cinacalcet

REMS

Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Hypercalcemia caused by parathyroid carcinoma.
Severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy.

Contraindicated in:

Hypersensitivity;
Hypocalcemia.

Use Cautiously in:

History of seizure disorder (↑ risk of seizures with hypocalcemia);
Chronic kidney disease patients who are not being dialyzed (↑ risk of hypocalcemia);
Intact parathyroid hormone (iPTH) level <150 pg/mL (dose ↓ or discontinuation may be warranted);
Moderate or severe hepatic impairment;
Congenital long QT syndrome, QT interval prolongation, family history of long QT syndrome or sudden cardiac death, or concurrent use of QT-interval-prolonging medications;
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

CV: ARRHYTHMIA, HF exacerbation, hypotension, QT interval prolongation, TORSADES DE POINTES

F and E: HYPOCALCEMIA

GI: nausea, vomiting

Metab: adynamic bone disease

Neuro: SEIZURES

Drug-drug:

Concurrent use of QT interval prolonging medications may ↑ risk of QT interval prolongation and/or torsade de pointes, especially in patients with hypocalcemia.
May ↑ levels and risk of toxicity of CYP2D6 substrates, including flecainide, vinblastine, thioridazine, metoprolol, carvedilol, and most tricyclic antidepressants; dose adjustments may be necessary.
Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, and erythromycin, may ↑ levels and risk of toxicity; monitoring and dose adjustment may be necessary.

(Generic available)

Tablets: 30 mg; 60 mg; 90 mg

Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis

PO (Adults ): 30 mg once daily; may ↑ dose every 2–4 wk (dose range 30–180 mg once daily) based on iPTH levels. Switching from etecalcetide: Discontinue etecalcetide for ≥4 wk and ensure corrected serum calcium is at or above lower limit of normal prior to starting cinacalcet.

Parathyroid Carcinoma or Primary Hyperparathyroidism

PO (Adults ): 30 mg twice daily; may ↑ every 2–4 wk up to 90 mg 3–4 times daily based on serum calcium levels.

Sensipar

Increases sensitivity of calcium-sensing receptors located on the surface of chief cells of parathyroid gland to levels of extracellular calcium. This decreases parathyroid hormone (PTH) production with resultant decrease in serum calcium.

Therapeutic effects:

Decreased bone turnover and fibrosis.
Decreased serum calcium.

Therapeutic Classification: hypocalcemics

Pharmacologic Classification: calcimimetic agents

Absorption: Well absorbed following oral administration; absorption is enhanced by food and further enhanced by a high-fat meal.

Distribution: Extensively distributed to tissues.

Protein Binding: 93–97%.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4, CYP2D6, and CYP1A2 isoenzymes; 80% excreted in urine as metabolites, 15% in feces.

Half-Life: 30–40 hr.

(effect on PTH levels)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	2–6 hr	6–12 hr

Instruct patient to take cinacalcet as directed.
Advise patient to report signs and symptoms of hypocalcemia, GI bleeding (black tarry stools, abdominal pain), nausea, and vomiting to health care professional promptly.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.
Emphasize the importance of follow-up lab tests to monitor safely and efficacy.

sin-a-KAL-set

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-6195- Cinacalcet
  - 0378-6195-93- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6195-93)

0378- Mylan Pharmaceuticals Inc.
- 0378-6196- Cinacalcet
  - 0378-6196-93- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6196-93)

0378- Mylan Pharmaceuticals Inc.
- 0378-6197- Cinacalcet
  - 0378-6197-93- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6197-93)

0591- Actavis Pharma, Inc.
- 0591-2416- Cinacalcet Hydrochloride
  - 0591-2416-30- 30 TABLET, FILM COATED in 1 BOTTLE (0591-2416-30)

0591- Actavis Pharma, Inc.
- 0591-2417- Cinacalcet Hydrochloride
  - 0591-2417-30- 30 TABLET, FILM COATED in 1 BOTTLE (0591-2417-30)

0591- Actavis Pharma, Inc.
- 0591-2418- Cinacalcet Hydrochloride
  - 0591-2418-30- 30 TABLET, FILM COATED in 1 BOTTLE (0591-2418-30)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-379- Cinacalcet
  - 47335-379-83- 30 TABLET, FILM COATED in 1 BOTTLE (47335-379-83)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-380- Cinacalcet
  - 47335-380-83- 30 TABLET, FILM COATED in 1 BOTTLE (47335-380-83)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-600- Cinacalcet
  - 47335-600-83- 30 TABLET, FILM COATED in 1 BOTTLE (47335-600-83)

50090- A-S Medication Solutions
- 50090-3529- Sensipar
  - 50090-3529-0- 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-3529-0)

50090- A-S Medication Solutions
- 50090-4470- Sensipar
  - 50090-4470-0- 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-4470-0)

55513- Amgen Inc
- 55513-073- Sensipar
  - 55513-073-30- 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-073-30)

55513- Amgen Inc
- 55513-074- Sensipar
  - 55513-074-30- 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-074-30)

55513- Amgen Inc
- 55513-075- Sensipar
  - 55513-075-30- 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-075-30)

60687- American Health Packaging
- 60687-525- Cinacalcet
  - 60687-525-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-525-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-525-11)

64380- Strides Pharma Science Limited
- 64380-883- Cinacalcet Hydrochloride
  - 64380-883-04- 30 TABLET, FILM COATED in 1 BOTTLE (64380-883-04)

64380- Strides Pharma Science Limited
- 64380-884- Cinacalcet Hydrochloride
  - 64380-884-04- 30 TABLET, FILM COATED in 1 BOTTLE (64380-884-04)

64380- Strides Pharma Science Limited
- 64380-885- Cinacalcet Hydrochloride
  - 64380-885-04- 30 TABLET, FILM COATED in 1 BOTTLE (64380-885-04)

65862- Aurobindo Pharma Limited
- 65862-831- Cinacalcet
  - 65862-831-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-831-01)

65862- Aurobindo Pharma Limited
- 65862-831- Cinacalcet
  - 65862-831-05- 500 TABLET, FILM COATED in 1 BOTTLE (65862-831-05)

65862- Aurobindo Pharma Limited
- 65862-831- Cinacalcet
  - 65862-831-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-831-30)

65862- Aurobindo Pharma Limited
- 65862-831- Cinacalcet
  - 65862-831-90- 90 TABLET, FILM COATED in 1 BOTTLE (65862-831-90)

65862- Aurobindo Pharma Limited
- 65862-832- Cinacalcet
  - 65862-832-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-832-01)

65862- Aurobindo Pharma Limited
- 65862-832- Cinacalcet
  - 65862-832-05- 500 TABLET, FILM COATED in 1 BOTTLE (65862-832-05)

65862- Aurobindo Pharma Limited
- 65862-832- Cinacalcet
  - 65862-832-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-832-30)

65862- Aurobindo Pharma Limited
- 65862-832- Cinacalcet
  - 65862-832-90- 90 TABLET, FILM COATED in 1 BOTTLE (65862-832-90)

65862- Aurobindo Pharma Limited
- 65862-833- Cinacalcet
  - 65862-833-01- 100 TABLET, FILM COATED in 1 BOTTLE (65862-833-01)

65862- Aurobindo Pharma Limited
- 65862-833- Cinacalcet
  - 65862-833-05- 500 TABLET, FILM COATED in 1 BOTTLE (65862-833-05)

65862- Aurobindo Pharma Limited
- 65862-833- Cinacalcet
  - 65862-833-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-833-30)

65862- Aurobindo Pharma Limited
- 65862-833- Cinacalcet
  - 65862-833-90- 90 TABLET, FILM COATED in 1 BOTTLE (65862-833-90)

67877- Ascend Laboratories, LLC
- 67877-503- Cinacalcet
  - 67877-503-01- 100 TABLET, FILM COATED in 1 BOTTLE (67877-503-01)

67877- Ascend Laboratories, LLC
- 67877-503- Cinacalcet
  - 67877-503-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-503-30)

67877- Ascend Laboratories, LLC
- 67877-503- Cinacalcet
  - 67877-503-33- 10 BLISTER PACK in 1 CARTON (67877-503-33) > 10 TABLET, FILM COATED in 1 BLISTER PACK

67877- Ascend Laboratories, LLC
- 67877-504- Cinacalcet
  - 67877-504-01- 100 TABLET, FILM COATED in 1 BOTTLE (67877-504-01)

67877- Ascend Laboratories, LLC
- 67877-504- Cinacalcet
  - 67877-504-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-504-30)

67877- Ascend Laboratories, LLC
- 67877-504- Cinacalcet
  - 67877-504-33- 10 BLISTER PACK in 1 CARTON (67877-504-33) > 10 TABLET, FILM COATED in 1 BLISTER PACK

67877- Ascend Laboratories, LLC
- 67877-505- Cinacalcet
  - 67877-505-01- 100 TABLET, FILM COATED in 1 BOTTLE (67877-505-01)

67877- Ascend Laboratories, LLC
- 67877-505- Cinacalcet
  - 67877-505-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-505-30)

67877- Ascend Laboratories, LLC
- 67877-505- Cinacalcet
  - 67877-505-33- 10 BLISTER PACK in 1 CARTON (67877-505-33) > 10 TABLET, FILM COATED in 1 BLISTER PACK

69097- Cipla USA Inc.
- 69097-410- CINACALCET
  - 69097-410-02- 30 TABLET in 1 BOTTLE (69097-410-02)

69097- Cipla USA Inc.
- 69097-411- CINACALCET
  - 69097-411-02- 60 TABLET in 1 BOTTLE (69097-411-02)

69097- Cipla USA Inc.
- 69097-412- CINACALCET
  - 69097-412-02- 90 TABLET in 1 BOTTLE (69097-412-02)

70436- Slate Run Pharmaceuticals
- 70436-007- cinacalcet hydrochloride
  - 70436-007-04- 30 TABLET, FILM COATED in 1 BOTTLE (70436-007-04)

70436- Slate Run Pharmaceuticals
- 70436-008- cinacalcet hydrochloride
  - 70436-008-04- 30 TABLET, FILM COATED in 1 BOTTLE (70436-008-04)

70436- Slate Run Pharmaceuticals
- 70436-009- cinacalcet hydrochloride
  - 70436-009-04- 30 TABLET, FILM COATED in 1 BOTTLE (70436-009-04)

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