Single Vial Docetaxel Injection - ION Solutions

16.2 Storage
Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). Retain in the original
package to protect from bright light. Freezing does not adversely affect the product. After first use and
following multiple needle entries and product withdrawals, Docetaxel Injection multi-use vials are stable
for up to 28 days when stored between 2°C and 8°C (36°F and 46°F and protected from light.
16.3 Handling and Disposal
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines
on this subject have been published [see References (15)].
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling
• Docetaxel Injection may cause fetal harm. Advise patients to avoid becoming pregnant while
receiving this drug. Women of childbearing potential should use effective contraceptives if
receiving Docetaxel Injection [see Warnings and Precautions (5.10) and Use in Specific
Populations (8.1)].
• Obtain detailed allergy and concomitant drug information from the patient prior to Docetaxel
Injection administration.
• Explain the significance of oral corticosteroids such as dexamethasone administration to the
patient to help facilitate compliance. Instruct patients to report if they were not compliant with
oral corticosteroid regimen.
• Instruct patients to immediately report signs of a hypersensitivity reaction.
• Tell patients to watch for signs of fluid retention such as peripheral edema in the lower
extremities, weight gain and dyspnea.
• Explain the significance of routine blood cell counts. Instruct patients to monitor their
temperature frequently and immediately report any occurrence of fever.
• Instruct patients to report myalgia, cutaneous, or neurologic reactions.
• Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue,
excessive tearing, infusion site reactions, and hair loss are associated with Docetaxel Injection
administration.
Patient Information
Read this Patient Information before you receive your first treatment with Docetaxel Injection and each
time before you are treated. There may be new information. This information does not take the place of
talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Docetaxel Injection
Docetaxel Injection can cause serious side effects, including death.
1. The chance of death in people who receive Docetaxel Injection is higher if you:
• have liver problems
• receive high doses of Docetaxel Injection
• have non-small cell lung cancer and have been treated with chemotherapy medicines that contain
platinum
2. Docetaxel Injection can affect your blood cells. Your doctor should do routine blood tests during
treatment with Docetaxel Injection. This will include regular checks of your white blood cell counts.
Page 42 of 46