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Home › All Therapies › Abraxane

Abraxane

nab-paclitaxel
Microtubule Inhibitor FDA Approved 2005 Celgene / BMS
Route
IV
Half-Life
27 hrs
FDA Approved
2005
Manufacturer
Celgene / BMS
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1. Indications and Usage

Breast cancer: Metastatic breast cancer after failure of combination chemotherapy.
NSCLC: First-line with carboplatin.
Pancreatic cancer: First-line with gemcitabine for metastatic adenocarcinoma.

2. Dosage and Administration

Breast: 260 mg/m² IV Q3W.
NSCLC: 100 mg/m² IV D1,8,15 Q21D.
Pancreatic: 125 mg/m² IV D1,8,15 Q28D before gemcitabine.

3. Dosage Forms and Strengths

Powder for injectable suspension: 100 mg/vial

4. Contraindications

ANC <1500. Severe hypersensitivity.

5. Warnings and Precautions
  • Bone Marrow Suppression: Do not administer if ANC <1500. Monitor CBCs.
  • Sensory Neuropathy: Grade 3 requires dose reduction.
  • Pneumonitis: Fatal cases reported.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Alopecia (90%), Neutropenia (80%), Neuropathy (71%), Fatigue (47%), Myalgia (44%), Nausea (30%), Diarrhea (27%), AST Elevation (39%)

Alopecia
90%
Neutropenia
80%
Neuropathy
71%
Fatigue
47%
Myalgia
44%
Nausea
30%
Diarrhea
27%
AST Elevation
39%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP2C8/CYP3A4: Caution with inhibitors/inducers.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Albumin-bound paclitaxel promotes microtubule assembly and prevents depolymerization, inhibiting mitotic cellular functions.

Pharmacokinetics

Half-life: 27h. Vd: 632 L/m². Protein binding: 89-98%. Feces ~20%, urine ~4%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Abraxane Trials on ClinicalTrials.gov ↗ 📚 PubMed: Abraxane Clinical Trials ↗
FDA-Approved Tumor Types

Abraxane has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Breast Cancer Lung Cancer Pancreatic Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Abraxane. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Abraxane (nab-paclitaxel) approved for?

Abraxane (nab-paclitaxel) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Abraxane (nab-paclitaxel) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Abraxane (nab-paclitaxel) work?

Albumin-bound paclitaxel promotes microtubule assembly and prevents depolymerization, inhibiting mitotic cellular functions.

What are the most common side effects?

Alopecia (90%), Neutropenia (80%), Neuropathy (71%), Fatigue (47%), Myalgia (44%), Nausea (30%), Diarrhea (27%), AST Elevation (39%) Alopecia 90% Neutropenia 80% Neuropathy 71% Fatigue 47% Myalgia 44% Nausea 30% Diarrhea 27% AST Elevation 39%

← All Therapies Full Prescribing Information ↗