Active Ingredients

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 the 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 ofthe heart
  • Shortness of breath if fluids build up in thelungs
  • 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 calcimimeticagent that allosterically modulates the calcium-sensing receptor (CaSR). Itbinds to CaSR and enhances activation of the receptor by extracellular calcium.Activation of the CaSR on parathyroid chief cells lessens parathyroid hormonesecretion.

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

How to use Etelcalcetide?

The dosage will depend on yourmedical condition, age, weight, and response to the treatment. Your doctor maystart at a low dose and gradually increase it. You must take this medicationexactly as it is prescribed. Do not take more or less than it is given by yourdoctor.

Etelcalcetide is to be given by injection intoa vein. This is usually given three times each week at the end of dialysistreatment. If you miss a regularly scheduled dialysis treatment, you should notreceive this medication. It is until the end of your next dialysis treatment. Ifyour 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 usedto lessen parathyroid hormone.

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

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 butserious side effects, call your doctor right away:

  • Hives, rash, or itching
  • Swelling of the face
  • Prickling, tingling, or burning sensation on theskin
  • Muscle pain or spasms
  • Irregular heartbeat
  • Seizures
  • Fainting
  • Shortness of breath
  • Weakness
  • New or worsening swelling in the ankles, feet, orlegs
  • 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 rightaway 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 takeincluding vitamins, prescription medicine, and herbal supplements.
  • Tell your doctor if you are allergic to it. Thisdrug may contain an inactive ingredient that causes an allergic reaction.
  • Without the consent of your doctor, you should notreceive 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 amedical history of stomach or intestinal problems and seizers.
  • Etelcalcetide may cause a condition that affectsthe heart rhythm.
  • Inform your doctor if you have any other medicalhistory before having this treatment.
  • This drug may cause dizziness or drowsiness. Don’tdrive or do dangerous activities until you know how this affects you.
  • Do not share this drug with others even if theyhave the same symptoms as yours.
  • While having this treatment, limit alcoholicbeverages.
  • Do not suddenly stop taking this medication evenif you feel well. It may worsen or may cause another complication.
  • Call your doctor if there happened to be any signsof an overdose.
  • Keep Etelcalcetide and your other medications farfrom heat, moisture, and reach of children.