Terlivaz Terlipressin .85 mg/5mL Injection, Powder, Lyophilized, For Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Vasopressin Receptor Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Terlipressin is used to improve how your kidneys work in adults with hepatorenal syndrome (a condition that causes kidney problems in individuals with serious liver disease). Terlipressin is in a class of medications called vasopressin receptor agonists. It works by increase blood flow in the kidneys.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Terlivaz .85 mg/5mLthis 43825-0200-01 | Mallinckrodt | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10335452 ↗ | Method of use | U-3711 | Apr 5, 2037 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Sep 14, 2027 |
| ODE-406 | Orphan Drug Exclusivity (7-year) | Sep 14, 2029 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 43825-0200-01 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2022-09-14 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ.
Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% [see Dosage and Administration (2.1) , Contraindications (4) , and Warnings and Precautions (5.1) ]. WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure.
Patients with volume overload or with ACLF Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve.
Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% ( 2.1 , 4 , 5.1 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit. TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
( 1 ) Limitation of Use Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initial dosing, assess patients for ACLF Grade 3 and obtain patient baseline oxygenation level. Monitor patient oxygen saturation with pulse oximetry. ( 2.1 ) Recommended Dosage Regimen: ( 2.2 ) 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. See full prescribing information for instructions on preparation and administration ( 2.3 ).
Flush IV line after administration.
2.1Important Considerations Prior to Initiating and During Therapy Obtain baseline oxygen saturation (SpO 2 ) prior to administering the first dose of TERLIVAZ. During treatment, monitor patient oxygen saturation using continuous pulse oximetry. Do not use TERLIVAZ treatment in patients experiencing hypoxia until hypoxia resolves [see Contraindications (4) , and Warnings and Precautions (5.1) ] .
Assess Acute-on-Chronic Liver Failure (ACLF) Grade and volume status before initiating TERLIVAZ [see Warnings and Precautions (5.1) and References (15) ].
2.2Recommended Dosage Record last available serum creatinine (SCr) value prior to initiating treatment (baseline SCr). The recommended starting dosage is TERLIVAZ 0.85 mg every 6 hours by slow intravenous bolus injection (over 2 minutes) on Days 1 through 3. Adjust the dose on Day 4 based on changes from baseline SCr using the dosing chart (Figure 1).
Figure 1: Dosing Chart a Baseline SCr is the last available serum creatinine before initiating treatment. Figure 1
2.3Preparation and Administration Reconstitute each vial with 5 mL of 0.9% Sodium Chloride Injection to prepare a 0.85 mg/5 mL solution. 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: TERLIVAZ 0.85 mg is a white to off-white lyophilized powder in a single-dose vial for reconstitution. For injection: TERLIVAZ 0.85 mg (1 vial) as a lyophilized powder in a single-dose vial for reconstitution. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS TERLIVAZ is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms. TERLIVAZ is contraindicated in patients with ongoing coronary, peripheral, or mesenteric ischemia. TERLIVAZ is contraindicated: In patients experiencing hypoxia or worsening respiratory symptoms. ( 4 ) In patients with ongoing coronary, peripheral, or mesenteric ischemia. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious or Fatal Respiratory Failure : Monitor patients for changes in respiratory status using pulse oximetry and regular clinical assessments. Actively manage intravascular volume overload and adjust TERLIVAZ therapy as appropriate. ( 5.1 ) Ineligibility for Liver Transplant : TERLIVAZ-related adverse reactions may make a patient ineligible for liver transplantation, if listed.
( 5.2 ) Ischemic Events : TERLIVAZ is a vasoconstrictor and can cause ischemic events (cardiac, peripheral, or mesenteric) that may require dose interruption or discontinuation. ( 5.3 ) Embryo-Fetal Toxicity : TERLIVAZ may cause fetal harm when used during pregnancy. Advise females of reproductive potential of the potential hazard to the fetus.
( 5.4 , 8.1 )
5.1Serious or Fatal Respiratory Failure In the primary clinical trial [see Clinical Studies (14) ] , serious or fatal respiratory failure occurred in 14% of patients treated with TERLIVAZ compared to 5% of patients on placebo. Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients [see Contraindications (4) ] . Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments.
Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms. Patients with fluid overload may be at increased risk of respiratory failure. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and judicious use of diuretics.
Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves [see Dosage and Administration (2.1) ] . Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure [see References (15) ] .
5.2Ineligibility for Liver Transplant TERLIVAZ-related adverse reactions (respiratory failure, ischemia) 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 [see Adverse Reactions (6.1) ].
5.3Ischemic Events TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions, cerebrovascular and ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions [see Dosage and Administration (2.1) and Adverse Reactions (6.1) ].
