Clinically Significant Adverse Reactions: Hepatic Impairment: If the signs or symptoms of hepatic impairment or laboratory abnormalities (abnormality of conjugated bilirubin, ALP or INR) are observed in addition to ALT elevations, treatment should be discontinued. [See Important Precautions and Patients with Hepatic Impairment under Precautions.]
Hypersensitivity (Including infusion reactions and anaphylactic reactions): Hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering, etc. may occur. [See Important Precautions under Precautions.]
Other adverse reactions: See Table 11.

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