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 clinically significant adverse reactions are described elsewhere in the labeling: • Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access [see Boxed Warning, Warnings and Precautions ( 5.1 )] .
• Risk of Hospitalization for Heart Failure [see Warnings and Precautions ( 5.2 )] .
• Hypertension [see Warnings and Precautions ( 5.3 )] .
• Gastrointestinal Erosion [see Warnings and Precautions ( 5.4 )] .
Most common adverse reactions (incidence ≥10%) are hypertension, thrombotic vascular events, and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of JESDUVROQ was evaluated in adults with dialysis-dependent chronic kidney disease with anemia in the ASCEND-D trial based on an on-study analysis (on and off treatment) [see Clinical Studies ( 14.1 )] .
Patients were randomized to JESDUVROQ or rhEPO (epoetin alfa for patients on hemodialysis;
darbepoetin alfa for patients on peritoneal dialysis).
5 WARNINGS AND PRECAUTIONS • Risk of Hospitalization for Heart Failure: Increased in patients with a history of heart failure.
( 5.2 ) • Hypertension: Worsening hypertension, including hypertensive crisis may occur.
Monitor blood pressure.
Adjust anti-hypertensive therapy as needed.
( 5.3 ) • Gastrointestinal Erosion: Gastric or esophageal erosions and gastrointestinal bleeding have been reported.
Like all medications, Jesduvroq 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: