)]: hypertension, arterial thromboembolic events, venous thromboembolic events, hemorrhage, gastrointestinal perforation and fistula formation, thyroid dysfunction, wound healing complications, RPLS, proteinuria, elevation of liver enzymes, and fetal development.
Clinical Trials Experience
The median duration of treatment was 6.4 months (range 0.03 to 22.0) for patients who received Inlyta 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 reaction occurred in 199/359 patients (55%) receiving Inlyta and 220/355 patients (62%) receiving sorafenib. Permanent discontinuation due to an adverse reaction occurred in 34/359 patients (9%) receiving Inlyta and 46/355 patients (13%) receiving sorafenib.
The most common (≥20%) adverse reactions observed following treatment with Inlyta were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. Table 1 presents adverse reactions reported in ≥10% patients who received Inlyta or sorafenib.
Table 1. Adverse Reactions Occurring in ≥10% of Patients Who Received Inlyta or Sorafenib
|
Inlyta |
Sorafenib |
|
(N=359) |
(N=355) |
|
All Grades† |
Grade 3/4 |
All Grades† |
Grade 3/4 |
|
% |
% |
% |
% |
|
|
|
Diarrhea |
55 |
11 |
53 |
7 |
|
Hypertension |
40 |
16 |
29 |
11 |
|
Fatigue |
39 |
11 |
32 |
5 |
|
Decreased appetite |
34 |
5 |
29 |
4 |
|
Nausea |
32 |
3 |
22 |
1 |
|
Dysphonia |
31 |
0 |
14 |
0 |
|
Palmar-plantar erythrodysesthesia syndrome |
27 |
5 |
51 |
16 |
|
Weight decreased |
25 |
2 |
21 |
1 |
|
Vomiting |
24 |
3 |
17 |
1 |
|
Asthenia |
21 |
5 |
14 |
3 |
|
Constipation |
20 |
1 |
20 |
1 |
|
Hypothyroidism |
19 |
<1 |
8 |
0 |
|
Cough |
15 |
1 |
17 |
1 |
|
Mucosal inflammation |
15 |
1 |
12 |
1 |
|
Arthralgia |
15 |
2 |
11 |
1 |
|
Stomatitis |
15 |
1 |
12 |
<1 |
|
Dyspnea |
15 |
3 |
12 |
3 |
|
Abdominal pain |
|
|
