Hyperparathyroidism, secondary: Note: Should only be used when standard therapies have proven ineffective. Ensure calcium is in normal range before initiating therapy and monitor closely throughout treatment. Dosing based on patient's dry weight.
Children ≥3 years and Adolescents: Limited data available, optimal dosage not established in pediatric patients: Oral:
Weight-directed dosing: Initial: ≤0.2 mg/kg/dose once daily; may titrate every 4 weeks to reach target range of intact parathyroid hormone (iPTH) of 100 to 300 pg/mL. Maximum daily dose: 180 mg/day or 2.5 mg/kg/dose (whichever is lower) (Warady 2019; Mimpara prescribing information [European Union] 2018). Dosing based on a randomized, double-blind study (n=43) with an open-label phase (n=12) with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis. Cinacalcet was started at ≤0.2 mg/kg/day in 22 patients (mean age: 13.3 ± 3.6 years) and titrated every 4 weeks to goal iPTH. For the efficacy endpoint phase, the mean weight adjusted dose was 1.54 mg/kg/day which corresponded to 50.4 mg/day. iPTH was decreased by ≥30% in 54% of patients receiving cinacalcet compared to 19% with placebo. Serum calcium was significantly reduced in patients receiving cinacalcet compared to placebo and severe hypocalcemia (<7.5 mg/dL) occurred in 3 patients, including 1 death where treatment-related cause could not be ruled out (corrected calcium was 5.3 mg/dL). This study was placed on hold following the reported death and ultimately terminated after 14 months. Despite the limited number of patients enrolled due to study termination, efficacy was still demonstrated (Warady 2019). Note: Cinacalcet use in children <3 years and infants as young as 8 months has been described; however, variable dosing strategies were used or only single doses were administered (Muscheites 2008; Platt 2010; Sohn 2019).
Weight-band (fixed) dosing (Mimpara prescribing information [European Union] 2018):
Weight Band |
Initial Dose |
Suggested Adjustment Doses |
---|---|---|
≥10 to <12.5 kg |
1 mg once daily |
1 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg |
≥12.5 to <25 kg |
2.5 mg once daily |
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 30 mg |
≥25 to <36 kg |
5 mg once daily |
5 mg, 10 mg, 15 mg, 30 mg, 60 mg |
≥36 to <50 kg |
5 mg once daily |
5 mg, 10 mg, 15 mg, 30 mg, 60 mg, 90 mg |
≥50 to <75 kg |
10 mg once daily |
10 mg, 15 mg, 30 mg, 60 mg, 90 mg, 120 mg |
≥75 kg |
15 mg once daily |
15 mg, 30 mg, 60 mg, 90 mg, 120 mg, 180 mg |
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity:
Dosage adjustment for hypocalcemia (Mimpara prescribing information [European Union] 2018): Children ≥3 years and Adolescents:
Corrected serum calcium at or below age-specific lower limit or symptoms of hypocalcemia (regardless of calcium concentration): Temporarily discontinue cinacalcet and administer calcium supplements, calcium-containing phosphate binders, and/or vitamin D to raise calcium.
Corrected serum calcium above age-specific lower limit and resolution of hypocalcemia symptoms: Re-initiate cinacalcet at a lower dose. If treatment is stopped for ≥14 days, restart at initial dose.
Dose adjustment based on iPTH (Mimpara prescribing information [European Union] 2018): Children ≥3 years and Adolescents:
If iPTH is ≥100 to <150 pg/mL: Reduce dose.
If iPTH <100 pg/mL: Discontinue cinacalcet until iPTH is >150 pg/mL; restart at lower dose; if treatment has been stopped for >14 days, restart at initial dose.
There are no pediatric-specific dosage adjustments in the manufacturer's labeling; however, adjustment is unnecessary as cinacalcet is indicated for use in chronic kidney disease.
