- Bladder, kidney, and other urologic cancers
- CNS cancers
- Colorectal and other GI cancers
- Gynecologic cancers
- Respiratory and thoracic cancers
Bladder, kidney, and other urologic cancers:
Indications for: MVASI
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 until disease progression or unacceptable toxicity.
Children Dosage:
<18yrs: not established.
MVASI Warnings/Precautions:
Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in ovarian cancer if evidence of recto-sigmoid involvement by pelvic exam, bowel involvement on CT scan, or symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ. Wound healing complications: withhold for ≥28 days prior to elective surgery; do not give for ≥28 days after major surgery and until adequate healing. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, Grade 4 venous thromboembolic event (including pulmonary embolism), hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if severe hypertension 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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
MVASI Classification:
Vascular endothelial growth factor (VEGF) inhibitor.
MVASI 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, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound dehiscence/impaired healing, necrotizing fasciitis (discontinue if occurs), hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia, infection.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (4mL, 16mL)—1
CNS cancers:
Indications for: MVASI
Recurrent gliobastoma 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.
MVASI Warnings/Precautions:
Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in ovarian cancer if evidence of recto-sigmoid involvement by pelvic exam, bowel involvement on CT scan, or symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ. Wound healing complications: withhold for ≥28 days prior to elective surgery; do not give for ≥28 days after major surgery and until adequate healing. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, Grade 4 venous thromboembolic event (including pulmonary embolism), hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if severe hypertension 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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
MVASI Classification:
Vascular endothelial growth factor (VEGF) inhibitor.
MVASI 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, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound dehiscence/impaired healing, necrotizing fasciitis (discontinue if occurs), hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia, infection.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (4mL, 16mL)—1
Colorectal and other GI cancers:
Indications for: MVASI
Metastatic colorectal carcinoma, 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-containing regimen.
Limitations 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 or unacceptable toxicity; 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.
MVASI Warnings/Precautions:
Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in ovarian cancer if evidence of recto-sigmoid involvement by pelvic exam, bowel involvement on CT scan, or symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ. Wound healing complications: withhold for ≥28 days prior to elective surgery; do not give for ≥28 days after major surgery and until adequate healing. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, Grade 4 venous thromboembolic event (including pulmonary embolism), hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if severe hypertension 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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
MVASI Classification:
Vascular endothelial growth factor (VEGF) inhibitor.
MVASI 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, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound dehiscence/impaired healing, necrotizing fasciitis (discontinue if occurs), hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia, infection.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (4mL, 16mL)—1
Gynecologic cancers:
Indications for: MVASI
Persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel/cisplatin, or paclitaxel/topotecan. Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer after initial surgical resection, in combination with carboplatin/paclitaxel, followed by Mvasi as a single agent. Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (platinum-resistant): in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan in patients who received no more than 2 prior chemotherapy regimens; (platinum-sensitive): in combination with carboplatin/paclitaxel or carboplatin/gemcitabine, followed by Mvasi as a single agent.
Adult Dosage:
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 until disease progression or unacceptable toxicity. Stage III/IV disease after initial surgical resection: 15mg/kg every 3 weeks with carboplatin/paclitaxel for up to 6 cycles; followed by Mvasi 15mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles or until disease progression, whichever occurs first. Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (platinum-resistant): 10mg/kg every 2 weeks with either paclitaxel, pegylated liposomal doxorubicin, or topotecan (weekly); 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 carboplatin/gemcitabine for 6–10 cycles; followed by Mvasi 15mg/kg every 3 weeks as a single agent until disease progression.
Children Dosage:
<18yrs: not established.
MVASI Warnings/Precautions:
Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in ovarian cancer if evidence of recto-sigmoid involvement by pelvic exam, bowel involvement on CT scan, or symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ. Wound healing complications: withhold for ≥28 days prior to elective surgery; do not give for ≥28 days after major surgery and until adequate healing. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, Grade 4 venous thromboembolic event (including pulmonary embolism), hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if severe hypertension 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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
MVASI Classification:
Vascular endothelial growth factor (VEGF) inhibitor.
MVASI 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, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound dehiscence/impaired healing, necrotizing fasciitis (discontinue if occurs), hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia, infection.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (4mL, 16mL)—1
Respiratory and thoracic cancers:
Indications for: MVASI
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 until disease progression or unacceptable toxicity.
Children Dosage:
<18yrs: not established.
MVASI Warnings/Precautions:
Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in ovarian cancer if evidence of recto-sigmoid involvement by pelvic exam, bowel involvement on CT scan, or symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ. Wound healing complications: withhold for ≥28 days prior to elective surgery; do not give for ≥28 days after major surgery and until adequate healing. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, Grade 4 venous thromboembolic event (including pulmonary embolism), hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if severe hypertension 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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
MVASI Classification:
Vascular endothelial growth factor (VEGF) inhibitor.
MVASI 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, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation and fistulae, wound dehiscence/impaired healing, necrotizing fasciitis (discontinue if occurs), hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia, infection.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (4mL, 16mL)—1
