ABEVMY 400 mg/16 ml Concentrate for solution for infusion

What is ABEVMY 400 mg/16 ml

ABEVMY 400 mg/16 ml is a concentrate solution for infusion containing the active ingredient Bevacizumab, a recombinant humanized monoclonal antibody. It is designed for intravenous administration and is supplied in a single 16 ml glass vial. This formulation is used in oncology as a targeted biological therapy against various types of solid tumors.

• ABEVMY targets cancers by inhibiting angiogenesis—the process by which tumors develop new blood vessels necessary for their growth and metastasis.
• Common indications include metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma, glioblastoma, cervical cancer, and ovarian cancer.
• It is often administered alongside chemotherapy agents to improve treatment efficacy and patient outcomes.
• ABEVMY represents a significant advancement in cancer treatment by specifically targeting tumor vasculature rather than directly attacking tumor cells.
• This medication must be used under close medical supervision in specialized oncology centers due to its potent effects and risk profile.

Overall, ABEVMY 400 mg/16 ml is an essential therapy for managing various malignancies, improving progression-free and overall survival in many patients.

How to use ABEVMY 400 mg/16 ml

Proper administration of ABEVMY is critical for maximizing its therapeutic benefit while minimizing risks. Here are key points on how to use it:

• Preparation: The vial contents must be diluted prior to infusion, typically in 100 ml or more of 0.9% sodium chloride or 5% dextrose solution according to official guidelines.
• Route: Administer ABEVMY intravenously using a controlled infusion pump to regulate the infusion rate.
• Infusion Rate: The first infusion is usually given over 90 minutes; if well tolerated, subsequent infusions may be reduced to 30–60 minutes.
• Frequency: Dosage is commonly given every 2 or 3 weeks, depending on the specific cancer type and treatment regimen.
• Monitoring: Patients should be closely monitored for infusion reactions, blood pressure changes, and signs of bleeding or thrombosis during and after administration.
• Combination Therapy: Often combined with chemotherapy; treatment schedules must be coordinated carefully to manage potential interactions and toxicities.
• Professional Administration: Only qualified healthcare professionals should prepare and administer ABEVMY to ensure correct dosing and manage any adverse reactions.

Following these steps helps ensure patient safety and effective treatment delivery.

Mode of Action ABEVMY 400 mg/16 ml

ABEVMY’s active ingredient, Bevacizumab, exerts its therapeutic effects through a highly specific mechanism:

• VEGF-A Targeting: Bevacizumab is a monoclonal antibody that binds to vascular endothelial growth factor A (VEGF-A), a key signaling protein responsible for angiogenesis.
• Inhibition of Angiogenesis: By neutralizing VEGF-A, it prevents VEGF from binding to its receptors on endothelial cells (VEGFR-1 and VEGFR-2), thereby blocking the formation of new blood vessels.
• Tumor Starvation: Without sufficient blood supply, tumors receive less oxygen and nutrients, which inhibits tumor growth and reduces the potential for metastasis.
• Normalization Effect: In some tumors, Bevacizumab transiently normalizes abnormal tumor vasculature, which can enhance delivery of concomitant chemotherapeutic agents.
• Selective Targeting: The drug specifically targets the tumor microenvironment rather than the tumor cells themselves, which reduces systemic cytotoxicity compared to traditional chemotherapy.

This targeted approach makes ABEVMY a powerful component of modern cancer therapy.

ABEVMY 400 mg/16 ml Interactions ABEVMY 400 mg/16 ml

Drug interactions can affect the safety and efficacy of ABEVMY. Consider these points:

• Chemotherapy Agents: Commonly used with drugs like paclitaxel, carboplatin, irinotecan, and fluorouracil. Co-administration requires monitoring due to overlapping toxicities such as myelosuppression and increased risk of bleeding.
• Anticoagulants and Antiplatelets: Bevacizumab may increase bleeding risk; caution is advised when combined with warfarin, aspirin, or other blood thinners.
• Antihypertensive Medications: Since ABEVMY can cause or exacerbate hypertension, dose adjustments of blood pressure medications may be necessary.
• NSAIDs and Corticosteroids: These may increase bleeding tendencies and should be used cautiously.
• Other Anti-Angiogenic Agents: Combining with other VEGF inhibitors or tyrosine kinase inhibitors targeting VEGF receptors is generally avoided to prevent compounded adverse effects.
• Vaccinations: Live vaccines should be avoided during treatment due to potential immunosuppression.

Always review the patient's full medication list to identify potential interactions before starting therapy.

Dosage of ABEVMY 400 mg/16 ml

The dosage depends on the specific indication, patient condition, and oncologist’s clinical judgment:

• Typical Dosing: Commonly administered at 5 mg/kg or 10 mg/kg body weight every 2 or 3 weeks via intravenous infusion.
• Preparation: The 400 mg vial is diluted to an appropriate volume before infusion (often in at least 100 ml of compatible IV fluid).
• Adjustments: Dose adjustments may be required in patients with renal or hepatic dysfunction or based on toxicity and tolerability.
• Duration: Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.
• Missed Doses: Administer as soon as possible, then continue the treatment schedule; do not double doses.
• Special Populations: Use caution and tailor doses for elderly patients or those with comorbidities.

Dosing must always be individualized and overseen by oncology specialists.

Possible side effects of ABEVMY 400 mg/16 ml

ABEVMY has a range of possible side effects; monitoring and early management are essential:

• Common Side Effects: Hypertension, fatigue, headache, nosebleeds, proteinuria, and diarrhea.
• Serious Adverse Effects: Gastrointestinal perforation, severe hemorrhage, arterial thromboembolism (such as stroke or myocardial infarction), and wound healing complications.
• Infusion Reactions: Fever, chills, rash, dyspnea, or hypotension occurring during or shortly after infusion.
• Infections: Increased risk due to immunomodulatory effects; patients should report any signs of infection promptly.
• Hypersensitivity: Allergic reactions including anaphylaxis, although rare, can occur.
• Kidney Effects: Proteinuria may indicate renal involvement and requires monitoring.
• Others: Abdominal pain, weight loss, nasal congestion, and hypertension-related complications.

Patients must be counseled to immediately report any unusual symptoms to their healthcare provider.

ABEVMY 400 mg/16 ml Contraindications ABEVMY 400 mg/16 ml

ABEVMY should not be used in the following circumstances:

• Hypersensitivity to Bevacizumab or any ingredient in the formulation.
• Active significant bleeding or recent history of severe hemorrhage.
• Gastrointestinal perforation or fistula within the past 6 months.
• Uncontrolled hypertension despite optimal medical treatment.
• Pregnant or breastfeeding women, unless benefits clearly outweigh risks.
• Patients with compromised wound healing or undergoing major surgery until complete healing.
• History of arterial thromboembolic events within 6 months unless benefits justify the risks.

Appropriate patient evaluation must be done before starting therapy to minimize risk.

Storage of ABEVMY 400 mg/16 ml

Proper storage maintains ABEVMY’s stability and efficacy:

• Store unopened vials refrigerated between 2°C and 8°C (36°F to 46°F).
• Protect from freezing; freezing can irreversibly damage the antibody structure.
• Keep vials in the original carton to protect from light exposure.
• Once diluted, use the solution promptly; do not store diluted solutions beyond 24 hours under recommended conditions.
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