Hectorol Inj

— THERAPEUTIC CATEGORIES —
  • Secondary hyperparathyroidism or hypocalcemia

Hectorol Inj Generic Name & Formulations

General Description

Doxercalciferol 2mcg/mL; soln for IV inj.

Pharmacological Class

Vit. D analog.

See Also

    How Supplied

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

    Manufacturer

    Hectorol Inj Indications

    Indications

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

    Hectorol Inj Dosage and Administration

    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.

    Hectorol Inj Contraindications

    Contraindications

    Hypercalcemia. Vit.D toxicity.

    Hectorol Inj Boxed Warnings

    Not Applicable

    Hectorol Inj Warnings/Precautions

    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.

    Hectorol Inj Pharmacokinetics

    See Literature

    Hectorol Inj Interactions

    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.

    Hectorol Inj Adverse Reactions

    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.

    Hectorol Inj Clinical Trials

    See Literature

    Hectorol Inj Note

    Not Applicable

    Hectorol Inj Patient Counseling

    See Literature