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Drug overview for PARSABIV (etelcalcetide hydrochloride):
Generic name: ETELCALCETIDE HYDROCHLORIDE (E-tel-KAL-se-tide)
Drug class: Calcimimetic, Parathyroid Calcium Recep Sensitivity Enhancer
Therapeutic class: Endocrine
Etelcalcetide hydrochloride, a calcimimetic agent, binds to and increases sensitivity of calcium-sensing receptors on the parathyroid glands to extracellular calcium, which results in reduced parathyroid hormone (PTH, parathormone) concentrations and concomitant decreases in serum calcium concentrations.
No enhanced Uses information available for this drug.
Generic name: ETELCALCETIDE HYDROCHLORIDE (E-tel-KAL-se-tide)
Drug class: Calcimimetic, Parathyroid Calcium Recep Sensitivity Enhancer
Therapeutic class: Endocrine
Etelcalcetide hydrochloride, a calcimimetic agent, binds to and increases sensitivity of calcium-sensing receptors on the parathyroid glands to extracellular calcium, which results in reduced parathyroid hormone (PTH, parathormone) concentrations and concomitant decreases in serum calcium concentrations.
No enhanced Uses information available for this drug.
DRUG IMAGES
PARSABIV 2.5 MG/0.5 ML VIAL
PARSABIV 5 MG/ML VIAL
PARSABIV 10 MG/2 ML VIAL
The following indications for PARSABIV (etelcalcetide hydrochloride) have been approved by the FDA:
Indications:
Hyperparathyroidism secondary to chronic renal failure with dialysis
Professional Synonyms:
Hyperparathyroidism associated with dialysis dependent renal failure
Indications:
Hyperparathyroidism secondary to chronic renal failure with dialysis
Professional Synonyms:
Hyperparathyroidism associated with dialysis dependent renal failure
The following dosing information is available for PARSABIV (etelcalcetide hydrochloride):
Dosage of etelcalcetide hydrochloride is expressed in terms of etelcalcetide.
For the management of secondary hyperparathyroidism associated with chronic renal disease in patients who are undergoing hemodialysis, the recommended initial adult dosage of etelcalcetide is 5 mg 3 times weekly. For patients who are being switched from cinacalcet to etelcalcetide therapy, an interval of at least 7 days should elapse between discontinuance of cinacalcet and initiation of etelcalcetide; patients being switched from cinacalcet should receive an initial etelcalcetide dose of 5 mg. If the albumin-corrected serum calcium concentration is below the lower limit of normal, etelcalcetide therapy should not be initiated or reinitiated (following an interruption in therapy) and the dosage should not be increased.
The maintenance dosage of etelcalcetide must be individualized within the range of 2.5-15 mg 3 times weekly to achieve a dosage that maintains parathyroid hormone (PTH) concentration within the recommended target range and albumin-corrected serum calcium concentration within the normal range. Albumin-corrected serum calcium concentration should be measured 1 week following initiation of therapy or subsequent dosage adjustment and every 4 weeks during maintenance therapy with the drug.
In addition, PTH concentration should be measured 4 weeks following initiation of therapy or subsequent dosage adjustment and according to standard practice during maintenance therapy.
In patients with albumin-corrected serum calcium concentration within the normal range and PTH concentration above the recommended target range, the dosage of etelcalcetide should be increased based on the patient's PTH concentration in increments of 2.5 or 5 mg no more frequently than every 4 weeks.
The etelcalcetide dosage should be decreased or therapy with etelcalcetide should be withheld in patients with PTH concentration below the target range. In patients with albumin-corrected serum calcium concentration less than the lower limit of normal but at least 7.5 mg/dL and in whom manifestations of hypocalcemia are not present, consideration should be given to reducing or withholding etelcalcetide or to using concomitant therapies to increase albumin-corrected serum calcium.
If etelcalcetide is withheld, the drug should be reinitiated at a lower dosage when PTH returns to the target range and hypocalcemia has been corrected.
