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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.
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Clinical trials have demonstrated a safety profile for
Rayaldee similar to placebo1,2

Common Adverse Reactions in Phase 3 Placebo-Controlled Trials Reported in ≥1.4% of Rayaldee-Treated Subjects1

Adverse ReactionsPlacebo (n=144)Rayaldee (n=285)
%
%
Anemia
3.5
4.9
Nasopharyngitis
2.8
4.9
Blood creatinine increased
1.4
4.9
Dyspnea
2.8
4.2
Cough
2.1
3.5
Cardiac failure congestive
0.7
3.5
Constipation
2.8
3.2
Bronchitis
0.7
2.8
Hyperkalemia
0.7
2.5
Osteoarthritis
0.7
2.1
Hyperuricemia
0.7
1.8
Contusion
0.0
1.8
Pneumonia
0.7
1.4
Chronic obstructive pulmonary disease
0.0
1.4