There are no pediatric-specific dosage adjustments in the manufacturer's labeling; in moderate to severe impairment, dosage adjustments may be necessary based on serum calcium, serum phosphorus, and/or intact parathyroid hormone.
(For additional information see "Cinacalcet: Drug information")
Hyperparathyroidism, primary: Oral: Initial: 30 mg twice daily; increase dose incrementally every 2 to 4 weeks (to 60 mg twice daily, 90 mg twice daily, and 90 mg 3 or 4 times daily) as necessary to normalize serum calcium levels.
Hyperparathyroidism, secondary: Oral: Initial: 30 mg once daily; increase dose incrementally every 2 to 4 weeks (to 60 mg once daily, 90 mg once daily, 120 mg once daily, and 180 mg once daily) as necessary to maintain intact parathyroid hormone (iPTH) level between 150 to 300 pg/mL. May be used alone or in combination with vitamin D and/or phosphate binders.
Conversion from etelcalcetide : Discontinue etelcalcetide for at least 4 weeks prior to initiating cinacalcet.
Parathyroid carcinoma: Oral: Initial: 30 mg twice daily; increase dose incrementally every 2 to 4 weeks (to 60 mg twice daily, 90 mg twice daily, and 90 mg 3 to 4 times daily) as necessary to normalize serum calcium levels.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate to severe impairment (Child-Pugh class B or C): There are no specific dosage adjustments provided in the manufacturer's labeling; exposure and half-life of cinacalcet is increased. Dosage adjustments may be necessary based on serum calcium, serum phosphorus, and/or intact parathyroid hormone (iPTH).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Sensipar: 30 mg, 60 mg, 90 mg
Generic: 30 mg, 60 mg, 90 mg
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Sensipar: 30 mg, 60 mg, 90 mg
Generic: 30 mg, 60 mg, 90 mg
Oral: Children ≥3 years and Adolescents: Administer with food or shortly after a meal. Administer tablets whole; do not chew, crush, or divide tablets. An extemporaneous preparation may be made if patients cannot swallow tablets.
Administer with food or shortly after a meal. Do not chew, crush, or divide tablet; administer whole.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Treatment of secondary hyperparathyroidism in dialysis patients; treatment of hypercalcemia in patients with parathyroid carcinoma; treatment of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy (All indications: FDA approved in adults)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Hypotension (12%)
Endocrine & metabolic: Hypocalcemia (<8.4 mg/dL: 6% to 75%; <7.5 mg/dL: 29% to 33%), hypoparathyroidism (intact parathyroid hormone <100 pg/mL: ≤11%)
Gastrointestinal: Nausea (29% to 31%), vomiting (26% to 27%), diarrhea (21%), abdominal pain (11%)
Nervous system: Headache (12%)
Neuromuscular & skeletal: Muscle spasm (11% to 18%), myalgia (15%), back pain (12%)
Respiratory: Dyspnea (13%), cough (12%)
1% to 10%:
Cardiovascular: Hypertension (7%)
Endocrine & metabolic: Hyperkalemia (8%)
Gastrointestinal: Upper abdominal pain (8%), dyspepsia (7%), anorexia (6%), decreased appetite (6%), constipation (5%)
Hypersensitivity: Hypersensitivity reaction (9%)
Nervous system: Dizziness (7% to 10%), noncardiac chest pain (6%), seizure (≤3%)
Neuromuscular & skeletal: Asthenia (5% to 7%)
Respiratory: Upper respiratory tract infection (8%)
Frequency not defined: Hematologic & oncologic: Upper gastrointestinal hemorrhage
<1%, postmarketing, and/or case reports: Adynamic bone disease, angioedema, calcium pyrophosphate deposition disease, cardiac arrhythmia, cardiac failure, gastrointestinal hemorrhage, prolonged QT interval on ECG (secondary to hypocalcemia), skin rash, urticaria, ventricular arrhythmia (secondary to hypocalcemia)
Serum calcium less than the lower limit of normal range
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to any component of the formulation
Concerns related to adverse effects:
• Adynamic bone disease: May develop if intact parathyroid hormone (iPTH) levels are suppressed <100 pg/mL; reduce dose or discontinue use of cinacalcet and/or vitamin D if iPTH levels decrease below 150 pg/mL.