Etelcalcetide should be withheld and hypocalcemia should be treated if the albumin-corrected serum calcium concentration falls below 7.5 mg/dL or if manifestations of hypocalcemia are present. Once albumin-corrected serum calcium concentration has returned to normal, manifestations of hypocalcemia have resolved, and predisposing factors for hypocalcemia have been addressed, etelcalcetide should be reinitiated at a dose 5 mg lower than the last administered dose (or 2.5 mg if the last administered dose was 2.5 or 5 mg).
If a regularly scheduled hemodialysis session is missed, the missed dose of etelcalcetide should not be administered. Instead, therapy should be resumed at the prescribed dosage with the next scheduled hemodialysis session. If doses of etelcalcetide are missed for more than 2 weeks, etelcalcetide should be reinitiated at the recommended initial dose of 5 mg (or 2.5 mg if that was the patient's last dose).
For the management of secondary hyperparathyroidism associated with chronic renal disease in patients who are undergoing hemodialysis, the recommended initial adult dosage of etelcalcetide is 5 mg 3 times weekly. For patients who are being switched from cinacalcet to etelcalcetide therapy, an interval of at least 7 days should elapse between discontinuance of cinacalcet and initiation of etelcalcetide; patients being switched from cinacalcet should receive an initial etelcalcetide dose of 5 mg. If the albumin-corrected serum calcium concentration is below the lower limit of normal, etelcalcetide therapy should not be initiated or reinitiated (following an interruption in therapy) and the dosage should not be increased.
The maintenance dosage of etelcalcetide must be individualized within the range of 2.5-15 mg 3 times weekly to achieve a dosage that maintains parathyroid hormone (PTH) concentration within the recommended target range and albumin-corrected serum calcium concentration within the normal range. Albumin-corrected serum calcium concentration should be measured 1 week following initiation of therapy or subsequent dosage adjustment and every 4 weeks during maintenance therapy with the drug.
In addition, PTH concentration should be measured 4 weeks following initiation of therapy or subsequent dosage adjustment and according to standard practice during maintenance therapy.
In patients with albumin-corrected serum calcium concentration within the normal range and PTH concentration above the recommended target range, the dosage of etelcalcetide should be increased based on the patient's PTH concentration in increments of 2.5 or 5 mg no more frequently than every 4 weeks.
The etelcalcetide dosage should be decreased or therapy with etelcalcetide should be withheld in patients with PTH concentration below the target range. In patients with albumin-corrected serum calcium concentration less than the lower limit of normal but at least 7.5 mg/dL and in whom manifestations of hypocalcemia are not present, consideration should be given to reducing or withholding etelcalcetide or to using concomitant therapies to increase albumin-corrected serum calcium.
If etelcalcetide is withheld, the drug should be reinitiated at a lower dosage when PTH returns to the target range and hypocalcemia has been corrected.
Etelcalcetide should be withheld and hypocalcemia should be treated if the albumin-corrected serum calcium concentration falls below 7.5 mg/dL or if manifestations of hypocalcemia are present. Once albumin-corrected serum calcium concentration has returned to normal, manifestations of hypocalcemia have resolved, and predisposing factors for hypocalcemia have been addressed, etelcalcetide should be reinitiated at a dose 5 mg lower than the last administered dose (or 2.5 mg if the last administered dose was 2.5 or 5 mg).
If a regularly scheduled hemodialysis session is missed, the missed dose of etelcalcetide should not be administered. Instead, therapy should be resumed at the prescribed dosage with the next scheduled hemodialysis session. If doses of etelcalcetide are missed for more than 2 weeks, etelcalcetide should be reinitiated at the recommended initial dose of 5 mg (or 2.5 mg if that was the patient's last dose).
Etelcalcetide hydrochloride is administered by direct (''bolus'') IV injection into the venous line of the dialysis circuit during the rinse-back procedure at the end of hemodialysis or IV after the rinse-back procedure has been completed. Etelcalcetide should be administered only at the end of hemodialysis sessions. If a regularly scheduled hemodialysis session is missed, the missed dose of etelcalcetide should not be administered.
