Safety | Adverse Reactions | Parsabiv® (etelcalcetide)

Indications and Limitations of Use:

  • Parsabiv® (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients chronic kidney disease (CKD) on hemodialysis. Read More
  • Sensipar® (cinacalcet) is indicated for the treatment of secondary HPT in adult patients with CKD on dialysis.
  • Parsabiv® (etelcalcetide) 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.
  • Sensipar® is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia. Close
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ADVERSE REACTIONS
TO PARSABIV® in
the clinical trials

Adverse reactions reported in ≥ 5% of
Parsabiv® (etelcalcetide)-treated patients1

Combined placebo-controlled substances

Parsabiv®
N = 503
Placebo
N = 513
Adverse Reaction* % %
Blood calcium decreased† 64 10
Muscle spasms 12 7
Diarrhea 11 9
Nausea 11 6
Vomiting 9 5
Headache 8 6
Hypocalcemia‡ 7 0.2
Paresthesia§ 6 1

*Included adverse reactions reported with at least 1% greater incidence in the Parsabiv® group compared to the placebo group.

†Asymptomatic reductions in calcium below 7.5 mg/dL or clinically significant asymptomatic reductions in corrected serum calcium between 7.5 and < 8.3 mg/dL (that required medical management).

‡Symptomatic reductions in corrected serum calcium < 8.3 mg/dL.

§Paresthesia includes preferred terms of paresthesia and hypoesthesia.

Discontinuations

  • Overall, in placebo-controlled studies, 1.8% of patients in the Parsabiv® (etelcalcetide) group and 2.5% of patients in the placebo group discontinued treatment due to an adverse event2

Low serum calcium

  • Most events of blood calcium decrease or hypocalcemia were mild or moderate in severity in both the placebo and Parsabiv® groups2,3
  • In combined placebo-controlled studies, 1% of patients who received Parsabiv® discontinued treatment due to low corrected serum calcium vs 0% with placebo1

Treatment-emergent adverse events experienced by ≥ 5% of Parsabiv®- or Sensipar® (oral cinacalcet)-treated patients4,5

Head-to-head study (active-controlled)

Parsabiv®
n = 338
Sensipar®
n = 341
Treatment Emergent
Adverse Events*		 % %
Blood calcium decreased† 69 60
Nausea 18 23
Vomiting 13 14
Hypotension 7 3
Headache 7 7
Muscle spasms 7 6
Diarrhea 6 10
Hypertension 6 7
Anemia 5 4
Hypocalcemia 5 2
Pain in extremity 5 4
Bronchitis 2 5

* The term treatment emergent refers to a condition either not present before exposure to a study drug that develops after drug exposure or a condition present before exposure that worsens in frequency or severity. Adverse events occurring after the first dose of study drug and up to 30 days after the last dose of study drug were included. Counts and proportions refer to patients rather than to adverse events. In other words, patients may have one or more adverse event.

†Defined as an albumin-corrected serum calcium concentration lower than 8.3 mg/dL (to convert to mmol/L, multiply by 0.25) that resulted in a medical intervention.

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Important Safety Information for Parsabiv® and Sensipar® (cinacalcet)

Contraindications: 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.

Sensipar® (cinacalcet) treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Hypocalcemia: Parsabiv® and Sensipar® lower serum calcium and can lead to hypocalcemia, sometimes severe. Life threatening events

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Important Safety Information for Parsabiv® and Sensipar® (cinacalcet)

Contraindications: 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.

Sensipar® (cinacalcet) treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Hypocalcemia: Parsabiv® and Sensipar® lower serum calcium and can lead to hypocalcemia, sometimes severe. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar®, including pediatric patients. The safety and effectiveness of Sensipar® have not been established in pediatric patients.

Significant lowering of serum calcium can cause QT interval prolongation and ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with Sensipar®. 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® or Sensipar®. Closely monitor corrected serum calcium and QT interval in patients at risk on Parsabiv® or Sensipar®.

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® or Sensipar®. Monitor corrected serum calcium in patients with seizure disorders on Parsabiv® or Sensipar®.

Concurrent administration of Parsabiv® or Sensipar® with calcium-lowering drugs including other calcimimetics could result in severe, life-threatening hypocalcemia. Parsabiv® and Sensipar® should not be given together. Patients switching from Sensipar® to Parsabiv® should discontinue Sensipar® for at least 7 days prior to initiating Parsabiv®. Closely monitor corrected serum calcium in patients receiving Parsabiv® or Sensipar® 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.

Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.

Hypotension, Worsening Heart Failure and/or Arrhythmias: 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.

In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Upper Gastrointestinal Bleeding: Cases of gastrointestinal (GI) bleeding, mostly upper GI bleeding, have occurred in patients using calcimimetics, including Sensipar®, from postmarketing and clinical trial sources.

In clinical studies, 2 patients treated with Parsabiv® in 1253 patient years of exposure had upper GI bleeding at the time of death. There were too few cases to determine whether these cases were related to Parsabiv®.

The exact cause of GI bleeding in these patients is unknown. 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® or Sensipar®. Monitor patients for worsening of common Parsabiv® or Sensipar® GI adverse reactions and for signs and symptoms of GI bleeding and ulcerations during Parsabiv® or Sensipar® 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%).

In clinical trials of patients with secondary HPT comparing Sensipar® to placebo, the most commonly reported side effects were nausea (31% vs. 19%), vomiting (27% vs. 15%), and diarrhea (21% vs. 20%).

Indications

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

Sensipar® (cinacalcet) is indicated for the treatment of secondary HPT in adult patients with CKD on dialysis.

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.

Sensipar® is not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Please see Parsabiv® (etelcalcetide) full Prescribing Information and Sensipar® full Prescribing Information.

References: 1. Parsabiv® (etelcalcetide) prescribing information, Amgen. 2. Data on file, Amgen; [Integrated Summary of Safety; 2015]. 3. Data on file, Amgen; [Summary of Clinical Safety; 2015]. 4. Block GA, Bushinsky DA, Cheng S, et al. Effect of etelcalcetide vs cinacalcet on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: a randomized trial. JAMA. 2017;317:156-164. 5. Data on file, Amgen; [Clinical Study Report 20120360; 2015].