Each single-dose vial contains: Docetaxel Trihydrate equivalent to Anhydrous Docetaxel 20 mg, Polysorbate 80 IP 0.5 ml
Each single-dose vial contains Docetaxel Trihydrate equivalent to Anhydrous Docetaxel 80 mg, Polysorbate 80 IP 2 ml
Each single-dose vial contains: Docetaxel Trihydrate equivalent to Anhydrous Docetaxel 120 mg, Polysorbate 80 IP 2 ml
Without a Prescription
Docetaxel is prescribed for the treatment of:
Docetaxel is prescribed for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
The recommended dose of Docetaxel is 60-100 mg/m 2 administered intravenously over 1 hour every 3 weeks.
In order to reduce adverse reactions like fluid retention, it is recommended that every patient should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day for 4-5 days starting 1 day before the administration of Docetaxel.
Docetaxel should not be administered until the neutrophil count is at least 1500 cell/mm 3.
Patients who experience either febrile neutropenia, neutrophil < 500 cell/mm 3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during Docetaxel therapy should have the dosage of Docetaxel reduced from 100 mg/m 2 to 75 mg/m2.
If the patient continues to experience these reactions at 75 mg/m 2, the dosage should be decreased from 75 mg/m 2 to 55 mg/m 2.
Preparation for the Intravenous administration
a. Preparation of Docetaxel premix solution:
Take out the required number of vials of Docetaxel from the refrigerator and allow them to stand for 5 minutes to bring it to room temperature.
Withdraw the entire contents of the solvent vial into a syringe and transfer especially to the vial of Docetaxel.
Gently rotate each premix solution vial for approximately 15 seconds to assure full mixture of the concentrate and the diluent.
The solution should be clear and homogenous.
b. Preparation of the infusion solution:
Aseptically withdraw the required amount of Docetaxel premix solution with a calibrated syringe and inject the premix volume into an infusion bag or bottle of either 0.9%.
Sodium Chloride Injection IP or 5% Dextrose Injection IP to produce a final concentration of 0.3 to 0.9 mg Docetaxelel /ml.
The infusion solution should then be thoroughly mixed by manual rotation.
Administer intravenously Docetaxel infusion solution as a one hour infusion under room temperature and normal lighting conditions.
Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended.
c. Preparation and Administration Precaution
Standard procedures for proper handling and disposal of anti-cancer drugs should be considered.
Docetaxel is contraindicated if you have any of the following conditions:
History of hypersensitivity reactions to Docetaxel or Polysorbate 80.
Patients with baseline neutrophil count of <1500 cells/mm 3 .
Carton containing a single-dose Docetaxel-20 vial.
Carton containing Solvent for Docetaxel Injection Concentrate 1.5 ml
Carton containing a single-dose Docetaxel-80 vial.
Carton containing Solvent for Docetaxel Injection Concentrate 6 ml
Carton containing a single-dose Docetaxel-120 vial.
Carton containing Solvent for Docetaxel Injection Concentrate 9 ml