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 discussed in greater detail in other sections of the labeling: Gastrointestinal toxicity [see Warnings and Precautions (5.1)] .
Myelosuppression [see Warnings and Precautions (5.2)] .
Hepatic toxicity [see Warnings and Precautions (5.3)] .
Cardiovascular toxicity [see Warnings and Precautions (5.4)].
Fluid retention [see Warnings and Precautions (5.5)] .
Renal toxicity [see Warnings and Precautions ( 5.6)] .
• Most common adverse reactions (≥20%), in adult patients with CML are diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, and respiratory tract infection.
The most common laboratory abnormalities (≥20%) in adult patients are creatinine increased, hemoglobin decreased, lymphocyte count decreased, platelets decreased, ALT increased, calcium decreased, white blood cell count decreased, AST increased, absolute neutrophil count decreased, glucose increased, phosphorus decreased, urate increased, alkaline phosphatase increased, lipase increased, creatine kinase increased, and amylase increased.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 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.
5 WARNINGS AND PRECAUTIONS • Gastrointestinal Toxicity: Monitor and manage as necessary.
Withhold, dose reduce, or discontinue bosutinib tablets.
( 2.3 , 5.1 ) • Myelosuppression: Monitor blood counts and manage as necessary.
Withhold, dose reduce or discontinue bosutinib tablets ( 2.4 , 5.2 ) • Hepatic Toxicity: Monitor liver enzymes at least monthly for the first 3 months and as needed.
Withhold, dose reduce, or discontinue bosutinib tablets.
Like all medications, Bosutinib 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: