Sensipar (Page 6 of 7)

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 Sensipar 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.

Sixty-seven patients with primary HPT who met criteria for parathyroidectomy on the basis of corrected total serum calcium (> 11.3 mg/dL [2.82 mmol/L] and ≤ 12.5 mg/dL [3.12 mmol/L]), but who were unable to undergo parathyroidectomy participated in a randomized, double-blind, placebo-controlled study. A total of 33 patients were randomized to Sensipar and 34 patients randomized to placebo. The mean age of the patients was 72 years, 52% were female, 61% were Caucasian, and 5% were Blacks. The study started with a 12-week titration phase, followed by a 16-week efficacy-assessment phase. Cinacalcet was initiated at a dose of 30 mg twice daily and titrated to maintain a corrected total serum calcium concentration within the normal range. During the efficacy period a significantly higher percentage of cinacalcet-treated patients compared with the placebo-treated patients achieved mean corrected total serum calcium concentration (≤ 10.3 mg/dL [2.57 mmol/L], 75.8% vs 0%, p < 0.001) and ≥ 1 mg/dL [0.25 mmol/L] decrease from baseline in mean corrected total serum calcium concentration (84.8% vs 5.9%, p < 0.001). The median dose of Sensipar at the completion of the study was 60 mg/day.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sensipar 30 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “30” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-073-30)

Sensipar 60 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “60” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-074-30)

Sensipar 90 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “90” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-075-30)

Storage

Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). [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 Sensipar 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 Sensipar 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 Sensipar therapy.

Sensipar® (cinacalcet) Tablets

Manufactured by:
Amgen Inc.
One Amgen Center Drive Thousand Oaks, California 91320-1799

Patent: http://pat.amgen.com/sensipar/

© 2004-2019 Amgen Inc. All rights reserved.

www.sensipar.com

1-800-77-AMGEN (1-800-772-6436)

1xxxxxx – v14

PRINCIPAL DISPLAY PANEL

AMGEN®

NDC 55513-073-30

Sensipar®

(cinacalcet) Tablets

Rx Only

30 tablets

30 mg

Each tablet contains:

Cinacalcet 30 mg (equivalent to 33 mg of cinacalcet hydrochloride).

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

See USP controlled room temperature.

Dispense in tight, light-resistant container per USP.

Dosage : See Package Insert.

© 2004-2018 Amgen Inc. All rights reserved.

Patent : http://pat.amgen.com/sensipar/

Distributed by : Amgen,

One Amgen Center Drive,

Thousand Oaks, CA 91320-1799

Made in Japan

PRINCIPAL DISPLAY PANEL
AMGEN®
NDC 55513-073-30
Sensipar®
(cinacalcet ) Tablets
Rx Only 
30 tablets
30 mg
Each tablet contains :
Cinacalcet 30 mg (equivalent to 33 mg of cinacalcet hydrochloride).
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
See USP controlled room temperature.
Dispense in tight, light-resistant container per USP.
Dosage : See Package Insert.
© 2004-2018 Amgen Inc. All rights reserved.
Patent : http://pat.amgen.com/sensipar/
Distributed by : Amgen,
One Amgen Center Drive,
Thousand Oaks, CA 91320-1799
Made in Japan
(click image for full-size original)

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.