Anticorpo monoclonal que inibe o VEGF e impede a angiogênese, sendo indicado para o tratamento de vários tipos de câncer.
Metastatic Colorectal Cancer (mCRC)
Bevanovis®, in combination with fluoropyrimidine-based chemotherapy, is indicated for the treatment of patients with metastatic colon or rectal carcinoma.
Locally advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC)
Bevanovis®, in combination with platinum-based chemotherapy, is indicated as first-line treatment for patients with unresectable, locally advanced, metastatic, or recurrent non-squamous, non-small cell lung cancer (NSCLC).
Bevanovis®, in combination with erlotinib, is indicated as first-line treatment for patients with unresectable, advanced, metastatic, or recurrent non-squamous, NSCLC with activating EGFR (epidermal growth factor receptor) mutations.
Metastatic or locally recurrent breast cancer (MBC)
Bevanovis®, in combination with paclitaxel, is indicated as first-line treatment for patients with locally recurrent or metastatic breast cancer who have not received prior chemotherapy for metastatic or locally recurrent disease. Bevanovis®, in combination with capecitabine, is indicated as first-line treatment for patients with locally recurrent or metastatic breast cancer for whom treatment with other chemotherapy options, including taxanes and anthracyclines, is not considered appropriate. Patients who have received adjuvant therapy regimens containing taxanes and anthracyclines within the last 12 months are not eligible for treatment with Bevanovis® in combination with capecitabine.
Metastatic and/or advanced renal cell carcinoma (mRCC)
Bevanovis®, in combination with alpha-interferon 2a, is indicated as first-line treatment for patients with advanced and/or metastatic renal cell carcinoma.
Epithelial ovarian, fallopian tube, and primary peritoneal cancer
Bevanovis®, in combination with carboplatin and paclitaxel, is indicated as first-line treatment for patients with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer (International Federation of Gynecology and Obstetrics – FIGO – stages III B, III C, and IV). Bevanovis®, in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with epithelial ovarian, fallopian tube, and primary peritoneal cancer with platinum-sensitive first recurrence and no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Bevanovis®, in combination with carboplatin and paclitaxel, is indicated for the treatment of adult patients with recurrent, platinum-sensitive epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Bevanovis®, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin, is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, and primary peritoneal cancer who have received no more than two prior chemotherapy regimens and who have not received previous therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Cervical cancer
Bevanovis®, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer.
Bevanovis® solution for dilution for infusion 100 mg
Active ingredient: bevacizumab ………………… 100 mg (25 mg/mL).
Excipients: trehalose dihydrate, sodium acetate trihydrate, acetic acid, polysorbate 20, and water for injection.
Bevanovis® solution for dilution for infusion 400 mg
Active ingredient: bevacizumab ……………….. 400 mg (25 mg/mL).
Excipients: trehalose dihydrate, sodium acetate trihydrate, acetic acid, polysorbate 20, and water for injection.
Bevanovis® 100 mg/4 mL (25 mg/mL) solution for dilution for infusion in a single-dose vial.
Bevanovis® 400 mg/16 mL (25 mg/mL) solution for dilution for infusion in a single-dose vial. .
INTRAVENOUS USE
ADULT USE
Do not use Bevanovis® if you are allergic to any component of the product or to other products containing substances similar to bevacizumab.
Pregnancy and breastfeeding
This medication should not be used by pregnant women without medical or dental advice.
Post-marketing reports have included cases of fetal abnormalities in women treated with Bevanovis® either as monotherapy or in combination with chemotherapeutic agents already known to be embryotoxic (see the package insert section “What adverse effects can this medication cause?”).
If you are a woman of childbearing potential, you must strictly follow your physician’s recommendations to avoid pregnancy during treatment and for at least six months after the last dose of Bevanovis®.
This medication is contraindicated for use by breastfeeding women.
It is not known whether bevacizumab is excreted in human milk, but this is considered highly likely. Therefore, if you are breastfeeding, you will need to discontinue nursing during treatment and for at least six months after the last dose of Bevanovis®.
Biologic antineoplastic; monoclonal antibody.
Anti-VEGF (angiogenesis inhibitor).
Oncology.
Sale by prescription only.
Restricted to healthcare facilities use.
Store refrigerated at 2°C to 8°C. Do not freeze it. Keep the vial inside its original cartridge to protect it from light.
Intravenous (IV). Adult use.
25 MG/ML IV INFUSION DILUTED SOLUTION, CLEAR GLASS VIAL, 4 ML.
Registration No.: 1.4531.0002.001-3
25 MG/ML IV INFUSION DILUTED SOLUTION, CLEAR GLASS VIAL, 16 ML.
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