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 in greater detail in other sections of the labeling: • Hyperkalemia [see Warnings and Precautions (5.1) ] HFrEF Post-MI: Most common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine.
( 6.1 ) Hypertension: In clinical studies, adverse reactions with INSPRA were uncommon.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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 to rates in clinical trials of another drug and may not reflect the rates observed in practice.
Heart Failure Post-Myocardial Infarction In EPHESUS, safety was evaluated in 3307 patients treated with INSPRA and 3301 placebo-treated patients.
The overall incidence of adverse events reported with INSPRA (78.9%) was similar to placebo (79.5%).
Adverse events occurred at a similar rate regardless of age, gender, or race.
Patients discontinued treatment due to an adverse event at similar rates in either treatment group (4.4% INSPRA vs.
4.3% placebo), with the most common reasons for discontinuation being hyperkalemia, MI, and abnormal renal function.
Adverse reactions that occurred more frequently in patients treated with INSPRA than placebo were hyperkalemia (3.4% vs.
5 WARNINGS AND PRECAUTIONS • Hyperkalemia: Patients with decreased renal function, diabetes, proteinuria or patients who are taking ACEs and ARBs, NSAIDs or moderate CYP3A inhibitors are at increased risk.
Monitor serum potassium levels and adjust dose as needed.
( 5.1 ) 5.1 Hyperkalemia The risk of hyperkalemia is higher in patients with impaired renal function, proteinuria, diabetes and those concomitantly treated with ACEs, ARBs, NSAIDs and moderate CYP3A inhibitors.
Minimize the risk of hyperkalemia with proper patient selection and monitoring [see Dosage and Administration (2.1) , Contraindications (4) , Adverse Reactions (6.2) , and Drug Interactions (7) ] .
Monitor patients for the development of hyperkalemia until the effect of INSPRA is established.
Like all medications, Inspra 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: