Zirabev

— THERAPEUTIC CATEGORIES —
  • Bladder, kidney, and other urologic cancers
  • CNS cancers
  • Colorectal and other GI cancers
  • Gynecologic cancers
  • Respiratory and thoracic cancers

Zirabev Generic Name & Formulations

General Description

Bevacizumab-bvzr 100mg, 400mg; per vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Vascular endothelial growth factor (VEGF) inhibitor.

How Supplied

Single-dose vial (4mL, 16mL)—1

Manufacturer

Generic Availability

NO

Mechanism of Action

Bevacizumab binds to VEGF and prevents the interaction of VEGF to its receptors (F1t-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis.

Zirabev Indications

Indications

Metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.

Zirabev Dosage and Administration

Adult

Give by IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. 10mg/kg every 2 weeks with interferon alfa.

Children

<18yrs: not established.

Administration

Administer only as an IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Nursing Considerations

Administer only as an IV infusion. Avoid administering or mixing with dextrose solution. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Zirabev Contraindications

Not Applicable

Zirabev Boxed Warnings

Not Applicable

Zirabev Warnings/Precautions

Warnings/Precautions

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Zirabev Pharmacokinetics

Distribution

The mean central volume of distribution is 2.9 (22%) L. 

Elimination

Half-life: ~20 days (range: 11–50 days).

Zirabev Interactions

Interactions

Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).

Zirabev Adverse Reactions

Adverse Reactions

Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound healing complications, necrotizing fasciitis, non-GI fistula formation, thromboembolic events, PRES, renal injury, infusion-related reactions, ovarian failure, neutropenia, infection.

Zirabev Clinical Trials

See Literature

Zirabev Note

Not Applicable

Zirabev Patient Counseling

See Literature

Zirabev Generic Name & Formulations

General Description

Bevacizumab-bvzr 100mg, 400mg; per vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Vascular endothelial growth factor (VEGF) inhibitor.

How Supplied

Single-dose vial (4mL, 16mL)—1

Manufacturer

Generic Availability

NO

Mechanism of Action

Bevacizumab binds to VEGF and prevents the interaction of VEGF to its receptors (F1t-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis.

Zirabev Indications

Indications

Recurrent glioblastoma in adults.

Zirabev Dosage and Administration

Adult

Give by IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. 10mg/kg every 2 weeks.

Children

<18yrs: not established.

Administration

Administer only as an IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Nursing Considerations

Administer only as an IV infusion. Avoid administering or mixing with dextrose solution. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Zirabev Contraindications

Not Applicable

Zirabev Boxed Warnings

Not Applicable

Zirabev Warnings/Precautions

Warnings/Precautions

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Zirabev Pharmacokinetics

Distribution

The mean central volume of distribution is 2.9 (22%) L. 

Elimination

Half-life: ~20 days (range: 11–50 days).

Zirabev Interactions

Interactions

Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).

Zirabev Adverse Reactions

Adverse Reactions

Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound healing complications, necrotizing fasciitis, non-GI fistula formation, thromboembolic events, PRES, renal injury, infusion-related reactions, ovarian failure, neutropenia, infection.

Zirabev Clinical Trials

See Literature

Zirabev Note

Not Applicable

Zirabev Patient Counseling

See Literature

Zirabev Generic Name & Formulations

General Description

Bevacizumab-bvzr 100mg, 400mg; per vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Vascular endothelial growth factor (VEGF) inhibitor.

How Supplied

Single-dose vial (4mL, 16mL)—1

Manufacturer

Generic Availability

NO

Mechanism of Action

Bevacizumab binds to VEGF and prevents the interaction of VEGF to its receptors (F1t-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis.

Zirabev Indications

Indications

Metastatic colorectal carcinoma (mCRC), in combination with 5-FU-based chemotherapy for first- or second-line treatment; or in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based therapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. Limitation of use: not for adjuvant treatment of colon cancer.

Zirabev Dosage and Administration

Adult

Give by IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. 5mg/kg (when used with bolus-IFL) or 10mg/kg (when used with FOLFOX-4) once every 2 weeks until disease progression detected; 5mg/kg every 2 weeks or 7.5mg/kg every 3 weeks (when used with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based therapy).

Children

<18yrs: not established.

Administration

Administer only as an IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Nursing Considerations

Administer only as an IV infusion. Avoid administering or mixing with dextrose solution. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Zirabev Contraindications

Not Applicable

Zirabev Boxed Warnings

Not Applicable

Zirabev Warnings/Precautions

Warnings/Precautions

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Zirabev Pharmacokinetics

Distribution

The mean central volume of distribution is 2.9 (22%) L. 

Elimination

Half-life: ~20 days (range: 11–50 days).

Zirabev Interactions

Interactions

Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).

