A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sensipar Indications, Dosage, Storage, Stability - Cinacalcet
Sensipar Indications, Dosage, Storage, Stability - Cinacalcet
INDICATIONS AND USAGE
Sensipar is indicated for the treatment of secondary hyperparathyroidism
in patients with Chronic Kidney Disease on dialysis.
Sensipar is indicated for the treatment of hypercalcemia in
patients with parathyroid carcinoma.
DOSAGE AND ADMINISTRATION
Sensipar tablets should be taken whole and should not be divided.
Sensipar should be taken with food or shortly after a meal.
Dosage must be individualized.
Secondary Hyperparathyroidism in Patients with Chronic Kidney
Disease on Dialysis
The recommended starting oral dose of Sensipar is 30 mg once
daily. Serum calcium and serum phosphorus should be measured within 1 week and
iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of
Sensipar . Sensipar should be titrated no more frequently than every 2 to 4
weeks through sequential doses of 60, 90, 120, and 180 mg once daily to target
iPTH consistent with the NKF-K/DOQI recommendation for CKD patients on dialysis
of 150-300 pg/mL.
Sensipar can be used alone or in combination with vitamin D
sterols and/or phosphate binders.
During dose titration, serum calcium levels should be monitored
frequently and if levels decrease below the normal range, appropriate steps
should be taken to increase serum calcium levels, such as by providing supplemental
calcium, initiating or increasing the dose of calcium-based phosphate binder,
initiating or increasing the dose of vitamin D sterols, or temporarily withholding
treatment with Sensipar (see PRECAUTIONS).
Parathyroid Carcinoma
The recommended starting oral dose of Sensipar™ is 30
mg twice daily.
The dosage of Sensipar™ should be titrated every 2 to
4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90
mg twice daily, and 90 mg three or four times daily as necessary to normalize
serum calcium levels.
Special Populations
Geriatric patients: Age does not alter the pharmacokinetics
of Sensipar ; no dosage adjustment is required for geriatric patients.
Patients with renal impairment: Renal impairment does
not alter the pharmacokinetics of Sensipar ; no dosage adjustment is necessary
for renal impairment.
Patients with hepatic impairment: Cinacalcet
exposures, as assessed by AUC(0-inf), in patients with moderate and
severe hepatic impairment (as indicated by the Child-Pugh method) were 2.4 and
4.2 times higher, respectively, then in normals. In patients with moderate and
severe hepatic impairment, PTH and serum calcium concentrations should be closely
monitored throughout treatment with Sensipar (see CLINICAL
PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS).
DRUG INTERACTIONS
Sensipar is metabolized in part by the enzyme CYP3A4. Co-administration
of ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold
increase in cinacalcet exposure. Dose adjustment of Sensipar may be required
and PTH and serum calcium concentrations should be closely monitored if a patient
initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole,
erythromycin, itraconazole; see CLINICAL PHARMACOLOGY,
Pharmacokinetics and PRECAUTIONS).
HOW SUPPLIED
Sensipar 30 mg tablets are formulated as light-green, film-coated,
oval-shaped tablets printed with "AMGEN" 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 printed with "AMGEN" 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 printed with "AMGEN" on one side and "90"
on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-075-30)
Storage
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF).
[See USP controlled room temperature].
This product, or its use, may be covered by one or more US
Patents including US Patent Nos. 6313146, 6211244, 6031003 and 6011068, in addition
to others, including patents pending.
REFERENCES
1. National Kidney Foundation: K/DOQI clinical practice guidelines:
bone metabolism and disease in chronic kidney disease. American Journal of Kidney
Disease 4 2:S1-S201, 2003
Manufactured for: Amgen Amgen Inc. One Amgen
Center Drive Thousand Oaks, CA 91320-1799 Issue Date 03/08/2004 ©2004 Amgen
Inc. All rights reserved. 3289800-v1
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