Etelcalcetide Injection

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving etelcalcetide injection,

• tell your doctor and pharmacist if you are allergic to etelcalcetide, any other medications, or any of the ingredients in etelcalcetide injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Also tell your doctor or pharmacist if you are taking cinacalcet (Sensipar) or have stopped taking it within the past seven days. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or anyone in your family has or has ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death) or if you have or have ever had an irregular heartbeat, heart failure, low levels of potassium or magnesium in the blood, seizures, stomach ulcers, any type of irritation or swelling of the stomach or esophagus (tube that connects the mouth and stomach), or severe vomiting.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving etelcalcetide injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving etelcalcetide injection.

Etelcalcetide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

1. nausea
2. vomiting
3. diarrhea
4. headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

1. rash
2. hives
3. itching
4. swelling of the face
5. tingling, prickling, or burning sensation on the skin
6. muscle spasms or pain
7. seizures
8. irregular heartbeat
9. fainting
10. shortness of breath
11. weakness
12. sudden, unexplained weight gain
13. new or worsening swelling in the ankles, legs, or feet
14. bright red blood in vomit
15. vomit that looks like coffee-grounds
16. black, tarry, or bright red stools

Etelcalcetide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

• Parsabiv^®