Vegzelma!" (Bevacizumab) 25 mg/mL concentrate for solution for infusion

Manufacturer
CELLTRION, Inc.(KOREA,SOUTH)

Registraction Number
MAL24106003AZ

Content:
Vegzelma™ (Bevacizumab) 25 mg/mL Concentrate for Solution for Infusion contains 25 mg of bevacizumab per mL. Bevacizumab is a recombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells1. Each vial contains either 100 mg (4 mL) or 400 mg (16 mL) of bevacizumab.
Indications:
Vegzelma is indicated for the treatment of various cancers, including:

• Metastatic colorectal cancer in combination with fluoropyrimidine-based chemotherapy.
• Metastatic breast cancer in combination with paclitaxel.
• Advanced, metastatic, or recurrent non-squamous non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel.
• Advanced and/or metastatic renal cell cancer in combination with interferon alfa-2a.
• Grade IV glioma as a single agent after relapse or disease progression.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel.

1. Preparation: Dilute the concentrate before intravenous use according to the instructions provided in the prescribing information.
2. Administration: Administer under the supervision of a healthcare professional. Follow the prescribed dosage and administration guidelines.
3. Monitoring: Regularly monitor for signs of infection, hypersensitivity, and infusion-related reactions.
4. Storage: Store at room temperature, away from moisture and heat.
5. Precautions: Do not use during any clinically important active infection. Evaluate patients for tuberculosis prior to initiating treatment.