5.4Embryo-Fetal Toxicity TERLIVAZ may cause fetal harm when administered to a pregnant woman based on the mechanism of action and data from published literature. Terlipressin induces uterine contractions and endometrial ischemia in both humans and animals. If this drug is used during pregnancy, the patient should be apprised of the potential risk to the fetus [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1) ] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Serious or Fatal Respiratory Failure [see Warnings and Precautions (5.1) ] Ischemic Events [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 1-800-844-2830 and www.Mallinckrodt.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of TERLIVAZ cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TERLIVAZ was evaluated in the CONFIRM trial [see Clinical Studies (14) ] . The average daily dose of TERLIVAZ was 3.1 mg (range 0.8 to 5.8 mg), with a mean duration of exposure to TERLIVAZ of 6.2 days (range 1 to 15 days).
Treatment discontinuation due to adverse events occurred in 12.0% (24/200) of patients receiving TERLIVAZ and 5.1% (5/99) of patients receiving placebo. The most common adverse reactions that led to TERLIVAZ discontinuation were respiratory failure, abdominal pain, and intestinal ischemia/obstruction. Table 1 lists adverse reactions that occurred more commonly on TERLIVAZ than on placebo, and in at least 4% of patients treated with TERLIVAZ in the CONFIRM trial.
The most commonly observed adverse reactions in TERLIVAZ-treated patients (≥10%) were abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. Table 1: Adverse Reactions Reported by ≥4 % of TERLIVAZ-Treated Patients Patients, n (%) TERLIVAZ (N=200) Placebo (N=99) Abdominal pain 39 (19.5) 6 (6.1) Nausea 32 (16.0) 10 (10.1) Respiratory failure 31 (15.5) 7 (7.1) Diarrhea 26 (13.0) 7 (7.1) Dyspnea 25 (12.5) 5 (5.1) Fluid overload 17 (8.5) 3 (3.0) Pleural effusion 11 (5.5) 0 (0.0) Sepsis 11 (5.5) 1 (1.0) Bradycardia 10 (5.0) 0 (0.0) Ischemia-related events Ischemia-related events include skin discoloration, cyanosis, ischemia, and intestinal ischemia.
9 (4.5) 0 (0.0)
6.2Postmarketing Experience Adverse reactions reported from the worldwide postmarketing experience with terlipressin include headache, hyponatremia, skin necrosis and gangrene. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to terlipressin exposure.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Based on findings from the published literature and on its mechanism of action, TERLIVAZ may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . In small, published studies, administration of a single intravenous dose of terlipressin to pregnant women during the first trimester induced uterine contractions and endometrial ischemia. The limited published data are not sufficient to determine a drug-associated risk for major birth defects or miscarriage .
If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In published reproductive toxicity animal studies, administration of terlipressin to pregnant guinea pigs at doses lower than the maximum recommended human dose of 4 mg/day caused a marked decrease in blood flow to the uterus and placenta. In rabbits, terlipressin is both embryotoxic and teratogenic (increased resorptions, increased implantation loss, fetal anomalies, and fetal deformities).
8.2Lactation Risk Summary 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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TERLIVAZ and any potential adverse effects on the breastfed child from TERLIVAZ or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness of TERLIVAZ have not been established in pediatric patients.
8.5Geriatric Use Of the total number of patients in clinical studies treated with TERLIVAZ, 55 (16%) were ≥65 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects; other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
8.6Hepatic Impairment No dose adjustment is required in patients with hepatic impairment [see Clinical Pharmacology (12.3) ] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from the published literature and on its mechanism of action, TERLIVAZ may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . In small, published studies, administration of a single intravenous dose of terlipressin to pregnant women during the first trimester induced uterine contractions and endometrial ischemia. The limited published data are not sufficient to determine a drug-associated risk for major birth defects or miscarriage .
If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In published reproductive toxicity animal studies, administration of terlipressin to pregnant guinea pigs at doses lower than the maximum recommended human dose of 4 mg/day caused a marked decrease in blood flow to the uterus and placenta. In rabbits, terlipressin is both embryotoxic and teratogenic (increased resorptions, increased implantation loss, fetal anomalies, and fetal deformities).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of TERLIVAZ have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients in clinical studies treated with TERLIVAZ, 55 (16%) were ≥65 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects; other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE Manifestations of TERLIVAZ overdose are expected to be similar to the adverse reactions described with therapeutic doses. In case of overdose, initiate close monitoring of vital signs, electrolytes, and potential ischemic events and initiate appropriate symptomatic treatment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Terlipressin is a synthetic vasopressin analogue with twice the selectivity for vasopressin V 1 receptors versus V 2 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).
