Terlipressin Injection

IMPORTANT WARNING:

Terlipressin may cause breathing problems that may be severe or life-threatening. If you experience any of the following symptoms, tell your doctor immediately: shortness of breath or trouble breathing.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to terlipressin.

WHY is this medicine prescribed?

Terlipressin is used to improve how your kidneys work in adults with hepatorenal syndrome (a condition that causes kidney problems in individuals with serious liver disease). Terlipressin is in a class of medications called vasopressin receptor agonists. It works by increase blood flow in the kidneys.

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?

Terlipressin comes as a powder to be mixed with a liquid to be given intravenously (into a vein) by a healthcare provider. It is usually given every 6 hours for 3 days. Your doctor will then continue your medication, increase your dose, or stop treatment based on your response to terlipressin.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking terlipressin,

• tell your doctor and pharmacist if you are allergic to terlipressin, any other medications, or any of the ingredients in terlipressin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you are short of breath or having breathing problems or if you have problems with blood flow to your heart, abdomen, or arms and legs. Your doctor may not give you terlipressin injection.

• tell your doctor if you have or have ever had a stroke, problems with blood flow to the heart or brain, or heart disease or if you are waiting for a liver transplant.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving terlipressin, call your doctor immediately.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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

• abdominal pain
• nausea
• diarrhea

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• changes in skin color or skin turning blue
• changes in heart rate
• chest pain
• sudden dizziness
• problems with vision, body movement, and speaking;loss of consciousness; weakness

Terlipressin 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to terlipressin.

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.