Secondary hyperparathyroidism or hypocalcemia:

Indications for HECTOROL INJ:

Secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on dialysis.

Adult:

Give by IV bolus inj. Dialysis: initially 4mcg three times weekly after dialysis; titrate dose to maintain desired iPTH therapeutic range and serum calcium within normal limits. If iPTH is not lowered by 50% and fails to reach target range, may increase by 1–2mcg at 8-week intervals; max 18mcg/week. Suspend or decrease dose if iPTH persistently or abnormally low or serum calcium consistently above normal range; if suspended, resume after 1 week at a dose that is at least 1mcg lower.

Children:

Not established.

Contraindications:

Hypercalcemia. Vit.D toxicity.

Warnings/Precautions:

Maintain appropriate calcium, phosphate intake. Monitor iPTH, serum calcium, phosphorus (Stage 3 or 4: every 2 weeks for 3 months during titration, then monthly for 3 months and every 3 months thereafter; dialysis: at baseline and weekly thereafter). Adynamic bone disease. Hepatic impairment: monitor iPTH, calcium, phosphorus levels more frequently. Inj: monitor for hypersensitivity at initiation; discontinue and treat if occurs. Pregnancy. Nursing mothers: monitor infants for hypercalcemia.

Pharmacologic Class:

Vit. D analog.

Interactions:

Concomitant high doses of calcium-containing preparations, thiazides, other Vit.D compounds may increase risk of hypercalcemia; monitor and adjust dose as needed. Hypermagnesemia with magnesium-containing antacids; avoid in patients on chronic dialysis. Monitor serum calcium and for digitalis toxicity when concomitant digitalis compounds. May be affected by CYP450 inhibitors (eg, ketoconazole, erythromycin) or hepatic enzyme inducers (eg, glutethimide, phenobarbital); dose adjustments may be needed. Caps: separate dosing by ≥1hr before or 4–6hrs after cholestyramine, mineral oil, other products that affect fat absorption.

Adverse Reactions:

Infection, UTI, chest pain, angina, constipation, dyspepsia, anemia, leucopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, increased cough, dyspnea, pruritus, sinusitis, rhinitis, headache, malaise, nausea/vomiting, dizziness, bradycardia; hypercalcemia.

How Supplied:

Caps—50; Single-dose vial (1mL, 2mL)—50; Multi-dose vial (2mL)—50