• Cardiovascular effects: QT prolongation and ventricular arrhythmia secondary to hypocalcemia may occur. Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk. Closely monitor corrected serum calcium and QT interval. Cases of idiosyncratic hypotension, worsening of heart failure, and/or arrhythmia have been reported in patients with impaired cardiovascular function; may correlate with decreased serum calcium.
• GI effects: GI bleeding, mostly upper GI bleeding, have been reported (exact cause unknown); patients with risk factors for upper GI bleeding (eg, gastritis, esophagitis, ulcers, severe vomiting) may be at increased risk. Monitor for worsening of common GI adverse reactions of nausea and vomiting and for signs and symptoms of GI bleeding and ulcerations during therapy.
• Hypocalcemia: Life-threatening and fatal events associated with hypocalcemia have occurred. Monitor serum calcium and for symptoms of hypocalcemia (eg, muscle spasms, myalgia, paresthesia, seizure, tetany). Use with caution in patients receiving concomitant therapies known to lower serum calcium concentrations. May require treatment interruption, dose reduction, or initiation (or dose increases) of calcium-based phosphate binder and/or vitamin D to raise serum calcium depending on calcium levels or symptoms of hypocalcemia. Do not initiate therapy if the corrected serum calcium is less than the lower limit of normal; corrected serum calcium must be at or above the lower limit of normal prior to initiation, dose increase, or reinitiation.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with moderate-to-severe hepatic impairment (Child-Pugh classes B and C); cinacalcet exposure and half-life are increased; monitor serum calcium, serum phosphorus and iPTH closely.
• Seizure disorder: Use with caution in patients with a history of seizure disorder; seizure threshold is lowered by significant serum calcium reductions. Monitor calcium levels closely.
Other warnings/precautions:
• Appropriate use: Not indicated for chronic kidney disease (CKD) patients not receiving dialysis. In the US, the long-term safety and efficacy of cinacalcet has not been evaluated in CKD patients with hyperparathyroidism not requiring dialysis. Although possibly related to lower baseline calcium levels, clinical studies have shown an increased incidence of hypocalcemia (<8.4 mg/dL) in patients not requiring dialysis.
Severe hypocalcemia has been reported in pediatric patients receiving cinacalcet; monitor serum calcium closely. During a phase 3 clinical trial in pediatric dialysis patients (n=22; mean age: 13.3 years; age range: 6 to <18 years) with secondary hypoparathyroidism receiving cinacalcet, mild hypocalcemia (<8.4 mg/dL) was reported in 7 patients, moderate hypocalcemia (<8 mg/dL) was reported in 5 patients, and severe hypocalcemia (<7.5 mg/dL) was reported in 3 patients, including 1 fatality. The patient who died had a calcium of 5.3 mg/dL; the patient death was attributed to multifactorial reasons; however, association with cinacalcet treatment could not be ruled out (Warady 2019). Asymptomatic hypocalcemia has also been reported in pediatric patients. Half of the patients enrolled in an open-label, single-dose safety, tolerability, and pharmacokinetic study (n=12) developed asymptomatic hypocalcemia; calcium concentrations ranged from 2 to 2.2 mmol/L within 12 hours post dose (Padhi 2012). In a retrospective case series (n=6), asymptomatic hypocalcemia occurred in 2 patients including 1 patient who was refractory to treatment requiring discontinuation of cinacalcet for 5 months (Platt 2010).
