Bevatas 400 Solution for Infusion

Product Description

1. Technical Specifications

2. Product Description

Bevatas (bevacizumab) is an anti-angiogenic monoclonal antibody that binds VEGF-A, preventing activation of VEGF receptors (VEGFR-1/2). This inhibits tumor blood-vessel formation, starving tumors of oxygen and nutrients and enhancing the effects of chemotherapy. It is for IV infusion only and is used across multiple solid tumors under oncologist supervision.

3. Product Highlights

4. Therapeutic Uses

• Metastatic colorectal cancer (with 5-FUbased chemotherapy)

• Non-squamous NSCLC (with platinum-based chemotherapy; not for squamous histology due to bleeding risk)

• Epithelial ovarian, fallopian tube, primary peritoneal cancer (front-line and recurrent settings in combinations/maintenance as per protocol)

• Cervical cancer (persistent/recurrent/metastatic, with chemotherapy)

• Renal cell carcinoma (with interferon alfa or per protocol)

• Glioblastoma (recurrent, per local guidelines)

• Hepatocellular carcinoma (with atezolizumab, per protocol)

Exact indication and regimen should follow current local labels/guidelines.

5. Side Effects

Very common/common:

• Hypertension

• Proteinuria (may be asymptomatic; can progress to nephrotic syndrome)

• Fatigue, headache

• Diarrhea, stomatitis, appetite loss

• Bleeding events (e.g., epistaxis), mucocutaneous hemorrhage

• Delayed wound healing

• Infusion-related reactions

Serious/clinically significant:

• Gastrointestinal perforation, fistula formation

• Severe hemorrhage (pulmonary, GI, CNScan be fatal)

• Arterial and venous thromboembolism (TIA/stroke/MI, DVT/PE)

• Congestive heart failure (risk with prior anthracyclines/radiation)

• Posterior reversible encephalopathy syndrome (PRES/RPLS)

• Severe hypertension/hypertensive crisis

• Severe proteinuria/nephrotic syndrome

• Wound-healing complications

• Gastrointestinal anastomotic complications (post-op)

6. Precautions

• Boxed/critical warnings: GI perforation, severe hemorrhage, and impaired wound healing.

• Blood pressure: Control before starting; monitor regularly; treat per guidelines; withhold for severe/uncontrolled hypertension.

• Proteinuria: Check urine protein periodically; withhold/discontinue for 2 g/24 h or nephrotic syndrome per protocol.

• Surgery/wounds: Stop 28 days before elective surgery and resume 28 days after and only when wounds are fully healed.

• Bleeding risk: Avoid in patients with recent significant hemoptysis or high bleeding risk; not indicated for squamous NSCLC.

• Arterial/venous thromboembolism: Use caution in patients with risk factors; discontinue for serious events.

• Cardiac function: Monitor in patients with prior anthracyclines/chest irradiation or cardiac history.

• Pregnancy & fertility: Embryo-fetal toxicity; use effective contraception during treatment and for at least 6 months after the last dose. May impair female fertility (ovarian failure). Avoid breastfeeding during therapy and for 6 months after last dose.

• Hypersensitivity: Contraindicated in patients with known serious hypersensitivity to bevacizumab or CHO-cell products.