Avastin

(Bevacizumab)
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Dosage & Administration

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

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.

)

Metastatic colorectal cancer (

2.2 Metastatic Colorectal Cancer

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

)


First-line non–squamous non–small cell lung cancer (

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.

)


Recurrent glioblastoma (

2.4 Recurrent Glioblastoma

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

)


Metastatic renal cell carcinoma

(
2.5 Metastatic Renal Cell Carcinoma

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

)


Persistent, recurrent, or metastatic cervical cancer (

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.

)


Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection (

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.

)


Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (

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.

)


Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (

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.

)


Hepatocellular Carcinoma (

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.

)


Administer as an intravenous infusion after dilution. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions (

2.9 Dosage Modifications for Adverse Reactions

Table 1describes dosage modifications for specific adverse reactions

.
No dose reductions for Avastin are recommended.

Table 1: Dosage Modifications for Adverse Reactions
Adverse ReactionSeverityDosage Modification
Gastrointestinal Perforations and Fistulae
[see Warnings and Precautions (5.1)].

Discontinue Avastin
Wound Healing Complications
[see Warnings and Precautions (5.2)].

Withhold AVASTIN until adequate wound healing.The safety of resumption of AVASTIN after resolution of wound healing complications has not been established.

Discontinue Avastin
Hemorrhage
[see Warnings and Precautions (5.3)].

Discontinue Avastin

Withhold Avastin
Thromboembolic Events
[see Warnings and Precautions (5.4, 5.5)].

Discontinue Avastin

Discontinue Avastin
Hypertension
[see Warnings and Precautions (5.6)].

Discontinue Avastin

Withhold Avastin if not controlled with medical management; resume once controlled
Posterior Reversible Encephalopathy Syndrome (PRES)
[see Warnings and Precautions (5.7)].

Discontinue Avastin
Renal Injury and Proteinuria
[see Warnings and Precautions (5.8)].

Discontinue Avastin

Withhold Avastin until proteinuria less than 2 grams per 24 hours
Infusion-Related Reactions
[see Warnings and Precautions (5.9)].

Discontinue Avastin

Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve

Decrease infusion rate
Congestive Heart Failure
[see Warnings and Precautions (5.12)].
AnyDiscontinue Avastin
,
2.10 Preparation and Administration

Preparation


Administration


)

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