Etelcalcetide

Etelcalcetide is used to treat an overactive parathyroid gland (hyperparathyroidism) in adults with chronic kidney failure who are receiving dialysis.

Etelcalcetide may also be used for other reasons that are not mentioned in this medication guide.

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 of 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.

Before you receive etelcalcetide, inform your doctor if you have taken cinacalcet in the past 7 days.

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 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.

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 right away 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 a tingling 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:

• 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.

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 rangeMaintenance dose: 2.5 to 15 mg IV 3 times per week Comments:-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.

Because you will get etelcalcetide in a clinical setting, it is unlikely that you will miss a dose.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.