B-Mab
(Bevacizumab)
Dosage form:
concentrate solution for infusion 100 mg/4ml 400 mg/16ml.
Pharmacotherapeutic group:
Anti-tumor agent, a monoclonal antibody.
ATC code: L01XC07.
Pharmacological properties:
Bevacizumab – recombinant humanized hyper-chimeric monoclonal antibody that selectively binds to the biologically active vascular endothelial growth factor(VEGF) and neutralizes it. Bevacizumab inhibits the binding of vascular endothelial growth factor to its receptor type 1 and 2 (Fit-1 , KDR) on the endothelial cells surface, that leads to decreased vascularization and inhibition of tumor growth.
Indications:
> Metastatic colorectal cancer:
1st line therapy in combination with:
5-fluorouracil/Folinic acid,
5-fluorouracil/Folinic acid/Irinotecan
Capecitabine/Oxaliplatin (XELOX)
2nd line therapy in combination with Irinotecan-or Oxaliplatin-based chemotherapy.
> Metastatic breast cancer:
1st line therapy in combination with paclitaxel.
> Advanced inoperable, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
– 1st line treatment in addition to cisplatin-or gemcitabine-based chemotherapy.
> Advanced and/or metastatic renal cell carcinoma:
1st line therapy in combination with interferon alpha-2a.
> Glioblastoma (glioma IV grade according to the classification of the World Health Organization(WHO)):
monotherapy of adults with advanced glioblastoma after primary therapy, including Temozolomide chemotherapy
> Ovarian cancer
1st line therapy in combination with carboplatin and paclitaxel at ovarian cancer III and IV stage.
(according to the International Federation of Gynecology and Obstetrics classification(FIGO).
in combination with carboplatin and gemcitabine in patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer.
in combination with paclitaxel or topotecan, or pegylated liposomal doxorubicin at recurrent who was not previously treated with bevacizumab or other VEGF inhibitors.
> Cervical cancer
therapy of patients with persisting, recurrent or metastatic cervical cancer in combination with chemotherapy.
Dosage and Administration:
Do not administer as an intravenous push or bolus!
Peculiarity of dosing regimens for various indications see full text of B-Mab Prescription information.
Contraindications:
Hypersensitivity to bevacizumab or to any other component of the drug, drugs based on Chinese hamster ovary cells or other recombinant human or close to the human antibodies.
Pregnancy and Nursing Mothers Children under 18 years old, renal and hepatic failure (efficiency and safety have not been established).
Side effects:
The most serious side effects: perforating gastrointestinal tract, hemorrhage, including pulmonary hemorrhage/ hemoptysis (more common in patients with non-small cell lung cancer), arterial thromboembolism, increased blood pressure, fatigue or asthenia, diarrhea and abdominal pain.
Pregnancy and Nursing Mothers:
Use of the drug is forbidden in pregnancy.
Women of childbearing age during bevacizumab treatment and, for at least 6 months after the end of treatment should be used reliable methods of contraception.
Breastfeeding is not recommended during bevacizumab treatment and, at least, within 6 months after the end of therapy with bevacizumab.
Prescription Status:
Available on prescription.
Expiration date:
2 years