Indications
Docetaxel PhaRes is a microtubule inhibitor indicated for:
- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
- Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
- Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
- Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
- Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
Pharmacology
Dosage & Administration
Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.
- BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent
- BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles
- NSCLC: after platinum therapy failure: 75 mg/m2 single agent
- NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2
- HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
- GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
- SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
- SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles
For all patients:
- Premedicate with oral corticosteroids
- Adjust dose as needed
Interaction
Contraindications
Docetaxel is contraindicated in patients with:
- Neutrophil counts of <1500 cells/mm3
- A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
Side Effects
Pregnancy & Lactation
Precautions & Warnings
- Docetaxel PhaRes should be administered under the supervision of a physician experienced in the use of antineoplastic agents
- There is a higher risk of developing severe adverse reactions including toxic death and fatal gastrointestinal hemorrhage in patients with hepatic impairment
- Docetaxel PhaRes therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3
- Fatal cases of enterocolitis, including ischemic colitis, colitis and neutropenic enterocolitis have been reported
- Severe hypersensitivity reactions, with a potential fatal outcome, requiringb immediate discontinuation of Docetaxel PhaRes may occur. Patients should be closely monitored
- Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel PhaRes
Reviews
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