Terlivaz

About Terlipressin 

• Terlivaz received Food and Drug Administration (FDA) approval On September 14, 2022, marking it as the treatment for hepatorenal syndrome. 
• Terlivaz is a vasopressin-related drug that belongs to the family called antidiuretic hormones. 
• Terlivaz is prescribed as a vasopressin receptor agonist to enhance kidney function in adults diagnosed with hepatorenal syndrome, particularly in cases of rapid kidney function decline. 
• Terlivaz in hepatorenal syndrome works by constricting blood vessels in the portal vein system, which reduces portal hypertension and blood flow to the liver, improving kidney function and reducing toxin release.
• Hepatorenal syndrome (HRS) refers to a serious complication of advanced liver disease, where progressive kidney dysfunction occurs. It typically arises in individuals with cirrhosis, severe alcoholic hepatitis, or other liver-related conditions. 
• HRS is characterized by a rapid deterioration in kidney function, leading to renal failure. 
• Symptoms may include reduced urine output, fluid retention, abdominal swelling, and potential mental confusion. HRS is considered a life-threatening condition requiring prompt medical attention.

Strength: 

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

Recommended Dosage:

Before the initial dose, assess patients for ACLF Grade 3 and determine baseline oxygenation levels. Monitor oxygen saturation using pulse oximetry. Reconstitute each vial with 5 mL of 0.9% Sodium Chloride Injection to create a 0.85 mg/5 mL solution. Visually inspect the solution for particulate matter and discoloration before administration. 

Administer Terlivaz through a peripheral or central line; a dedicated central line is not necessary. Flush the line post-administration. If not used immediately, store Terlivaz at 2°C to 8°C (36°F to 46°F) for up to 48 hours, avoiding freezing. The reconstituted solution does not require protection from light. Record the last available serum creatinine (SCr) value before treatment initiation (baseline SCr). Your doctor will determine the dosage based on your body weight and medical condition.

• During Days 1 to 3, administer Terlivaz 0.85 mg (1 vial) intravenously every 6 hours. On Day 4, assess serum creatinine (SCr) compared to baseline. 
• If SCr has decreased by at least 30% from baseline, continue Terlivaz 0.85 mg (1 vial) intravenously every 6 hours. 
• In case the SCr has decreased by less than 30% from baseline, consider increasing the dose to Terlivaz 1.7 mg (2 vials) intravenously every 6 hours. 
• If SCr is at or above the baseline value, discontinue Terlivaz. 
• Continue Terlivaz until 24 hours after two consecutive SCr values are ≤1.5 mg/dL, spaced at least 2 hours apart, or for a maximum of 14 days.

Important:

Before initiating Terlivaz injection, it’s imperative to have a comprehensive discussion about your medical history and current health status with your doctor. Regarding medications, ensure that you inform your doctor about all prescribed drugs, over-the-counter medications, and herbal supplements you are taking. Throughout the course of Terlivaz, anticipate regular monitoring of your blood pressure, oxygen levels, and kidney function. 

Additionally, consider the following precautions: cease smoking, as it can exacerbate the effects of Terlivaz, and refrain from alcohol consumption to prevent potential liver damage. Should you encounter any new or worsening symptoms while on Terlivaz, promptly inform your doctor.

Warnings & Precautions

• Terlivaz has the potential to induce hypersensitivity reactions, including the severe condition of anaphylaxis. If such a reaction occurs, immediate discontinuation of Terlivaz is essential, and prompt initiation of appropriate medical treatment is warranted.
• Inform your doctor if you have serious or fatal respiratory failure (breathing problems), which is a severe condition affecting your breathing, particularly if you have excess fluid in your body or advanced liver failure. 
• Your doctor will assess your oxygen levels before starting Terlivaz, and if your oxygen levels are too low (SpO2 <90%), the medication will not be initiated. 
• Throughout treatment, your doctor will monitor your oxygen levels, and if they fall below 90%, Terlivaz will be stopped. 
• Additionally, if you are on the list for a liver transplant, adverse reactions to Terlivaz may impact your eligibility for the transplant. It’s crucial to keep your doctor informed about your status. 
• Terlivaz can also potentially cause ischemic events, affecting blood flow to various body parts. Your doctor may need to adjust or discontinue the dose accordingly. 
• Always maintain open communication with your doctor regarding your health conditions and any concerns you may have.

Common Terlivaz Side Effects:

• Belly pain
• Nausea
• Diarrhea
• Headache
• Fatigue
• Slow heart rate
• Shortness of breath
• Respiratory failure
• Liver damage
• Low blood pressure
• Seizures

Use in Specific Population

• Before starting the treatment with this medicine, inform your doctor if you are pregnant or plan to become pregnant. Terlivaz may cause harm to the fetus when it is administered to a pregnant woman. 
• Notify your doctor if you are breastfeeding or plan to breastfeed because it is unknown  whether Terlivaz passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking Terlivaz. 
• Terlivaz safety and effectiveness remain unestablished in pediatric patients. No significant differences were noted in comparison to younger subjects. 
• Based on reported experiences, older patients and younger ones have shown similar responses to Terlivaz. However, it’s essential to note that some older individuals might be more sensitive to the medication.
• No dose adjustment is required in patients with hepatic impairment. 

Storage and Handling

Before handling Terlipressin injections, ensure your hands are clean by washing them with soap and water. 

• Keep Terlivaz vials refrigerated in the carton between 2°C to 8°C (36°F to 46°F). 
• Store in the original carton to shield from light before reconstitution.
• Protect Terlivaz from light and moisture.
• Do not store Terlivaz in the bathroom or in other areas where it may be exposed to heat or humidity.
• Keep Terlivaz out of the reach of children and pets.