Therapy Management Strategies

Therapy Management Strategies
Warnings & precautions: Guidance to help manage INLYTA® (axitinib) therapy
NOTE: For suspected immune-mediated ARs, refer to the full Prescribing Information for pembrolizumab
  • Hypertension, including hypertensive crisis, has been observed with INLYTA
  • In a clinical trial of INLYTA alone, the median onset time for hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) was within the first month of the start of INLYTA treatment, and blood pressure increases have been observed as early as 4 days after starting INLYTA
  • Blood pressure should be well controlled prior to initiating INLYTA
  • In clinical trials, venous thromboembolic events (including Grade 3/4 pulmonary embolism, deep vein thrombosis, retinal vein occlusion, and retinal vein thrombosis) and arterial thromboembolic events (including transient ischemic attack, cerebrovascular accident, myocardial infarction, and retinal artery occlusion) have been reported and can be fatal
  • Hemorrhagic events (including fatal events) have been reported with INLYTA
  • Cardiac failure has been observed and can be fatal
  • Gastrointestinal perforation and fistula, including death, have occurred
  • Hypothyroidism requiring thyroid hormone replacement has been reported
  • Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway
  • INLYTA has the potential to adversely affect wound healing
  • RPLS has been observed
  • RPLS is a neurological disorder that can present with headache, seizure, lethargy, confusion, blindness, and other visual and neurological disturbances
  • Mild to severe hypertension may be present
  • Proteinuria has been reported in patients treated with INLYTA (including Grade 3 proteinuria)
  • INLYTA in combination with pembrolizumab can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 ALT and AST elevation
  • Systemic exposure to INLYTA was higher in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal hepatic function
  • Based on its mechanism of action and findings from animal studies, INLYTA can cause fetal harm when administered to pregnant women
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