12.2Pharmacodynamics After administration of a single 0.85 mg dose of terlipressin in patients with hepatorenal syndrome type 1 (HRS-1), an increase in the diastolic, systolic, and mean arterial pressure (MAP), and decrease in heart rate were evident within 5 minutes after dosing and were maintained for at least 6 hours after dosing. The maximum change in blood pressure and heart rate occurred at 1.2 to 2 hours post dose. For MAP, the estimated maximum effect was an increase of 16.2 mmHg.
The estimated maximum effect for heart rate was a decrease of 10.6 beats/minute. Cardiac Electrophysiology The effect of terlipressin on QTc interval was evaluated in 41 patients with HRS-1. Patients received an initial dose of 1 mg terlipressin acetate every 6 hours for a period of up to 14 days.
No clinically meaningful changes from baseline were detected in the trial based on the Fridericia correction method. Increases of the mean QTc interval of <10 ms were reported.
12.3Pharmacokinetics The pharmacokinetic parameters of terlipressin and its major active metabolite, lysine-vasopressin, were derived from population pharmacokinetic modeling with sparse PK samples from 69 patients with HRS-1. Following a 1 mg IV injection of terlipressin acetate, the median C max , AUC 24h and C ave of terlipressin at steady state was 70.5 ng/mL, 123 ng×hr/mL and 14.2 ng/mL, respectively. The median C max , AUC 24h and C ave of lysine-vasopressin were 1.2 ng/mL, 11.2 ng×hr/mL and 0.5 ng/mL, respectively.
Terlipressin and lysine-vasopressin exhibit linear pharmacokinetics in healthy subjects. Plasma concentrations of terlipressin demonstrate proportional increases with the dose administered. Distribution The volume of distribution (V d ) of terlipressin was
6.3L and 1370 L for lysine-vasopressin. Elimination The clearance of terlipressin was
27.4L/hr and 318 L/hr for lysine-vasopressin. There were no dose-dependent changes in the elimination rate constant of terlipressin in healthy subjects. Clearance of terlipressin in HRS-1 patients increased with body weight, while body weight had no effect on the clearance of lysine-vasopressin.
The terminal half-life of terlipressin was 0.9 hours and 3.0 hours for lysine-vasopressin. Metabolism Terlipressin is metabolized by cleavage of the N-terminal glycyl residues of terlipressin by various tissue peptidases, resulting in release of the pharmacologically active metabolite lysine-vasopressin. Once formed, lysine-vasopressin is metabolized by body tissue via various peptidase-mediated routes.
Terlipressin is not metabolized in blood or plasma. Due to the ubiquitous nature of peptidases in body tissue, it is unlikely that the metabolism of terlipressin will be affected by disease state or other drugs. Excretion Less than 1% of terlipressin and <0.1% of lysine-vasopressin is excreted in urine in healthy subjects.
Specific Populations Gender, age, creatinine clearance, Child-Pugh score, serum alkaline phosphatase, serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), and total bilirubin do not appear to have any clinically significant effect on clearance of either terlipressin or lysine-vasopressin. Drug Interactions In vitro studies in human liver microsomes demonstrated that there was little or no evidence that terlipressin was a direct-, time-, or metabolism-dependent inhibitor and inducer of any of the CYP enzymes evaluated.
In addition, there was little or no evidence tha…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Terlipressin is a synthetic vasopressin analogue with twice the selectivity for vasopressin V 1 receptors versus V 2 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).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING TERLIVAZ is supplied as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials containing 0.85 mg of terlipressin. Each vial is supplied in a carton (NDC 43825-200-01). 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.
📦 Storage and Handling ▾
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.
📋 Description ▾
11 DESCRIPTION TERLIVAZ contains terlipressin, a vasopressin receptor agonist. Terlipressin is a 12-amino acid peptide with the chemical name N -[ N -( N -glycylglycyl)glycyl]-8-L-lysinevasopressin. The structure of terlipressin acetate is shown below: Molecular formula: C 52 H 74 N 16 O 15 S 2 ∙ (C 2 H 4 O 2 ) n ; (n=number of acetate molecules; theoretical n=2.8) Average molecular weight: 1227.38 (as free base) TERLIVAZ is supplied as a sterile, preservative-free, lyophilized, white-to off-white powder for intravenous administration.
Each vial contains 0.85 mg terlipressin, equivalent to 1 mg terlipressin acetate, and 10.0 mg mannitol. Glacial acetic acid and/or sodium hydroxide may be added to adjust pH at the time of manufacture. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Embryo-Fetal Toxicity Inform female patients of reproductive potential that TERLIVAZ may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1) ] .