Etelcalcetide is a prescription indicated for the treatment of an increased amount of a certain hormone called parathyroid. It is in people with long-term kidney disease who are on dialysis. Dialysis treatment usually causes higher than normal amounts of certain substances such as:

  • Calcium
  • Parathyroid hormone
  • Phosphorus

This medication helps lower calcium and phosphorus levels in your blood. Having the right amounts of parathyroid hormone, phosphorus, and calcium in your body can help prevent bone problems.

Kidney disease describes the gradual loss of kidney function. Your kidneys filter wastes and excess fluids from your blood. These are then being excreted in your urine. When chronic kidney disease reaches an advanced stage, dangerous levels of fluid and wastes can build up in your body. Treatment of kidney disease focuses on slowing the progression of kidney damage. Usually, it is by controlling the underlying cause. This disease can progress to end-stage kidney failure which is fatal without dialysis. Signs and symptoms may include:

  • Vomiting
  • Nausea
  • Fatigue and weakness
  • Loss of appetite
  • Changes in how much you urinate
  • Sleep problems
  • Persistent itching
  • Muscle cramps
  • Chest pain if fluid builds up around the lining of the heart
  • Shortness of breath if fluids build up in the lungs
  • High blood pressure that is difficult to control

Etelcalcetide is in the class of medications called calcimimetics. Calcimimetic is a drug that mimics the action of calcium on tissues. It is by allosteric activation of the calcium-sensing receptors that is expressed in various human organ tissues. This medication lessens how much parathyroid hormone your body creates. This product is supplied in a single-dose vial containing 5mg/mL of Etelcalcetide. It is a sterile, preservative-free, and ready-to-use clear and colorless solution for intravenous injection. Each dose has the active ingredient of Etelcalcetide which is a white to off-white powder. This is available in the dosage forms of 2.5 mg/0.5 mL, 5 mg/ml, and 10 mg/2 mL. The Food and Drug Administration (FDA) has already approved this medication.

How does Etelcalcetide work?

Etelcalcetide is a calcimimetic agent that allosterically modulates the calcium-sensing receptor (CaSR). It binds to CaSR and enhances activation of the receptor by extracellular calcium. Activation of the CaSR on parathyroid chief cells lessens parathyroid hormone secretion.

When cells in the parathyroid gland notice high levels of calcium in the blood, they lessen the amount of parathyroid hormone entering the blood. Etelcalcetide imitates the action of calcium on these cells. In this way, it decreases the parathyroid hormone levels in the blood. The reduced parathyroid hormone decreases the levels of calcium in the blood.

How to use Etelcalcetide?

The dosage will depend on your medical condition, age, weight, and response to the treatment. Your doctor may start at a low dose and gradually increase it. You must take this medication exactly as it is prescribed. Do not take more or less than it is given by your doctor.

Etelcalcetide is to be given by injection into a vein. This is usually given three times each week at the end of dialysis treatment. If you miss a regularly scheduled dialysis treatment, you should not receive this medication. It is until the end of your next dialysis treatment. If your doctor is switching you from treatment with cinacalcet to this medication, it should be stopped at least 7 days before starting Etelcalcetide. Cinacalcet a different drug used to lessen parathyroid hormone.

Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Clean the injection site with rubbing alcohol before injecting each dose. Learn how to store and discard medical supplies safely. To get the most benefit from it, use the medication regularly. Remember to use the prescription at the same time each day. Let your doctor know if your condition does not improve or if it gets worse. If you missed a dose, take it as soon as you remember it. If it is almost time for your next dose, skip the missed dose and follow your regular schedule. Do not double the dose to make up for the missed dose.

What are the side effects of Etelcalcetide?

Common side effects:

  • Muscle spasms
  • Decreased blood calcium
  • Nausea
  • Diarrhea
  • Headache
  • Vomiting
  • Numbness and tingling

If you have these unlikely but serious side effects, call your doctor right away:

  • Hives, rash, or itching
  • Swelling of the face
  • Prickling, tingling, or burning sensation on the skin
  • Muscle pain or spasms
  • Irregular heartbeat
  • Seizures
  • Fainting
  • Shortness of breath
  • Weakness
  • New or worsening swelling in the ankles, feet, or legs
  • Sudden and unexplained weight gain
  • Vomit that looks like coffee grounds
  • Bright red blood in vomit
  • Tarry, black, or bright red stools

Get emergency medical help right away if there any signs of an allergic reaction such as:

  • Hives
  • Trouble or difficulty breathing
  • Swelling of your face, lips, tongue, or throat

Warnings and Precautions

  • Let your doctor know about the drugs you take including vitamins, prescription medicine, and herbal supplements.
  • Tell your doctor if you are allergic to it. This drug may contain an inactive ingredient that causes an allergic reaction.
  • Without the consent of your doctor, you should not receive any vaccination or immunization.
  • This medication should not be used by pregnant, planning to become pregnant, or breastfeeding women.
  • This should be used with caution in people with a medical history of stomach or intestinal problems and seizures.
  • Etelcalcetide may cause a condition that affects the heart rhythm.
  • Inform your doctor if you have any other medical history before having this treatment.
  • This drug may cause dizziness or drowsiness. Don’t drive or do dangerous activities until you know how this affects you.
  • Do not share this drug with others even if they have the same symptoms as yours.
  • While having this treatment, limit alcoholic beverages.
  • Do not suddenly stop taking this medication even if you feel well. It may worsen or may cause another complication.
  • Call your doctor if there happened to be any signs of an overdose.
  • Keep Etelcalcetide and your other medications far from heat, moisture, and reach of children.