Terlipressin

What is Terlipressin?

• Terlipressin (Terlivaz), is a vasopressin receptor agonist.
• Terlipressin is a 12-amino acid peptide with the chemical name N-[N-(N-glycylglycyl)glycyl]-8-L-lysinevasopressin.

Terlipressin

What are the uses of this medicine?

• Terlipressin (Terlivaz) is used to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Limitation of Use:

• Terlipressin (Terlivaz) cannot be used in patients with a serum creatinine > 5 mg/dL.

How does this medicine work?

• Terlipressin is a synthetic vasopressin analogue with twice the selectivity for vasopressin V1 receptors versus V2 receptors.
• Terlipressin acts as both a prodrug for lysine-vasopressin, as well as having pharmacologic activity on its own. Terlipressin is thought to increase renal blood flow in patients with hepatorenal syndrome by reducing portal hypertension and blood circulation in portal vessels and increasing effective arterial volume and mean arterial pressure (MAP).

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypoxia or worsening respiratory symptoms.
• ongoing coronary, peripheral or mesenteric ischemia.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Terlipressin was approved for medical use in the United States in 2022.
• The US Food and Drug Administration considers it to be a first-in-class medication.

How should this medicine be used?

• Obtain baseline oxygen saturation (SpO2) prior to administering the first dose of Terlivaz. During treatment, monitor patient oxygen saturation using continuous pulse oximetry.
• Assess Acute-on-Chronic Liver Failure (ACLF) Grade and volume status before initiating Terlivaz.

Recommended dosage:

• Days 1 to 3: Administer Terlivaz 0.85 mg (1 vial) intravenously every 6 hours.
• Day 4: Assess serum creatinine (SCr) versus baseline.
• If SCr has decreased by at least 30% from baseline, continue Terlivaz 0.85 mg (1 vial) intravenously every 6 hours.
• If SCr has decreased by less than 30% from baseline, dose may be increased to Terlivaz 1.7 mg (2 vials) intravenously every 6 hours.
• If SCr is at or above baseline value, discontinue Terlivaz.
• Continue Terlivaz until 24 hours after two consecutive SCr ≤1.5 mg/dL values at least 2 hours apart or a maximum of 14 days.

Administration:

• Terlivaz is supplied as a sterile, preservative-free, lyophilized, white-to off-white powder for intravenous administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Administer Terlivaz through a peripheral or central line. A dedicated central line is not required.
• Flush the line after Terlivaz administration.
• If not administered immediately, store Terlivaz at 2°C to 8°C (36°F to 46°F) for up to 48 hours.
• Do not freeze.
• The reconstituted solution does not need protection from light.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: Terlivaz 0.85 mg (1 vial) as a lyophilized powder in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Terlivaz

What side effects can this medication cause?

The most common side effects of this medicine include:

• Abdominal pain
• Nausea
• Respiratory failure
• Diarrhea
• Dyspnea
• Fluid overload
• Pleural effusion
• Sepsis
• Bradycardia
• Ischemia-related events

Less common, but serious side effects may include:

• Serious or Fatal Respiratory Failure
• Ischemic Events

What special precautions should I follow?

• Serious or fatal respiratory failure occurred in 14% of patients treated with Terlivaz.
• Terlivaz-related adverse reactions may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥ 35), the benefits of Terlivaz may not outweigh its risks.
• Terlivaz may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Discontinue Terlivaz in patients who experience signs or symptoms suggestive of ischemic adverse reactions.
• Inform female patients of reproductive potential that Terlivaz may cause fetal harm and to inform their prescriber of a known or suspected pregnancy.
• There are no data on the presence of terlipressin in human or animal milk, the effects on the breastfed infant, or the effect on milk production.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Manifestations of Terlivaz overdose are expected to be similar to the adverse reactions.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In case of overdose, initiate close monitoring of vital signs, electrolytes, and potential ischemic events and initiate appropriate symptomatic treatment.

Can this medicine be used in pregnancy?

• Based on findings from the published literature and on its mechanism of action, Terlivaz may cause fetal harm when administered to a pregnant woman.
• If Terlivaz is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of Terlivaz have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Terlipressin

Inactive ingredients:

• mannitol
• Glacial acetic acid and/or sodium hydroxide may be added.

Who manufactures and distributes this medicine?

Distributed by:

• Mallinckrodt Hospital Products Inc.
• Bridgewater, NJ, USA

What should I know about storage and disposal of this medication?

• Store Terlivaz vials in the carton under refrigerated conditions at 2°C to 8°C (36°F to 46°F).
• Store in the original carton to protect from light prior to reconstitution.

• Dailymed label info on Terlipressin
• FDA Terlipressin