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
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