Abraxane® is a solvent‑free, nanoparticle albumin‑bound formulation of paclitaxel supplied as a sterile, white‑to‑yellow, lyophilized powder in single‑dose vials for intravenous infusion; each 100 mg vial contains paclitaxel bound to approximately 900 mg human albumin, and 250 mg vials are also available in some markets, both reconstituted to 5 mg/mL with 0.9% sodium chloride . Manufactured originally by Abraxis BioScience (now Celgene, a Bristol‑Myers Squibb company), it is approved for metastatic breast cancer, first‑line non‑small cell lung cancer (in combination with carboplatin), and metastatic pancreatic adenocarcinoma (with gemcitabine) in adults .
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Composition & Formulation
Active Ingredient: Paclitaxel 100 mg or 250 mg per vial, bound to human serum albumin as ~130 nm nanoparticles .
Excipients: Human albumin (~900 mg per 100 mg vial), sodium caprylate, sodium acetyltryptophanate; no Cremophor EL or other solvents .
Reconstitution: Add 20 mL 0.9% NaCl to 100 mg vial (or 50 mL to 250 mg vial) over ≥ 1 minute; yields 5 mg/mL suspension. Use immediately or refrigerate (2–8 °C) ≤ 24 h in vial, then ≤ 4 h at ambient temperature after transfer to infusion bag .
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Indications & Uses
1. Metastatic Breast Cancer (MBC): After failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant therapy (anthracycline unless contraindicated) .
2. Non‑Small Cell Lung Cancer (NSCLC): First‑line treatment of locally advanced or metastatic disease, in combination with carboplatin, in patients unsuitable for curative surgery or radiation .
3. Metastatic Adenocarcinoma of the Pancreas: First‑line therapy in combination with gemcitabine .
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Mechanism of Action
Paclitaxel binds to β‑tubulin within microtubules, preventing their depolymerization and thereby inhibiting the dynamic reorganization of the microtubule network essential for mitosis, leading to cell cycle arrest (G2/M phase) and apoptosis .
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Pharmacokinetics
Administration & Absorption: Intravenous infusion yields 100% systemic availability.
Distribution: Extensive tissue distribution; high plasma protein binding (89–98%) .
Metabolism: Hepatic via CYP2C8 and CYP3A4 to inactive metabolites .
Elimination: Terminal half‑life ~5.8 hours; excreted in feces (major route) and urine (minor) .
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Dosage and Administration
Metastatic Breast Cancer
Dose: 260 mg/m² IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity .
NSCLC
Dose: Same 260 mg/m² IV over 30 minutes on Day 1 of a 21‑day cycle, combined with carboplatin (AUC 6) on Day 1 .
Pancreatic Cancer
Dose (MPACT regimen): Nab‑paclitaxel 125 mg/m² IV over 30 minutes followed by gemcitabine 1 000 mg/m² IV on Days 1, 8, and 15 of each 28-day cycle .
Dosage Modifications
Myelosuppression: Withhold or reduce dose for Grade 3–4 neutropenia or thrombocytopenia per prescribing guidelines .
Neuropathy: Hold until ≤ Grade 1, then resume at next lower dose level .
Hepatic Impairment: Reduce initial dose in moderate–severe impairment; avoid if bilirubin > 5 × ULN or AST > 10 × ULN .
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Side Effects & Precautions
Common: Neutropenia, peripheral sensory neuropathy, alopecia, fatigue, nausea, myalgia, arthralgia, anemia, thrombocytopenia .
Serious: Febrile neutropenia, sepsis (especially with biliary obstruction), severe hypersensitivity, pneumonitis, cardiotoxicity in predisposed patients .
Hypersensitivity: Severe reactions possible; do not require routine premedication (no Cremophor EL), but monitor for anaphylaxis and discontinue permanently if severe .
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Contraindications
Baseline ANC < 1 500 cells/mm³ .
History of severe hypersensitivity to Abraxane or albumin-containing products .
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Reconstitution, Packaging & Storage
Vial Strengths: 100 mg and 250 mg single‑dose vials.
Reconstitution: 0.9% NaCl, USP (20 mL for 100 mg; 50 mL for 250 mg).
Storage (Lyophilized): 2–8 °C, protect from light.
Post‑Reconstitution: Use immediately or store 2–8 °C ≤ 24 h (vial or infusion bag), then ambient ≤ 4 h; discard unused .
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Pricing & Availability
U.S. Cash Price: Approximately USD 1 700 per 100 mg vial (brand) and ~USD 1 254 for generics .
Global: Widely available by prescription in oncology centers; reimbursement varies by country.
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References
1. DailyMed: ABRAXANE paclitaxel injection, powder, lyophilized…
2. DailyMed: PACLITAXEL PROTEIN-BOUND PARTICLES albumin-bound…
3. eMC: Abraxane® 5 mg/mL powder for dispersion for infusion (UK)
4. DailyMed (PDF): ABRAXANE Indications – breast, lung, pancreas
5. PMC: Taxol® mechanism review
6. NCBI PubChem & Wikipedia: Paclitaxel pharmacokinetics
7. NEJ
M MPACT trial: Gemcitabine + nab‑paclitaxel in pancreatic cancer
8. Medscape: Dose modifications & safety
9. Drugs.com: Abraxane price guide
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