ABEVMY 100 mg/4 ml Concentrate for solution for infusion

What is ABEVMY 100 mg/4 ml

ABEVMY 100 mg/4 ml is a concentrate solution for infusion containing the active ingredient Bevacizumab. Bevacizumab is a monoclonal antibody used as a targeted biological therapy in oncology. It is supplied in a single 4 ml glass vial and administered intravenously under medical supervision.

• ABEVMY is primarily indicated for the treatment of various solid tumors, including metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma, glioblastoma, and cervical cancer.
• It works as an anti-angiogenic agent by inhibiting the formation of new blood vessels that tumors require for growth and metastasis.
• As a biologic therapy, it is often combined with chemotherapy or other anticancer agents to improve therapeutic outcomes.
• The medication is used in adults and must be administered in specialized clinical settings due to its potent effects and potential side effects.
• ABEVMY represents an advanced cancer treatment option that specifically targets the tumor microenvironment rather than the tumor cells directly.

Overall, ABEVMY 100 mg/4 ml is a vital tool in the management of several aggressive cancers, offering improved survival rates when used appropriately.

How to use ABEVMY 100 mg/4 ml

Proper administration of ABEVMY is crucial for maximizing efficacy and minimizing adverse effects. The following points guide its use:

• Preparation: The vial must be diluted before infusion, typically in 0.9% sodium chloride or 5% dextrose solution according to the manufacturer’s instructions.
• Administration Route: Administer intravenously via infusion using an infusion pump to control the rate.
• Infusion Rate: The initial infusion is generally given over 90 minutes; if tolerated, subsequent infusions may be shortened to 30-60 minutes.
• Frequency: Usually administered every 2 or 3 weeks depending on the cancer type and treatment protocol.
• Pre-medication: Premedication is generally not required but may be used to prevent infusion-related reactions in some patients.
• Monitoring: Continuous monitoring during infusion for signs of hypersensitivity, hypertension, or other acute reactions is essential.
• Combination Therapy: Often given with chemotherapy; coordination with oncologists is necessary to manage schedules and interactions.

Only trained healthcare professionals should prepare and administer ABEVMY to ensure patient safety.

Mode of Action ABEVMY 100 mg/4 ml

ABEVMY contains Bevacizumab, a recombinant humanized monoclonal antibody with a specific mechanism targeting tumor angiogenesis:

• VEGF Inhibition: Bevacizumab binds to vascular endothelial growth factor A (VEGF-A), a protein essential for angiogenesis (the growth of new blood vessels).
• Blocking Blood Vessel Formation: By neutralizing VEGF-A, ABEVMY prevents VEGF from interacting with its receptors (VEGFR-1 and VEGFR-2) on endothelial cells.
• Starving Tumors: Without new blood vessels, tumors receive less oxygen and nutrients, which inhibits their growth and reduces metastatic potential.
• Normalization of Vasculature: In some cases, ABEVMY may transiently normalize abnormal tumor blood vessels, improving delivery of chemotherapy agents.
• Specificity: The targeted action on VEGF-A spares most normal tissues, reducing systemic toxicity compared to traditional chemotherapy.

This anti-angiogenic mode of action forms the basis for ABEVMY’s effectiveness in controlling tumor progression.

ABEVMY 100 mg/4 ml Interactions ABEVMY 100 mg/4 ml

Drug interactions with ABEVMY must be carefully considered to avoid enhanced toxicity or reduced effectiveness:

• Chemotherapy Agents: Often combined with agents like fluorouracil, irinotecan, paclitaxel, or carboplatin. Close monitoring is required due to overlapping toxicities such as myelosuppression and hypertension.
• Anticoagulants: Bevacizumab can increase the risk of bleeding; co-administration with warfarin or other blood thinners necessitates careful INR and bleeding risk assessment.
• Anti-hypertensive Drugs: ABEVMY may cause or exacerbate hypertension, potentially requiring adjustments in antihypertensive therapy.
• NSAIDs and Corticosteroids: These may affect platelet function and bleeding risk when used concurrently.
• Live Vaccines: Use with caution as ABEVMY can impair wound healing and immune response.
• Other Targeted Therapies: Concomitant use with other VEGF inhibitors or anti-angiogenic agents is generally avoided due to increased risk of adverse events.

Always inform the healthcare team of all medications, supplements, and herbal products before starting therapy.

Dosage of ABEVMY 100 mg/4 ml

The dosage of ABEVMY varies based on the type of cancer, patient condition, and treatment protocol:

• Typical Dose: The most common dose is 5 mg/kg or 10 mg/kg body weight administered every 2 or 3 weeks intravenously.
• Infusion Volume: The drug is diluted to appropriate volume before infusion (e.g., 100 ml or more of saline).
• Adjustments: Dose adjustments may be required in patients with renal or hepatic impairment or based on toxicity profile.
• Duration: Treatment duration depends on clinical response, tolerance, and cancer type; therapy may continue until disease progression or unacceptable toxicity.
• Special Populations: Use in elderly patients requires caution and monitoring; pediatric use is limited and based on specialist advice.
• Missed Dose: Administer as soon as possible and adjust the schedule accordingly; do not double doses.

Only oncology specialists should determine and supervise the exact dosing regimen.

Possible side effects of ABEVMY 100 mg/4 ml

ABEVMY can cause a range of side effects; patients should be closely monitored for these adverse reactions:

• Common Side Effects: Hypertension, fatigue, headache, proteinuria, nosebleeds, and diarrhea.
• Serious Side Effects: Gastrointestinal perforation, hemorrhage, arterial thromboembolic events (e.g., stroke, heart attack), wound healing complications, and severe infusion reactions.
• Infusion Reactions: Fever, chills, rash, or breathing difficulties during or shortly after infusion.
• Infections: Increased susceptibility to infections due to immunomodulation.
• Hypersensitivity: Allergic reactions ranging from mild rash to anaphylaxis.
• Kidney Effects: Proteinuria and potential renal impairment.
• Others: Abdominal pain, weight loss, hypertension-related complications.

Prompt reporting of side effects to healthcare providers is essential to manage risks effectively.

ABEVMY 100 mg/4 ml Contraindications ABEVMY 100 mg/4 ml

ABEVMY should not be used in the following conditions:

• Known hypersensitivity to Bevacizumab or any component of the formulation.
• Patients with recent history of significant hemorrhage or gastrointestinal perforation.
• Severe uncontrolled hypertension despite optimal medical management.
• Pregnant or breastfeeding women, unless the potential benefit outweighs risks, due to possible fetal harm.
• Patients with severe wound healing disorders or those scheduled for major surgery until wound healing is complete.
• Use with caution in patients with cardiovascular disease due to risk of thromboembolism.

Strict patient evaluation and risk-benefit analysis should precede therapy initiation.

Storage of ABEVMY 100 mg/4 ml

Proper storage of ABEVMY ensures its stability and safety:

• Store the unopened vial refrigerated at 2°C to 8°C (36°F to 46°F).
• Do not freeze the product; freezing can damage the monoclonal antibody.
• Protect from light by keeping the vial in the outer carton until use.
• After dilution, use the infusion solution promptly; do not store diluted solutions for more than 24 hours under recommended conditions.
• Keep out of reach of children and unauthorized personnel.

Adhering to storage recommendations maintains drug efficacy and patient safety.