Parsabiv 2.5 mg/0.5 mL – 6 Vials for Intravenous Injection

Parsabiv 2.5 mg/0.5 mL – 6 Vials for Intravenous Injection

Parsabiv (Etelcalcetide) 2.5 mg/0.5 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, which help reduce parathyroid hormone (PTH) secretion by activating calcium-sensing receptors in the parathyroid glands.

Secondary hyperparathyroidism may develop in patients with chronic kidney disease due to disturbances in calcium, phosphorus and vitamin D regulation.

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

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

Pack Contents: 6 vials, each containing 2.5 mg of etelcalcetide in 0.5 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 goals in hemodialysis patients.

Strength: 2.5 mg/0.5 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 targets.

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.

This effect may also lower serum calcium, making regular calcium monitoring essential.

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 PTH and calcium levels.
• Usual dose range: 2.5–15 mg three times weekly.
• Dose adjustment: Based on treatment response and laboratory results.
• Route: Intravenous injection.
• Self-administration: Not intended for home use.

Important: The 2.5 mg vial may be used for dose adjustment and does not represent the usual starting dose.

Monitoring Requirements

Regular monitoring includes:

• Corrected serum calcium: To detect hypocalcemia.
• Parathyroid hormone (PTH): To assess treatment response.
• Serum phosphorus: To monitor mineral metabolism.
• Neuromuscular symptoms: Such as spasms or tingling.
• Cardiac status when indicated: Especially in patients at risk of arrhythmias.

Calcium should be assessed before treatment and generally within one week of initiation or dose adjustment, followed by periodic monitoring.

Possible Side Effects

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

Serious Adverse Effects

Severe hypocalcemia may cause:

• 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 must not be initiated if 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 2.5 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 2.5 mg, 5 mg and 10 mg?

They contain different amounts of etelcalcetide per vial, with corresponding volumes of 0.5 mL, 1 mL and 2 mL, respectively. All have a concentration of 5 mg/mL.

Is Parsabiv 2.5 mg the starting dose?

No. The usual starting dose is 5 mg three times weekly. The 2.5 mg strength may be used for individualized dose adjustments.

Can Parsabiv be administered at home?

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

Can Parsabiv be used with cinacalcet?

Concurrent use is not recommended because of the increased risk of hypocalcemia.

Does Parsabiv require refrigeration?

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

How many vials are included?

6 vials, each containing 2.5 mg/0.5 mL.

Product Details

• Brand Name: Parsabiv
• Active Ingredient: Etelcalcetide
• Strength: 2.5 mg/0.5 mL
• Concentration: 5 mg/mL
• Vial Volume: 0.5 mL
• Pack Size: 6 Vials
• Total Active Ingredient per Pack: 15 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