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 in detail in other sections of the label: • Infusion reaction [see Warnings and Precautions (5.1) ] .
• Infections [see Warnings and Precautions (5.2) ] .
• Second Primary Malignancies [ see Warnings and Precautions (5.3) ] .
• Hepatotoxicity [see Warnings and Precautions (5.4) ] .
• Interference with determination of complete response [see Warnings and Precautions (5.5) ] .
Most common adverse reactions (20% or higher) • with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia.
(6.1) • with pomalidomide and dexamethasone are constipation and hyperglycemia.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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 the clinical trials of another drug and may not reflect the rates observed in practice.
EMPLICITI in Combination with Lenalidomide and Dexamethasone [ELOQUENT-2] The safety data described in this section are based on the ELOQUENT-2 study, a randomized, open-label clinical trial in patients with previously treated multiple myeloma.
5 WARNINGS AND PRECAUTIONS • Infusion reactions: Premedication is required.
Interrupt EMPLICITI for Grade 2 or higher and permanently discontinue for severe infusion reaction.
( 2.3 , 2.4 , 5.1) • Infections: Monitor for fever and other signs of infection and treat promptly.
(5.2) • Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI.
(5.3) • Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is suspected.
Like all medications, Empliciti 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: