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SENSIPAR
Cytoprotective and supportive care agents
Secondary hyperparathyroidism or hypocalcemia
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Drug Name:

SENSIPAR Rx

Generic Name and Formulations:
Cinacalcet 30mg, 60mg, 90mg, tabs.

Company:
Amgen, Inc.

Therapeutic Use:

Indications for SENSIPAR:

Hypercalcemia in patients with parathyroid carcinoma or with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.

Adult:

Swallow whole; take with food. Individualize. Initially 30mg twice daily. May titrate dose every 2–4 weeks through sequential doses of 30mg twice daily, 60mg twice daily, 90mg twice daily, and 90mg 3–4 times daily until serum calcium normalizes. Monitoring and dose adjustment: see full labeling.

Children:

Not established.

Contraindications:

When serum calcium is less than the lower limit of the normal range.

Warnings/Precautions:

Hypocalcemia: may increase risk of QT prolongation and ventricular arrhythmias in congenital or family history of long QT syndrome or sudden cardiac death, history of QT prolongation and other predispositions; monitor closely. Seizure disorders. If corrected serum calcium is below lower limit of normal or symptoms of hypocalcemia occurs, initiate or increase calcium supplementation. Monitor for adynamic bone disease; if iPTH levels decrease to <150pg/mL, reduce dose (Vit.D sterols and/or cinacalcet) or discontinue. Known gastritis, esophagitis, ulcers, severe vomiting: monitor for worsening GI reactions, bleeding, and ulcerations. Impaired cardiac function. Moderate and severe hepatic impairment. Pregnancy. Nursing mothers.

Interactions:

Potentiates CYP2D6 substrates (eg, desipramine, metoprolol, carvedilol) and drugs with a narrow therapeutic index (eg, flecainide, TCAs). Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole); monitor and may need dose adjustment. Risk of severe hypocalcemia with concomitant calcium-lowering drugs including other calcium-sensing receptor agonists.

Pharmacological Class:

Calcimimetic.

Adverse Reactions:

Nausea, vomiting; QT prolongation, ventricular arrhythmia, hypocalcemia; possible hypotension, worsening heart failure, and/or arrhythmias.

How Supplied:

Tabs—30

Indications for SENSIPAR:

Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Adult:

Swallow whole; take with food. Individualize. Initially 30mg once daily. Measure serum calcium and serum phosphorus within 1 week and iPTH within 1–4 weeks after start initiation or dose adjustment. Titrate dose every 2–4 weeks through sequential doses of 30mg, 60mg, 90mg, 120mg, and 180mg once daily until target iPTH levels of 150–300pg/mL. Assess serum iPTH levels no earlier than 12hrs after most recent dose. May take with Vit.D sterols and/or phosphate binders. Monitoring and dose adjustment: see full labeling.

Children:

Not established.

Contraindications:

When serum calcium is less than the lower limit of the normal range.

Warnings/Precautions:

Hypocalcemia: may increase risk of QT prolongation and ventricular arrhythmias in congenital or family history of long QT syndrome or sudden cardiac death, history of QT prolongation and other predispositions; monitor closely. Seizure disorders. If corrected serum calcium is below lower limit of normal or symptoms of hypocalcemia occurs, initiate or increase calcium supplementation. Monitor for adynamic bone disease; if iPTH levels decrease to <150pg/mL, reduce dose (Vit.D sterols and/or cinacalcet) or discontinue. Known gastritis, esophagitis, ulcers, severe vomiting: monitor for worsening GI reactions, bleeding, and ulcerations. Impaired cardiac function. Moderate and severe hepatic impairment. Pregnancy. Nursing mothers.

Interactions:

Potentiates CYP2D6 substrates (eg, desipramine, metoprolol, carvedilol) and drugs with a narrow therapeutic index (eg, flecainide, TCAs). Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole); monitor and may need dose adjustment. Risk of severe hypocalcemia with concomitant calcium-lowering drugs including other calcium-sensing receptor agonists.

Pharmacological Class:

Calcimimetic.

Adverse Reactions:

Nausea, vomiting; QT prolongation, ventricular arrhythmia, hypocalcemia; possible hypotension, worsening heart failure, and/or arrhythmias.

How Supplied:

Tabs—30

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