contribute to high PTH, calcium, and phosphorus

Kidneys1,2

  • Healthy kidneys filter waste and help keep PTH, calcium, and phosphorus from getting too high.
  • When your kidneys fail, they can no longer do this.
  • For example, they may not be able to get rid of the phosphorus from the food you eat.

Parathyroid glands3

  • You have four parathyroid glands in your neck that make PTH.
  • They are each about the size of a pea.
  • When your kidneys fail, the parathyroid glands make too much PTH and can grow too big.

Bones4,5

  • Most of the calcium and phosphorus in your body is stored in your bones.
  • When your parathyroid glands make too much PTH, calcium and phosphorus are released from your bones.
  • This may increase your calcium and phosphorus levels.
When your PTH level is too high, it can cause your calcium and phosphorus to be out of their goal range.5

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Indication

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 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 1-800-FDA-1088 (332-1088).

References: 1. Pollak MR, Yu ASL, Taylor EN. Disorders of calcium, magnesium, and phosphate balance: disorders of phosphate homeostasis. In: Brenner BM, Levine SA, eds. Brenner & Rector’s The Kidney. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:602-604. 2. Hruska KA, Mathew S, Lund R, Qiu P, Pratt R. Hyperphosphatemia of chronic kidney disease. Kidney Int. 2008;74:148-157. 3. Rodriguez M, Nemeth E, Martin D. The calcium-sensing receptor: a key factor in the pathogenesis of secondary hyperparathyroidism. Am J Physiol Renal Physiol. 2005;288:F253-F264. 4. Bringhurst FR, Demay MB, Kronenberg HM. Hormones and disorders of mineral metabolism: basic biology of mineral metabolism. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR, eds. Williams Textbook of Endocrinology. 11th ed. Philadelphia, PA: Saunders Elsevier; 2008:1203-1223. 5. Moe SM. Disorders involving calcium, phosphorus, and magnesium. Prim Care Clin Office Pract. 2008; 35:215-237.