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CINACALCET

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Overview

What is CINACALCET?

Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet tablets contain the hydrochloride salt of cinacalcet. Its empirical formula is CHFN⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity.

The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water.

Cinacalcet tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively).

The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula:

Inactive Ingredients

The following are the inactive ingredients in cinacalcet hydrochloride tablets: pre-gelatinized starch (botanical source is maize starch), microcrystalline cellulose, povidone, crospovidone, magnesium stearate and isopropyl alcohol. Tablets are coated with Opadry II Green (hypromellose, lactose monohydrate, titanium dioxide, triacetin, FD&C blue #2/indigo carmine AL, iron oxide yellow).



What does CINACALCET look like?



What are the available doses of CINACALCET?

Tablets: 30mg, 60mg, and 90 mg tablets ()

What should I talk to my health care provider before I take CINACALCET?

How should I use CINACALCET?

Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis

Limitations of Use:

Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia

Cinacalcet hydrochloride tablets should be taken with food or shortly after a meal.

Cinacalcet hydrochloride tablets are administered orally and should always be taken whole and not chewed, crushed, or divided.


What interacts with CINACALCET?

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What are the warnings of CINACALCET?

Sorry No Records found


What are the precautions of CINACALCET?

Sorry No Records found


What are the side effects of CINACALCET?

Sorry No records found


What should I look out for while using CINACALCET?

Cinacalcet hydrochloride tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range


What might happen if I take too much CINACALCET?

Overdosage of cinacalcet hydrochloride may lead to hypocalcemia. In the event of overdosage, patients should be monitored for signs and symptoms of hypocalcemia and appropriate measures taken to correct serum calcium levels .

Since cinacalcet hydrochloride is highly protein bound, hemodialysis is not an effective treatment for overdosage of cinacalcet hydrochloride tablets.

 


How should I store and handle CINACALCET?

Cinacalcet hydrochloride 30 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "410" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-410-02).Cinacalcet hydrochloride 60 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "411" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-411-02).Cinacalcet hydrochloride 90 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "412" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-412-02).StorageStore at 25 °C (77 °F), excursions permitted from 15to 30 °C (59 to 86 °F). [See USP controlled room temperature.]Cinacalcet hydrochloride 30 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "410" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-410-02).Cinacalcet hydrochloride 60 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "411" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-411-02).Cinacalcet hydrochloride 90 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "412" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-412-02).StorageStore at 25 °C (77 °F), excursions permitted from 15to 30 °C (59 to 86 °F). [See USP controlled room temperature.]Cinacalcet hydrochloride 30 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "410" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-410-02).Cinacalcet hydrochloride 60 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "411" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-411-02).Cinacalcet hydrochloride 90 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "412" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-412-02).StorageStore at 25 °C (77 °F), excursions permitted from 15to 30 °C (59 to 86 °F). [See USP controlled room temperature.]Cinacalcet hydrochloride 30 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "410" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-410-02).Cinacalcet hydrochloride 60 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "411" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-411-02).Cinacalcet hydrochloride 90 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "412" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-412-02).StorageStore at 25 °C (77 °F), excursions permitted from 15to 30 °C (59 to 86 °F). [See USP controlled room temperature.]Cinacalcet hydrochloride 30 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "410" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-410-02).Cinacalcet hydrochloride 60 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "411" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-411-02).Cinacalcet hydrochloride 90 mg tablets are formulated as light-green, film-coated, oval-shaped, biconvex tablets debossed with "CL" on one side and "412" on the opposite side, packaged in bottles of 30 tablets. (NDC 69097-412-02).StorageStore at 25 °C (77 °F), excursions permitted from 15to 30 °C (59 to 86 °F). [See USP controlled room temperature.]


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH synthesis and secretion. Cinacalcet, the active ingredient in cinacalcet hydrochloride tablets, directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.

Non-Clinical Toxicology
Cinacalcet hydrochloride tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range

Cinacalcet hydrochloride tablets lowers serum calcium and can lead to hypocalcemia 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 have been reported in patients treated with cinacalcet hydrochloride tablets, including in pediatric patients. The safety and effectiveness of cinacalcet hydrochloride tablets have not been established in pediatric patients

Cinacalcet hydrochloride tablets are not indicated for patients with CKD not on dialysis . In patients with secondary HPT and CKD not on dialysis, the long term safety and efficacy of cinacalcet hydrochloride tablets have not been established. Clinical studies indicate that cinacalcet-treated patients with CKD not on dialysis have an increased risk for hypocalcemia compared with cinacalcet-treated patients with CKD on dialysis, which may be due to lower baseline calcium levels. In a phase 3 study of 32 weeks duration and including 404 patients with CKD not on dialysis (302 cinacalcet, 102 placebo), in which the median dose for cinacalcet was 60 mg per day at the completion of the study, 80% of cinacalcet-treated patients experienced at least one serum calcium value < 8.4 mg/dL compared with 5% of patients receiving placebo.

QT Interval Prolongation and Ventricular Arrhythmia

Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet hydrochloride tablets.

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 cinacalcet hydrochloride. Closely monitor corrected serum calcium and QT interval in patients at risk receiving cinacalcet hydrochloride.

Seizures

In clinical studies, seizures (primarily generalized or tonic-clonic) were observed in 1.4% (43/3049) of cinacalcet-treated patients and 0.7% (5/687) of placebo-treated patients. While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels. Monitor serum calcium levels in patients with seizure disorder receiving cinacalcet hydrochloride tablets

Concurrent administration of cinacalcet hydrochloride with calcium-lowering drugs including other calcium-sensing receptor agonists could result in severe hypocalcemia. Closely monitor serum calcium in patients receiving cinacalcet hydrochloride and concomitant therapies known to lower serum calcium levels.

Educate patients on the symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur.

If corrected serum calcium falls below the lower limit of normal or symptoms 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). Cinacalcet hydrochloride tablets dose reduction or discontinuation of cinacalcet hydrochloride tablets may be necessary

The following adverse reactions are discussed in greater detail in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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