Parsabiv (Etelcalcetide) is a calcimimetic peptide that reduces the serum parathyroid hormone levels along with calcium and phosphate.

Parsabiv (Etelcalcetide) Uses:

• It is used in the treatment of secondary hyperparathyroidism in adults with chronic kidney disease who are on hemodialysis.
• It is not recommended in elevated parathyroid hormone levels caused by:
  • Parathyroid carcinoma,
  • Primary hyperparathyroidism, or
  • Patients with CKD who are not on hemodialysis.

Parsabiv (Etelcalcetide) Dose in Adults

Note: Prior to the treatment initiation, dose-escalation, or reinitiation of the drug, the serum calcium should be above the lower limits of normal.

Parsabiv (Etelcalcetide) Dose in the treatment of secondary hyperparathyroidism (in patients with chronic kidney disease on hemodialysis)

• 5 mg intravenous bolus three times per week at the end of hemodialysis.

• Dosage adjustments:

  • The dose should be titrated in 2.5 mg or 5 mg increments every 4 weeks to maintain the serum PTH levels within the recommended target range and corrected serum calcium within the normal range.
  • The maximum maintenance dose is 15 mg three times per week and the minimum maintenance dose is 2.5 mg three times per week.

• Conversion from cinacalcet:

  • Cinacalcet should be discontinued at least seven days prior to initiating Etelcalcetide.

• Missed dose :

  • It should not be administered if hemodialysis is missed.
  • The treatment may be resumed at the end of the next hemodialysis.
  • If Etelcalcetide doses are missed for greater than 2 weeks, reinitiate the treatment with 5 mg or 2.5 mg (if that was the patient's last dose) three times per week.

Parsabiv (Etelcalcetide) use in Children:

The safety and efficacy of Etelcalcetide in children is not established.

Parsabiv (Etelcalcetide) Pregnancy Risk Factor: D 

• Animal reproduction studies have shown adverse fetal events. It can also lead to maternal hypocalcemia.
• This is why it is not recommended during pregnancy.

Etelcalcetide use during breastfeeding:

• It is unknown if the drug will be excreted into breastmilk.
• The manufacturer doesn't recommend breastfeeding while receiving Etelcalcetide treatment for severe hypocalcemia.

Parsabiv (Etelcalcetide) Dose in Kidney Disease:

Dose adjustment in CKD is not necessary.

Parsabiv (Etelcalcetide) Dose in Liver disease:

The manufacturer has not provided any adjustment in the dose in patients with liver disease.

Common Side Effects of Parsabiv (Etelcalcetide) Include:

• Endocrine & Metabolic:

  • Decreased Serum Calcium
  • Hypophosphatemia

• Gastrointestinal:

  • Diarrhea
  • Nausea

• Neuromuscular & Skeletal:

  • Muscle Spasm

Less Common Side Effects Of Parsabiv (Etelcalcetide):

• Cardiovascular:

  • Prolonged Q-T Interval On ECG
  • Cardiac Failure

• Central Nervous System:

  • Headache
  • Paresthesia

• Endocrine & Metabolic:

  • Hypocalcemia
  • Hyperkalemia

• Gastrointestinal:

  • Vomiting

• Immunologic:

  • Antibody Development

• Neuromuscular & Skeletal:

  • Myalgia

Contraindication of Parsabive(Etelcalcetide):

Allergy to etelcalcetide and any component of the formulation

Warnings and precautions

• A dynamic bone disease

  • Adynamic bone disease may be a result of patients with chronically low levels of parathyroid hormone.
  • If the levels of parathyroid hormones fall below the target ranges, the patient should reduce or stop taking Etelcalcetide.

• Cardiovascular effects

  • Hypocalcemia has been shown to increase the risk of QT prolongation, ventricular arrhythmia and Etelcalcetide.
  • Patients with congenital long QT syndrome should be closely monitored and their serum calcium checked before starting treatment.
  • Etelcalcetide can also cause hypotension, heart disease, and reduced myocardial function. It is unknown if these cardiac manifestations are caused by the drug or hypocalcemia.
  • Patients, especially those at high risk, need to be monitored closely for signs and symptoms of heart disease.

