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 most common adverse reactions (≥25%) in metastatic breast cancer were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.
( 6.1 ) The most common adverse reactions (≥25%) in liposarcoma and leiomyosarcoma were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia.
The most common (≥5%) Grade 3 to 4 laboratory abnormalities in liposarcoma and leiomyosarcoma were neutropenia, hypokalemia, and hypocalcemia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy’s Laboratories, Inc., at 1-888-375-3784 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 a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
The following adverse reactions are discussed in detail in other sections of the labeling: Neutropenia [see Warnings and Precautions ( 5.1) ] Peripheral neuropathy [see Warnings and Precautions (5.2) ] QT prolongation [see Warnings and Precautions (5.4) ] In clinical trials, eribulin mesylate has been administered to 1,963 patients including 467 patients exposed to eribulin mesylate for 6 months or longer.
The majority of the 1,963 patients were women (92%) with a median age of 55 years (range: 17 to 85 years).
The racial and ethnic distribution was White (72%), Black (4%), Asian (9%), and other (3%).
Metastatic Breast Cancer The most common adverse reactions (≥25%) reported in patients receiving eribulin mesylate were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.
5 WARNINGS AND PRECAUTIONS Neutropenia : Monitor peripheral blood cell counts and adjust dose as appropriate.
( 5.1 ) Peripheral Neuropathy : Monitor for signs of neuropathy.
Manage with dose delay and adjustment.
( 5.2 ) Embryo-Fetal Toxicity : Can cause fetal harm.
Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Like all medications, Eribulin Mesylate 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: