Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Sensipar Generic Name & Formulations
Legal Class
Rx
General Description
Cinacalcet 30mg, 60mg, 90mg, tabs.
Pharmacological Class
Calcimimetic.
How Supplied
Tabs—30
Manufacturer
Sensipar Indications
Indications
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.
Sensipar Dosage and Administration
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.
Sensipar Contraindications
Contraindications
When serum calcium is less than the lower limit of the normal range.
Sensipar Boxed Warnings
Not Applicable
Sensipar Warnings/Precautions
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.
Sensipar Pharmacokinetics
See Literature
Sensipar Interactions
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.
Sensipar Adverse Reactions
Adverse Reactions
Nausea, vomiting; QT prolongation, ventricular arrhythmia, hypocalcemia; upper GI bleeding, possible hypotension, worsening heart failure, and/or arrhythmias.
Sensipar Clinical Trials
See Literature
Sensipar Note
Not Applicable
Sensipar Patient Counseling
See Literature
Sensipar Generic Name & Formulations
Legal Class
Rx
General Description
Cinacalcet 30mg, 60mg, 90mg, tabs.
Pharmacological Class
Calcimimetic.
How Supplied
Tabs—30
Manufacturer
Sensipar Indications
Indications
Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Sensipar Dosage and Administration
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. Switching from etelcalcetide: discontinue etelcalcetide for ≥4 weeks before starting cinacalcet. Monitoring and dose adjustment: see full labeling.
Children
Not established.
Sensipar Contraindications
Contraindications
When serum calcium is less than the lower limit of the normal range.
Sensipar Boxed Warnings
Not Applicable
Sensipar Warnings/Precautions
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.
Sensipar Pharmacokinetics
See Literature
Sensipar Interactions
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.
Sensipar Adverse Reactions
Adverse Reactions
Nausea, vomiting; QT prolongation, ventricular arrhythmia, hypocalcemia; upper GI bleeding, possible hypotension, worsening heart failure, and/or arrhythmias.
Sensipar Clinical Trials
See Literature
Sensipar Note
Not Applicable
Sensipar Patient Counseling
See Literature
Images