• Gastrointestinal effects:

  • Use of telcalcetide has been linked to an increased risk for upper gastrointestinal bleeding.
  • Patients with severe vomiting, gastritis, esophagitis or ulcers and upper gastrointestinal symptoms are at greater risk for upper GI bleeding.
  • Patients should be closely monitored for signs of gastrointestinal bleeding, ulceration, or worsening nausea and vomiting.

• Hypocalcemia:

  • Patients who use Etelcalcetide may experience hypocalcemia symptoms.
  • Hypocalcemia can be life-threatening and severe. These symptoms may include:
    • Muscle spasms
    • myalgias,
    • paresthesias,
    • seizures,
    • Longer QT interval
    • ventricular arrhythmia.
  • Patients with hypocalcemia may require a reduction in the dose, interruption in the treatment, a reduction in the dose, or treatment with calcium-containing phosphate binders, and vitamin D.
  • If serum calcium levels fall below the normal limits, treatment with Etelcalcetide must be delayed. Before treatment is initiated, dose-escalation or reinitiation, these patients should first be treated with vitamin D and calcium.

• Heart failure:

  • Patients with heart disease should not use it.
  • Regular monitoring is necessary.

• Seizure disorder:

  • Seizure threshold may be reduced if serum calcium levels are significantly lower.
  • Patients at high risk of seizures should not use it. The serum calcium levels must be closely monitored.

Etelcalcetide: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitor:

• Clinical features of hypocalcemia,
• Observe for any worsening symptoms of heart failure,
• Observe for gastrointestinal bleeding or ulcerations.
• Monitor for QT interval in patients who are at risk for QT interval prolongation and ventricular arrhythmia.

The following recommendations should be followed for correcting the serum calcium and PTH levels:

• Correction of serum calcium levels:

  • Correct serum calcium levels and monitor before treatment initiation and one week after the dose administration or dose adjustment.
  • Monitor every four weeks thereafter (once the maintenance dose is established)

• Correction of serum PTH levels:

  • Monitor serum PTH levels before treatment initiation and four weeks after the dose initiation or dose adjustment.
  • When the maintenance dose is established, monitor as indicated.

How to administer Parsabiv (Etelcalcetide)?

• It is administered as an undiluted intravenous bolus into the venous line of the dialysis circuit after hemodialysis during rinse back or IV after rinse back.
• If it is administered during rinse back, administer a sufficient volume (150 mL or more of rinse back) after etelcalcetide injection into the dialysis tubing.
• If administered after rinse back, followed by an intravenous administration with 10 mL saline flush or more.
• The injection should not be mixed or diluted prior to its administration. It must be administered when the blood is no longer circulating through the dialyzer.

Mechanism of action of Parsabiv (Etelcalcetide):

• Etelcalcetide, a synthetic calcimimetic protein, is available as an injection. It lowers the level of PTH in patients with secondary hyperparathyroidism on hemodialysis. 
• It activates the calcium-sensing receiver (CaSR), which is located on the parathyroid. It has been

The beginning of action A reduction in the PTH can be seen within 30 minutes. It can be conjugated with albumin to make albumin peptides. It is also known as The half-life elimination Etelcalcetide is available in CKD patients on hemodialysis for 3 - 4 days, and healthy individuals for 18.4 - 20. It takes time to get their steady serum concentration It takes 7 - 8 weeks for CKD patients. It is excreted Dialysate mainly, about 60% of the administered dosage and approximately 89% of the recovered dose), urine (3.2%) and feces (4.5%) in CKD patients who are on hemodialysis. It is mostly excreted in urine in healthy people.

International Brands of Etelcalcetide (Parsabiv):

• Parsabiv

Etelcalcetide Brand Names in Pakistan:

No Brands Available in Pakistan.