These highlights do not include all the information needed to use AVASTIN safely and effectively. See full prescribing information for AVASTIN. AVASTIN (bevacizumab) Solution for intravenous infusion Initial U.S. Approval: 2004
Gastrointestinal Perforations

The incidence of gastrointestinal perforation, some fatal, in Avastin‑treated patients ranges from 0.3 to 2.4%. Discontinue Avastin in patients with gastrointestinal perforation. [ See Dosage and Administration (2.4), Warnings and Precautions (5.1). ]

Surgery and Wound Healing Complications

The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin‑treated patients. Discontinue Avastin in patients with wound dehiscence. The appropriate interval between termination of Avastin and subsequent elective surgery required to reduce the risks of impaired wound healing/wound dehiscence has not been determined. Discontinue at least 28 days prior to elective surgery. Do not initiate Avastin for at least 28 days after surgery and until the surgical wound is fully healed. [ See Dosage and Administration (2.4), Warnings and Precautions (5.2), and Adverse Reactions (6.1). ]

Hemorrhage

Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous systems (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five‑fold more frequently in patients receiving Avastin. Do not administer Avastin to patients with serious hemorrhage or recent hemoptysis. [ See Dosage and Administration (2.4), Warnings and Precautions (5.3), and Adverse Reactions (6.1). ]

Avastin is indicated for the first‑ or second‑line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5‑fluorouracil‑based chemotherapy.

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

Avastin is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2‑negative breast cancer in combination with paclitaxel.

The effectiveness of Avastin in MBC is based on an improvement in progression free survival. There are no data demonstrating an improvement in disease‑related symptoms or increased survival with Avastin. [ See Clinical Studies (14.3). ]

Avastin is not indicated for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.

Avastin is indicated for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent.

The effectiveness of Avastin in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease‑related symptoms or increased survival with Avastin. [ See Clinical Studies (14.4). ]

Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.

Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion.

Patients should continue treatment until disease progression or unacceptable toxicity.

Metastatic Colorectal Cancer (mCRC)