Development of biopharmaceuticals based on cloning technology.Bevacizumab is derived from the murine VEGF monoclonal antibody A4.6. It is ∼93% human and 7% murine protein sequence, producing an agent with the same biochemical and pharmacologic properties as the parental antibody, but with reduced immunogenicity, and a longer biological half-life.
9. Formulation
5 mg/kg every 2 weeks intravenously in combination with bolus-IFL.
10 mg/kg every 2 weeks intravenously in combination with FOLFOX4.
1)Avastin is provided as a concentrate for solution for infusion in a
single-use vial, which contains a nominal amount of either 100 mg of
bevacizumab in 4 ml or 400 mg of bevacizumab in 16 ml (concentration
of 25 mg/ml).
2) Bevacizumab is formulated with 51 mM sodium phosphate pH 6.2,
60 mg/ml α,α-trehalose dihydrate and 0.04% polysorbate 20.
3) The drug product is a clear to slightly opalescent, colourless to pale
brown sterile liquid solution that has to be diluted in 0.9 % sodium
chloride solution prior to administration.
10. Pharmacology & Pharmacodynamics:
Bevacizumab is derived from the murine VEGF monoclonal antibody A4.6.
It is ∼93% human and 7% murine protein sequence, producing an agent with the same
biochemical and pharmacologic properties as the parental antibody, but with reduced
immunogenicity, and a longer biological half-life.
Experimental studies show that bevacizumab and A4.6.1 neutralize all isoforms of
human VEGF with a dissociation constant (Kd) of 1.1 and 0.8 nmol/L, respectively.
They also inhibit VEGF-induced proliferation of endothelial cells in vitro with ED50 of 50 ±
5 and 48 ± 8 ng/mL, respectively.
Both also block tumor angiogenesis and growth with almost identical potency and
efficacy.
12. Administration: Bevacizumab is not administered as a single agent: it is always
administered with chemotherapy. If the Bevacizumab is held, however the chemotherapy
may continue under standard parameters. Bevacizumab must be diluted in normal saline
(not a dextrose-containing solution). Please refer to the Parenteral Drug Manual
(PDM)Sheet for further administration instructions. Administer Bevacizumab at a rate of
0.5 mg/kg/minute.
Storage & Handling: Avastin vials [100 mg (NDC 50242-060-01) and 400 mg
(NDC 50242-061-01)] are stable at 2−8°C (36−46°F). Avastin vials should be protected
from light. Do not freeze or shake. Diluted Avastin solutions may be stored at 2−8°C
(36−46°F) for up to 8 hours. Store in the original carton until time of use. No
incompatibilities between Avastin and polyvinylchloride or polyolefin bags have been
observed.
13. Side effects: •trouble breathing,
•swelling of ankles or feet,
•sudden weight gain,
•fast heartbeat,
•signs of infection (e.g., fever, persistent sore
throat),
•muscle cramps,
•muscle loss,
•yellowing eyes or skin,
•frothy or dark urine,
•difficulty urinating, or
•decreased amount of urine.
14. Contraindication: 1) Defective Internal Secretion of Ovaries
2) Decrease of Neutrophils in the Blood from Cancer
Chemotherapy
3) Decreased Neutrophils a Type of White Blood Cell
4) high blood pressure
5) heart attack
6) Angina
7) chronic heart failure
8) Transient Ischemic Attack
9) Obstruction of a Blood Vessel by a Blood Clot
10) bleeding
11) Inflammation of the Esophagus with Erosion
12) Abnormal Connection Between Esophagus and Windpipe
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