Dosing & Monitoring | Parsabiv® (etelcalcetide)

Indication and Limitations of Use:

  • Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Read More
  • Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations. Close
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FLEXIBLE TITRATION TO HELP MY PATIENTS
LOWER AND MAINTAIN KEY LAB VALUES.1

All while managing corrected serum calcium levels within normal limits.1

Things to know before you initiate Parsabiv®

Switching to Parsabiv® (etelcalcetide) from oral cinacalcet

Ensure your patient discontinues use of oral cinacalcet for at least 7 days prior to starting Parsabiv®1

Discontinue oral cinacalcet for at least 7 days graphic Discontinue oral cinacalcet for at least 7 days graphic

Initiate Parsabiv® after day 7 if corrected serum calcium is at or above the lower limit of normal*

*Lower limit of reference range in phase 3 trials was 8.3 mg/dL.1,2

Parsabiv® dosing at initiation

The approved starting dose is 5 mg, TIW1

The starting dose of Parsabiv® is 5 mg, 3 times a week The starting dose of Parsabiv® is 5 mg, 3 times a week

Parsabiv® administration

  • DO NOT administer Parsabiv® (etelcalcetide) more frequently than TIW1
  • Ensure corrected serum calcium is at or above the lower limit of normal prior to Parsabiv® initiation, a dose increase, or reinitiation after dosing interruption1
  • If a regularly scheduled hemodialysis treatment is missed, DO NOT administer any missed doses. Resume Parsabiv® at the end of the next hemodialysis treatment at the prescribed dose1
  • If doses of Parsabiv® are missed for more than 2 weeks, reinitiate Parsabiv® at the recommended starting dose of 5 mg (or 2.5 mg if that was the patient’s last dose)1
TIW = three times a week.

When switching to Parsabiv® (etelcalcetide), consider prior oral cinacalcet dose when evaluating early results

In a post-hoc analysis, phase 3 trials showed that when initiating Parsabiv® 5 mg three times weekly after a minimum 7-day washout of oral cinacalcet, results correlated with previous oral cinacalcet dose strength3

iPTH change from baseline by prior oral cinacalcet dose3

Graph of iPTH change from baseline by prior oral cinacalcet dose Graph of iPTH change from baseline by prior oral cinacalcet dose

Total placebo-controlled studies: Studies 20120229 and 20120230. Based on exclusion criteria, patients were required to be off oral cinacalcet at least 4 weeks before entering trial. Only oral cinacalcet records with stop date prior to and within 1 year of treatment start date are considered. The last oral cinacalcet dose prior to the treatment start date is used in the analysis.

Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

Parsabiv® (etelcalcetide) was titrated no more frequently than every 4 weeks to a maximum dose of 15 mg TIW to achieve target PTH.2,4,5

  • The starting dose of Parsabiv® was 5 mg at the end of hemodialysis TIW2,4,5
  • The dose was titrated by 2.5 mg or 5 mg at weeks 5, 9, 13, and 17 to achieve predialysis serum iPTH ≤ 300 pg/mL2,4,5
  • The average dose of Parsabiv® at the time of the EAP (defined as weeks 20 through 27, inclusive) was 7.2 mg TIW1
EAP = efficacy assessment phase.

How to monitor and titrate Parsabiv®

Check their labs and know where they stand1

Monitoring for PTH and corrected serum calcium graphic Monitoring for PTH and corrected serum calcium graphic

Adjust the dose of Parsabiv® (etelcalcetide) based on PTH and corrected serum calcium1

Titrate Parsabiv® up or down graphic Titrate Parsabiv® up or down graphic

Start at 5 mg—then titrate up or down

Reductions too great? Titrate down:

  • Decrease or temporarily discontinue Parsabiv® (etelcalcetide) when PTH is below target range
  • Consider decreasing or temporarily discontinuing Parsabiv®, or use concomitant therapies,* when corrected serum calcium is below lower limit of normal† but ≥ 7.5 mg/dL without symptoms of hypocalcemia

Need greater reductions? Titrate up:

  • Increase the dose of Parsabiv® in 2.5 mg or 5 mg increments until PTH is within recommended target range and corrected serum calcium is within normal range
  • Increase no more frequently than every 4 weeks up to a maximum dose of 15 mg TIW

Reinitiating Parsabiv®:

  • If dose is stopped, reinitiate Parsabiv® at a lower dose when PTH is within target range and hypocalcemia has been corrected

*Concomitant therapies include calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration.

†Lower limit of reference range in phase 3 trials was 8.3 mg/dL.1,2

Managing calcium in patients taking Parsabiv®1

    Initiate Parsabiv®

  • DO NOT initiate Parsabiv® if corrected serum calcium is less than the lower limit of normal*
  • Monitor corrected serum calcium within 1 week after initiation or dose adjustment and every 4 weeks during treatment with Parsabiv®® Educate patients on the symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur

    Adjust Treatment as Needed

  • Consider decreasing or temporarily discontinuing Parsabiv® or use concomitant therapies to increase corrected serum calcium (including calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration)

    Withhold Parsabiv® and Monitor

  • Stop Parsabiv® and treat hypocalcemia
  • Start or increase calcium supplementation (including calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration)

  • Throughout the studies, dialysate calcium concentration could be adjusted but had to remain ≥ 2.25 mEq/L1

  • Significant lowering of serum calcium can cause paresthesias, myalgias, muscle spasms, seizures, QT interval prolongation, and ventricular arrhythmias1

*Lower limit of reference range in phase 3 trials was 8.3 mg/dL.1,2
When cCa returns ≥ 8.3 mg/dL*—
Reinitiate Parsabiv® (etelcalcetide)

