RAYALDEE

Posology The initial dose of Rayaldee is 30 microgram, administered orally once daily at bedtime, at least 2 hours after any meals. 4). The dose should be increased to 60 microgram administered orally at bedtime, at least 2 hours after any meal after approximately 3 months, if intact PTH remains above the desired therapeutic range, individualised per patient.

78 mmol/L and serum 25-hydroxyvitamin D should be below 162 nmol/L. 78 mmol/L. Serum calcium, serum phosphorus, serum 25-hydroxyvitamin D 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.

4), or if serum 25-hydroxyvitamin D is consistently above 250 nmol/L. Treatment should be restarted at a reduced dose after these laboratory values have normalized. Paediatric population The safety and efficacy of Rayaldee in children and adolescents below the age of 18 years have not been established No data are available.

Elderly No dose adjustment is required in elderly patients. Of the total number of subjects in phase 3 placebo-controlled clinical studies of Rayaldee, 63% were ≥65 years of age and 22% were ≥75 years of age. No overall differences in the safety or efficacy of Rayaldee were observed between subjects older than 65 years and younger subjects.

4). Hepatic impairment No data is available Method of administration Rayaldee is for oral use. The capsules should be swallowed whole. The prolonged-release capsule should be taken once a day at bedtime, at least 2 hours after any meal.

Summary of the Safety Profile The current safety profile of Rayaldee is based on a total of 435 patients with chronic kidney disease (CKD) not on dialysis suffering from SHPT who received Rayaldee for up to 52 weeks. The majority of adverse drug reactions (ADRs) reported from trials were blood phosphorus increased, hypercalcemia and gastrointestinal disorders.

Tabulated List of Adverse Reactions System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Metabolism and nutrition disorders blood phosphorus increased Hypercalcemia Decreased appetite Gastrointestinal disorders Constipation Nausea Diarrhea Abdominal discomfort Dry mouth Vomiting General disorders and administration site conditions Asthenia Nervous system disorders Dizziness Headache Description of Selected Adverse Reactions Not applicable Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

2). Acute hypercalcemia may increase the risk of cardiac arrhythmias and seizures. Chronic hypercalcemia can lead to vascular calcification and other soft-tissue calcification. Severe hypercalcemia may require emergency attention. Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium containing preparations, thiazide diuretics, or other vitamin D compounds.

In these clinical situations, more frequent serum calcium monitoring and Rayaldee dose adjustments may be required. Patients with a history of hypercalcemia prior to initiating therapy with Rayaldee should be monitored more frequently for possible hypercalcemia during therapy.

In CKD, high intake of calcium concomitantly with vitamin D compounds may lead to hypercalciuria. Patients should be informed about the symptoms of elevated serum calcium. 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. 5). Patients using Rayaldee concomitantly with digitalis compounds should be monitored for increases in serum calcium, and for signs and symptoms of digitalis toxicity.

5). 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. 2). Renal impairment The dosing recommendations are provided for adult patients with chronic kidney disease not on dialysis.

No difference in efficacy was observed between patients with stage 3 chronic kidney disease or those with stage 4 disease in subgroup analysis. Safety outcomes were similar in these subgroups. The safety and efficacy of Rayaldee in the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on dialysis have not been established.

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