Terlipressin is used in adults to improve kidney function in people with hepatorenal syndrome.

Terlipressin may also be used for purposes not listed in this medication guide.

Terlipressin may cause serious or fatal respiratory failure. Call your doctor at once if you have breathing problems.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor will change your dose based on the results of your kidney function.

Terlipressin is injected into a vein by a healthcare provider.

Your breathing, oxygen levels, and other vital signs will be watched closely.

Store this medicine in the original container in the refrigerator away from light. Do not freeze.

Usual Adult Dose for Hepatorenal Syndrome:

Initial dose:
Day 1 to 3:
0.85 mg IV bolus injection every 6 hours over a period of two minutes

Day 4:
-If serum creatinine (SCr) has decreased by 30% or more from baseline:
0.85 mg IV bolus injection every 6 hours over a period of two minutes

-If SCr has decreased by less than 30% from baseline:
1.7 mg IV bolus injection every 6 hours over a period of two minutes

Duration of therapy: Until 24h after patient achieves a second consecutive SCr value of less than or equal to 1.5 mg/dL at least 2 hours apart or for a maximum of 14 days

Comments:
-Monitor oxygen saturation using continuous pulse oximetry.
-Obtain baseline oxygen saturation prior to starting therapy.
-Record the serum creatinine (baseline SCr) value prior to starting treatment.
-Assess serum creatinine (SCr) versus baseline prior to starting day 4 treatment.
-If SCr is at or above the baseline value after the third day of treatment, stop therapy with this drug.

Use: To improve kidney function in adults with hepatorenal syndrome

You should not use terlipressin if you have:

• low blood oxygen levels or lack of blood supply to the heart, arms, legs, stomach, or bowel; or

• trouble breathing.

Tell your doctor if you have or have ever had:

• breathing problems;

• fluid retention;

• heart problems;

• blood circulation problems; or

• if you are waiting for a liver transplant.

May harm an unborn baby. Use birth control and tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using terlipressin.

Call your doctor for instructions if you miss an appointment for your terlipressin injection.

In a medical setting an overdose would be treated quickly.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Terlipressin may cause serious side effects. Call your doctor at once if you have:

• blue-colored appearance in your skin, lips, fingers, or toes;

• a light-headed feeling, like you might pass out;

• chest pain or pressure;

• fever or chills, feeling cold;

• pain in your arms or legs;

• numbness or tingling in your hands or feet;

• bloody or tarry stools;

• weight gain, or swelling in your arms or legs; or

• hypoxia symptoms--restlessness, headache, confusion, rapid heart rate, rapid breathing, anxiety, or breathing problems.

Common side effects of terlipressin may include:

• stomach pain, nausea, diarrhea; or

• respiratory failure, trouble breathing.

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.

Other drugs may affect terlipressin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.