When corrected serum calcium levels are within normal limits, symptoms of hypocalcemia have resolved, and predisposing factors for hypocalcemia have been addressed, reinitiate Parsabiv® (etelcalcetide) at a dose 5 mg lower than the last administered dose. If patient’s last administered dose of Parsabiv® was 2.5 mg or 5 mg, reinitiate at a dose of 2.5 mg

Calcium reductions by baseline corrected calcium level

In combined placebo-controlled studies, calcium reductions with Parsabiv® (etelcalcetide) during the EAP were lowest among patients initiated at the lowest baseline calcium (8.3-9.2 mg/dL)6

Chart depicting reductions in corrected calcium based on varying baseline correct calcium ranges Chart depicting reductions in corrected calcium based on varying baseline correct calcium ranges

Regardless of baseline calcium, levels remained above the lower limit of normal6,*

Post-hoc analysis of pooled data from two phase 3, 26-week, randomized, double-blind, placebo-controlled studies comparing Parsabiv® with placebo in patients with CKD on hemodialysis with iPTH > 400 pg/mL and corrected calcium ≥ 8.3 mg/dL; N = 1023. Patients in both treatment arms could be treated with vitamin D sterols and/or phosphate binders. Mean baseline iPTH in the Parsabiv® group and placebo group were 847 pg/mL and 836 pg/mL, respectively. The primary endpoint of each study was the proportion of patients who achieved a > 30% reduction from baseline in mean iPTH during the EAP (defined as weeks 20 through 27, inclusive).1,2,7

Data are presented by baseline corrected calcium quartile for Parsabiv®-treated patients only.6

*Lower limit of reference range in phase 3 trials was 8.3 mg/dL.1,2
​

Learn about getting started and addressing changes in calcium during Parsabiv® treatment from nephrologist Dr. Sprague

Tips for calcium management as well as initiation, Parsabiv® dosing, Parsabiv® administration, and more

​
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Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred.

Hypocalcemia: Parsabiv® lowers serum calcium and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due

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Important Safety Information for Parsabiv®

Contraindication: Parsabiv® (etelcalcetide) is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. Hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred.

Hypocalcemia: Parsabiv® lowers serum calcium and can lead to hypocalcemia, sometimes severe. Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. Patients with conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to Parsabiv®. Closely monitor corrected serum calcium and QT interval in patients at risk on Parsabiv®.

Significant reductions in corrected serum calcium may lower the threshold for seizures. Patients with a history of seizure disorder may be at increased risk for seizures if they develop hypocalcemia due to Parsabiv®. Monitor corrected serum calcium in patients with seizure disorders on Parsabiv®.

Concurrent administration of Parsabiv® with another oral calcimimetic could result in severe, life-threatening hypocalcemia. Patients switching from cinacalcet to Parsabiv® should discontinue cinacalcet for at least 7 days prior to initiating Parsabiv®. Closely monitor corrected serum calcium in patients receiving Parsabiv® and concomitant therapies known to lower serum calcium.

Measure corrected serum calcium prior to initiation of Parsabiv®. Do not initiate in patients if the corrected serum calcium is less than the lower limit of normal. Monitor corrected serum calcium within 1 week after initiation or dose adjustment and every 4 weeks during treatment with Parsabiv®. Measure PTH 4 weeks after initiation or dose adjustment of Parsabiv®. Once the maintenance dose has been established, measure PTH per clinical practice.

Worsening Heart Failure: In Parsabiv® clinical studies, cases of hypotension, congestive heart failure, and decreased myocardial performance have been reported. Closely monitor patients treated with Parsabiv® for worsening signs and symptoms of heart failure.

Upper Gastrointestinal Bleeding: In clinical studies, 2 patients treated with Parsabiv® in 1253 patient years of exposure had upper gastrointestinal (GI) bleeding at the time of death. The exact cause of GI bleeding in these patients is unknown and there were too few cases to determine whether these cases were related to Parsabiv®.

Patients with risk factors for upper GI bleeding, such as known gastritis, esophagitis, ulcers or severe vomiting, may be at increased risk for GI bleeding with Parsabiv®. Monitor patients for worsening of common Parsabiv® GI adverse reactions and for signs and symptoms of GI bleeding and ulcerations during Parsabiv® therapy.

Adynamic Bone: Adynamic bone may develop if PTH levels are chronically suppressed.

Adverse Reactions: In clinical trials of patients with secondary HPT comparing Parsabiv® to placebo, the most common adverse reactions were blood calcium decreased (64% vs. 10%), muscle spasms (12% vs. 7%), diarrhea (11% vs. 9%), nausea (11% vs. 6%), vomiting (9% vs. 5%), headache (8% vs. 6%), hypocalcemia (7% vs. 0.2%), and paresthesia (6% vs. 1%).

Indication

Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Limitations of Use: Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

Limitations of Use: Parsabiv® has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.

Please see Parsabiv® (etelcalcetide) full Prescribing Information.

References: 1. Parsabiv® (etelcalcetide) prescribing information, Amgen. 2. Block GA, Bushinsky DA, Cunningham J, et al. Effect of etelcalcetide vs placebo on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: two randomized clinical trials. JAMA. 2017;317:146-155. 3. Data on file, Amgen; [Change from Baseline in iPTH by Prior Cinacalcet Doses - Studies 20120229 and 20120230; 2018]. 4. Data on file, Amgen; [Clinical Study Report 20120229; 2014]. 5. Data on file, Amgen; [Clinical Study Report 20120230; 2014]. 6. Data on file, Amgen; [Calcium Change by Baseline Calcium; 2016]. 7. Data on file, Amgen; [Summary of Clinical Efficacy; 2015].