Take SHPT treatment in a different direction

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Treating secondary hyperparathyroidism

Rayaldee® (calcifediol) is the first and only extended-release prohormone of the active form of vitamin D3 that brings 25-hydroxyvitamin D [25(OH)D] levels up, brings intact parathyroid hormone (iPTH) levels down, and has effects on calcium and phosphorus that are similar to those of placebo in adults with secondary hyperparathyroidism (SHPT) with stage 3 or 4 chronic kidney disease (CKD) and low vitamin D levels.*1,2

* Calcium: Rayaldee 0.2 (0.02) mg/dL versus placebo 0.1 (0.03) mg/dL (P<0.001); Phosphorus: Rayaldee 0.2 (0.03) mg/dL versus placebo 0.1 (0.04) mg/dL1
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Clinical trial highlights

In the clinical trials, significantly more adults achieved reduction in iPTH by ≥30% from baseline and increase in 25(OH)D to adequate levels (versus placebo; P<0.001)2

Increased serum 25(OH)D levels were associated with corresponding increases in serum 1,25D levels2
Serum iPTH levels declined over time with Rayaldee compared to placebo treatment (P<0.001)2
The effect of Rayaldee on serum levels of calcium and phosphorus was similar to that of placebo*1
* Calcium: Rayaldee 0.2 (0.02) mg/dL versus placebo 0.1 (0.03) mg/dL (P<0.001); Phosphorus: Rayaldee 0.2 (0.03) mg/dL versus placebo 0.1 (0.04) mg/dL1
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Comprehensive support for your patients

Access matters. That’s why OPKO Connect was created. OPKO Connect is more than a patient assistance program. OPKO Connect can also help with prior authorizations for Rayaldee. Additionally, through OPKO Connect, patients can speak with pharmacists and general support experts to better understand Rayaldee and SHPT.

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References: 1. Rayaldee [package insert]. Miami, FL: OPKO Pharmaceuticals, LLC; June 2016. 2. 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.

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.

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.