Terlipressin

Terlipressin is a prescription medication used to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

• Terlipressin is available under the following different brand names: Terlivaz

Common side effects of Terlipressin include:

• abdominal pain,
• nausea, and
• diarrhea

Serious side effects of Terlipressin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• dizziness,
• weight gain,
• swelling,
• shortness of breath,
• cough,
• sharp chest pain,
• slow or fast heart rate,
• slurring speech,
• chest pain or pressure,
• sudden numbness or weakness on one side of the body,
• rapid breathing,
• confusion,
• fever,
• chills,
• clammy or sweaty skin, and
• pain or discomfort

Rare side effects of Terlipressin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 0.85 mg/vial

Hepatorenal Syndrome

Adult dosage

• Days 1-3: 0.85 mg slow IV bolus q6hr
• Day 4
  • Adjust dose based on changes from baseline serum creatinine (SCr)
  • SCr decreased by more than 30% from baseline: Continue at 0.85 mg IV every 6 hours 
  • SCr decreased by less than 30% from baseline: Increase to 1.7 mg IV every 6 hours 
  • SCr at or above baseline: Discontinue
• Days 4-14
  • Continue until 24 hours after the second consecutive SCr of less than 1.5 mg/dL at least 2 hours apart OR for a maximum of 14 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Terlipressin has no noted severe interactions with any other drugs.
• Terlipressin has no noted serious interactions with any other drugs.
• Terlipressin has no noted moderate interactions with any other drugs.
• Terlipressin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Patients experiencing hypoxia or worsening respiratory symptoms
• Patients with ongoing coronary, peripheral, or mesenteric ischemia

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Terlipressin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Terlipressin?”

Cautions

• May cause fetal harm when administered to pregnant females; terlipressin induces uterine contractions and endometrial ischemia in both humans and animals
• May cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia; avoid with a history of severe cardiovascular conditions, cerebrovascular, and ischemic disease; discontinue signs or symptoms suggestive of ischemic adverse reactions occur
• Serious or fatal respiratory failure
  • May cause serious or fatal respiratory failure
  • Obtain baseline SpO2 and do not initiate in hypoxic patients
  • Monitor for changes in respiratory status using continuous pulse oximetry and regular clinical assessments
  • Discontinue if hypoxia or increased respiratory symptoms occur
  • Fluid overload may increase risk; manage intravascular volume overload by reducing or discontinuing albumin and/or other fluids and judicious diuretic use
  • Temporarily interrupt, reduce, or discontinue treatment until volume status improves
  • Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure
• Ineligibility for liver transplant
  • Terlipressin-related adverse reactions (respiratory failure, ischemia) may make patients ineligible for liver transplantation (if listed)
  • For patients with high prioritization for liver transplantation (eg, MELD more than 35), the benefits of terlipressin may not outweigh the risks

Pregnancy and Lactation

• May cause fetal harm, based on its mechanism of action and findings in published literature
• In small, published studies, administration of a single IV dose to pregnant females during the first trimester induced uterine contractions and endometrial ischemia
• Limited published data are not sufficient to determine a drug-associated risk for major birth defects or miscarriage
• Inform pregnant patients of the potential risk to the fetus
• Lactation
  • Data are not available regarding the presence in human or animal milk, its effects on breastfed infants, or its effect on milk production