Bevacizumab-Maly (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- ALYMSYS
Contraindications
None.
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)]. Congestive Heart Failure [see Warnings and Precautions (5.12)].
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.
Mechanism of Action
Bevacizumab products bind VEGF and prevent the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused reduction of microvascular growth and inhibition of metastatic disease progression.