Vasopressin and analogues

Terlivaz

Approved 14 Sept 2022IntravenousPowder

Indications

TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. 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 ) Limitation of Use Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit.

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 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 )

5.1 Serious 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.

Indications

Contraindications

Warnings and precautions

( 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 )

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.

Terlivaz

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Terlivaz

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.2Ineligibility for Liver Transplant

5.3Ischemic Events

5.4Embryo-Fetal Toxicity

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information

At a glance