Etelcalcetide (e-tel-KAL-se-tide)

Treats hyperparathyroidism (overactive parathyroid glands) in patients with chronic kidney disease who are on dialysis.

Brand Name(s):

Parsabiv

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bone disease, heart disease, heart rhythm problems (such as QT prolongation), stomach or digestive problems (such as ulcers), or a history of seizures.
• This medicine may cause the following problems:
  • Hypocalcemia (low levels of calcium in the blood)
  • Worsening of heart failure
  • Stomach bleeding
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, fast or uneven heartbeat, trouble breathing
• Decrease in how much or how often you urinate
• Numbness and tingling around the mouth, fingertips, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe stomach pain, bloody or black, tarry stools, vomiting of blood or material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Nausea
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088