(See Dosage and Administration: Dosage.) Etelcalcetide hydrochloride solution is clear and colorless; the vial should be visually inspected for particulate matter and discoloration prior to administration and should be discarded if either is present. Etelcalcetide hydrochloride should not be admixed with any other solutions or diluted prior to administration.
(See Dosage and Administration: Dosage.) Etelcalcetide hydrochloride solution is clear and colorless; the vial should be visually inspected for particulate matter and discoloration prior to administration and should be discarded if either is present. Etelcalcetide hydrochloride should not be admixed with any other solutions or diluted prior to administration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PARSABIV 2.5 MG/0.5 ML VIAL | Maintenance | Adults inject 0.5 milliliter (2.5 mg) by intravenous route 3 times per week at the end of dialysis after rinse back |
| PARSABIV 5 MG/ML VIAL | Maintenance | Adults inject 1 milliliter (5 mg) by intravenous route 3 times per week at the end of dialysis after rinse back |
| PARSABIV 10 MG/2 ML VIAL | Maintenance | Adults inject 2 milliliters (10 mg) by intravenous route 3 times per week at the end of dialysis after rinse back |
No generic dosing information available.
The following drug interaction information is available for PARSABIV (etelcalcetide hydrochloride):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Etelcalcetide/Cinacalcet; Evocalcet SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Etelcalcetide is a calcimimetic agent that binds to the extracellular domain of the calcium-sensing receptor (CaSR) and enhances activation of the receptor by extracellular calcium.(1) Cinacalcet and evocalcet also increase the sensitivity of the CaSR to extracellular calcium but bind to the CaSR but at the transmembrane region of the receptor.(2-4) Activation of the CaSR decreases parathyroid hormone (PTH) secretion and subsequently decreases calcium levels. Additive decreases in PTH with subsequent additive decreases in calcium levels may occur with concurrent use. CLINICAL EFFECTS: Concurrent administration of etelcalcetide with another oral calcium-sensing receptor agonist may result in severe, life-threatening, hypocalcemia. Hypocalcemia can cause paresthesias, myalgias, muscle spasms, seizures, QT prolongation, and ventricular arrhythmias.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of etelcalcetide recommends discontinuation of cinacalcet at least 7 days prior to starting etelcalcetide. When transitioning from cinacalcet to etelcalcetide, initiate etelcalcetide at a starting dose of 5 mg.(1) The US manufacturer of cinacalcet recommends discontinuation of etelcalcetide for at least 4 weeks prior to initiating cinacalcet. Initiate cinacalcet at a starting dose of 30 mg daily.(2) The UK manufacturer of cinacalcet states that an appropriate washout period of etelcalcetide has not been studied and recommends completion of at least three subsequent hemodialysis sessions and ensuring normal serum calcium before initiating cinacalcet.(3) The manufacturer of evocalcet does not provide recommendations for concurrent use with etelcalcetide but similar additive effects are expected based on a similar mechanism as cinacalcet.(4) Consider similar washout periods when transitioning from etelcalcetide to evocalcet. Before initiating these calcimimetics, ensure corrected serum calcium is at or above the lower limit of normal. Closely monitor corrected serum calcium and concurrent therapies known to lower serum calcium. Serum calcium monitoring is recommended within 1 week after initiation of etelcalcetide and every 4 weeks during treatment.(1) DISCUSSION: Concurrent administration of etelcalcetide with other oral calcium-sensing receptor agonists may result in severe, life-threatening, hypocalcemia. Pooled data from two placebo-controlled clinical studies in patients with chronic kidney disease and secondary hyperparathyroidism on hemodialysis were reviewed with a mean duration of 23.6 weeks. More patients on etelcalcetide versus placebo developed at least one corrected serum calcium level less than 7 mg/dL (7.6% v. 3.1%, respectively), less than 7.5 mg/dL (27% v. 5.5%, respectively), and less than 8.3 mg/dL (79% v. 19%, respectively). Symptomatic reductions in serum calcium less than 8.3 mg/dL occurred in 7% of patients receiving etelcalcetide versus 0.2% of patients receiving placebo.(1) |
CINACALCET HCL, SENSIPAR |
There are 0 moderate interactions.
