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Important Safety Information
Prescribing Information
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Healthcare professionals outside of the US: click here.

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About SHPT

SHPT is a major complication of CKD

Chronic kidney disease (CKD) patients 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: CYP27B1, 1-α hydroxylase; CYP24A1, 24-hydroxylase; 1,25D, 1,25-dihydroxyvitamin D; Ca, calcium; 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

Patients may be asymptomatic or have mild or nonspecific symptoms, so obtaining lab values is key to diagnosing SHPT.3-5

Left untreated, SHPT can progress and lead to cardiovascular events, fractures, and increased morbidity and mortality.5,6

See the faces of SHPT
CKD Progression and Dialysis

CKD patients with SHPT progress more quickly to dialysis than CKD patients without SHPT7

Cardiovascular Events

Risk of cardiovascular disease increases by 6% for each 1 pmol/L increment in PTH8

Fractures

Elevated PTH is associated with decreased bone mineral density9

Parathyroid Hyperplasia

Parathyroid glands become enlarged and overactive10

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

See the 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. Lewis JL. Hyperparathyroidism. Merck Manual Professional Version. Updated September 2022. Accessed September 28, 2022. https://www.merckmanuals.com/professional/endocrine-and-metabolic-disorders/parathyroid-disorders/hyperparathyroidism 4. Uhlig K, Berns JS, Kestenbaum B, et al. KDOQI US commentary on the 2009 KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of CKD-Mineral and Bone Disorder (CKD-MBD). Am J Kidney Dis. 2010;55(5):773-799. doi:10.1053/j.ajkd.2010.02.340 5. Yuen NK, Ananthakrishnan S, Campbell MJ. Hyperparathyroidism of renal disease. Perm J. 2016;20(3):78-83. doi:10.7812/TPP/15-127 6. Cunningham J, Locatelli F, Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options. Clin J Am Soc Nephrol. 2011;6:913-921. doi:10.2215/CJN.06040710 7. 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 8. 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 9. 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 10. Andress DL, Coyne DW, Kalantar-Zadeh K, Molitch ME, Zangeneh F, Sprague SM. Management of secondary hyperparathyroidism in stages 3 and 4 chronic kidney disease. Endocr Pract. 2008;14(1):18-27. doi:10.4158/EP.14.1.18

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.