Mvasi

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

Mvasi Generic Name & Formulations

General Description

Bevacizumab-awwb 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

Mvasi Indications

Indications

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

Mvasi 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 until disease progression or unacceptable toxicity.

Children

<18yrs: not established.

Mvasi Contraindications

Not Applicable

Mvasi Boxed Warnings

Not Applicable

Mvasi Warnings/Precautions

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 Pharmacokinetics

See Literature

Mvasi Interactions

Interactions

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

Mvasi Adverse Reactions

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.

Mvasi Clinical Trials

See Literature

Mvasi Note

Not Applicable

Mvasi Patient Counseling

See Literature

Mvasi Generic Name & Formulations

General Description

Bevacizumab-awwb 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

Mvasi Indications

Indications

Recurrent gliobastoma in adults.

Mvasi 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.

Mvasi Contraindications

Not Applicable

Mvasi Boxed Warnings

Not Applicable

Mvasi Warnings/Precautions

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 Pharmacokinetics

See Literature

Mvasi Interactions

Interactions

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

Mvasi Adverse Reactions

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.

Mvasi Clinical Trials

See Literature

Mvasi Note

Not Applicable

Mvasi Patient Counseling

See Literature

Mvasi Generic Name & Formulations

General Description

Bevacizumab-awwb 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

Mvasi Indications

Indications

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.

Mvasi 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 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

<18yrs: not established.

Mvasi Contraindications

Not Applicable

Mvasi Boxed Warnings

Not Applicable

Mvasi Warnings/Precautions

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 Pharmacokinetics

See Literature

Mvasi Interactions

Interactions

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

Mvasi Adverse Reactions

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.

Mvasi Clinical Trials

See Literature

Mvasi Note

Not Applicable

Mvasi Patient Counseling

See Literature

Mvasi Generic Name & Formulations

General Description

Bevacizumab-awwb 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

Mvasi Indications

Indications

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.

Mvasi 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 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

<18yrs: not established.

Mvasi Contraindications

Not Applicable

Mvasi Boxed Warnings

Not Applicable

Mvasi Warnings/Precautions

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 Pharmacokinetics

See Literature

Mvasi Interactions

Interactions

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

Mvasi Adverse Reactions

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.

Mvasi Clinical Trials

See Literature

Mvasi Note

Not Applicable

Mvasi Patient Counseling

See Literature

Mvasi Generic Name & Formulations

General Description

Bevacizumab-awwb 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

Mvasi 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.

Mvasi 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 until disease progression or unacceptable toxicity.

Children

<18yrs: not established.

Mvasi Contraindications

Not Applicable

Mvasi Boxed Warnings

Not Applicable

Mvasi Warnings/Precautions

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 Pharmacokinetics

See Literature

Mvasi Interactions

Interactions

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

Mvasi Adverse Reactions

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.

Mvasi Clinical Trials

See Literature

Mvasi Note

Not Applicable

Mvasi Patient Counseling

See Literature