Parsabiv 10 mg/2 mL – 6 Vials for Intravenous Injection

Parsabiv 10 mg/2 mL – 6 Vials for Intravenous Injection

Parsabiv (Etelcalcetide) 10 mg/2 mL is a prescription medication indicated for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease receiving hemodialysis.

Parsabiv belongs to a class of medications known as calcimimetics. It works by activating calcium-sensing receptors in the parathyroid glands, reducing the secretion of parathyroid hormone (PTH).

Secondary hyperparathyroidism is a common complication of chronic kidney disease, particularly in patients receiving dialysis, and may contribute to mineral and bone disorders.

Parsabiv helps control elevated PTH levels as part of a specialist-supervised treatment plan involving regular monitoring of serum calcium, phosphorus and PTH.

The medication is administered intravenously by trained healthcare professionals at the end of hemodialysis sessions.

Pack Contents: 6 vials, each containing 10 mg of etelcalcetide in 2 mL of solution.

Active Ingredient & Strength

Etelcalcetide

Etelcalcetide is a calcimimetic agent that activates calcium-sensing receptors in the parathyroid glands.

Therapeutic benefits:

• Reduce elevated PTH levels.
• Help control secondary hyperparathyroidism.
• Support management of mineral metabolism disorders associated with chronic kidney disease.
• Help achieve individualized treatment targets determined by a nephrologist.

Strength: 10 mg/2 mL, equivalent to 5 mg/mL.

Therapeutic Indications

Parsabiv is indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease receiving hemodialysis.

It helps:

• Reduce parathyroid hormone secretion.
• Control elevated PTH levels.
• Support management of mineral and bone disorders associated with chronic kidney disease.
• Maintain specialist-directed treatment goals.

Parsabiv is not routinely indicated for patients with chronic kidney disease who are not receiving hemodialysis.

How It Works

Calcium-sensing receptors in the parathyroid glands help regulate PTH secretion according to serum calcium levels.

Etelcalcetide activates these receptors, reducing PTH secretion.

As a result, serum calcium levels may decrease, making regular calcium monitoring essential throughout treatment.

Dosage & Administration

Parsabiv is administered intravenously at the end of hemodialysis sessions by healthcare professionals.

• Usual starting dose: 5 mg three times weekly.
• Maintenance dose: Individualized according to treatment response.
• Usual dose range: 2.5–15 mg three times weekly.
• Dose adjustments: Based on PTH and corrected serum calcium levels.
• Route: Intravenous injection.
• Self-administration: Not intended for home injection.

Important: A 10 mg vial does not mean that 10 mg is the appropriate starting dose. The prescribed dose is determined by the treating specialist.

Monitoring Requirements

Treatment requires regular monitoring of:

• Corrected serum calcium: To identify hypocalcemia.
• Parathyroid hormone (PTH): To evaluate treatment response.
• Serum phosphorus: As part of chronic kidney disease mineral management.
• Cardiac status when indicated: Particularly in patients at risk of arrhythmias.
• Neuromuscular symptoms: To detect possible signs of low calcium.

Serum calcium is generally checked within one week after initiation or dose adjustment and periodically during maintenance treatment.

Possible Side Effects

• Hypocalcemia.
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Muscle spasms.
• Tingling or numbness.
• Hypotension.

Serious Adverse Effects

Severe hypocalcemia may lead to:

• Severe muscle spasms.
• Seizures.
• Cardiac arrhythmias.
• QT interval prolongation.
• Worsening heart failure in susceptible patients.

Seek immediate medical attention for severe palpitations, fainting, seizures or significant tingling around the mouth and extremities.

Contraindications

• Known hypersensitivity to etelcalcetide or any component of the formulation.
• Treatment should not be initiated when corrected serum calcium is below the lower limit of normal.

Warnings & Precautions

• Prescription-only medication.
• Must be administered under nephrologist supervision.
• For intravenous administration by trained healthcare professionals.
• Requires regular serum calcium monitoring.
• May cause severe hypocalcemia.
• Use caution in patients at risk of cardiac arrhythmias.
• Severe hypocalcemia may increase seizure risk.
• Do not use concurrently with cinacalcet.
• Inform the physician about all medications and supplements.
• Dose adjustment or temporary interruption may be necessary if calcium levels decrease.
• Do not change the prescribed dose independently.
• Pregnancy and breastfeeding require specialist assessment.
• Not intended for pediatric use without an approved indication.
• Not intended for intramuscular or subcutaneous injection.
• Not suitable for self-injection at home.

Storage

• Store refrigerated at 2°C–8°C.
• Do not freeze.
• Keep in the original carton to protect from light.
• Follow manufacturer instructions regarding handling outside refrigeration.
• Keep out of reach of children.

Frequently Asked Questions

What is Parsabiv 10 mg used for?

It treats secondary hyperparathyroidism in adults with chronic kidney disease receiving hemodialysis.

What is the active ingredient in Parsabiv?

Etelcalcetide.

Does Parsabiv lower PTH?

Yes. It reduces PTH secretion through calcium-sensing receptor activation.

Can Parsabiv lower calcium levels?

Yes. Hypocalcemia is an important treatment risk requiring regular monitoring.

What is the difference between Parsabiv 5 mg and 10 mg?

The 5 mg vial contains 1 mL, while the 10 mg vial contains 2 mL. Both have a concentration of 5 mg/mL.

Is 10 mg the starting dose?

No. The usual starting dose is 5 mg three times weekly, with subsequent adjustments determined by the specialist.

Can Parsabiv be administered at home?

No. It is administered by healthcare professionals at the end of hemodialysis.

Is Parsabiv the same as cinacalcet?

Both are calcimimetics, but Parsabiv is intravenous while cinacalcet is oral. They should not be used together.

Does Parsabiv require refrigeration?

Yes. Store at 2°C–8°C according to the manufacturer instructions.

How many vials are included?

6 vials, each containing 10 mg/2 mL.

Product Details

• Brand Name: Parsabiv
• Active Ingredient: Etelcalcetide
• Strength: 10 mg/2 mL
• Concentration: 5 mg/mL
• Vial Volume: 2 mL
• Pack Size: 6 Vials
• Total Active Ingredient per Pack: 60 mg
• Dosage Form: Solution for Intravenous Injection
• Drug Class: Calcimimetic
• Indication: Secondary Hyperparathyroidism in Adults with Chronic Kidney Disease Receiving Hemodialysis
• Route of Administration: Intravenous, at the End of Hemodialysis
• Dosage: As Prescribed Based on Calcium and PTH Levels
• Manufacturer: Amgen
• Storage: Refrigerate at 2–8°C
• Prescription Status: Prescription Only
• Category: Kidney & Parathyroid Medications