Etelcalcetide

What is Etelcalcetide?

• Etelcalcetide (PARSABIV) is a calcium-sensing receptor agonist for the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis.

What are the uses of this medicine?

This medicine is used for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

How does this medicine work?

• A calcimimetic and calcium-sensing receptor (CaSR) agonist composed of a synthetic peptide comprised of seven D-amino acids that can be used to treat secondary hyperparathyroidism (sHPT) in hemodialysis patients with chronic kidney disease (CKD).
• Upon intravenous administration, etelcalcetide mimics calcium and allosterically binds to and activates the CaSR expressed by the parathyroid gland.
• This suppresses the synthesis and secretion of parathyroid hormone (PTH), thereby reducing PTH levels and lowering serum calcium and phosphorus levels.
• Elevated PTH is often observed in patients with CKD and is associated with dysregulated calcium-phosphate homeostasis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to etelcalcetide or any of its excipients

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with PARSABIV.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation, dose increase, or re-initiation.

Recommended Dosageː

• The recommended starting dose is 5 mg administered by intravenous bolus injection three times per week at the end of hemodialysis treatment.
• The maintenance dose is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response. The dose range is 2.5 to 15 mg three times per week.
• The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks.
• Measure serum calcium within 1 week after initiation or dose adjustment and every 4 weeks for maintenance.
• Measure PTH after 4 weeks from initiation or dose adjustment.
• Decrease or temporarily discontinue PARSABIV in individuals with PTH levels below the target range.
• Consider decreasing or temporarily discontinuing PARSABIV or use concomitant therapies to increase corrected serum calcium in patients with a corrected serum calcium below the lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia.
• Stop PARSABIV and treat hypocalcemia if the corrected serum calcium falls below 7.5 mg/dL or patients report symptoms of hypocalcemia.

Administration

• Do not mix or dilute PARSABIV prior to administration. The solution is clear and colorless.
• Inspect PARSABIV for particulate matter and discoloration prior to administration.
• Do not use PARSABIV vials if particulate matter or discoloration is observed.
• PARSABIV is removed by the dialyzer membrane and must be administered after blood is no longer circulating through the dialyzer.
• Administer PARSABIV by intravenous bolus injection into the venous line of the dialysis circuit after hemodialysis during rinse back or intravenously after rinse back.
• Administer a sufficient volume of saline, e.g. 150 mL of rinse back, after PARSABIV injection into the dialysis tubing.
• If PARSABIV is administered after rinse back, administer PARSABIV intravenously followed by at least 10 mL of saline flush.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 2.5 mg/0.5 mL solution in a single-dose vial
• Injection: 5 mg/mL solution in a single-dose vial
• Injection: 10 mg/2 mL solution in a single-dose vial

This medicine is available in fallowing brand namesː

• PARSABIV

What side effects can this medication cause?

The most common side effects of this medicine include:

• blood calcium decreased
• muscle spasms
• diarrhea
• nausea
• vomiting
• headache
• hypocalcemia
• paresthesia

What special precautions should I follow?

• PARSABIV lowers serum calcium and can lead to hypocalcemia, sometimes severe. Severe hypocalcemia can cause paresthesias, myalgias, muscle spasms, seizures, QT prolongation, and ventricular arrhythmias. Patients predisposed to QT interval prolongation, ventricular arrhythmias, and seizures may be at increased risk and require close monitoring. Educate patients on the symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur.
• In clinical studies with PARSABIV, cases of hypotension, congestive heart failure, and decreased myocardial performance have been reported. Reductions in corrected serum calcium may be associated with congestive heart failure, however, a causal relationship to PARSABIV could not be completely excluded. Closely monitor patients for worsening signs and symptoms of heart failure.
• 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 while receiving PARSABIV treatment. Monitor patients and promptly evaluate and treat any suspected GI bleeding.
• Adynamic bone may develop if PTH levels are chronically suppressed. If PTH levels decrease below the recommended target range, the dose of PARSABIV should be reduced or discontinued.

What to do in case of emergency/overdose?

• There is no clinical experience with PARSABIV overdosage.
• Overdosage of PARSABIV may lead to hypocalcemia with or without clinical symptoms and may require treatment.

Management for overdosage:

• Although PARSABIV is cleared by dialysis, hemodialysis has not been studied as a treatment for PARSABIV overdosage. In the event of overdosage, corrected serum calcium should be checked and patients should be monitored for symptoms of hypocalcemia, and appropriate measures should be taken.

Can this medicine be used in pregnancy?

• There are no available data on the use of PARSABIV in pregnant women.

Can this medicine be used in children?

• The safety and efficacy of PARSABIV have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ETELCALCETIDE HYDROCHLORIDE

Inactive ingredients:

• SODIUM CHLORIDE
• SUCCINIC ACID
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID

Who manufactures and distributes this medicine?

• Manufactured for:

KAI Pharmaceuticals, Inc., a wholly owned subsidiary of Amgen, Inc.

What should I know about storage and disposal of this medication?

• Store in the original carton in refrigerator at 2°C to 8°C (36°F to 46°F) to protect from light.

Once removed from the refrigerator:

• Do not expose to temperatures above 25°C (77°F).
• Use within 7 days if stored in the original carton.
• Use within 4 hours and do not expose to direct sunlight if removed from the original carton.

• Dailymed label info on Etelcalcetide
• FDA Etelcalcetide

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