Lung Cancer: Avastin Safety Profile

First-line non-squamous non-small cell lung cancer (NSCLC)
Avastin, in combination with carboplatin and paclitaxel, is indicated for the first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer.

Boxed WARNINGS

  • Gastrointestinal (GI) perforation
    • Discontinue for gastrointestinal perforation
  • Surgery and wound healing complications
    • Withhold Avastin for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed
    • Discontinue in patients with wound healing complications requiring medical intervention
  • Hemorrhage
    • Severe or fatal hemorrhage have occurred
    • Do not administer Avastin to patients with serious hemorrhage or recent history of hemoptysis
    • Discontinue for Grade 3-4 hemorrhage

As shown in Study E4599, Avastin plus PC has a well-documented safety profile[1]

Study E4599: Avastin plus paclitaxel/carboplatin (PC)[1]

Grade 3–5 non-hematologic and grade 4–5 hematologic adverse reactions occurring at a higher incidence (≥2%) in patients receiving Avastin plus PC compared with patients receiving chemotherapy alone

Adverse reactions Patients (%)
Avastin + PC
(n=427)*
PC alone
(n=441)*
Neutropenia 27 17
Fatigue 16 13
Hypertension 8 0.7
Infection without neutropenia 7 3
Venous thromboembolism 5 3
Febrile neutropenia 5 2
Pneumonitis/pulmonary infiltrates 5 3
Infection with grade 3 or 4 neutropenia 4 2
Hyponatremia 4 1
Headache 3 1
Proteinuria 3 0

PC=paclitaxel + carboplatin.
*The safety analysis includes all patients known to have received study treatment.[8]