Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for ZIRABEV:

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

Adult Dosage:

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 Dosage:

<18yrs: not established.

ZIRABEV 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 Classification:

Vascular endothelial growth factor (VEGF) inhibitor.

ZIRABEV Interactions:

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

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.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 16mL)—1

Pricing for ZIRABEV

4ml of 100mg vial (Qty: 1)
Appx. price $635
GoodRx

CNS cancers:

Indications for ZIRABEV:

Recurrent glioblastoma in adults.

Adult Dosage:

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 Dosage:

<18yrs: not established.

ZIRABEV 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 Classification:

Vascular endothelial growth factor (VEGF) inhibitor.

ZIRABEV Interactions:

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

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.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 16mL)—1

Pricing for ZIRABEV

4ml of 100mg vial (Qty: 1)
Appx. price $635
GoodRx

Colorectal and other GI cancers:

Indications for ZIRABEV:

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.

Adult Dosage:

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 Dosage:

<18yrs: not established.

ZIRABEV 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 Classification:

Vascular endothelial growth factor (VEGF) inhibitor.

ZIRABEV Interactions:

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

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.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 16mL)—1

Pricing for ZIRABEV

4ml of 100mg vial (Qty: 1)
Appx. price $635
GoodRx

Gynecologic Cancers:

Pricing for ZIRABEV

4ml of 100mg vial (Qty: 1)
Appx. price $635
GoodRx

Respiratory and thoracic cancers:

Indications for ZIRABEV:

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

Adult Dosage:

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 Dosage:

<18yrs: not established.

ZIRABEV 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 Classification:

Vascular endothelial growth factor (VEGF) inhibitor.

ZIRABEV Interactions:

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

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.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 16mL)—1

Pricing for ZIRABEV

4ml of 100mg vial (Qty: 1)
Appx. price $635
GoodRx