Etalcalcetide

Etelcalcetide is a prescription medication indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

• Etelcalcetide is available un the following different brand names: Parsabiv

Common side effects of Etelcalcetide include:

• decreased blood calcium
• muscle spasms
• diarrhea
• nausea
• vomiting
• headache
• numbness and tingling

Serious side effects of Etelcalcetide include:

• hives
• trouble breathing
• swelling of the face, lips, tongue, or throat
• a seizure (convulsions)
• shortness of breath (even with mild exertion), swelling, rapid weight gain
• irregular heartbeats
• low calcium levels--muscle spasms or contractions, numbness, or tingly feeling (around the mouth, or in the fingers and toes); or signs of stomach bleeding—bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds

Rare side effects of Etelcalcetide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution (single-dose vials)

• 2.5 mg/0.5 mL
• 5 mg/mL
• 10 mg/2 mL

Secondary hyperparathyroidism

Adult dosage

• Initial dose
  • Ensure corrected serum calcium is at or above the lower limit of normal before initiation, a dose increase, or reinitiation of therapy after a dosing interruption
  • 5 mg IV push 3 times/week at the end of hemodialysis treatment
• Maintenance dose
  • Individualize and determine by titration based on parathyroid hormone (PTH) and corrected serum calcium response
  • 2.5 mg IV 3 times/week; titrate dose by 2.5-or 5-mg increments not more frequently than every 4 weeks to maintain PTH levels within the target range and corrected serum calcium within the normal range; maximum dose of 15 mg 3 times/week

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Etelcalcetide has severe interactions with the following drug:
  • cinacalcet
• Etelcalcetide has serious interactions with no other drugs
• Etelcalcetide has moderate interactions with no other drugs
• Etelcalcetide has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to etelcalcetide or any of its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Etelcalcetide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Etelcalcetide?”

Cautions

• Cases of hypotension, congestive heart failure, and decreased myocardial performance reported in clinical trials; reductions in corrected serum calcium may be associated with congestive heart failure, however, a causal relationship could not be completely excluded closely monitor for worsening signs and symptoms of heart failure
• Adynamic bone may develop if PTH levels are chronically suppressed; if PTH levels decrease below the recommended target range, the dose of vitamin D sterols and/or Etelcalcetide should be reduced or discontinued; after discontinuation, resume therapy at a lower dose to maintain PTH levels in the target range
• Rare reports of upper gastrointestinal (GI) bleeding occurred during clinical trials; the exact cause of the GI bleeds was unknown and there were too few cases to determine if GI bleeding was related to this medication; 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 therapy; monitor patients for worsening of common GI adverse reactions of nausea and vomiting associated with this medication and for signs and symptoms of GI bleeding and ulcerations during therapy; promptly evaluate and treat any suspected GI bleeding
• Hypocalcemia
  • Etelcalcetide lowers serum calcium and can lead to hypocalcemia, sometimes severe; low serum calcium can cause paresthesias, myalgias, muscle spasms, seizures, QT interval prolongation, and ventricular arrhythmia
  • Coadministration with another oral calcium-sensing receptor agonist could result in severe, life-threatening hypocalcemia; closely monitor corrected serum calcium in patients receiving etelcalcetide and concomitant therapies known to lower serum calcium
  • Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other 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 therapy; closely monitor corrected serum calcium and QT interval in patients at risk receiving therapy
  • 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 this medication; monitor corrected serum calcium in patients with seizure disorders receiving therapy
  • Do not initiate in patients if 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; educate patients on symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur
  • If corrected serum calcium falls below the lower limit of normal or symptoms of hypocalcemia develop, start, or increase calcium supplementation (including calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration); dose reduction or discontinuation of therapy may be necessary

Pregnancy and Lactation

• There are no available data on the use in pregnant women
• Lactation
  • Unknown if distributed in human breast milk
  • Studies in rats showed distribution in milk at concentrations similar to plasma
  • Because of the potential for etelcalcetide to cause adverse effects in breastfed infants, including hypocalcemia, use is not recommended while breastfeeding