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 are discussed in more detail in other sections of the labeling: Cerebrovascular and Ischemic Cardiovascular Events [see Warnings and Precautions (5.1) ] .
Fractures [see Warnings and Precautions (5.2) ] .
Falls [see Warnings and Precautions (5.3) ] .
Seizure [see Warnings and Precautions (5.4) ] .
Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions (5.5) ] .
Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.6) ] .
The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial 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 the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions (≥ 10%) that occurred more frequently in the ERLEADA-treated patients (≥ 2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.
5 WARNINGS AND PRECAUTIONS Cerebrovascular and ischemic cardiovascular events occurred in patients receiving ERLEADA.
Monitor for signs and symptoms of cerebrovascular disorders and ischemic heart disease.
Optimize management of cardiovascular risk factors.
Fractures occurred in patients receiving ERLEADA.
Evaluate patients for fracture risk and treat patients with bone-targeted agents according to established guidelines.
Like all medications, Erleada 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: