The U.S. Food and Drug Administration approved Terlivaz for injection, making it the first and only FDA-approved product indicated to improve kidney function in adults with Hepatorenal Syndrome (HRS) involving a rapid reduction in kidney function. It is manufactured by Mallinckrodt, a global specialty pharmaceutical company.
What Is Terlivaz?
Terlivaz contains the active ingredient called terlipressin, a vasopressin receptor agonist, in a sterile, preservative-free, lyophilized powder for intravenous use. Each vial holds 0.85 mg of terlipressin, equivalent to 1 mg terlipressin acetate, and 10.0 mg mannitol.
The molecular formula is C52H74N16O15S2 (free base), with an average molecular weight of 1227.38. The formulation undergoes pH adjustment with glacial acetic acid and/or sodium hydroxide during manufacturing.
Indication
Terlivaz is a medication acting as a vasopressin receptor agonist, prescribed to enhance kidney function in adults experiencing hepatorenal syndrome with a swift decline in kidney function.
What Is Hepatorenal Syndrome?
Hepatorenal syndrome (HRS) is a potentially severe and life-threatening condition impacting the kidneys. It manifests as a swift and progressive decline in kidney function, typically affecting individuals with advanced liver disease. In HRS, the kidneys struggle to effectively filter and remove waste products from the bloodstream, resulting in diminished kidney function.
This syndrome commonly arises in the context of liver cirrhosis, portal hypertension, and the accumulation of abdominal fluid known as ascites. Although the precise cause of HRS remains not entirely elucidated, it is thought to involve intricate interactions among the circulatory system, kidneys, and hormonal factors.
Key characteristics of hepatorenal syndrome encompass a notable reduction in urine output and heightened levels of creatinine in the blood. As kidney function worsens, individuals may exhibit symptoms like fluid retention, swelling, and confusion.
HRS is recognized as a critical complication of advanced liver disease, necessitating a comprehensive approach that addresses the underlying liver condition and employs specific measures to bolster kidney function. Timely identification and intervention play a pivotal role in enhancing outcomes for individuals grappling with hepatorenal syndrome.
Mechanism of Terlivaz
Terlipressin, a synthetic vasopressin analog, enhances renal blood flow in hepatorenal syndrome by reducing portal hypertension and increasing effective arterial volume. Acting as a prodrug for lysine-vasopressin, it demonstrates higher selectivity for vasopressin V1 receptors.
Warning, Precaution, and Contraindication
Hypersensitive reaction: Do not take this medicine if you are allergic to Terlivaz and any of its ingredients. It is recommended to inform your doctor before starting the treatment.
Serious or Fatal Respiratory Failure: In the primary trial, 14% of Terlivaz-treated patients experienced serious respiratory failure, compared to 5% of placebo. Avoid initiation in hypoxic patients, monitor respiratory status, and discontinue Terlivaz if hypoxia occurs. Manage fluid overload to mitigate respiratory risk.
Ineligibility for Liver Transplant: Terlivaz-related adverse reactions may deem a patient ineligible for liver transplantation, especially those with high prioritization (e.g., MELD ≥ 35). Evaluate risks and benefits in such cases.
Ischemic Events: Terlivaz may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid in patients with severe cardiovascular conditions or ischemic disease. Discontinue Terlivaz for signs of ischemic adverse reactions.
Embryo-Fetal Toxicity: Terlivaz poses a risk of fetal harm. Pregnant women should be informed, and careful consideration is needed for use during pregnancy due to terlipressin’s impact on contractions and endometrial ischemia.
Drug Interaction
Terlivaz may interact with other vasoconstrictors, antihypertensive drugs, and drugs that affect renal function. It is important to consult a healthcare professional for a complete list of drug interactions before using Terlivaz.
Usage Of Terivaz In Specific Population
Pregnancy:
Terlivaz may pose a risk of fetal harm when administered to pregnant women, as suggested by findings in published literature and its mechanism of action. Limited data from small studies indicate that a single intravenous dose of terlipressin during the first trimester induced uterine contractions and endometrial ischemia. However, the available data are insufficient to determine the drug-associated risk for major birth defects or miscarriage. If Terlivaz is considered during pregnancy, patients should be informed about the potential risk to the fetus.
Lactation:
No data are available on the presence of terlipressin in human or animal milk, its effects on the breastfed infant, or its impact on milk production. The decision to breastfeed should be made by considering the developmental and health benefits, weighing the mother’s clinical need for Terlivaz, and evaluating potential adverse effects on the breastfed child either from Terlivaz or the underlying maternal condition.
Pediatric Use:
The safety and effectiveness of Terlivaz have not been established in pediatric patients.
Geriatric Use:
In clinical studies, 16% of patients treated with Terlivaz were ≥65 years of age. No notable differences in safety or effectiveness were observed between these elderly subjects and younger ones. While reported clinical experience has not identified differences in responses between the elderly and younger patients, some older individuals may exhibit greater sensitivity.
Hepatic Impairment:
No dose adjustment is required in patients with hepatic impairment.
Side Effects
The most commonly observed adverse reactions in patients treated with Terlivaz include nausea, respiratory failure, diarrhea, and dyspnea. If you notice any side effects it is recommended to contact your healthcare professional immediately.
Storage Condition
Maintain Terlivaz vials in the carton under refrigerated conditions at 2°C to 8°C (36°F to 46°F). Preserve the medication in its original carton to prevent light exposure before the reconstitution process.
How To Buy Terlivaz Online?
The procurement of Terlivaz online may involve dealing with complex regulations. Sansfro Health, a specialized pharmaceutical procurement company, is ready to assist in this importation process, ensuring transparency in pricing. For information on the Terlivaz price in India and guidance on the importation process, contact the dedicated Patient Support Team at (+91) 9315705373 or via email at help@sansfro.com. Sansfro is committed to simplifying the importation of medication and providing accurate pricing details.
Conclusion
Terlivaz, or terlipressin, is a significant advancement in treating HRS in adults. Its FDA approval and unique mechanism of action make it a valuable addition to the available treatment options for this condition. However, it is crucial to use this medication cautiously and under the supervision of a healthcare professional due to the potential for serious side effects and drug interactions.
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