Etelcalcetide is used to treat overactive parathyroid gland (hyperparathyroidism) in adults with chronic kidney failure who are on dialysis.
Etelcalcetide may also be used for purposes not listed in this medication guide.
uses
What is Parsabiv (Etelcalcetide) used for?
- Secondary Hyperparathyroidism
warnings
What is the most important information I should know about Parsabiv (Etelcalcetide)?
You should not be treated with etelcalcetide if you are allergic to it.
Tell your doctor if you have ever had:
- congestive heart failure;
- stomach or intestinal bleeding;
- a seizure;
- long QT syndrome (in you or a family member); or
- if you have used cinacalcet (Sensipar) within the past 7 days.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breast-feed while using this medicine.
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Side Effects
What are the side effects of Parsabiv (Etelcalcetide)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- 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 your mouth, or in your fingers and toes); or
- signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
- numbness or tingling;
- muscle spasms;
- low calcium;
- headache; or
- nausea, vomiting, diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Parsabiv (Etelcalcetide) if I’m pregnant or breastfeeding?
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breast-feed while using this medicine.
Interactions
What drugs and food should I avoid while taking Parsabiv (Etelcalcetide)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Parsabiv (Etelcalcetide)?
Use Parsabiv (Etelcalcetide) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Etelcalcetide is given as an infusion into a vein. A healthcare provider will give you this injection as part of your dialysis treatment.
Etelcalcetide is usually given 3 times per week at the end dialysis.
Your doctor may occasionally change your dose amount or schedule.
You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.
Because you will receive etelcalcetide in a clinical setting, you are not likely to miss a dose.
Overdose Signs
What happens if I overdose on Parsabiv (Etelcalcetide)?
Overdose may cause calcium levels to get too low. Symptoms include muscle cramps, confusion, and numbness or tingling.
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