Alymsys

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

Alymsys Generic Name & Formulations

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

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

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

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

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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