Cinacalcet is the generic equivalent of the brand-name drug Cinacalcet. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Cinacalcet through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1) Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3) 1.1 Secondary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in…
Adverse Reactions
6 ADVERSE REACTIONS 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)] The most common adverse reactions (i.e., ≥ 25%) associated with cinacalcet were nausea and vomiting. (6) To report…
Drug Interactions
7 DRUG INTERACTIONS Coadministration with a strong CYP3A4 inhibitor may increase serum levels of cinacalcet. Dose adjustment and monitoring of iPTH serum phosphorus and serum calcium may be required. (7.1) Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6. (7.2) 7.1 Strong CYP3A4 Inhibitors Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of cinacalcet may be required if a patient in…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Cinacalcet tablets should be taken with food or shortly after a meal (2.1). Tablets should always be taken whole and not divided (2.1) Secondary HPT in patients with CKD on dialysis (2.2): Starting dose is 30 mg once daily. Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily as necessary to achieve targeted intact parathyroid hormone (iPTH) levels. iPTH levels should be measured no earlier than 12…
Patient Counseling Information
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 may worsen their heart failure and additional monitoring may be required [see Warnings and Precautions (5.3)]. Advise p…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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