Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 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.
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.
Like all medications, Terlivaz can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: