Zirabev

ZIRABEV- bevacizumab injection, solution
Pfizer Laboratories Div Pfizer Inc

1 INDICATIONS AND USAGE

1.1 Metastatic Colorectal Cancer

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

ZIRABEV, 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 bevacizumab product-containing regimen.

Limitations of Use: ZIRABEV 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

ZIRABEV, 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

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

1.4 Metastatic Renal Cell Carcinoma

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

1.5 Persistent, Recurrent, or Metastatic Cervical Cancer

ZIRABEV, 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

ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV 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.

ZIRABEV, 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.

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

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 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 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

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