Paclitaxel Abraxane 100mg Injection

Product Description

1. Technical Specifications

Attribute	Details
Brand Name	Abraxane Injection
Generic Name	Paclitaxel (Albumin-bound Nanoparticle formulation)
Strength	100 mg per vial
Dosage Form	Lyophilized Powder for Suspension for Injection (IV infusion after reconstitution)
Packaging Size	1 vial per pack
Packaging Type	Sterile glass vial
Medicine Type	Anticancer Chemotherapy (Taxane derivative)
Manufacturer	Biocon Biologics India Ltd. (under license from Celgene / BMS)
Distributed By	Authorized oncology distributors / specialty pharmacies in India

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2. Product Description

Abraxane 100 mg Injection (Biocon) contains Paclitaxel bound to albumin nanoparticles.
This novel formulation avoids the use of solvent carriers (e.g., Cremophor EL), significantly reducing hypersensitivity reactions compared to conventional paclitaxel.

• Mechanism: Stabilizes microtubules prevents breakdown inhibits mitosis causes apoptosis in cancer cells.

• Advantage: No need for corticosteroid or antihistamine premedication.

3. Product Highlights

Attribute	Details
Therapeutic Category	Anticancer Taxane Chemotherapy
Application Area	Metastatic Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Metastatic Pancreatic Cancer
Mechanism of Action	Binds to tubulin stabilizes microtubules blocks cell division induces programmed cell death
Administration	Intravenous infusion, administered by oncologists only
Storage Conditions	Store below 25 C; protect from moisture & light; use reconstituted solution immediately or within recommended stability window

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4. Therapeutic Uses

• Metastatic Breast Cancer: Especially for patients resistant to anthracyclines.

• NSCLC (Non-Small Cell Lung Cancer): In combination with carboplatin, first-line therapy for patients not eligible for curative surgery/radiation.

• Metastatic Pancreatic Cancer: In combination with gemcitabine as first-line therapy.

5. Side Effects

Common:

• Fatigue, weakness

• Nausea, vomiting, diarrhea

• Alopecia (hair loss)

• Peripheral neuropathy (numbness/tingling in hands & feet)

• Myalgia, arthralgia

• Low blood counts (anemia, neutropenia, thrombocytopenia)

Serious / Severe:

• Severe neutropenia risk of infections

• Peripheral neuropathy requiring dose modification

• Hepatotoxicity (liver enzyme elevation, jaundice)

• Rare hypersensitivity reactions (less than conventional paclitaxel)

• Pulmonary toxicity (rare but possible)

6. Precautions

• Medical Supervision: Strictly IV infusion in oncology centers only.

• Myelosuppression: CBC monitoring before and during each cycle.

• Liver Impairment: Dose adjustment required.

• Neuropathy: Monitor closely; discontinue or reduce dose if severe.

• Pregnancy/Breastfeeding: Contraindicated (teratogenic); effective contraception required.

• Drug Interactions: CYP3A4 modulators (rifampicin, ketoconazole, erythromycin, etc.) can affect drug levels.