Bevacizumab-maly
Generic Name: bevacizumab-maly
Brand Names:
Alymsys
11 DESCRIPTION Bevacizumab-maly is a vascular endothelial growth factor inhibitor. Bevacizumab-maly is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-maly has an approximate molecular weight of 149 kDa. Bevacizumab-maly is produced in a mammalian cell (Chinese Hamster Ovary) expression system.
Overview
11 DESCRIPTION Bevacizumab-maly is a vascular endothelial growth factor inhibitor. Bevacizumab-maly is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-maly has an approximate molecular weight of 149 kDa. Bevacizumab-maly is produced in a mammalian cell (Chinese Hamster Ovary) expression system.
Uses
1 INDICATIONS AND USAGE Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) Limitations of Use: Alymsys is not indicated for adjuvant treatment of colon cancer. (1.1) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
Dosage
2 DOSAGE AND ADMINISTRATION Withhold for at least 28 days prior to elective surgery. Do not administer Alymsys for 28 days following major surgery and until adequate wound healing. (2.1) Metastatic colorectal cancer (2.2) 5 mg/kg every 2 weeks with bolus-IFL 10 mg/kg every 2 weeks with FOLFOX4 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after progression on a first-line bevacizumab product-containing regimen First-line non−squamous non−small cell lung cancer (2.3) 15 mg/kg every 3 weeks with carboplatin and paclitaxel Recurrent glioblastoma (2.4) 10 mg/kg every 2 weeks Metastatic renal cell carcinoma (2.5) 10 mg/kg every 2 weeks with interferon alfa Persistent, recurrent, or metastatic cervical cancer...
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)] . Surgery and Wound Healing Complications [see Warnings and Precautions (5.2)] . Hemorrhage [see Warnings and Precautions (5.3)] . Arterial Thromboembolic Events [see Warnings and Precautions (5.4)] . Venous Thromboembolic Events [see Warnings and Precautions (5.5)] . Hypertension [see Warnings and Precautions (5.6)] . Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.7)] . Renal Injury and Proteinuria [see Warnings and Precautions (5.8)] . Infusion-Related Reactions [see Warnings and Precautions (5.9)] . Ovarian Failure [see Warnings and Precautions (5.11)] .
Interactions
7 DRUG INTERACTIONS Effects of Alymsys on Other Drugs No clinically meaningful effect on the pharmacokinetics of irinotecan or its active metabolite SN38, interferon alfa, carboplatin or paclitaxel was observed when bevacizumab was administered in combination with these drugs; however, 3 of the 8 patients receiving bevacizumab with paclitaxel and carboplatin had lower paclitaxel exposure after four cycles of treatment (at Day 63) than those at Day 0, while patients receiving paclitaxel and carboplatin alone had a greater paclitaxel exposure at Day 63 than at Day 0.
Warnings
5 WARNINGS AND PRECAUTIONS Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ (5.1) Surgery and Wound Healing Complications: In patients who experience wound healing complications during Alymsys treatment, withhold Alymsys until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer Alymsys for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complication of necrotizing fasciitis. (5.2) Hemorrhage: Severe or fatal hemorrhages have occurred. 4 CONTRAINDICATIONS None. None (4)
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and their mechanism of action [see Clinical Pharmacology (12.1)] , bevacizumab products may cause fetal harm in pregnant women. Limited postmarketing reports describe cases of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks.
Storage
16 HOW SUPPLIED Alymsys (bevacizumab-maly) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a carton containing single-dose vial in the following strengths and packaging configurations: 100 mg/4 mL (25 mg/mL): carton of one vial (NDC 85006-1754-1). 400 mg/16 mL (25 mg/mL): carton of one vial (NDC 85006-1755-1).
Frequently Asked Questions
What is Bevacizumab-maly used for?▼
1 INDICATIONS AND USAGE Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1) Limitations of Use: Alymsys is not indicated for adjuvant treatment of colon cancer. (1.1) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
What are the side effects of Bevacizumab-maly?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)] . Surgery and Wound Healing Complications [see Warnings and Precautions (5.2)] . Hemorrhage [see Warnings and Precautions (5.3)] . Arterial Thromboembolic Events [see Warnings and Precautions (5.4)] . Venous Thromboembolic Events [see Warnings and Precautions (5.5)] . Hypertension [see Warnings and Precautions (5.6)] . Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.7)] . Renal Injury and Proteinuria [see Warnings and Precautions (5.8)] . Infusion-Related Reactions [see Warnings and Precautions (5.9)] . Ovarian Failure [see Warnings and Precautions (5.11)] .
Can I take Bevacizumab-maly during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings from animal studies and their mechanism of action [see Clinical Pharmacology (12.1)] , bevacizumab products may cause fetal harm in pregnant women. Limited postmarketing reports describe cases of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks.
What are the important warnings for Bevacizumab-maly?▼
5 WARNINGS AND PRECAUTIONS Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ (5.1) Surgery and Wound Healing Complications: In patients who experience wound healing complications during Alymsys treatment, withhold Alymsys until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer Alymsys for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complication of necrotizing fasciitis. (5.2) Hemorrhage: Severe or fatal hemorrhages have occurred. 4 CONTRAINDICATIONS None. None (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.