Indicated for the treatment of:

Metastatic Colorectal Cancer (mCRC):

• Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer.

• Avastin, in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.

Avastin is not indicated for adjuvant treatment of colon cancer.

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.

Recurrent Glioblastoma (GBM):

• The treatment of recurrent glioblastoma in adults.

Metastatic Renal Cell Carcinoma (mRCC):

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

Persistent, Recurrent, or Metastatic Cervical Cancer:

• Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer:

• Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

• Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

• Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Hepatocellular Carcinoma:

• Avastin, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

There are no recommended dose reductions.

Withhold for at least 28 days prior to elective surgery. Do not administer Avastin until at least 28 days following major surgery and until adequate wound healing.

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.

The incidence of ovarian failure was 34% vs. 2% in premenopausal women receiving Avastin with chemotherapy as compared to those receiving chemotherapy alone for adjuvant treatment of a solid tumor.

Avastin is not indicated for use with anthracycline-based chemotherapy. In previously untreated patients with a hematological malignancy, the incidence of CHF and decline in left ventricular ejection fraction (LVEF) were increased in patients receiving Avastin with anthracycline-based chemotherapy compared to patients receiving placebo with the same chemotherapy regimen.

Discontinue Avastin for:

• Any grade gastrointestinal perforation, any grade tracheoesophageal fistula, fistula, Grade 4, or fistula formation involving any internal organ
• Wound healing complications requiring medical intervention and necrotizing fasciitis
• Hemorrhage Grade 3 or 4
• Severe arterial thromboembolism or Grade 4 venous thromboembolism
• Grade 4 Hypertensive crisis or hypertensive encephalopathy
• Posterior Reversible Encephalopathy Syndrome (PRES)
• Nephrotic syndrome
• Severe infusion reaction
• Congestive Heart Failure

Withhold Avastin for:

• At least 28 days prior to elective surgery. Do not administer for at least 28 days following surgery and until the wound is fully healed
• Recent history of hemoptysis 1/2 teaspoon (2.5 mL) or more
• Severe hypertension not controlled with medical management
• Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome

The incidence of gastrointestinal perforation, some fatal, in patients receiving Avastin ranges from 0.3% to 3%. Discontinue Avastin in patients who develop gastrointestinal perforation. Perforation can be complicated by intra-abdominal abscess, fistula formation, and the need for diverting ostomies. The majority of perforations occurred within 50 days of the first dose.

Serious fistulae (including, tracheoesophageal, bronchopleural, biliary, vaginal, renal and bladder sites) occur at a higher incidence in patients receiving Avastin compared to patients receiving chemotherapy. The majority of fistulas occurred within 6 months of the first dose. Patients who develop a gastrointestinal vaginal fistula may also have a bowel obstruction and require surgical intervention, as well as a diverting ostomy.

Avoid Avastin in patients with ovarian cancer who have evidence of rectosigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction. 

Avastin can result in two distinct patterns of bleeding: minor hemorrhage, most commonly Grade 1 epistaxis; and serious, and in some cases fatal, hemorrhagic events. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently in patients receiving Avastin compared to patients receiving only chemotherapy.

Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and a variety of other ATE occurred at a higher incidence in patients receiving Avastin compared to those in the control arm. Among patients receiving Avastin in combination with chemotherapy, the risk of developing ATE during therapy was increased in patients with a history of arterial thromboembolism, diabetes, or age greater than 65 years.

An increased risk of venous thromboembolic events (VTE) was observed across clinical studies.

Patients treated for persistent, recurrent, or metastatic cervical cancer with Avastin may be at increased risk of venous thromboembolic events (VTE).

The incidence of severe hypertension is increased in patients receiving Avastin as compared to patients receiving chemotherapy alone.

Posterior Reversible Encephalopathy Syndrome has been reported and the onset of symptoms occurred from 16 hours to 1 year after initiation of Avastin.

The incidence and severity of proteinuria is higher in patients receiving Avastin as compared to patients receiving chemotherapy.

Infusion reactions reported across clinical studies and post-marketing experience include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, chest pain, headaches, rigors, and diaphoresis.

Avastin increases the risk of ovarian failure and may impair fertility. Inform females of reproductive potential of the risk of ovarian failure prior to the first-dose of Avastin. Long-term effects of Avastin on fertility are not known.

Avastin may cause fetal harm when administered to a pregnant woman. Advise female of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose of Avastin.

Because of the potential for serious adverse reactions in breastfed infants from bevacizumab, advise women to not breastfeed during treatment with Avastin and for 6 months following the final dose.

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• Use in patients under the age of 18. GoToSource

• Age-related macular degeneration. GoToSource

• First-line treatment of metastatic breast cancer. GoToSource

• Acoustic neuroma, adrenocortical carcinoma, angle neovascularization in diabetes, bladder cancer, carcinoid tumors, cholangiocarcinoma, coat’s disease, desmoid tumor, esophageal cancer, exudative retinopathy, gallbladder cancer, gastric cancer, hereditary hemorrhagic telangiectasia, islet cell cancer, laryngeal papillomatosis, melanoma (including choroidal melanoma), meningioma, mesothelioma, mucoepidermoid carcinoma of the salivary gland, multiple myeloma, neuroendocrine tumors, neurofibromatosis, pancreatic cancer, pelvic bone cancer, primary pterygium, prostate cancer, radiation necrosis/radiation-induced brain edema, radiation retinopathy, retinal arterial occlusion, sarcomas, squamous cell carcinoma of the head and neck, uterine cancer, vitreous hemorrhage, vogt-koyanagi-harada syndrome and von hippel lindau disease. GoToSource 

Vision loss. GoToSource

Severe acne. GoToSource

Arterial hypertension, arterial and venous thrombosis, cardiovascular events, febrile neutropenia, heart failure, gastrointestinal tract perforation and hemorrhage. GoToSource

Periaortitis (inflammation of adventitia and tissues around the aorta). GoToSource

Non-gastrointestinal fistulas. GoToSource

Reversible posterior leukoencephalopathy syndrome (syndrome characterized by headache, confusion, seizures and visual loss). GoToSource

Wound healing and surgical complications, including fatal complications. GoToSource

Osteonecrosis of the jaw. GoToSource

Kidney failure. GoToSource 

Proteinuria (large amounts of protein in urine), including nephrotic syndrome. GoToSource

Necrotizing fasciitis (bacterial infection that destroys tissue under the skin) and hypersensitivity reactions. GoToSource  

Ovarian failure. GoToSource

Lawsuits filed for hemorrhage, worsening of coronary artery disease, worsening of peripheral artery disease, gastrointestinal tract perforation heart attacks, strokes and reversible posterior leukoencephalopathy syndrome.