ZIRABEV Dosage and Administration

(bevacizumab-bvzr)

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

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

2.2 Metastatic Colorectal Cancer

The recommended dosage when ZIRABEV 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 bevacizumab product-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 ZIRABEV 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 ZIRABEV 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 ZIRABEV 15 mg/kg every 3 weeks as a single agent until disease progression.

2.8 Dosage Modifications for Adverse Reactions

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

Table 1: Dosage Modifications for Adverse Reactions
Adverse ReactionSeverityDosage 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 ZIRABEV

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

•
Any

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

•
Necrotizing fasciitis

Discontinue ZIRABEV

Hemorrhage [see Warnings and Precautions (5.3)].

•
Grade 3 or 4

Discontinue ZIRABEV

•
Recent history of hemoptysis of 1/2 teaspoon (2.5 mL) or more

Withhold ZIRABEV

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

•
Arterial thromboembolism, severe

Discontinue ZIRABEV

•
Venous thromboembolism, Grade 4

Discontinue ZIRABEV

Hypertension [see Warnings and Precautions (5.6)].

•
Hypertensive crisis
•
Hypertensive encephalopathy

Discontinue ZIRABEV

•
Hypertension, severe

Withhold ZIRABEV if not controlled with medical management; resume once controlled

Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)].

•
Any

Discontinue ZIRABEV

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

•
Nephrotic syndrome

Discontinue ZIRABEV

•
Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome

Withhold ZIRABEV until proteinuria less than 2 grams per 24 hours

Infusion-Related Reactions [see Warnings and Precautions (5.9)].

•
Severe

Discontinue ZIRABEV

•
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 ZIRABEV

2.9 Preparation and Administration

Preparation

•
Use appropriate aseptic technique.
•
Use sterile needle and syringe to prepare ZIRABEV.
•
Visually inspect vial for particulate matter and discoloration prior to preparation for administration. Discard vial if solution is cloudy, discolored, or contains particulate matter.
•
Withdraw necessary amount of ZIRABEV and dilute in a total volume of 100 mL of 0.9% Sodium Chloride Injection, USP. DO NOT ADMINISTER OR MIX WITH DEXTROSE SOLUTION.
•
Discard any unused portion left in a vial, as the product contains no preservatives.
•
Diluted ZIRABEV solution may be stored at 2°C to 8°C (36°F to 46°F) for up to 16 days, if not used immediately.
•
No incompatibilities between ZIRABEV and polyvinylchloride or polyolefin bags have been observed.

Administration

•
Administer as an intravenous infusion.
•
First infusion: Administer infusion over 90 minutes.
•
Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated. Administer all subsequent infusions over 30 minutes if second infusion over 60 minutes is tolerated.

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Prescribing Information
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Health Professional Information

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

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

2.2 Metastatic Colorectal Cancer

The recommended dosage when ZIRABEV 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 bevacizumab product-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 ZIRABEV 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 ZIRABEV 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 ZIRABEV 15 mg/kg every 3 weeks as a single agent until disease progression.

2.8 Dosage Modifications for Adverse Reactions

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

Table 1: Dosage Modifications for Adverse Reactions
Adverse ReactionSeverityDosage 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 ZIRABEV

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

•
Any

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

•
Necrotizing fasciitis

Discontinue ZIRABEV

Hemorrhage [see Warnings and Precautions (5.3)].

•
Grade 3 or 4

Discontinue ZIRABEV

•
Recent history of hemoptysis of 1/2 teaspoon (2.5 mL) or more

Withhold ZIRABEV

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

•
Arterial thromboembolism, severe

Discontinue ZIRABEV

•
Venous thromboembolism, Grade 4

Discontinue ZIRABEV

Hypertension [see Warnings and Precautions (5.6)].

•
Hypertensive crisis
•
Hypertensive encephalopathy

Discontinue ZIRABEV

•
Hypertension, severe

Withhold ZIRABEV if not controlled with medical management; resume once controlled

Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)].

•
Any

Discontinue ZIRABEV

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

•
Nephrotic syndrome

Discontinue ZIRABEV

•
Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome

Withhold ZIRABEV until proteinuria less than 2 grams per 24 hours

Infusion-Related Reactions [see Warnings and Precautions (5.9)].

•
Severe

Discontinue ZIRABEV

•
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 ZIRABEV

2.9 Preparation and Administration

Preparation

•
Use appropriate aseptic technique.
•
Use sterile needle and syringe to prepare ZIRABEV.
•
Visually inspect vial for particulate matter and discoloration prior to preparation for administration. Discard vial if solution is cloudy, discolored, or contains particulate matter.
•
Withdraw necessary amount of ZIRABEV and dilute in a total volume of 100 mL of 0.9% Sodium Chloride Injection, USP. DO NOT ADMINISTER OR MIX WITH DEXTROSE SOLUTION.
•
Discard any unused portion left in a vial, as the product contains no preservatives.
•
Diluted ZIRABEV solution may be stored at 2°C to 8°C (36°F to 46°F) for up to 16 days, if not used immediately.
•
No incompatibilities between ZIRABEV and polyvinylchloride or polyolefin bags have been observed.

Administration

•
Administer as an intravenous infusion.
•
First infusion: Administer infusion over 90 minutes.
•
Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated. Administer all subsequent infusions over 30 minutes if second infusion over 60 minutes is tolerated.
Medication Guide

Health Professional Information

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