Terlivaz .85 mg/5mL
Terlipressin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Mallinckrodt Hospital Products Inc.
Terlivaz is a injection, powder, lyophilized, for solution containing terlipressin at .85 mg/5mL, taken intravenous. Manufactured by Mallinckrodt Hospital Products Inc..
Key Facts
- Brand Name
- Terlivaz
- Generic Name
- Terlipressin
- NDC Code (Product)
43825-200- Manufacturer
- Mallinckrodt Hospital Products Inc.
- Strength
- .85 mg/5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA022231
- Drug Class
- Vasopressin Receptor Agonist [EPC]
- Marketing Start
- 09/14/2022
Recall History
Mallinckrodt Hospital Products Inc.
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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. 2.1 Important 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 treatm…
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 )
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 . 6.1 Clinical 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 …
Frequently Asked Questions
What is Terlivaz used for?
Terlivaz contains Terlipressin. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Terlivaz a controlled substance?
Terlivaz is not classified as a controlled substance by the DEA.
What is the generic name for Terlivaz?
The generic name for Terlivaz is Terlipressin. There are no other listed brand versions of Terlipressin.
What is the NDC code for Terlivaz .85 mg/5mL?
The NDC (National Drug Code) for Terlivaz .85 mg/5mL is 43825-200, listed by Mallinckrodt Hospital Products Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)