Substrate of CYP1A2 (minor), CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2D6 (moderate)
Ajmaline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Ajmaline. Risk C: Monitor therapy
Amitriptyline: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Amitriptyline. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amitriptyline. Risk C: Monitor therapy
Amoxapine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amoxapine. Risk C: Monitor therapy
Amphetamines: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a moderate CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs Risk C: Monitor therapy
ARIPiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy, indication, or dosage form. Consult full interaction monograph for specific recommendations. Risk C: Monitor therapy
ARIPiprazole Lauroxil: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of ARIPiprazole Lauroxil. Risk C: Monitor therapy
Atomoxetine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Atomoxetine. Risk C: Monitor therapy
Brexpiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Brexpiprazole. Management: If brexpiprazole is to be used together with both a moderate CYP2D6 inhibitor and a strong or moderate CYP3A4 inhibitor, the brexpiprazole dose should be reduced to 25% of the usual dose when treating indications other than major depressive disorder. Risk C: Monitor therapy
Carvedilol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Carvedilol. Risk C: Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
ClomiPRAMINE: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of ClomiPRAMINE. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of ClomiPRAMINE. Risk C: Monitor therapy
CloZAPine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of CloZAPine. Risk C: Monitor therapy
Codeine: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of Codeine. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Cinacalcet. Risk C: Monitor therapy
Denosumab: May enhance the hypocalcemic effect of Calcimimetic Agents. Risk C: Monitor therapy
Desipramine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Desipramine. Risk C: Monitor therapy
Deutetrabenazine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Deutetrabenazine. Risk C: Monitor therapy
Dextromethorphan: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Dextromethorphan. Risk C: Monitor therapy
Doxepin (Systemic): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Doxepin (Systemic). Risk C: Monitor therapy
Doxepin (Topical): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Doxepin (Topical). Risk C: Monitor therapy
DOXOrubicin (Conventional): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of DOXOrubicin (Conventional). Risk X: Avoid combination
Eliglustat: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Eliglustat. Management: Eliglustat dose is 84 mg daily with CYP2D6 inhibitors. Use is contraindicated (COI) when also combined with strong CYP3A4 inhibitors. When also combined with a moderate CYP3A4 inhibitor, use is COI in CYP2D6 EMs or IMs and should be avoided in CYP2D6 PMs. Risk D: Consider therapy modification
Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Etelcalcetide: Cinacalcet may enhance the hypocalcemic effect of Etelcalcetide. Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Flecainide: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Flecainide. Risk C: Monitor therapy
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Haloperidol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Haloperidol. Risk C: Monitor therapy
Iloperidone: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P95 may be decreased. CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P88 may be increased. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Iloperidone. Risk C: Monitor therapy
Imipramine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Imipramine. Concentrations of desipramine may be increased. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Imipramine. Risk C: Monitor therapy
Indoramin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Indoramin. Risk C: Monitor therapy
Lofepramine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Lofepramine. The active metabolite of lofepramine is desipramine. Risk C: Monitor therapy
Mequitazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Mequitazine. Risk X: Avoid combination
Metoclopramide: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Metoclopramide. Risk C: Monitor therapy
Metoprolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Metoprolol. Risk C: Monitor therapy
Nebivolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Nebivolol. Risk C: Monitor therapy
Nortriptyline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Nortriptyline. Risk C: Monitor therapy
Oliceridine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Oliceridine. Risk C: Monitor therapy
Olmutinib: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Olmutinib. Risk C: Monitor therapy
PARoxetine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of PARoxetine. Risk C: Monitor therapy
Perhexiline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Perhexiline. Risk C: Monitor therapy
Perphenazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Perphenazine. Risk C: Monitor therapy
Pimozide: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Pimozide. Risk C: Monitor therapy
Pitolisant: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Pitolisant. Risk C: Monitor therapy
Propafenone: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Propafenone. Risk C: Monitor therapy
Propranolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Propranolol. Risk C: Monitor therapy
Protriptyline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Protriptyline. Risk C: Monitor therapy
RisperiDONE: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of RisperiDONE. Risk C: Monitor therapy
Siponimod: Calcimimetic Agents may increase the serum concentration of Siponimod. Management: Coadministration of siponimod with drugs which are both moderate inhibitors of CYP2C9 and moderate or strong inhibitors of CYP3A4 is not recommended. Risk D: Consider therapy modification
Tacrolimus (Systemic): Cinacalcet may decrease the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Tamoxifen: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Tamoxifen. Specifically, CYP2D6 inhibitors may decrease the metabolic formation of highly potent active metabolites. Management: Consider alternatives to the use of moderate CYP2D6 inhibitors with tamoxifen when possible, as the combination may be associated with reduced clinical effectiveness of tamoxifen. Risk D: Consider therapy modification
Tamsulosin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Tamsulosin. Risk C: Monitor therapy
Tetrabenazine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Tetrabenazine. Specifically, concentrations of the active alpha- and beta-dihydrotetrabenazine metabolites may be increased. Risk C: Monitor therapy
Thioridazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Thioridazine. Risk X: Avoid combination
Timolol (Systemic): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Timolol (Systemic). Risk C: Monitor therapy
TraMADol: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of TraMADol. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of TraMADol. Risk C: Monitor therapy
Trimipramine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Trimipramine. Risk C: Monitor therapy
Valbenazine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Valbenazine. Risk C: Monitor therapy
Vortioxetine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Vortioxetine. Risk C: Monitor therapy
Zuclopenthixol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Zuclopenthixol. Risk C: Monitor therapy
Food increases bioavailability. Management: Administer with food or shortly after a meal.
Information related to the use of cinacalcet in pregnant women is limited (Edling 2014; Horjus 2009; Nadarasa 2014; Rey 2016; Vera 2016).
Serum calcium concentrations prior to initiation and within a week of initiation or dosage adjustment; intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dosage adjustment. After the maintenance dose is established, weekly calcium concentrations, monthly phosphorus concentrations, and iPTH every 1 to 3 months are required; monitor growth.
Target intact parathyroid hormone (iPTH): 100 to 300 pg/mL (Warady 2019). Note: KDIGO guidelines suggest that the optimal parathyroid hormone level is unknown, follow trends in iPTH values to guide therapy changes (KDIGO 2017).
Increases the sensitivity of the calcium-sensing receptor on the parathyroid gland thereby, concomitantly lowering parathyroid hormone (PTH), serum calcium, and serum phosphorus levels, preventing progressive bone disease and adverse events associated with mineral metabolism disorders.
Distribution: Vd: ~1,000 L
Protein binding: ~93% to 97%
Metabolism: Hepatic (extensive) via CYP3A4, 2D6, 1A2; forms inactive metabolites
Half-life elimination: Terminal: 30 to 40 hours; moderate hepatic impairment: 65 hours; severe hepatic impairment: 84 hours
Time to peak, plasma: ~2 to 6 hours; increased with food.
Excretion: Urine ~80% (as metabolites); feces ~15%
Hepatic function impairment: In patients with moderate or severe hepatic impairment, the AUCs were 2.4 and 4.2 times higher, respectively, than in healthy subjects; the half-life is increased to 65 hours and 84 hours in patients with moderate and severe hepatic impairment, respectively.
5 mg/mL Oral Suspension
A 5 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus. Crush five 30 mg tablets in a glass mortar and reduce to a fine powder. Add 15 mL of Ora-Plus in parts and triturate into a smooth suspension. Transfer to a calibrated 2 oz amber bottle. Rinse mortar with Ora-Sweet or Ora-Sweet SF and add to bottle for a final volume of 30 mL and shake suspension. Label “shake well”. Stable for 64 days refrigerated or at room temperature (Thomson 2018).
Tablets (Cinacalcet HCl Oral)
30 mg (per each): $12.75 - $36.41
60 mg (per each): $25.51 - $61.85
90 mg (per each): $38.26 - $92.77
Tablets (Sensipar Oral)
30 mg (per each): $32.27
60 mg (per each): $64.54
90 mg (per each): $96.80
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