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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011
WARNINGS AND PRECAUTIONS
Increased Mortality Observed with Nexavar Administered in Combination with Carboplatin/Paclitaxel and Gemcitabine/Cisplatin in Squamous Cell Lung Cancer
- In a subset analysis of two randomized controlled trials in chemo-naive patients with Stage IIIB-IV non-small cell lung cancer...
Risk of QT Interval Prolongation
- Nexavar can prolong the QT/QTc interval and increase the risk
Additional Data from Multiple Clinical Trials
The following additional drug-related adverse reactions and laboratory abnormalities were reported from clinical trials of Nexavar (very common 10% or greater, common 1 to less than 10%, uncommon 0.1% to less than 1%):
- Cardiovascular: Common: congestive heart failure*, myocardial ischemia and/or infarction Uncommon: hypertensive crisis* Rare: QT prolongation*
- Dermatologic: Stevens-Johnson syndrome and toxic epidermal necrolysis(TEN)
- Effect of Cytochrome P450 on Sorafenib : Rifampicin, a strong CYP3A4 inducer, administered......
- Neomycin administered at a dose of 1g three times daily for 5 days decreased.....
USE IN SPECIAL POPULATIONS
Patients With Hepatic Impairment
- In a trial of HCC patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, the systemic exposure (AUC) of sorafenib was .....
Patients With Renal Impairment
- No correlation between sorafenib exposure and renal function was observed following administration of a single 400 mg dose.....
PATIENT COUNSELING INFORMATION
QT Interval Prolongation
- Inform patients with a history of prolonged QT interval that Nexavar can worsen the condition [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].