cinacalcet

Therapeutic Classification: hypocalcemics

Pharmacologic Classification: calcimimetic agents

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.

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.

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

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: HF exacerbation, QT interval prolongation, ARRHYTHMIA, hypotension, 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.

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.

(Generic available)

Tablets: 30 mg; 60 mg; 90 mg;

Monitor for signs and symptoms of hypocalcemia (paresthesias, myalgias, cramping, tetany, convulsions) during therapy. If calcium levels decrease to below normal, serum calcium may be increased by adjusting dose (see Lab Test Considerations) and providing supplemental serum calcium, initiating or increasing dose of calcium-based phosphate binder or vitamin D.
Monitor ECG for prolonged QT interval periodically during therapy.

Lab Test Considerations:

Monitor serum calcium and phosphorus levels within 1 wk after initiation of therapy or dose adjustment and monthly for patients with hyperparathyroidism or every 2 mo for patients with parathyroid carcinoma once maintenance dose has been established, especially in patients with a history of seizure disorder. Therapy should not be initiated in patients with serum calcium less than the lower limit of normal (8.4 mg/dL).
- If serum calcium ↓ below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur, use calcium-containing phosphate binders and/or vitamin D sterols to ↑ serum calcium. If serum calcium ↓ below 7.5 mg/dL, or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be ↑, withhold administration of cinacalcet until serum calcium levels reach 8.0 mg/dL, and/or symptoms of hypocalcemia resolve. Reinitiate therapy using next lowest dose of cinacalcet.
- Monitor serum iPTH levels 1 to 4 wk after initiation of therapy or dose adjustment, and every 1 to 3 mo after maintenance dose has been established. If iPTH levels ↓ below 150–300 pg/mL, reduce dose or discontinue cinacalcet. Assess iPTH levels no earlier than 12 hr after dose.
- Monitor liver function tests in patients with moderate to severe hepatic impairment during therapy.

Cinacalcet may be used alone or in combination with vitamin D and/or phosphate binders.
PO: Administer with food or shortly after a meal. Take tablets whole; DNC: do not crush, break, or chew.

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.

Decreased serum calcium levels.

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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