EFFICACY MEASURES
PRIMARY ENDPOINT
6.7 months median PFS
P
SECONDARY ENDPOINT
19.4% ORR
The P
SECONDARY ENDPOINT
20.1 months median OS
INLYTA® (axitinib) is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
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.
PP-INL-USA-0460-03 © 2018 Pfi zer Inc.