Bevanovis® (bevacizumab)

Anticorpo monoclonal que inibe o VEGF e impede a angiogênese, sendo indicado para o tratamento de vários tipos de câncer.

Bevanovis®

Active Ingredient: Bevacizumab

Indications for Bevacizumab

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.

Metastatic Colorectal Cancer (mCRC)
Bevanovis®, in combination with fluoropyrimidine-based chemotherapy, is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum.

Metastatic and/or Advanced Renal Cell Carcinoma (mRCC)
Bevanovis®, in combination with interferon alfa-2a, is indicated for the first-line treatment of patients with advanced and/or metastatic renal cell carcinoma.

Metastatic or Locally Recurrent Breast Cancer (MBC)
Bevanovis®, in combination with paclitaxel, is indicated for the first-line treatment of 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 for the first-line treatment of 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 treatment regimens containing taxanes and anthracyclines within the last 12 months are not eligible for treatment with Bevanovis® in combination with capecitabine.

Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
Bevanovis®, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of patients with unresectable, locally advanced, metastatic, or recurrent non-squamous non-small cell lung cancer.

Bevanovis®, in combination with erlotinib, is indicated for the first-line treatment of patients with unresectable, advanced, metastatic, or recurrent non-squamous non-small cell lung cancer with activating EGFR (epidermal growth factor receptor) mutations.

Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Bevanovis®, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer (International Federation of Gynecology and Obstetrics – FIGO – III B, III C, and IV).

Bevanovis®, in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrent platinum-sensitive epithelial ovarian, fallopian tube, and primary peritoneal cancer who have not received 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 primary epithelial ovarian, fallopian tube, and 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 not received more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

Concentration:

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.

Presentation:

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

Contraindications:

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.

In the post-marketing setting, cases of fetal abnormalities have been observed in women treated with Bevanovis® alone or in combination with known embryotoxic chemotherapeutic agents (see section “What adverse reactions can this medication cause?”).

If you are a woman of childbearing potential, follow your doctor’s instructions carefully to avoid pregnancy during treatment and for at least six months after the last dose of Bevanovis®.

This medication is contraindicated during breastfeeding.

It is unknown whether bevacizumab is excreted in human milk, but it is highly likely that it is. Therefore, if you are breastfeeding, you will need to discontinue breastfeeding during treatment and for at least six months after the last dose of Bevanovis®.

Specifications

Type of medication:

Biological - monoclonal antibody.

Mechanism of Action:

Anti-VEGF (angiogenesis inhibitor).

Therapeutic Area:

Oncology.

Prescription needed?

Sold by prescription only.
Restricted to healthcare establishments.

Storage conditions:

Store refrigerated at 2°C to 8°C. Do not freeze. Keep the vial in the original carton to protect it from light.

Administration route:

Intravenous (IV). Adult use.

M.S. Registration: 1.4531.0002.002-1

25 MG/ML SOL DIL INFUS IV CT FA VD TRANS X 4 ML

M.S. Registration: 1.4531.0002.001-3
25 MG/ML SOL DIL INFUS IV CT FA VD TRANS X 16 ML