Version May 2024
Secondary hyperparathyroidism: Oral: Initial: 30 mcg once daily at bedtime; may increase to 60 mcg once daily at bedtime after 3 months if intact PTH remains above desired therapeutic range. Note: Ensure corrected serum total calcium is below 9.8 mg/dL prior to initiating therapy. Maintenance dose should target total 25-hydroxyvitamin D levels between 30 and 100 ng/mL, intact PTH levels within desired therapeutic range, serum calcium <9.8 mg/dL, and serum phosphorus <5.5 mg/dL.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Hypercalcemia, low PTH, or serum total 25-hydroxyvitamin D >100 ng/mL: Temporarily discontinue therapy for persistently low intact PTH levels, or consistently elevated calcium or 25-hydroxyvitamin D levels (>100 ng/mL); resume therapy at a reduced dose after laboratory values have normalized.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Cardiovascular: Heart failure (4%)
Endocrine & metabolic: Hypercalcemia (4%), hyperkalemia (3%), hyperuricemia (2%)
Hematologic & oncologic: Anemia (5%), bruise (2%)
Neuromuscular & skeletal: Osteoarthritis (2%)
Renal: Increased serum creatinine (5%)
Respiratory: Bronchitis (3%), chronic obstructive pulmonary disease (1%), cough (4%), dyspnea (4%), nasopharyngitis (5%), pneumonia (1%)
<1%: Endocrine & metabolic: Hyperphosphatemia
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Excessive vitamin D: Excessive vitamin D administration may lead to over suppression of PTH, progressive or acute hypercalcemia, hypercalciuria, hyperphosphatemia and adynamic bone disease.
• Hypercalcemia: Progressive and/or acute hypercalcemia may increase risk of cardiac arrhythmias and seizures; chronic hypercalcemia may lead to generalized vascular and other soft-tissue calcification, exacerbate nephrolithiasis, and has been associated with increased mortality in adults with chronic kidney disease (CKD) (KDIGO 2017). Risk of hypercalcemia may be increased by concomitant use of calcium-containing supplements, vitamin D containing compounds, and/or medications that increase serum calcium (eg, thiazide diuretics). Monitor calcium levels closely with initiation of therapy and with dose adjustments; discontinue use promptly in patients who develop hypercalcemia. Patients with a history of hypercalcemia prior to therapy should be monitored more frequently.
• Hyperphosphatemia: Should be corrected before initiating therapy; exacerbates secondary hyperparathyroidism, diminishing the effect of calcifediol.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule Extended Release, Oral:
Rayaldee: 30 mcg [contains carrageenan, fd&c blue #1 (brilliant blue)]
No
Capsule Extended Release (Rayaldee Oral)
30 mcg (per each): $48.67
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer at bedtime. Swallow capsule whole.
Bariatric surgery: Capsule, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Cannot open capsule. No IR formulation available. Switch to calcitriol.
Secondary hyperparathyroidism: 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.
Limitations of use: Not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease (ESRD) on dialysis.
Calcifediol may be confused with alfacalcidol, calciferol, calcitriol, paricalcitol
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aluminum Hydroxide: Vitamin D Analogs may increase the serum concentration of Aluminum Hydroxide. Specifically, the absorption of aluminum may be increased, leading to increased serum aluminum concentrations. Management: Consider avoiding chronic use of aluminum and aluminum-containing products in patients who are also taking active vitamin D analogs. If coadministered, monitor aluminum status and for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification
Bile Acid Sequestrants: May decrease the serum concentration of Vitamin D Analogs. More specifically, bile acid sequestrants may impair absorption of Vitamin D Analogs. Management: Avoid concomitant administration of vitamin D analogs and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the potential risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification
Burosumab: Vitamin D Analogs may enhance the adverse/toxic effect of Burosumab. Risk X: Avoid combination
Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy
Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Calcifediol. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Calcifediol. Risk C: Monitor therapy
Danazol: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy
Erdafitinib: Serum Phosphate Level-Altering Agents may diminish the therapeutic effect of Erdafitinib. Management: Avoid coadministration of serum phosphate level-altering agents with erdafitinib before initial dose increase period based on serum phosphate levels (Days 14 to 21). Risk D: Consider therapy modification
Mineral Oil: May decrease the serum concentration of Vitamin D Analogs. More specifically, mineral oil may interfere with the absorption of Vitamin D Analogs. Management: Avoid concomitant, oral administration of mineral oil and vitamin D analogs. Consider separating the administration of these agents by several hours to minimize the risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination
Orlistat: May decrease the absorption of Vitamins (Fat Soluble). Management: Administer oral fat soluble vitamins at least 2 hours before or 2 hours after the administration of orlistat. Avoid concomitant administration due to the risk of impaired vitamin absorption. Risk D: Consider therapy modification
Sucralfate: Vitamin D Analogs may increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Management: Consider avoiding chronic use of aluminum and aluminum-containing products, such as sucralfate, in patients who are also taking active vitamin D analogs. If combined, monitor for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy
Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Risk X: Avoid combination
Endogenous calcifediol crosses the placenta in concentrations generally lower than those in the maternal plasma; supplementation increases cord blood 25OHD concentrations (IOM 2011).
