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:
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- 5 mg/kg intravenously every 2 weeks in combination with bolus-IFL.
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- 10 mg/kg intravenously every 2 weeks in combination with FOLFOX4.
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- 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.
Adverse Reaction | Severity | Dosage Modification |
---|---|---|
Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)]. |
| Discontinue ZIRABEV |
Wound Healing Complications [see Warnings and Precautions (5.2)]. |
| Withhold ZIRABEV until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complications has not been established. |
| Discontinue ZIRABEV | |
Hemorrhage [see Warnings and Precautions (5.3)]. |
| Discontinue ZIRABEV |
| Withhold ZIRABEV | |
Thromboembolic Events [see Warnings and Precautions (5.4, 5.5)]. |
| Discontinue ZIRABEV |
| Discontinue ZIRABEV | |
Hypertension [see Warnings and Precautions (5.6)]. |
| Discontinue ZIRABEV |
| Withhold ZIRABEV if not controlled with medical management; resume once controlled | |
Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)]. |
| Discontinue ZIRABEV |
Renal Injury and Proteinuria [see Warnings and Precautions (5.8)]. |
| Discontinue ZIRABEV |
| Withhold ZIRABEV until proteinuria less than 2 grams per 24 hours | |
Infusion-Related Reactions [see Warnings and Precautions (5.9)]. |
| Discontinue ZIRABEV |
| Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve | |
| Decrease infusion rate | |
Congestive Heart Failure [see Warnings and Precautions (5.12)]. |
| Discontinue ZIRABEV |
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