Orkedia Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Evocalcet

Indications/Uses

Secondary hyperparathyroidism in patients on maintenance dialysis. Hypercalcaemia in patients w/ parathyroid carcinoma & hypercalcaemia in patients w/ primary hyperparathyroidism who are unable to undergo parathyroidectomy or patients w/ recurrent primary hyperparathyroidism after parathyroidectomy.

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Dosage/Direction for Use

Adult Secondary hyperparathyroidism in patient on maintenance dialysis Initially 1 mg once daily. Starting dose may be 2 mg once daily depending on patient's condition (parathyroid hormone [PTH] level ≥500 pg/mL & serum Ca level ≥9 mg/dL). Adjust subsequent dose w/in range of 1-8 mg once daily & closely monitor PTH & serum Ca levels. Increase dose in 1 mg increments at intervals of at least 2 wk. May increase dose up to 12 mg once daily in case of inadequate response. Hypercalcaemia in patient w/ parathyroid carcinoma & hypercalcaemia in patient w/ primary hyperparathyroidism who are unable to undergo parathyroidectomy or patient w/ recurrent primary hyperparathyroidism after parathyroidectomy Initially 2 mg once daily. Starting dose may be 2 mg bd depending on patient's serum Ca levels (>12.5 mg/dL). Adjust subsequent dose depending on serum Ca levels, & may increase to max of 6 mg qds. Increase doses step by step w/ intervals of at least 2 wk. Step 1: 2 mg once daily. Step 2: 2 mg bd. Step 3: 4 mg bd. Step 4: 6 mg bd. Step 5: 6 mg tds. Step 6: 6 mg qds.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Pregnant or possibly pregnant women.

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Special Precautions

Measure serum Ca levels periodically & prevent occurrence of hypocalcemia during treatment. Consider dose reduction, as well as administration of Ca &/or vit D prep, when hypocalcemia has occurred or may possibly occur. Immediately interrupt treatment if serum Ca level ≤7.5 mg/dL. May aggravate hypocalcemia in patients w/ hypocalcemia. Reports of adynamic bone disease due to excessive decrease in PTH induced by Ca receptor agonists. Reports of hungry bone syndrome w/ hypocalcemia & hypophosphatemia due to rapid decrease in PTH after administration of Ca receptor agonists. Not recommended in patients w/ severe hepatic impairment. Discontinue immediately in case of pregnancy during treatment. Breast-feeding is not recommended. Clinical studies w/ efficacy & safety in ped subjects have not been conducted.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypocalcemia, QT prolongation.

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Drug Interactions

Potentiated blood Ca-lowering effect w/ denosumab, bisphosphonates (eg, alendronate Na hydrate, risedronate Na hydrate, minodronic acid hydrate, ibandronate Na hydrate, zoledronic acid hydrate), calcitonin, corticosteroids (eg, prednisolone, dexamethasone). Increased blood conc of theophylline. Digitoxin & diazepam may affect blood conc of Orkedia.

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Storage

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Description

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Action

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MIMS Class

Other Agents Affecting Metabolism

ATC Classification

H05BX06 - evocalcet ; Belongs to the class of other anti-parathyroid agents. Used in the management of calcium homeostasis.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Orkedia FC tab 1 mg

Packing/Price

100's

Form

Orkedia FC tab 2 mg

Packing/Price

100's

Orkedia

Manufacturer:

Kyowa Kirin

Distributor:

DKSH