Avastin

AVASTIN- bevacizumab injection, solution
Genentech, Inc.

1 INDICATIONS AND USAGE

1.1 Metastatic Colorectal Cancer

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

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

Limitations of Use: Avastin is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2)].

1.2 First-Line Non-Squamous Non–Small Cell Lung Cancer

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 (NSCLC).

1.3 Recurrent Glioblastoma

Avastin is indicated for the treatment of recurrent glioblastoma (GBM) in adults.

1.4 Metastatic Renal Cell Carcinoma

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

1.5 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.

1.6 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.

1.7 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

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.

2.2 Metastatic Colorectal Cancer

The recommended dosage when Avastin is administered in combination with intravenous fluorouracil-based chemotherapy is:

  • 5 mg/kg intravenously every 2 weeks in combination with bolus-IFL.
  • 10 mg/kg intravenously every 2 weeks in combination with FOLFOX4.
  • 5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy in patients who have progressed on a first-line Avastin-containing regimen.

2.3 First-Line Non-Squamous Non-Small Cell Lung Cancer

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel.

2.4 Recurrent Glioblastoma

The recommended dosage is 10 mg/kg intravenously every 2 weeks.

2.5 Metastatic Renal Cell Carcinoma

The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with interferon alfa.

2.6 Persistent, Recurrent, or Metastatic Cervical Cancer

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

2.7 Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Stage III or IV Disease Following Initial Surgical Resection

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by Avastin 15 mg/kg every 3 weeks as a single agent for a total of up to 22 cycles or until disease progression, whichever occurs earlier.

Recurrent Disease

Platinum Resistant

The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week).

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with topotecan (every 3 weeks).

Platinum Sensitive

The recommended dosage is 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and paclitaxel for 6 to 8 cycles, followed by Avastin 15 mg/kg every 3 weeks as a single agent until disease progression.

The recommended dosage is 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and gemcitabine for 6 to 10 cycles, followed by Avastin 15 mg/kg every 3 weeks as a single agent until disease progression.

2.8 Hepatocellular Carcinoma

The recommended dosage is 15 mg/kg intravenously after administration of 1,200 mg of atezolizumab intravenously on the same day, every 3 weeks until disease progression or unacceptable toxicity.

Refer to the Prescribing Information for atezolizumab prior to initiation for recommended dosage information.

2.9 Dosage Modifications for Adverse Reactions

Table 1 describes dosage modifications for specific adverse reactions. No dose reductions for Avastin are recommended.

Table 1: Dosage Modifications for Adverse Reactions
Adverse Reaction Severity Dosage Modification
Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)].
  • Gastrointestinal perforation, any grade
  • Tracheoesophageal fistula, any grade
  • Fistula, Grade 4
  • Fistula formation involving any internal organ
Discontinue Avastin
Wound Healing Complications [see Warnings and Precautions (5.2)].
  • Any
Withhold AVASTIN until adequate wound healing.The safety of resumption of AVASTIN after resolution of wound healing complications has not been established.
  • Necrotizing fasciitis
Discontinue Avastin
Hemorrhage [see Warnings and Precautions (5.3)].
  • Grade 3 or 4
Discontinue Avastin
  • Recent history of hemoptysis of 1/2 teaspoon (2.5 mL) or more
Withhold Avastin
Thromboembolic Events [see Warnings and Precautions (5.4, 5.5)].
  • Arterial thromboembolism, severe
Discontinue Avastin
  • Venous thromboembolism, Grade 4
Discontinue Avastin
Hypertension [see Warnings and Precautions (5.6)].
  • Hypertensive crisis
  • Hypertensive encephalopathy
Discontinue Avastin
  • Hypertension, severe
Withhold Avastin if not controlled with medical management; resume once controlled
Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)].
  • Any
Discontinue Avastin
Renal Injury and Proteinuria [see Warnings and Precautions (5.8)].
  • Nephrotic syndrome
Discontinue Avastin
  • Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome
Withhold Avastin until proteinuria less than 2 grams per 24 hours
Infusion-Related Reactions [see Warnings and Precautions (5.9)].
  • Severe
Discontinue Avastin
  • Clinically significant
Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve
  • Mild, clinically insignificant
Decrease infusion rate
Congestive Heart Failure [see Warnings and Precautions (5.12)]. Any Discontinue Avastin

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