Zirabev
(Bevacizumab-Bvzr)Dosage & Administration
Withhold for at least 28 days prior to elective surgery. Do not administer ZIRABEV for 28 days following major surgery and until adequate wound healing. (
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.
Metastatic colorectal cancer. (
The recommended dosage when ZIRABEV is administered in combination with intravenous fluorouracil-based chemotherapy is:
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. (
The recommended dosage is 10 mg/kg intravenously every 2 weeks.
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. (
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. (
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.
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).
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.
Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. (
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.
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).
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.
Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (
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.
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).
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.
Administer as an intravenous infusion after dilution. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. (
Table 1 describes dosage modifications for specific adverse reactions
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 |
Zirabev Prescribing Information
Dosage and Administration, Preparation and Administration ( Preparation
Administration
| 8/2024 |
ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of:
• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ()1.1 Metastatic Colorectal CancerZIRABEV, 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)].• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ()1.1 Metastatic Colorectal CancerZIRABEV, 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)].
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.
• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ()1.2 First-Line Non-Squamous Non-Small Cell Lung CancerZIRABEV, 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).
• Recurrent glioblastoma in adults. ()1.3 Recurrent GlioblastomaZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa. ()1.4 Metastatic Renal Cell CarcinomaZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. ()1.5 Persistent, Recurrent, or Metastatic Cervical CancerZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer:o in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, for stage III or IV disease following initial surgical resection. ()1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerZIRABEV, 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.
o in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens. ()1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerZIRABEV, 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.
o in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by ZIRABEV as a single agent, for platinum-sensitive recurrent disease. ()1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerZIRABEV, 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.
Withhold for at least 28 days prior to elective surgery. Do not administer ZIRABEV for 28 days following major surgery and until adequate wound healing. (
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.
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.
• 5 mg/kg every 2 weeks with bolus-IFL.• 10 mg/kg every 2 weeks with FOLFOX4.• 5 mg/ kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line bevacizumab product containing regimen.
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.
• 15 mg/kg every 3 weeks with carboplatin and paclitaxel.
Recurrent glioblastoma. (
The recommended dosage is 10 mg/kg intravenously every 2 weeks.
• 10 mg/kg every 2 weeks.
Metastatic renal cell carcinoma.
The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with interferon alfa.
• 10 mg/kg every 2 weeks with interferon alfa.
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.
• 15 mg/kg every 3 weeks with paclitaxel and cisplatin or paclitaxel and topotecan.
Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer 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.
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).
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.
• 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles.
Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. (
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.
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).
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.
• 10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan given every week.• 15 mg/kg every 3 weeks with topotecan given every 3 weeks
Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (
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.
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).
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.
• 15 mg/kg every 3 weeks with carboplatin and paclitaxel for 6–8 cycles, followed by 15 mg/kg every 3 weeks as a single agent.• 15 mg/kg every 3 weeks with carboplatin and gemcitabine for 6–10 cycles, followed by 15 mg/kg every 3 weeks as a single agent.
Administer as an intravenous infusion after dilution. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. (
Table 1 describes dosage modifications for specific adverse reactions
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 |
• 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 to16 days, if not used immediately.• No incompatibilities between ZIRABEV and polyvinylchloride or polyolefin bags have been observed.
• 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.
Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) clear to slightly opalescent, colorless to pale brown solution in a single-dose vial
Lactation: Advise not to breastfeed. (
No data are available regarding the presence of bevacizumab products in human milk, the effects on the breast fed infant, or the effects on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with ZIRABEV and for 6 months after the last dose.
None.