ABRAXANE 100mg Injection/Suspension for

What is ABRAXANE 100mg

ABRAXANE 100mg is a chemotherapy medication formulated as an injection/suspension containing paclitaxel bound to albumin nanoparticles (protein-bound particles). It is supplied in a 50ml single-use glass vial designed for intravenous infusion. This novel formulation improves the delivery and reduces some toxicities associated with conventional paclitaxel formulations.

• ABRAXANE is primarily used to treat various cancers, including metastatic breast cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer.
• The albumin-bound formulation enhances solubility and allows higher drug concentrations without the need for toxic solvents like Cremophor EL.
• This results in a reduced risk of hypersensitivity reactions and shorter infusion times compared to traditional paclitaxel.
• ABRAXANE is administered under strict medical supervision by oncology specialists as part of combination chemotherapy regimens or as monotherapy in certain cases.
• The medication is a key component in treatment protocols aimed at inhibiting tumor growth and improving survival outcomes in cancer patients.

Overall, ABRAXANE offers an effective chemotherapeutic option leveraging nanoparticle technology for enhanced cancer treatment.

How to use ABRAXANE 100mg

Proper administration of ABRAXANE 100mg is critical for maximizing therapeutic effects and minimizing risks. Important points include:

• Preparation: The suspension is provided as a ready-to-use vial and requires dilution with an appropriate intravenous solution such as 0.9% sodium chloride or 5% dextrose before infusion.
• Infusion: Administer ABRAXANE via intravenous infusion over approximately 30 minutes. Use a non-PVC infusion set to avoid leaching of plasticizers.
• Premedication: Unlike conventional paclitaxel, ABRAXANE generally does not require corticosteroid or antihistamine premedication, though clinical judgment should guide this.
• Dosing Schedule: Typically administered every 3 weeks (21-day cycles), either alone or in combination with other chemotherapy agents as per oncology protocols.
• Monitoring: Patients should be closely observed for infusion-related reactions, blood counts, and other chemotherapy-related toxicities.
• Handling: Follow aseptic techniques during preparation and administration. Use protective gloves and minimize exposure to the drug.
• Single Use: The vial is for single use only; discard any unused portion.

Following these steps ensures safe and effective use of ABRAXANE in cancer therapy.

Mode of Action ABRAXANE 100mg

ABRAXANE’s active component, paclitaxel, acts as a potent antineoplastic agent through several mechanisms:

• Microtubule Stabilization: Paclitaxel binds to β-tubulin subunits in microtubules, stabilizing them and preventing their normal dynamic disassembly during cell division.
• Mitotic Arrest: This stabilization disrupts the mitotic spindle, arresting cells in the G2/M phase of the cell cycle and inhibiting mitosis.
• Induction of Apoptosis: The prolonged mitotic arrest leads to programmed cell death (apoptosis) of rapidly dividing cancer cells.
• Albumin-Bound Delivery: The nanoparticle albumin-bound formulation facilitates receptor-mediated transport across endothelial cells, enhancing tumor targeting and drug accumulation.
• Reduced Solvent Toxicity: Avoidance of Cremophor EL solvent reduces hypersensitivity and other solvent-related adverse effects.

Through these actions, ABRAXANE effectively halts cancer cell proliferation and contributes to tumor regression.

ABRAXANE 100mg Interactions ABRAXANE 100mg

Drug interactions can affect the safety and efficacy of ABRAXANE. Key considerations include:

• CYP2C8 and CYP3A4 Metabolism: Paclitaxel is metabolized primarily by these hepatic enzymes. Strong inhibitors (e.g., ketoconazole, clarithromycin) can increase paclitaxel levels, increasing toxicity risk.
• Inducers of CYP450 Enzymes: Drugs like rifampin or phenytoin may reduce paclitaxel plasma concentration, potentially lowering efficacy.
• Other Chemotherapy Agents: When used in combination, overlapping toxicities such as myelosuppression must be monitored.
• Anticoagulants: Paclitaxel may potentiate anticoagulant effects, requiring careful monitoring of coagulation parameters.
• Live Vaccines: Immunosuppressive effects may reduce vaccine efficacy or increase risk of infection.
• Concomitant Medications: Monitor for additive neuropathy risk with other neurotoxic drugs (e.g., platinum agents).

Close clinical assessment and appropriate dose adjustments or monitoring can help manage these interactions.

Dosage of ABRAXANE 100mg

The dosing of ABRAXANE depends on the cancer type, patient status, and treatment regimen:

• Metastatic Breast Cancer: Typically 260 mg/m² intravenously over 30 minutes every 3 weeks.
• Non-Small Cell Lung Cancer: Often combined with carboplatin, dosed at 100 mg/m² on days 1, 8, and 15 of a 21-day cycle.
• Pancreatic Cancer: Used in combination with gemcitabine, dosed at 125 mg/m² on days 1, 8, and 15 every 28 days.
• Dose Adjustments: Required for patients with hepatic impairment, severe neutropenia, or neuropathy.
• Body Surface Area: Dosing is based on body surface area (BSA), calculated from weight and height.
• Monitoring: Regular blood tests to assess blood counts and liver function are mandatory during therapy.
• Missed Dose: Should be administered as soon as possible, but avoid administration within 3 days of the next scheduled dose.

Dosing must be individualized and guided by oncology specialists.

Possible side effects of ABRAXANE 100mg

ABRAXANE may cause various side effects, ranging from mild to severe. Important ones include:

• Common Side Effects: Fatigue, nausea, vomiting, alopecia (hair loss), peripheral neuropathy (tingling or numbness in hands/feet), and myelosuppression (low blood counts).
• Hematologic Toxicity: Neutropenia, anemia, and thrombocytopenia increase infection and bleeding risk.
• Hypersensitivity Reactions: Less common due to albumin formulation but can include rash, itching, or anaphylaxis.
• Neuropathy: Dose-limiting peripheral neuropathy characterized by numbness, pain, or motor weakness.
• Liver Toxicity: Elevated liver enzymes and rarely severe hepatic dysfunction.
• Cardiovascular Effects: Rare arrhythmias or hypotension.
• Other: Mucositis, diarrhea, fever, and joint pain.

Patients must report any new or worsening symptoms promptly for timely management.

ABRAXANE 100mg Contraindications ABRAXANE 100mg

ABRAXANE should not be used in the following situations:

• Known hypersensitivity to paclitaxel, albumin, or any component of the formulation.
• Severe baseline neutropenia or thrombocytopenia due to increased risk of severe myelosuppression.
• Pregnancy and breastfeeding unless benefits outweigh risks; consult oncology and obstetric specialists.
• Severe hepatic impairment as metabolism and clearance may be significantly reduced.
• Uncontrolled infections or medical conditions that increase risk of complications.
• Use with caution in patients with pre-existing peripheral neuropathy or cardiovascular disease.

Thorough patient evaluation is essential before starting therapy.

Storage of ABRAXANE 100mg

Proper storage is important to maintain ABRAXANE’s stability and efficacy:

• Store the vial in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Protect from light; keep the vial in its original carton until use.
• Do not freeze the product as freezing can compromise its stability.
• Once opened, the suspension should be used immediately and not stored for later use.
• Keep out of reach of children and unauthorized persons.
• Dispose of any unused or expired medication according to local regulations for cytotoxic drugs.

Adherence to storage guidelines ensures drug potency and patient safety.