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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  • Storing

  • Prepping

  • Administering

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Storing Parsabiv®

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Storing Parsabiv®

Parsabiv® is available in 3 different, single-use, single-dose vials1

Not an actual Parsabiv® vial. The displayed vials are for illustrative purposes only.

Parsabiv® is heat sensitive

Keep cold1

  • Keep Parsabiv® (in the original, closed carton) in the refrigerator until ready to use it (2°C to 8°C, [36°F to 46°F])
  • DO NOT expose to temperatures above 25°C (77°F)
    • DO NOT place cartons, vials, or drawn syringes of Parsabiv® on warm/hot surfaces, including dialysis machines
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STORAGE, HANDLING & ADMINISTRATION GUIDE

A quick reference on how to use Parsabiv®

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DOSING & MONITORING

Switching from oral
cinacalcet to Parsabiv®
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PREPPING PARSABIV®

Vial handling best practices
and withdrawal tips
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READY TO USE PARSABIV®?

Learn all about proper administration
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Prepping Parsabiv® for administration

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Prepping Parsabiv® for administration

Until you’re ready to use Parsabiv®:

Store it in the refrigerator (2°C to 8°C [36°F to 46°F]) in original closed carton

Protect from light1

  • DO NOT remove the carton lid
  • Minimize exposure of vials and drawn syringes of Parsabiv® to sunlight, direct light, and indirect light from natural or artificial sources (including light sources that may be inside the refrigerator)
  • Avoid exposure to light (the medication may not work as expected if exposed to light [natural or artificial])

Helpful tips for Parsabiv® withdrawal1,2

It is important to ensure that the full volume is withdrawn. This may or may not be different than how you withdraw other medications.

To ensure the prescribed dose is withdrawn from the vial, keep it upright. DO NOT invert the vial.

Consider using a 1.5" needle for withdrawal of Parsabiv® to ensure that the needle reaches the bottom of the vial.

Insert the needle and tilt the vial approximately 45 degrees to withdraw all of the prescribed dose.

DO NOT mix or dilute Parsabiv® prior to administration.1 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.

Once Parsabiv® is withdrawn, it is important to ensure that it is protected from all sources of light and heat. Store until administration (in the dark, away from heat), maintain sterility, and administer within 4 hours.

Not an actual Parsabiv® vial. The displayed vial is for illustrative purposes only.

$name

STORAGE, HANDLING & ADMINISTRATION GUIDE

A quick reference on how to use Parsabiv®

$name

DOSING & MONITORING

Switching from oral
cinacalcet to Parsabiv®
$name

STORING & HANDLING

Learn about dose sizes
and safe storage

$name

READY TO USE PARSABIV®?

Learn all about proper administration
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Administration: Using Parsabiv®

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Administration: Using Parsabiv®

When you’re ready to administer Parsabiv®

Use promptly1

Once Parsabiv® is removed from the refrigerator:

  • Use within 7 days if stored in the original carton
  • Use within 4 hours and DO NOT expose to light if removed from original carton
    • If Parsabiv® is withdrawn into a syringe, keep syringe in the dark, away from heat, maintain sterility, and administer within 4 hours
    • DO NOT tape a syringe containing Parsabiv® to a dialysis machine—this may expose the medication to light and heat

How to administer Parsabiv®1

HOW

By intravenous bolus injection

WHERE

Into the venous line of the dialysis circuit

WHEN

Only at the end of hemodialysis, IV after rinse back or during rinse back

  • This is important to prevent the medication from being dialyzed

DO NOT:

  • Administer into the arterial line (the dose will be dialyzed out)

Helpful tips for Parsabiv® and hemodialysis

Flush with saline to make sure all medication reaches systemic circulation1

If giving IV after rinse back, flush with at least 10 mL of saline

OR

If giving during rinse back, flush with at least 150 mL of saline

  • Without adequate saline flush, Parsabiv® could remain within the dialysis tubing and therefore not reach the patient

Parsabiv® is removed by the dialyzer membrane and must be administered after blood is no longer circulating through the dialyzer.1

$name

STORAGE, HANDLING & ADMINISTRATION GUIDE

A quick reference on how to use Parsabiv®

$name

DOSING & MONITORING

Switching from oral
cinacalcet to Parsabiv®
$name

STORING & HANDLING

Learn about dose sizes
and safe storage

$name

PREPPING PARSABIV®

Vial handling best practices
and withdrawal tips
See More

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

Close

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.

Please see Parsabiv® full Prescribing Information.

References: 1. Parsabiv® (etelcalcetide) prescribing information, Amgen. 2. Data on file, Amgen; [Parsabiv® Withdrawable Volume-TRPT-030117; 2017].