Is Terlipressin approved by the FDA?

Terlipressin, marketed under the brand name Terlivaz, was approved by the FDA on September 14, 2022, for the treatment of hepatorenal syndrome in adults. This medication belongs to the drug class of antidiuretic hormones and is administered via intravenous injection.

What is Terlipressin? 

Terlipressin is a synthetic vasopressin analog that works by constricting blood vessels, which helps to increase blood flow to the kidneys. This mechanism of action helps to improve kidney function in people with hepatorenal syndrome, a condition often seen in patients with advanced liver disease.

Dosage and Administration:

• Initial Dose (Days 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: Treatment continues until 24 hours after the patient achieves a second consecutive SCr value of ≤ 1.5 mg/dL at least 2 hours apart, or for a maximum of 14 days.

Side Effects: 

Common side effects of terlipressin may include stomach pain, nausea, diarrhea, respiratory failure, and trouble breathing. Serious side effects can include blue-colored skin, lips, fingers, or toes; light-headedness; chest pain; fever; pain in arms or legs; numbness or tingling; bloody stools; weight gain; swelling; and symptoms of hypoxia such as restlessness, headache, confusion, rapid heart rate, and anxiety. Patients are advised to seek emergency medical help if they experience any signs of an allergic reaction or serious side effects.

Warnings:

• Respiratory Failure: Terlipressin may cause serious or fatal respiratory failure. Patients should contact their doctor immediately if they have breathing problems.
• Other Risks: Patients with low blood oxygen levels, lack of blood supply to the heart, arms, legs, stomach, or bowel, or trouble breathing should not use terlipressin.

Precautions: 

Before starting terlipressin, patients should inform their healthcare provider if they have a history of breathing problems, fluid retention, heart problems, or blood circulation problems. Pregnant women should avoid using terlipressin as it may harm the unborn baby. It is also important to discuss the safety of breastfeeding while using this medication.

Conclusion: 

Terlipressin (Terlivaz) is an FDA-approved treatment for improving kidney function in adults with hepatorenal syndrome. Approved on September 14, 2022, terlipressin offers a critical therapeutic option for managing this severe condition associated with liver disease. Patients should follow their healthcare provider's instructions carefully and be aware of the potential side effects and precautions associated with this medication. Regular monitoring and adherence to the prescribed dosage regimen are essential for achieving the best outcomes with terlipressin treatment.

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