CINACALCET (Page 6 of 6)

14.2 Parathyroid Carcinoma

Twenty-nine patients with Parathyroid Carcinoma were enrolled in a single-arm, open-label study. The study consisted of two phases, a dose-titration phase and a maintenance phase. Patients initially received 30 mg cinacalcet twice daily and then were titrated every 2 weeks to a maximum dose of 90 mg four times daily. Dosage escalation during the variable-length (2 to 16 weeks) titration phase continued until the serum calcium concentration was ≤ 10 mg/dL (2.5 mmol/L), the patient reached the highest possible dosage, or adverse events precluded further dosage increases.

Twenty-nine patients entered the study. The median exposure to cinacalcet was 229 days (range: 1 to 1051). At baseline the mean (SE) serum calcium was 14.1 (0.4) mg/dL. At the end of the titration phase, the mean (SE) serum calcium was 12.4 (0.5) mg/dL, which is a mean reduction of 1.7 (0.6) mg/dL from baseline. Figure 3 illustrates mean serum calcium (mg/dL) over time for all patients still on study at each time point from the beginning of titration to study visit week 80. Daily dose during the study ranged from 30 mg twice daily to 90 mg four times daily.

Figure 3. Serum Calcium Values in Patients With Parathyroid Carcinoma Receiving Cinacalcet at Baseline, Titration, and Maintenance Phase

Figure 3. Serum Calcium Values in Patients With Parathyroid Carcinoma Receiving Sensipar at Baseline, Titration, and Maintenance Phase
(click image for full-size original)

n = Number of patients with non-missing values at the timepoint.

End of Titration (EOT) phase could occur at any visit from week 2 to 16. Patients at EOT are those who completed titration.

14.3 Patients with Hypercalcemia Due to Primary Hyperparathyroidism

Seventeen patients with severe hypercalcemia due to primary HPT, who had failed or had contraindications to parathyroidectomy, participated in an open-label, single-arm study. The study consisted of two phases, a dose-titration phase and a maintenance phase. In this trial, severe hypercalcemia was defined as a screening serum calcium level of > 12.5 mg/dL. Patients initially received 30 mg cinacalcet twice daily and then were titrated every 2 weeks to a maximum dose of 90 mg 4 times daily. Dosage escalation during the variable-length (2 to 16 weeks) titration phase continued until the serum calcium concentration was ≤ 10 mg/dL (2.5 mmol/L), the patient reached the highest possible dosage, or adverse events precluded further dosage increases.

Seventeen patients entered the study. The median exposure to cinacalcet was 270 days (range: 32 to 1,105). At baseline the mean (SE) serum calcium was 12.7 (0.2) mg/dL. At the end of the titration phase the mean (SE) serum calcium was 10.4 (0.3) mg/dL, which is a mean reduction of 2.3 (0.3) mg/dL from baseline. Figure 4 illustrates mean serum calcium (mg/dL) over time for all patients still on study at each time point from the beginning of titration to study visit week 80. Daily dose during the study ranged from 30 mg twice a day to 90 mg four times a day.

Figure 4. Mean Serum Calcium (SE) at Baseline, End of Titration, and Scheduled Maintenance Visits (Patients with Severe intractable primary HPT)

Figure 4. Mean Serum Calcium (SE) at Baseline, End of Titration, and Scheduled Maintenance Visits (Patients with Severe intractable primary HPT)
(click image for full-size original)

n = Number of patients with non-missing values at the timepoint.

End of Titration (EOT) phase could occur at any visit from week 2 to 16. Patients at EOT are those who completed titration.

16 HOW SUPPLIED/STORAGE AND HANDLING

Cinacalcet tablets 30 mg tablets are formulated as light green colored, oval shaped, biconvex, film-coated tablets debossed with “HB1″ on one side and plain on other side, packaged in bottles with child-resistant closure of 30 tablets (NDC 16729-440-10), 90 tablets (NDC 16729-440-15), and 100 tablets (NDC 16729-440-01).

Cinacalcet tablets 60 mg tablets are formulated as light green colored, oval shaped, biconvex, film-coated tablets debossed with “HB2″ on one side and plain on other side, packaged in bottles with child-resistant closure of 30 tablets (NDC 16729-441-10), 90 tablets (NDC 16729-441-15), and 100 tablets (NDC 16729-441-01).

Cinacalcet tablets 90 mg tablets are formulated as light green colored, oval shaped, biconvex, film-coated tablets debossed with “HB3″ on one side and plain on other side, packaged in bottles with child-resistant closure of 30 tablets (NDC 16729-442-10), 90 tablets (NDC 16729-442-15), and 100 tablets (NDC 16729-442-01).

Storage

Store at 25ºC (77ºF); excursions permitted from 15°C to 30ºC (59°F to 86ºF). [See USP controlled room temperature.]

17 PATIENT COUNSELING INFORMATION

  • 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 tablets may worsen their heart failure [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 tablets 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 tablets therapy.

Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210,
INDIA.

10 2736 1 6000275

Issued January 2020

PRINCIPAL DISPLAY PANEL

NDC 16729- 440 -10

Cinacalcet Tablets

30 mg

Rx Only

30 Tablets

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

NDC 16729- 441 -10

Cinacalcet Tablets

60 mg

Rx Only

30 Tablets

PRINCIPAL DISPLAY PANEL
(click image for full-size original)

NDC 16729- 442 -10

Cinacalcet Tablets

90 mg

Rx Only

30 Tablets

PRINCIPAL DISPLAY PANEL
(click image for full-size original)
CINACALCET cinacalcet tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-440
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE (CINACALCET) CINACALCET 30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color green (light green) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code HB1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-440-10 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:16729-440-15 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:16729-440-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211892 06/16/2020
CINACALCET cinacalcet tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-441
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE (CINACALCET) CINACALCET 60 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color green (light green) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code HB2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-441-10 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:16729-441-15 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:16729-441-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211892 06/16/2020
CINACALCET cinacalcet tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-442
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE (CINACALCET) CINACALCET 90 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color green (light green) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code HB3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-442-10 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:16729-442-15 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:16729-442-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211892 06/16/2020
Labeler — Accord Healthcare, Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 manufacture (16729-440), manufacture (16729-441), manufacture (16729-442), analysis (16729-440), analysis (16729-441), analysis (16729-442)

Revised: 06/2020 Accord Healthcare, Inc.

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