It is not known if calcifediol is present in breast milk.
Endogenous calcifediol is poorly excreted into breast milk, but milk concentrations may be increased with supplementation (IOM 2011). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Breastfed infants should be monitored for signs and symptoms of hypercalcemia (eg, constipation, seizures, vomiting, weight loss); also consider monitoring serum calcium in the infant.
Serum calcium, serum phosphorus, serum total 25-hydroxyvitamin D and intact PTH levels within 3 months after initiation of therapy or dose adjustment, and subsequently at least every 6 to 12 months; signs and symptoms of hypercalcemia.
KDIGO guidelines:
Serum calcium, phosphorus, and parathyroid hormone (PTH): Frequency of measurement may be dependent upon the presence and magnitude of abnormalities, the rate of progression of chronic kidney disease (CKD), and the use of treatments for chronic kidney disease-mineral and bone disorder (CKD-MBD) (KDIGO 2017):
CKD stage G3a-G3b: Serum calcium and phosphate: Every 6 to 12 months; PTH: Frequency based on baseline level and progression of CKD
CKD stage G4: Serum calcium and phosphate: Every 3 to 6 months; PTH: Every 6 to 12 months
CKD stage G5 and G5D: Serum calcium and phosphate: Every 1 to 3 months; PTH: Every 3 to 6 months
Note: Due to the complexity and interdependency of the laboratory parameters used for therapeutic decisions in chronic kidney disease-mineral and bone disorder (CKD-MBD) patients, serial assessments of phosphate, calcium, and parathyroid hormone (PTH) levels should be considered together (KDIGO 2017)
Calcium (total): Adults: Normal range: 8.6 to 10.2 mg/dL (SI: 2.2 to 2.6 mmol/L). Avoid hypercalcemia for chronic kidney disease (CKD) stages G3a-G5D (KDIGO 2017)
Phosphorus: 3 to 4.5 mg/dL (SI: 1 to 1.5 mmol/L). Lower elevated phosphorus levels toward the normal range for CKD stages G3a-G5D (KDIGO 2017)
PTH:
CKD stage G3a-G5: Optimal PTH level is unknown; evaluate patients with progressively elevated intact PTH levels or if levels are consistently above the normal range (assay-dependent) (KDIGO 2017)
Dialysis patients: Maintain intact parathyroid hormone (iPTH) within 2 to 9 times the upper limit of normal for the assay used (KDIGO 2017)
Calcifediol, a prohormone of the active form of vitamin D3, calcitriol (1,25 dihydroxyvitamin D3), is catalyzed to calcitriol by the 1-alpha-hydroxylase enzyme, CYP27B1, primarily in the kidney. Calcitriol binds to vitamin D receptors in target tissues activating vitamin D responsive pathways resulting in increased intestinal absorption of calcium and phosphorus and reduced parathyroid hormone synthesis.
Onset: ~2 weeks; maximum effect: ~3 months
Distribution: Vd: Healthy adults: 8.8 L; Stage 3 and 4 CKD: 30.1 L
Protein binding: >98%
Metabolism: Primarily to calcitriol by CYP27B1 (1-alpha-hydroxylase enzyme) in the kidney
Half-life elimination: Healthy adults: ~11 days; Stage 3 and 4 CKD: ~25 days
Excretion: Feces
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