Generic name: etelcalcetide [ E-tel-KAL-se-tide ]
Brand name: Parsabiv
Dosage form: intravenous solution (5 mg/mL)
Drug class: Calcimimetics
What is etelcalcetide?
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.
Before you receive etelcalcetide, tell your doctor if you have taken cinacalcet within the past 7 days.
Before taking this medicine
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;
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 etelcalcetide 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.
How is etelcalcetide given?
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.
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.
Etelcalcetide side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Etelcalcetide may cause serious side effects. Call your doctor at once if you have:
a seizure (convulsions);
shortness of breath (even with mild exertion), swelling, rapid weight gain;
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 of etelcalcetide may include:
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.
Etelcalcetide dosing information
Usual Adult Dose for Secondary Hyperparathyroidism:
Initial dose: 5 mg IV 3 times per week
-Adjust dose in increments of 2.5 or 5 mg no more frequently than every 4 weeks to achieve a dose that maintains parathyroid hormone levels within the target range and corrected serum calcium within the normal range
Maintenance dose: 2.5 to 15 mg IV 3 times per week
-If switching from cinacalcet, discontinue cinacalcet at least 7 days prior to starting this drug.
-Ensure corrected serum calcium is at or above the lower limit of normal prior to initiating therapy; a dose increase, or re-initiation after a dose interruption.
-Dose should be administered by IV bolus at the end of hemodialysis treatment.
-If a hemodialysis treatment is missed, do not give this drug; resume this drug at the end of the next hemodialysis session at the prescribed dose; if more than 2 weeks of hemodialysis treatments are missed, reinitiate this drug at the recommended starting dose (5 mg) or 2.5 mg if that was the patient's last dose.
Use: For the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.
What other drugs will affect etelcalcetide?
Other drugs may affect 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.
Parsabiv (etelcalcetide) is an intravenous (IV) injection used to treat secondary hyperparathyroidism in adults with chronic kidney disease (CKD) who are on hemodialysis.
Parsabiv binds to and activates calcium-sensing receptors (CaSRs) in parathyroid tissue, mimicking the action of calcium. It reduces the amount of parathyroid hormone (PTH) in the circulation by decreasing the amount that is secreted.
Too much PTH can cause bone disease and the build-up of calcium in blood vessels, the heart and other organs. Continue reading
More about etelcalcetide
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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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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