Alymsys Generic Name & Formulations
Legal Class
Rx
General Description
Bevacizumab-maly 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)—10
Manufacturer
Generic Availability
NO
Alymsys Indications
Indications
Metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.
Alymsys 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.
Alymsys Contraindications
Not Applicable
Alymsys Boxed Warnings
Not Applicable
Alymsys 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 perforation, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any internal 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 (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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
Alymsys Pharmacokinetics
See Literature
Alymsys Interactions
Interactions
Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).
Alymsys 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, hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia.
Alymsys Clinical Trials
See Literature
Alymsys Note
Not Applicable
Alymsys Patient Counseling
See Literature
Alymsys Generic Name & Formulations
Legal Class
Rx
General Description
Bevacizumab-maly 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)—10
Manufacturer
Generic Availability
NO
Alymsys Indications
Indications
Recurrent gliobastoma in adults.
Alymsys 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.
Alymsys Contraindications
Not Applicable
Alymsys Boxed Warnings
Not Applicable
Alymsys 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 perforation, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any internal 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 (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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
Alymsys Pharmacokinetics
See Literature
Alymsys Interactions
Interactions
Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).
Alymsys 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, hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia.
Alymsys Clinical Trials
See Literature
Alymsys Note
Not Applicable
Alymsys Patient Counseling
See Literature
Alymsys Generic Name & Formulations
Legal Class
Rx
General Description
Bevacizumab-maly 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)—10
Manufacturer
Generic Availability
NO
Alymsys 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-containing regimen.
Limitations of Use
Not for adjuvant treatment of colon cancer.
Alymsys 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.
Alymsys Contraindications
Not Applicable
Alymsys Boxed Warnings
Not Applicable
Alymsys 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 perforation, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any internal 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 (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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
Alymsys Pharmacokinetics
See Literature
Alymsys Interactions
Interactions
Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).
Alymsys 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, hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia.
Alymsys Clinical Trials
See Literature
Alymsys Note
Not Applicable
Alymsys Patient Counseling
See Literature
Alymsys Generic Name & Formulations
Legal Class
Rx
General Description
Bevacizumab-maly 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)—10
Manufacturer
Generic Availability
NO
Alymsys Indications
Indications
Persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel/cisplatin, or paclitaxel/topotecan. 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.
Alymsys 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. 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).
Children
<18yrs: not established.
Alymsys Contraindications
Not Applicable
Alymsys Boxed Warnings
Not Applicable
Alymsys 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 perforation, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any internal 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 (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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
Alymsys Pharmacokinetics
See Literature
Alymsys Interactions
Interactions
Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).
Alymsys 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, hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia.
Alymsys Clinical Trials
See Literature
Alymsys Note
Not Applicable
Alymsys Patient Counseling
See Literature
Alymsys Generic Name & Formulations
Legal Class
Rx
General Description
Bevacizumab-maly 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)—10
Manufacturer
Generic Availability
NO
Alymsys 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.
Alymsys 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.
Alymsys Contraindications
Not Applicable
Alymsys Boxed Warnings
Not Applicable
Alymsys 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 perforation, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any internal 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 (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 the last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after the last dose).
Alymsys Pharmacokinetics
See Literature
Alymsys Interactions
Interactions
Increased risk of CHF and decline in LVEF with concomitant anthracycline-based therapy (not indicated use).
Alymsys 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, hemorrhage, non-GI fistula formation, arterial or venous thromboembolic events, PRES, infusion-related reactions, ovarian failure, neutropenia.
Alymsys Clinical Trials
See Literature
Alymsys Note
Not Applicable
Alymsys Patient Counseling
See Literature
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