Inlyta Adverse Reactions

The safety of axitinib has been evaluated in 672 patients with advanced RCC who participated in the pivotal randomized clinical study or 4 additional monotherapy studies with axitinib. The data described as follows reflect exposure to axitinib in 359 patients with advanced RCC who participated in a randomized clinical study versus sorafenib.
The median duration of treatment was 6.4 months (range 0.03 to 22.0) for patients who received axitinib and 5.0 months (range 0.03 to 20.1) for patients who received sorafenib. Dose modifications or temporary delay of treatment due to an adverse event occurred in 199/359 patients (55%) receiving axitinib and 220/355 patients (62%) receiving sorafenib. Permanent discontinuation due to an adverse event occurred in 33/359 patients (9%) receiving axitinib and 46/355 patients (13%) receiving sorafenib.
The most common (≥20%) adverse reactions observed following treatment with axitinib were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthsia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation.
The following risks, including appropriate action to be taken, are discussed in greater detail in Precautions: cardiac failure events, hypertension, thyroid dysfunction, arterial thromboembolic events, venous thromboembolic events, elevation of hemoglobin or hematocrit, haemorrhage, gastrointestinal perforation and fistula formation, wound healing complications, RPLS, proteinuria, and elevation of liver enzymes.
Table 2 presents adverse reactions reported in patients who received axitinib or sorafenib.
The adverse reactions are listed by system organ class, frequency category and grade of severity. Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 2.)

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