ABRAXANE 5 mg/ml Powder for suspension 20ml Vial

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Product Overview

Key Benefits

• Targeted delivery of paclitaxel to cancer cells due to its albumin-bound nanoparticle form.
• Effective in treating metastatic breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma.
• May be used in patients who have failed prior chemotherapy or for whom other treatments are not suitable.
• Potentially reduces the risk of severe hypersensitivity reactions compared to solvent-based paclitaxel, as it does not require pre-medication with corticosteroids and antihistamines.
• Improved tumor response rates and progression-free survival in certain indications.

How to Use

Abraxane is a powerful medication and must be administered by a healthcare professional experienced in the use of chemotherapeutic agents. The following steps outline the general process and are for informational purposes only. Always follow your doctor's specific instructions and the preparation guidelines provided in the official prescribing information.

1. Abraxane is supplied as a sterile, lyophilized powder containing 100 mg of paclitaxel in a single-use vial.
2. The powder must be reconstituted by a trained healthcare professional using 20 mL of 0.9% Sodium Chloride Injection to achieve a concentration of 5 mg/mL.
3. Gently swirl the vial for at least 2 minutes to ensure complete dissolution, avoiding vigorous shaking.
4. The reconstituted suspension should be milky and homogeneous. If visible particulates are present, it should be gently inverted until dissolution.
5. Immediately after reconstitution, the required amount of suspension should be further diluted for intravenous infusion into an appropriate infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
6. The final concentration for infusion should be between 0.6 mg/mL and 1.2 mg/mL.
7. Administer the infusion intravenously over a period of 30 to 40 minutes, as directed by your physician.
8. Do not use if the reconstituted solution is discolored or contains particulate matter after appropriate mixing.

Caution & Warnings

• FOR INTRAVENOUS USE ONLY. Abraxane should only be administered under the supervision of a physician experienced in the use of antineoplastic agents.
• Bone Marrow Suppression: Severe myelosuppression (neutropenia, anemia, thrombocytopenia) is common and dose-limiting. Monitor complete blood counts frequently.
• Peripheral Neuropathy: May occur and is often dose-dependent. Monitor for symptoms of neuropathy, which can be severe and persistent. Dose reduction or interruption may be required.
• Hypersensitivity Reactions: While less common than with solvent-based paclitaxel, severe and rare fatal hypersensitivity reactions can still occur.
• Hepatic Impairment: Patients with hepatic impairment may have increased exposure to paclitaxel. Dose adjustments may be necessary.
• Pregnancy and Lactation: Abraxane can cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy. Women should not breastfeed during treatment.
• Drug Interactions: Be aware of potential interactions with other medications, especially those metabolized by CYP2C8 and CYP3A4.
• Extravasation: Care should be taken to avoid extravasation during infusion.
• Keep out of reach of children.
• Store as per recommended conditions (unreconstituted at room temperature, reconstituted solutions often require refrigeration if not used immediately).

Ingredients

• Active Ingredient: Paclitaxel (as albumin-bound nanoparticles). Each vial contains 100 mg of paclitaxel.
• Excipients: Human albumin.

Product Details

• Strength: 100 mg per vial (reconstitutes to 5 mg/ml with 20 ml diluent)
• Form: Powder for Suspension for Infusion
• Package Size: 1 Vial
• Manufacturer: Bristol-Myers Squibb
• Brand: Abraxane