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 (greater than 20%) adverse reactions during treatment with lapatinib plus capecitabine were diarrhea, palmar-plantar erythrodysesthesia, nausea, rash, vomiting, and fatigue.
The most common (greater than or equal to 20%) adverse reactions during treatment with lapatinib plus letrozole were diarrhea, rash, nausea, and fatigue.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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.
HER2-Positive Metastatic Breast Cancer : The safety of lapatinib has been evaluated in more than 12,000 patients in clinical trials.
The efficacy and safety of lapatinib in combination with capecitabine in breast cancer was evaluated in 198 patients in a randomized, Phase 3 trial [see Clinical Studies ( 14.1 )] .
Adverse reactions, which occurred in at least 10% of patients in either treatment arm and were higher in the combination arm, are shown in Table
The most common adverse reactions (greater than 20%) during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhea, nausea, and vomiting), dermatologic (palmar-plantar erythrodysesthesia and rash), and fatigue.
Diarrhea was the most common adverse reaction resulting in discontinuation of study medication.
The most common Grades 3 and 4 adverse reactions (NCI CTCAE v3.0) were diarrhea and palmar-plantar erythrodysesthesia.
5 WARNINGS AND PRECAUTIONS Decreases in left ventricular ejection fraction (LVEF) have been reported.
Confirm normal LVEF before starting lapatinib and continue evaluations during treatment.
( 5.1 ) Lapatinib has been associated with hepatotoxicity.
Monitor liver function tests before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated.
Discontinue and do not restart lapatinib if patients experience severe changes in liver function tests.
Like all medications, Lapatinib 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: