Regpara

Cinacalcet HCl

Secondary hyperparathyroidism in patients undergoing maintenance dialysis. Hypercalcemia in patients w/ parathyroid carcinoma; primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

Adult Secondary hyperparathyroidism in patients undergoing maintenance dialysis Initially 25 mg once daily. May adjust dose w/in 25-75 mg once daily. May be increased by 25 mg for at least 3-wk interval up to 100 mg once daily if required or no improvement on parathyroid hormone (PTH). Hypercalcemia in patients w/ parathyroid carcinoma & primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy Initially 25 mg bid. May adjust dose w/in 25-75 mg bid. May be increased by 25 mg for at least 2-wk interval up to 75 mg tid or qid if required or no improvement in serum Ca levels.

Should be taken with food: Take w/ or immediately after meals. Swallow whole, do not divide.

Hypersensitivity.

W/draw treatment immediately if serum Ca level decreases to ≤7.5 mg/dL (1.9 mmol/L). Possible occurrence of hypocalcemia if administration of Ca or vit D prep is discontinued during treatment. Adynamic bone disease; hungry bone syndrome accompanied by hypocalcaemia & hypophosphatemia. Patients w/ hypocalcemia; existing or history of seizure, GI hemorrhage & ulcer. Confirm if patient's serum Ca level is not low [≥9.0 mg/dL (2.2 mmol/L)] prior to administration. Determine serum Ca level once a wk at start of administration & during dose adjustment period, & at least once every 2 wk during maintenance period or periodically during maintenance period; serum PTH level before administration, twice a mth at start of administration & during dose adjustment period (about 3 mth after start of administration), & at least once a mth after serum PTH level is almost stable. Periodically measure serum Ca level & use Ca, vit D prep or reduce dose of therapy to avoid hypocalcemia. Frequently monitor patient's symptoms at start of administration & during dose adjustment period. Not approved for use in patients w/ chronic renal failure accompanied by secondary hyperparathyroidism who have not yet been on dialysis. Hepatic impairment. Not to be used in pregnancy. Discontinue breastfeeding during treatment. Childn. Elderly ≥65 yr.

Hypocalcaemia/decreased serum Ca; prolonged QT interval; nausea/vomiting, gastric discomfort, anorexia, abdominal distension. Upper abdominal pain, abdominal pain & discomfort, diarrhea, constipation, gastroduodenitis, reflux esophagitis, dyspepsia, GI disorder; increased BP, arrhythmia; numbness, dizziness, paraesthesia, headache, insomnia; muscle spasm, pain in extremities, arthralgia; taste abnormality; increased alkaline phosphatase; pruritus; anemia; malaise, edema.

Increased plasma conc w/ CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole), macrolides (eg, erythromycin, clarithromycin), amiodarone HCl, grapefruit juice. Increased AUC w/ ketoconazole. Increased blood conc of TCAs (eg, amitriptyline HCl, imipramine HCl), antitussive drugs (eg, dextromethorphan), butyrophenone antipsychotics (eg, haloperidol), flecainide acetate, vinblastine sulfate. Increased AUC of dextromethorphan HBr. Decreased serum Ca w/ calcitonin, bisphosphonate, bone resorption inhibitors (eg, pamidronate Na hydrate, alendronate Na hydrate, incadronate disodium), corticosteroids (eg, cortisol, prednisolone, dexamethasone). Affected blood conc w/ digitoxin & diazepam.

Other Agents Affecting Metabolism

H05BX01 - cinacalcet ; Belongs to the class of other anti-parathyroid agents. Used in the management of calcium homeostasis.

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