Terlipressin

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

Terlipressin may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor will change your dose based on how your kidneys are functioning.

Terlipressin is injected into a vein by a healthcare provider.

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

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

Terlipressin can lead to serious or life-threatening respiratory failure. Contact your doctor immediately if you experience any breathing issues.

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.

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

Terlipressin may cause serious side effects. Call your doctor right away if you have:

• a blue color in your skin, lips, fingers, or toes;
• feeling light-headed, as if you might faint;
• 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 black stools;
• weight gain or swelling in your arms or legs; or
• symptoms of low oxygen--restlessness, headache, confusion, fast heart rate, fast breathing, anxiety, or trouble breathing.

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

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 minutesDay 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 minutesDuration 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 daysComments:-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

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

In a medical setting, an overdose will be treated quickly.

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

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