For US healthcare professionals only. Healthcare professionals outside of the US: click here.

Indication
Important Safety Information
Prescribing Information
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For US healthcare professionals only.
Healthcare professionals outside of the US: click here.

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About SHPT

SHPT is a major complication of CKD

Patients with chronic kidney disease (CKD) are at risk for developing secondary hyperparathyroidism (SHPT).1

Kidney function flow chart. Description below

Adapted from Hyder R, Sprague SM. Secondary hyperparathyroidism in a patient with CKD. Clin J Am Soc Nephrol. 2020;15(7):1041-1043. doi:10.2215/CJN.13411119

Abbreviations: 1,25D, 1,25-dihydroxyvitamin D; Ca, calcium; CYP24A1, 24-hydroxylase; CYP27B1, 1α hydroxylase; FGF23, fibroblast growth factor 23; P, phosphorus; PTH, parathyroid hormone.

As kidney function declines2:

1

Phosphate retention increases, raising serum phosphate levels

2

CYP27B1 declines and CYP24A1 increases, leading to a decline in serum 1,25D and decreased serum calcium

3

Serum FGF23 increases with phosphate retention, further reducing serum 1,25D

4

Elevated PTH is driven by elevated serum phosphorus and reduced serum 1,25D and calcium

In fact, 40% of people with stage 3 CKD and 82% of those with stage 4 CKD ultimately develop SHPT.1

Early diagnosis and management of SHPT is crucial

Left untreated, SHPT increases the risk of CKD progression and death.3,4

See REAL faces of SHPT
CKD Progression and Dialysis

CKD patients with SHPT progress more quickly to dialysis than CKD patients without SHPT5

Cardiovascular Events

Risk of cardiovascular disease increases by 6% for each 1 pmol/L increment in PTH6

Fractures

Elevated PTH is associated with decreased bone mineral density7

Rayaldee® (calcifediol) has not been proven to reduce the risk of cardiovascular events, bone fractures, or CKD progression.

See REAL faces of SHPT

References: 1.Sprague SM, Crawford PW, Melnick JZ, et al. Use of extended-release calcifediol to treat secondary hyperparathyroidism in stages 3 and 4 chronic kidney disease. Am J Nephrol. 2016;44(4):316-325. doi:10.1159/000450766 2. Hyder R, Sprague SM. Secondary hyperparathyroidism in a patient with CKD. Clin J Am Soc Nephrol. 2020;15(7):1041-1043. doi:10.2215/CJN.13411119 3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59. doi:10.1016/j.kisu.2017.04.001 4. Bishop CW, Ashfaq A, Strugnell SA, et al. Sustained reduction of elevated intact parathyroid hormone concentrations with extended-release calcifediol slows chronic kidney disease progression in secondary hyperparathyroidism patients. Am J Nephrol. Published online August 27, 2024. doi:10.1159/000541138 5. Schumock GT, Andress D, E Marx S, Sterz R, Joyce AT, Kalantar-Zadeh K. Impact of secondary hyperparathyroidism on disease progression, healthcare resource utilization and costs in pre-dialysis CKD patients. Curr Med Res Opin. 2008;24(11):3037-3048. doi:10.1185/03007990802437943 6. Fisher A, Srikusalanukul W, Davis M, Smith P. Cardiovascular diseases in older patients with osteoporotic hip fracture: prevalence, disturbances in mineral and bone metabolism, and bidirectional links. Clin Interv Aging. 2013;8:239-256. doi:10.2147/CIA.S38856 7. Rix M, Andreassen H, Eskildsen P, Langdahl B, Olgaard K. Bone mineral density and biochemical markers of bone turnover in patients with predialysis chronic renal failure. Kidney Int. 1999;56(3):1084-1093. doi:10.1046/j.1523-1755.1999.00617.x

Important Safety Information

  • Hypercalcemia: Excessive administration of vitamin D compounds, including Rayaldee, can cause hypercalcemia and hypercalciuria. Severe hypercalcemia due to substantial overdosage of vitamin D and its metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium.
  • Digitalis toxicity: Potentiated by hypercalcemia of any cause. Monitor serum calcium and signs and symptoms of digitalis toxicity more frequently when initiating or adjusting the dose of Rayaldee.
  • Adynamic Bone Disease: Monitor for abnormally low levels of intact parathyroid hormone (iPTH) levels when using Rayaldee, and adjust dose if needed.
  • The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
  • Care should be taken while dosing Rayaldee with cytochrome P450 inhibitors, thiazides, cholestyramine or drugs stimulating microsomal hydroxylation due to the potential for drug interactions.
  • Serum calcium should be below 9.8 mg/dL before initiating treatment.
  • Monitor serum calcium, phosphorus, 25-hydroxyvitamin D and iPTH 3 months after starting therapy or changing dose.

Please see Full Prescribing Information.

Indication and Limitations of Use

Rayaldee® (calcifediol) extended-release 30 mcg capsules is indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

Rayaldee is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis.

Important Safety Information

  • Hypercalcemia: Excessive administration of vitamin D compounds, including Rayaldee, can cause hypercalcemia and hypercalciuria. Severe hypercalcemia due to substantial overdosage of vitamin D and its metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium.
  • Digitalis toxicity: Potentiated by hypercalcemia of any cause. Monitor serum calcium and signs and symptoms of digitalis toxicity more frequently when initiating or adjusting the dose of Rayaldee.
  • Adynamic Bone Disease: Monitor for abnormally low levels of intact parathyroid hormone (iPTH) levels when using Rayaldee, and adjust dose if needed.
  • The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
  • Care should be taken while dosing Rayaldee with cytochrome P450 inhibitors, thiazides, cholestyramine or drugs stimulating microsomal hydroxylation due to the potential for drug interactions.
  • Serum calcium should be below 9.8 mg/dL before initiating treatment.
  • Monitor serum calcium, phosphorus, 25-hydroxyvitamin D and iPTH 3 months after starting therapy or changing dose.

Please see Full Prescribing Information.