Etelcalcetide Injection

WHY is this medicine prescribed?

Etelcalcetide injection is used to treat secondary hyperparathyroidism (condition in which the body produces too much parathyroid hormone [PTH; natural substance needed to control the amount of calcium in the blood]) in adults with chronic kidney disease (condition in which the kidneys stop working slowly and gradually) who are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly.) Etelcalcetide injection is in a class of medications called calcimimetics. It works by signaling the body to produce less parathyroid hormone in order to decrease the amount of calcium in the blood.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Etelcalcetide injection comes as a solution (liquid) to inject intravenously (into a vein). It is usually given 3 times a week at the end of each dialysis session by a doctor or nurse at the dialysis center.

Your doctor will probably start you on an average dose of etelcalcetide injection and gradually adjust your dose depending on your body's response to the medication, not more than once every 4 weeks.

What SPECIAL PRECAUTIONS should I follow?

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.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

This medication is only given with your dialysis treatment. If you miss a scheduled dialysis treatment, skip the missed dose of medication and continue your regular dosing schedule at the next dialysis session.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• diarrhea
• headache

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

• rash
• hives
• itching
• swelling of the face
• tingling, prickling, or burning sensation on the skin
• muscle spasms or pain
• seizures
• irregular heartbeat
• fainting
• shortness of breath
• weakness
• sudden, unexplained weight gain
• new or worsening swelling in the ankles, legs, or feet
• bright red blood in vomit
• vomit that looks like coffee-grounds
• 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).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to etelcalcetide injection.

Ask your pharmacist any questions you have about etelcalcetide injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.