1. Drug Identification

  • Brand Name: ABRAXANE®
  • Generic Name: paclitaxel protein-bound particles for injectable suspension (albumin-bound)

2. Available Strengths and Vial Sizes

  • 100 mg of paclitaxel in single-use vial

3. Storage Conditions (Unopened Vials)

  • Unopened vials should be stored at 20°C to 25°C (68°F to 77°F)
  • Excursions permitted between 15°C to 30°C (59°F to 86°F)
  • Original package protected from light

4. Special Compounding Considerations

  • Reconstitution time: Allow approximately 20 minutes for complete dissolution
  • Handling instructions: Gently swirl and/or invert the vial slowly to reconstitute
  • Do not shake or vigorously agitate

5. Reconstitution Diluent

  • Sterile 0.9% Sodium Chloride Injection, USP

6. Amount of Diluent Required

  • 20 mL of 0.9% Sodium Chloride Injection, USP per vial

7. Reconstituted Concentration

  • 5 mg/mL suspension

8. Compatible Solutions for Dilution

  • 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP

9. IV Bag Size

  • Not specifically stated in the package insert; depends on the calculated dose

10. Specific Concentration Range

  • Administer as 5 mg/mL suspension; no further dilution is required

11. Special Syringe Requirements

  • Use appropriate aseptic technique
  • Not specified for special syringes

12. Filter Requirements

  • In-line filtration should NOT be used during administration

13. Final Appearance

  • Slightly milky to yellow suspension

14. Storage of Reconstituted Product

  • Reconstituted suspension should be used immediately but may be refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours if necessary
  • If not used immediately, the vial of reconstituted suspension can be stored in a refrigerator for a maximum of 24 hours

15. Light Protection During Administration

  • Protection from light is required during storage, but specific light protection during administration is not explicitly stated

16. Hazardous Classification

  • Classified as hazardous
  • Can cause fetal harm when administered to pregnant women
  • Potential risk of birth defects

17. Oncology Use

  • Yes, indicated for:
    • Metastatic breast cancer
    • Non-small cell lung cancer (NSCLC)
    • Metastatic adenocarcinoma of the pancreas (in combination with gemcitabine)

Additional Important Notes:

  • ABRAXANE is NOT interchangeable with other paclitaxel formulations

Based on the FDA package insert information from 2020:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021660s047lbl.pdf