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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

Do not administer ZIRABEV until at least 28 days following surgery and the wound is fully healed.

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 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)].
  • Wound healing complications requiring medical intervention
  • 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

2.8 Preparation and Administration

Preparation

  • Use appropriate aseptic technique.
  • Visually inspect vial for particulate matter and discoloration prior to preparation and 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.
  • Store diluted ZIRABEV solution at 2°C to 8°C (36°F to 46°F) for up to 8 hours.
  • 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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