Prescribing Information

Abbreviated prescribing information Rayaldee®
For full prescribing information refer to the Summary of Product Characteristics (SmPC).

Presentation and active ingredient: Calcifediol (as calcifediol monohydrate) prolonged-release capsule containing 30 mcg calcifediol.

Indication: Treatment of secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD) Stage 3 or 4 and vitamin D insufficiency or deficiency.  

Dosage and administration: The initial dose of Rayaldee® is 30 mcg, administered orally once daily at bedtime, at least 2 hours after any meals. Prior to initiation of the treatment, serum calcium should be below 2.45 mmol/L, serum phosphorus should be below 1.78 mmol/L. If the intact parathyroid hormone (PTH) remains greater than the desired therapeutic range individualised per patient after approx. 3 months, the dose should be increased to 60 mcg administered orally at bedtime, at least 2 hours after any meal. Prior to titration to the higher dose, serum calcium should be below 2.45 mmol/L, serum phosphorus should be below 1.78 mmol/L and serum 25-hydroxyvitamin D (25D) should be below 162 nmol/L. The maintenance dose of Rayaldee® should target serum 25D levels between 75 and 250 nmol/L, PTH levels within the desired therapeutic range, serum calcium within the normal range and serum phosphorus below 1.78 mmol/L. Serum calcium, serum phosphorus, serum 25D and intact PTH levels should be monitored at a minimum of 3 months after initiation of therapy or dose adjustment, and subsequently at least every 6 to 12 months. Dosing should be suspended if intact PTH is persistently abnormally low to reduce the risk of adynamic bone disease, if serum calcium is consistently above the normal range to reduce the risks associated with hypercalcemia, or if serum 25D is consistently above 250 nmol/L. Treatment should be restarted at a reduced dose after these laboratory values have normalized.

Contraindications: Rayaldee® is contraindicated in patients with a history of a hypersensitivity reaction to Rayaldee® or any of its excipients. 

Special warnings and precautions: Hypercalcemia and hyperphosphatemia: 
Hypercalcemia may occur during Rayaldee® treatment. Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium containing preparations, thiazide diuretics, or other vitamin D compounds. Patients with a history of hypercalcemia prior to initiating therapy with Rayaldee should be monitored more frequently for possible hypercalcemia during therapy. Increased phosphate intake concomitantly with vitamin D compounds may lead to hyperphosphatemia. Patients with a history of hyperphosphatemia prior to initiating therapy with Rayaldee should be monitored more frequently for possible hyperphosphatemia during therapy. Digitalis toxicity: Hypercalcemia of any cause, including hypercalcemia associated with Rayaldee® use, increases the risk of digitalis toxicity. Patients using Rayaldee® concomitantly with digitalis compounds should be monitored for increases in serum calcium, and for signs and symptoms of digitalis toxicity. Adynamic bone disease: Adynamic bone disease with subsequent increased risk of fractures may develop if intact PTH levels are over-suppressed for extended periods of time. 

Overdosage: Overdosage of calcifediol may lead to hypercalcaemia, hypercalciuria, hyperphosphatemia, and over-suppression of PTH. In the event of an overdose, signs and symptoms of hypercalcemia (serum calcium levels) should be monitored. Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting.

Special populations: The use of Rayaldee® has not been studied in children and adolescents under 18 years. There is limited amount of data from the use of calcifediol in pregnant women. Rayaldee® should not be used during pregnancy unless the clinical condition of the woman requires treatment with calcifediol and the potential benefits to the mother outweigh the potential risks to the fetus.  No special dose and administration guidelines are recommended for elderly population.  The safety and efficacy of Rayaldee® in patients with end-stage renal disease on dialysis have not been established.

Undesirable effects: Common (≥1/100 to <1/10): blood phosphorus increased, hypercalcemia, constipation, nausea, diarrhea. Please consult the SmPC in relation to other undesirable effects.

Prescription Only Medicine. Full prescribing information is available on request. Please read the full SmPC prior to administration. Rayaldee® is a registered trademark.

Date of preparation: July 2020
Version: 1
Job number: HQ-RAY-2000023

For information about available doses, special warnings, overdosing and interactions with other medicinal products, please refer to the Rayaldee® Summary of Product Characteristics.

ATC code: H05BX05 
ATC level name: calcifediol
DDD: 30 mcg O