cinacalcet (Rx)

Brand and Other Names:Sensipar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 30mg
  • 60mg
  • 90mg
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Secondary Hyperparathyroidism (HPT)

Indicated for secondary HPT in patients with chronic kidney disease on dialysis

Initial dose: 30 mg PO qDay

May increase if needed by titrating at 2-4 week intervals through sequential doses of 60, 90, 120, or 180 mg qDay

Hypercalcemia in Patients with Parathyroid Carcinoma

Initial dose: 30 mg PO q12hr

May increase if needed at 2-4 week intervals through sequential doses 60 mg q12hr, 90 mg q12hr, or 90 mg q6-8hr as necessary to normalize serum calcium levels

Hypercalcemia With Primary Hyperparathyroidism (HPT)

Indicated for severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy

Initial dose: 30 mg PO q12hr

May increase if needed at 2-4 week intervals through sequential doses 60 mg q12hr, 90 mg q12hr, or 90 mg q6-8hr as necessary to normalize serum calcium levels

Renal Impairment

Dose adjustment not necessary

Monitor

Secondary parathyroidism: Serum calcium (Ca), serum phosphorus and parathyroid hormone (PTH)

Parathyroid Cancer: Serum Ca

Monitoring of PTH and serum Ca particularly important for patients with hepatic impairment

Safety and efficacy not established

Secondary Hyperparathyroidism (Orphan)

Orphan designation for treatment of secondary hyperparathyroidism (HPT) in pediatric patients with chronic kidney disease receiving dialysis

Sponsor

  • Amgen, Inc; One Amgen Center Drive; Bldg 17, 1A-4-4, Mail Stop 17-1-B; Thousand Oaks, California 91320
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Interactions

Interaction Checker

and cinacalcet

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Secondary Parathyroidism

            • Diarrhea (20%)
            • Nausea (19%)
            • Vomiting (15%)
            • Myalgia (14%)

            1-10%

            Secondary Parathyroidism

            • Dizziness (8%)
            • Hypertension (5%)
            • Access infection (4%)
            • Anorexia (4%)
            • Asthenia (4%)
            • Noncardiac chest pain (4%)
            • Seizures 1.4%

            Frequency Not Defined

            Parathyroid CA

            • Nausea/vomiting
            • Hypocalcemia

            Postmarketing Reports

            Hypotension

            Worsening heart failure and/or arrhythmias

            Adynamic bone disease

            Gastrointestinal bleeding

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            Warnings

            Contraindications

            Hypersensitivity

            Should not be initiated in severe hypocalcemia (serum Ca <lower limit of normal)

            Cautions

            History of seizure; seizures (primarily generalized or tonic-clonic) were observed in clinical trials (1.4% compared with 0.7% in placebo)

            Not for therapy of patients with chronic kidney disease not on dialysis due to increased risk for hypokalemia

            Cinacalcet exposure is increased in patients with moderate and severe hepatic impairment; monitor serum calcium, serum phosphorus, and intact parathyroid hormone closely

            Cases of gastrointestinal bleeding, mostly upper gastrointestinal bleeding, reported in patients using calcimimetics, the exact cause of GI bleeding is unknown; patients with risk factors for upper GI bleeding (such as known gastritis, esophagitis, ulcers or severe vomiting) may be at increased risk for GI bleeding when receiving treatment; monitor patients for worsening of common GI adverse reactions of nausea and vomiting associated with therapy and for signs and symptoms of GI bleeding and ulcerations during therapy; promptly evaluate and treat any suspected GI bleeding

            Adynamic bone disease may develop if PTH levels <100 pg/mL

            Parathyroid carcinoma or primary hyperparathyroidism: Monitor serum calcium every 2 months

            Monitoring serum calcium for secondary hyperparathyroidism in patients with CKD on dialysis

            • Monitor serum calcium monthly
            • Significant lowering of serum calcium can cause paresthesias, myalgias, muscle spasms, tetany, seizures, QT interval prolongation and ventricular arrhythmia; life threatening events and fatal outcomes associated with hypocalcemia reported in patients treated with Sensipar, including in pediatric patients
            • If calcium levels fall to 7.5-8.4 mg/dL or hypocalcemia symptoms occur, give calcium-containing phosphate binders and/or vitamin D sterols to raise serum calcium
            • If calcium levels <7.5 mg/dL or hypocalcemia symptoms persist and the dose of vitamin D cannot be increased, withhold cinaclacet until calcium levels reach 8 mg/dL and/or hypocalcemia symptom resolve, then reinitiate using next lowest dose
            • If corrected serum calcium falls below lower limit of normal or symptoms Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to therapy; closely monitor corrected serum calcium and QT interval in patients at risk receiving of hypocalcemia develop, start or increase calcium supplementation (including calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration); dose reduction or discontinuation may be necessary
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            Pregnancy & Lactation

            Pregnancy

            Limited case reports of use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes; in animal reproduction studies, when female rats were exposed to the drug during the period of organogenesis through to weaning at 2-3 times systemic drug levels (based on AUC) at maximum recommended human dose (MRHD) of 180 mg/day, peripartum and early postnatal pup loss and reduced pup body weight gain were observed in the presence of maternal hypocalcemia

            Lactation

            There are no data regarding presence in human milk or effects on breastfed infant or on milk production; studies in rats showed that cinacalcet was excreted in milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Increases sensitivity of Ca-sensing receptor in parathyroid cells to activation by extracellular Ca, thereby downregulating PTH levels and consequently lowering serum Ca & phosphorus

            Absorption

            Bioavailability: High fat meal increases both peak plasma concentration and AUC vis-a-vis fasting

            Peak Plasma Time: 2-6 hr

            Distribution

            Protein Bound: 93-97%

            Vd: 1000 L

            Metabolism

            Metabolism: metabolized by CYP3A4, CYP2D6 & CYP1A2

            Metabolites: hydrocinnamic and hydroxy-hydrocinnamic acid, naphthalene-ring-containing molecules, dihydrodiols

            Enzyme Inhibited: CYP2D6

            Elimination

            Half-Life: 30-40 hr

            Excretion: Urine (80%); feces (15%)

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            Administration

            Oral Administration

            Take with food or shortly after meal

            Swallow tablet whole, do not chew, crush, or divide

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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