The following contraindication information is available for PARSABIV (etelcalcetide hydrochloride):
Drug contraindication overview.
Etelcalcetide is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.
Etelcalcetide is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.
There are 0 contraindications.
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Congenital long QT syndrome |
| Gastrointestinal hemorrhage |
| Hypocalcemia |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
| Lower seizure threshold |
| Seizure disorder |
The following adverse reaction information is available for PARSABIV (etelcalcetide hydrochloride):
Adverse reaction overview.
Adverse effects reported in clinical trials in 5% or more of patients receiving etelcalcetide and more frequently than in those receiving placebo include asymptomatic reductions in blood calcium concentration, muscle spasms, diarrhea, nausea, vomiting, headache, symptomatic hypocalcemia, and paresthesia.
Adverse effects reported in clinical trials in 5% or more of patients receiving etelcalcetide and more frequently than in those receiving placebo include asymptomatic reductions in blood calcium concentration, muscle spasms, diarrhea, nausea, vomiting, headache, symptomatic hypocalcemia, and paresthesia.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypocalcemia |
Hypophosphatemia Hypotension |
| Rare/Very Rare |
|---|
|
Adynamic bone disease Chronic heart failure Hyperkalemia Prolonged QT interval Upper GI bleed Urticaria Ventricular arrhythmias |
There are 10 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Headache disorder Muscle spasm Nausea Paresthesia Vomiting |
None. |
| Rare/Very Rare |
|---|
|
Facial edema Myalgia Pruritus of skin Skin rash |
The following precautions are available for PARSABIV (etelcalcetide hydrochloride):
Safety and efficacy of etelcalcetide have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data on use of etelcalcetide in pregnant women are lacking. IV administration of etelcalcetide in rats during the period of organogenesis through delivery and weaning resulted in a slight increase in perinatal pup mortality, delay in parturition, and transient effects on pup growth at an exposure level of 1.8 times that associated with the recommended human dosage (15 mg 3 times weekly); no effects on sexual maturation, neurobehavioral function, or reproductive function in the offspring were observed.
In embryofetal development studies in rats and rabbits, reduced fetal growth was observed at etelcalcetide exposures of 2.7 and 7 times, respectively, that associated with the recommended human dosage. The effects in animal studies were observed at dosages that produced maternal toxicity, including hypocalcemia.
In embryofetal development studies in rats and rabbits, reduced fetal growth was observed at etelcalcetide exposures of 2.7 and 7 times, respectively, that associated with the recommended human dosage. The effects in animal studies were observed at dosages that produced maternal toxicity, including hypocalcemia.
It is not known whether etelcalcetide is distributed into human milk, affects milk production, or affects the breast-fed infant; however, in lactating rats given radiolabeled etelcalcetide, concentrations of radioactivity in milk were comparable to those in plasma. Because of the potential for adverse effects, including hypocalcemia, in nursing infants, use of etelcalcetide in nursing women is not recommended.
Of the 503 patients in placebo-controlled studies who received etelcalcetide, 35% were 65 years of age or older, while 14% were 75 years of age or older. No clinically important differences in plasma concentrations of etelcalcetide and no overall differences in safety or efficacy were observed between geriatric patients and younger adults.
The following prioritized warning is available for PARSABIV (etelcalcetide hydrochloride):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for PARSABIV (etelcalcetide hydrochloride)'s list of indications:
| Hyperparathyroidism secondary to CRF with dialysis | |
| N18.6 | End stage renal disease |
| N25.81 | Secondary hyperparathyroidism of renal origin |
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