What is the most important information I should know about etelcalcetide?
Before you receive etelcalcetide, tell your doctor if you have taken cinacalcet within the past 7 days.
What is etelcalcetide?
Etelcalcetide decreases levels of parathyroid hormone (PTH), calcium, and phosphorous in the body.
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.
What should I discuss with my healthcare provider before receiving etelcalcetide?
You should not be treated with etelcalcetide if you are allergic to it.
To make sure etelcalcetide is safe for you, 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.
It is not known whether etelcalcetide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How is etelcalcetide given?
Etelcalcetide is injected into a vein through an IV. A healthcare provider will give you this injection as part of your dialysis treatment.
Etelcalcetide is usually given once every 3 weeks at the end dialysis.
Your doctor may occasionally change your dose amount or schedule.
To be sure this medicine is helping your condition, you may need frequent blood tests. Your treatment with etelcalcetide may be delayed based on the results of these tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with etelcalcetide.
What happens if I miss a dose?
Because you will receive etelcalcetide in a clinical setting, you are not likely to miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose may cause calcium levels to get too low. Symptoms include muscle cramps, confusion, and numbness or tingling.
What should I avoid while using etelcalcetide?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of 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.
What other drugs will affect etelcalcetide?
Other drugs may interact with etelcalcetide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about etelcalcetide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01. Revision date: 12/7/2017.
