NEXAVAR (n=297) | Placebo (n=302) | |||||
---|---|---|---|---|---|---|
AEs | All grades (%) | Grade 3 (%) | Grade 4 (%) | All grades (%) | Grade 3 (%) | Grade 4 (%) |
Any adverse reaction | 98 | 39 | 6 | 96 | 24 | 8 |
Gastrointestinal | ||||||
Diarrhea | 55 | 10 | <1 | 25 | 2 | 0 |
Anorexia | 29 | 3 | 0 | 18 | 3 | <1 |
Nausea | 24 | 1 | 0 | 20 | 3 | 0 |
Vomiting | 15 | 2 | 0 | 11 | 2 | 0 |
Constipation | 14 | 0 | 0 | 10 | 0 | 0 |
Constitutional symptoms | ||||||
Fatigue | 46 | 9 | 1 | 45 | 12 | 2 |
Weight loss | 30 | 2 | 0 | 10 | 1 | 0 |
Pain | ||||||
Pain, abdomen | 31 | 9 | 0 | 26 | 5 | 1 |
Dermatology/skin | ||||||
Hand-foot skin reaction (HFSR) | 21 | 8 | 0 | 3 | <1 | 0 |
Rash/desquamation | 19 | 1 | 0 | 14 | 0 | 0 |
Alopecia | 14 | 0 | 0 | 2 | 0 | 0 |
Pruritus | 14 | <1 | 0 | 11 | <1 | 0 |
Dry skin | 10 | 0 | 0 | 6 | 0 | 0 |
Hepatobiliary/pancreas | ||||||
Liver dysfunction | 11 | 2 | 1 | 8 | 2 | 1 |
NEXAVAR (n=297) | |||
---|---|---|---|
AEs | All grades (%) | Grade 3 (%) | Grade 4 (%) |
Any adverse reaction | 98 | 39 | 6 |
Gastrointestinal | |||
Diarrhea | 55 | 10 | <1 |
Anorexia | 29 | 3 | 0 |
Nausea | 24 | 1 | 0 |
Vomiting | 15 | 2 | 0 |
Constipation | 14 | 0 | 0 |
Constitutional symptoms | |||
Fatigue | 46 | 9 | 1 |
Weight loss | 30 | 2 | 0 |
Pain | |||
Pain, abdomen | 31 | 9 | 0 |
Dermatology/skin | |||
Hand-foot skin reaction (HFSR) | 21 | 8 | 0 |
Rash/ desquamation |
19 | 1 | 0 |
Alopecia | 14 | 0 | 0 |
Pruritus | 14 | <1 | 0 |
Dry skin | 10 | 0 | 0 |
Hepatobiliary/ pancreas |
|||
Liver dysfunction | 11 | 2 | 1 |
Placebo (n=302) | |||
---|---|---|---|
AEs | All grades (%) | Grade 3 (%) | Grade 4 (%) |
Any adverse reaction | 96 | 24 | 8 |
Gastrointestinal | |||
Diarrhea | 25 | 2 | 0 |
Anorexia | 18 | 3 | <1 |
Nausea | 20 | 3 | 0 |
Vomiting | 11 | 2 | 0 |
Constipation | 10 | 0 | 0 |
Constitutional symptoms | |||
Fatigue | 45 | 12 | 2 |
Weight loss | 10 | 1 | 0 |
Pain | |||
Pain, abdomen | 26 | 5 | 1 |
Dermatology/skin | |||
Hand-foot skin reaction (HFSR) | 3 | <1 | 0 |
Rash/ desquamation |
14 | 0 | 0 |
Alopecia | 2 | 0 | 0 |
Pruritus | 11 | <1 | 0 |
Dry skin | 6 | 0 | 0 |
Hepatobiliary/ pancreas |
|||
Liver dysfunction | 8 | 2 | 1 |
*AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0.
*AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0.
Similar discontinuation rates due to AEs in the SHARP trial: 32% with NEXAVAR vs 35% with placebo
Most AEs were Grade 1 or 2 with NEXAVAR
Grade 3 AEs were experienced in 39% of patients treated with NEXAVAR vs 24% of patients treated with placebo
Grade 4 AEs were experienced in 6% of patients treated with NEXAVAR vs 8% of patients treated with placebo
The most common AEs reported for NEXAVAR-treated patients vs placebo in unresectable HCC, respectively, were diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and HFSR (21% vs 3%)
Monitor patients early and often: NEXAVAR oral systemic therapy dosing and administration guidelines1
The recommended dosage of NEXAVAR is 400 mg orally taken twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs
Impaired wound healing can occur in patients who receive drugs that inhibit the VEGF signaling pathway. Therefore, NEXAVAR has the potential to adversely affect wound healing. Withhold NEXAVAR for at least 10 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of NEXAVAR after resolution of wound healing complications has not been established
Temporary interruption or permanent discontinuation of NEXAVAR may be required for the following: cardiac ischemia or infarction, congestive heart failure, hemorrhage requiring medical intervention, severe or persistent hypertension, gastrointestinal perforation, QTc prolongation, drug-induced liver injury, or nonhematological toxicity
When dose reduction is necessary for HCC, the NEXAVAR dosage may be reduced to 400 mg once daily. If additional dose reduction is required, NEXAVAR may be reduced to a single 400-mg dose every other day
No starting dose adjustment is necessary for mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment