INLYTA® (axitinib) is indicated for the treatment of advanced renal cell
carcinoma (RCC) after failure of one prior systemic therapy.
Important Safety Information
Hypertension including hypertensive crisis has been observed. Blood
pressure should be well controlled prior to initiating INLYTA. Monitor for
hypertension and treat as needed. For persistent hypertension, despite
use of antihypertensive medications, reduce the dose. Discontinue INLYTA
if hypertension is severe and persistent despite use of antihypertensive
therapy and dose reduction of INLYTA, and discontinuation should be
considered if there is evidence of hypertensive crisis.
Arterial and venous thrombotic events have been observed and can be
fatal. Use with caution in patients who are at increased risk or who have a
history of these events.
Hemorrhagic events, including fatal events, have been reported. INLYTA
has not been studied in patients with evidence of untreated brain
metastasis or recent active gastrointestinal bleeding and should not be
used in those patients. If any bleeding requires medical intervention,
temporarily interrupt the INLYTA dose.
Cardiac failure has been observed and can be fatal. Monitor for signs or
symptoms of cardiac failure throughout treatment with INLYTA.
Management of cardiac failure may require permanent discontinuation
of INLYTA.
Gastrointestinal perforation and fi stula, including death, have
occurred. Use with caution in patients at risk for gastrointestinal
perforation or fi stula. Monitor for symptoms of gastrointestinal
perforation or fi stula periodically throughout treatment.
Hypothyroidism requiring thyroid hormone replacement has been
reported. Monitor thyroid function before initiation of, and periodically
throughout, treatment.
No formal studies of the effect of INLYTA on wound healing have been
conducted. Stop INLYTA at least 24 hours prior to scheduled surgery.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
has been observed. If signs or symptoms occur, permanently
discontinue treatment.
PP-INL-USA-0390 © 2016 Pfi zer Inc.