Zirabev Adverse Reactions

Adverse Reactions

Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound healing complications, necrotizing fasciitis, non-GI fistula formation, thromboembolic events, PRES, renal injury, infusion-related reactions, ovarian failure, neutropenia, infection.

Zirabev Clinical Trials

See Literature

Zirabev Note

Not Applicable

Zirabev Patient Counseling

See Literature

Zirabev Generic Name & Formulations

General Description

Bevacizumab-bvzr 100mg, 400mg; per vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Vascular endothelial growth factor (VEGF) inhibitor.

How Supplied

Single-dose vial (4mL, 16mL)—1

Manufacturer

Generic Availability

NO

Mechanism of Action

Bevacizumab binds to VEGF and prevents the interaction of VEGF to its receptors (F1t-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis.

Zirabev Indications

Indications

Persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel/cisplatin, or paclitaxel/topotecan. Epithelial ovarian, fallopian tube or primary peritoneal cancer: for Stage III or IV disease after initial surgical resection, in combination with carboplatin/paclitaxel followed by Zirabev as a single agent; for platinum-resistant recurrent disease in patients who received ≤2 prior chemotherapy regimens, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan; or for platinum-sensitive recurrent disease, in combination with carboplatin/paclitaxel or carboplatin/gemcitabine followed by Zirabev as a single agent.

Zirabev Dosage and Administration

Adult

Give by IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Cervical cancer: 15mg/kg every 3 weeks with either paclitaxel/cisplatin, or paclitaxel/topotecan. Epithelial ovarian, fallopian tube or primary peritoneal cancer (Stage III or IV disease): 15mg/kg every 3 weeks with carboplatin/paclitaxel for up to 6 cycles, followed by 15mg/kg every 3 weeks (as a single agent) for a total of up to 22 cycles or until disease progression. Recurrent disease (platinum-resistant): 10mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week); or 15mg/kg every 3 weeks with topotecan (every 3 weeks); (platinum-sensitive): 15mg/kg every 3 weeks with carboplatin/paclitaxel for 6–8 cycles or with carboplatin/gemcitabine for 6–10 cycles; followed by 15mg/kg every 3 weeks (as a single agent) until disease progression.

Children

<18yrs: not established.

Administration

Administer only as an IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Nursing Considerations

Administer only as an IV infusion. Avoid administering or mixing with dextrose solution. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Zirabev Contraindications

Not Applicable

Zirabev Boxed Warnings

Not Applicable

Zirabev Warnings/Precautions

Warnings/Precautions

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Zirabev Pharmacokinetics

Distribution

The mean central volume of distribution is 2.9 (22%) L. 

Elimination

Half-life: ~20 days (range: 11–50 days).

Zirabev Interactions

Interactions

Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).

Zirabev Adverse Reactions

Adverse Reactions

Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound healing complications, necrotizing fasciitis, non-GI fistula formation, thromboembolic events, PRES, renal injury, infusion-related reactions, ovarian failure, neutropenia, infection.

Zirabev Clinical Trials

See Literature

Zirabev Note

Not Applicable

Zirabev Patient Counseling

See Literature

Zirabev Generic Name & Formulations

General Description

Bevacizumab-bvzr 100mg, 400mg; per vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Vascular endothelial growth factor (VEGF) inhibitor.

How Supplied

Single-dose vial (4mL, 16mL)—1

Manufacturer

Generic Availability

NO

Mechanism of Action

Bevacizumab binds to VEGF and prevents the interaction of VEGF to its receptors (F1t-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis.

Zirabev Indications

Indications

First-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel.

Zirabev Dosage and Administration

Adult

Give by IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. 15mg/kg every 3 weeks with carboplatin/paclitaxel.

Children

<18yrs: not established.

Administration

Administer only as an IV infusion. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Nursing Considerations

Administer only as an IV infusion. Avoid administering or mixing with dextrose solution. Infuse 1st dose over 90mins; if tolerated, infuse 2nd dose over 60mins, and subsequent doses over 30mins. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing.

Zirabev Contraindications

Not Applicable

Zirabev Boxed Warnings

Not Applicable

Zirabev Warnings/Precautions

Warnings/Precautions

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Zirabev Pharmacokinetics

Distribution

The mean central volume of distribution is 2.9 (22%) L. 

Elimination

Half-life: ~20 days (range: 11–50 days).

Zirabev Interactions

Interactions

Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).

Zirabev Adverse Reactions

Adverse Reactions

Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound healing complications, necrotizing fasciitis, non-GI fistula formation, thromboembolic events, PRES, renal injury, infusion-related reactions, ovarian failure, neutropenia, infection.

Zirabev Clinical Trials

See Literature

Zirabev Note

Not Applicable

Zirabev Patient Counseling

See Literature