Docetaxel PhaRes - Injection Docetaxel - 20mg/Vial 1 Injection(s) / Injection ZAS Corporation Introduction: Docetaxel PhaRes is an anti-cancer medication used for the treatment of breast cancer, non-small cell lung cancer, prostate cancer and cancers of head and neck. It is given as an injection by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks... Uses of Docetaxel PhaRes: Breast cancerNon-small cell lung cancerProstate cancerCancer of head and neck Side effects of Docetaxel PhaRes: BreathlessnessConstipationEdema (swelling)InfectionLoss of appetiteMuscle painNail disorderPainWeakness How to use Docetaxel PhaRes: Your doctor or nurse will give you this medicine. Kindly do not self administer. How Docetaxel PhaRes works: Docetaxel PhaRes is an anticancer medication. It works by interfering with the microtubule structures which help the cancer cells to divide and multiply. This slows the growth of cancer cells and eventually kills them. Indication: Breast cancer, Lung cancer, Prostate cancer, Stomach cancer, Head/neck cancer Administration: IV Preparation Dual vial formulation Requires 2-step dilution Reconstitute vial contents (20 mg/0.5 mL or 80 mg/2 mL) with supplied diluent (13% (w/w) ethanol/water) to obtain a 10 mg/mL solution Further dilute with NS or D5W to a final concentration of 0.3-0.74 mg/mL and prepare in a glass bottle, polypropylene, or polyolefin plastic bag to prevent leaching of plasticizers Use within 4 hr (including the 1 hr infusion) Single vial formulation Requires 1-step dilution Available as 20 mg/mL solution; further dilute with NS or D5W to a final concentration of 0.3-0.74 mg/mL and prepare in a glass bottle, polypropylene, or... Adult Dose: Intravenous Breast cancer Adult: 60-100 mg/m2 by infusion over 1 hr once every 3 wk. In combination w/ doxorubicin or capecitabine or as adjuvant therapy w/ doxorubicin and cyclophosphamide: 75 mg/m2 once every 3 wk. In combination w/ trastuzumab: 100 mg/m2 once every 3 wk. Hepatic impairment: Mild to moderate: Reduce dose from 100 mg/m2 to 75 mg/m2. Severe: Avoid use. Intravenous Head and neck cancer; Prostate cancer ; Non-small cell lung cancer; Gastric adenocarcinoma Adult: 75 mg/m2 by infusion over 1 hr once every 3 wk. For gastric adenocarcinoma: Dose is given before cisplatin and fluorouracil. For head and... Renal Dose: Renal Impairment Dose adjustment not necessary Contraindication: Previous severe hypersensitivity reaction to docetaxel, the solvent or polysorbate 80. Severe neutropenia; pregnancy, severe liver impairment. Mode of Action: Docetaxel disrupts the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. It binds to the free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly, resulting in inhibition of mitosis. Precaution: Lactation. Hepatic impairment. Monitor liver blood function and blood counts regularly. Premedication with oral dexamethsaone at 16 mg daily for 3 days, starting one day before docetaxel treatment is recommended. Lactation: Not known if excreted in breast milk, do not nurse Side Effect: >50% Alopecia,Anemia,Leukopenia,Neutropenia,Asthenia 10-50% Fever,Infections,Fluid retention,Hypersensitivity,Skin reactions,Diarrhea,Nausea,Vomiting,Sensory neuropathy,Myalgia,Nail changes 1-10% Arthralgia,Thrombocytopenia Potentially Fatal: Neutropenia; fluid retention syndrome; anaemia. Pregnancy Category Note: Pregnancy Based on findings in animal reproduction studies and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited available human data are not sufficient to inform drug-associated risk during pregnancy Verify the pregnancy status of females of reproductive potential prior to initiating therapy Contraception Females of reproductive potential: Use effective contraception during treatment and for 6 months following last dose Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months following last dose Infertility Based on findings in animal studies, therapy may impair fertility in males of... Interaction: CYP3A4 inducers, inhibitors, or substrates may alter docetaxel metabolism.