Cinacalcet - Bryant Ranch Prepack

1 INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS & STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Cinacalcet tablets is available as film-coated tablets. Cinacalcet tablets are formulated as light green colored, oval shaped, film coated tablets debossed with “A33”, “A34” , “A35” on one side and “30” or “60” or “90” on the other side of the 30 mg, 60 mg, or 90 mg strengths, respectively.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Cinacalcet treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [ see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reactions are discussed in greater detail in other sections of labeling: Hypocalcemia [see Warnings and Precautions (5.1)] Upper Gastrointestinal Bleeding [see Warnings and Precautions (5.2)] Hypotension, Worsening Heart Failure and/or Arrhythmias [see Warnings and Precautions (5.3)] Adynamic Bone Disease [see Warnings and Precautions (5.4)]

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Overdosage of cinacalcet 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 [see Warnings and Precautions (5.1)]. Since cinacalcet is highly protein bound, hemodialysis is not an effective treatment for overdosage of cinacalcet .

11 DESCRIPTION

DESCRIPTION SECTION

Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C 22 H 22 F 3 N⋅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, powder that is soluble in methanol, 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 tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Cinacalcet Tablets 30 mg are formulated as light green colored, oval shaped, film coated tablets debossed with “A33” on one side and “30” on other side, packaged in: NDC 63629-8763-1: 30 tablets in a Bottle. Store at 25ºC (77ºF); excursions permitted from 15°C to 30ºC (59°F to 86ºF). [See USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Hypocalcemia: Advise patients to report symptoms of hypocalcemia, including paresthesias, myalgias, muscle spasms, and seizures, to their healthcare provider [ see Warnings and Precautions (5.1)]. Upper Gastrointestinal Bleeding: Advise patients to report any symptoms of upper gastrointestinal bleeding to their health care provider [see Warnings and Precautions (5.2)]. Heart Failure: Advise patients with heart failure that use of cinacalcet may worsen their heart failure and additional monitoring may be required [see Warnings and Precautions (5.3)]. Advise patients to report nausea and vomiting to their health care provider [see Adverse Reactions (6.1)]. Advise patients to take cinacalcet with food or shortly after a meal and to take the tablets whole and not divide them [see Dosage and Administration (2.1)]. Inform patients of the importance of regular blood tests, in order to monitor the safety and efficacy of cinacalcet therapy. All trademarks are the property of their respective owners. Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: November, 2021 PT 2787-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cinacalcet HCL 30 mg Tablet #30