DOCETAXEL SPC Concentrate for Solution for Infusion
Docetaxel
20 mg/ml
SUDAIR PHARMA COMPANY
| Pack size | 1 Glass Vial (1 ml) |
|---|---|
| Dispensing mode | POM |
| Source | SAUDI ARABIA |
| Agent | Gulf Drug LLC |
| Retail Price | 221.50 AED |
Available as:
Indications
DOCETAXEL SPC Concentrate for Solution for Infusion is used for:
Breast cancer, Lung cancer, Prostate cancer, Stomach cancer, Head/neck cancer
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 neck cancer: Given before cisplatin and fluorouracil for 3 cycles followed by chemoradiotherapy or 4 wk followed by radiotherapy alone.
For prostate cancer: May be given w/ oral prednisolone 5 mg bid continuously during treatment.
Child Dose
Renal Dose
Renal Impairment
Dose adjustment not necessary
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 polyolefin plastic bag to prevent leaching of plasticizers
Use within 4 hr (including the 1 hr infusion)
IV Administration
Anaphylactoid-like reactions have been reported: premedicate with dexamethasone (Breast CA, NSCLC: 8 mg PO q12hr for 3 days starting 1 day prior to administration of docetaxel; Prostate CA: 8 mg PO at 12 hr-, 3 hr- and 1 hr preinfusion)
Infuse over 1 hr
When administered as sequential infusions, taxane derivatives should be administered before platinum derivatives (cisplatin, carboplatin) to limit myelosuppression and to enhance efficacy
Contra Indications
Previous severe hypersensitivity reaction to docetaxel, the solvent or polysorbate 80. Severe neutropenia; pregnancy, severe liver impairment.
Precautions
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
Pregnancy-Lactation
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 reproductive potential
Lactation
There is no information regarding presence of docetaxel in human milk, or effects on milk production or the breast-fed child; no lactation studies in animals have been conducted; because of potential for serious adverse reactions in a breast-fed child from docetaxel exposure, including toxic death, hepatotoxicity, neutropenia, and acute myeloid leukemia, advise women not to breastfeed during treatment and for 2 weeks after last dose
Interactions
CYP3A4 inducers, inhibitors, or substrates may alter docetaxel metabolism.
Adverse Effects
Side effects of Docetaxel :
>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.
Mechanism 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.
Note
DOCETAXEL SPC 20 mg/ml Concentrate for Solution for Infusion manufactured by SUDAIR PHARMA COMPANY. Its generic name is Docetaxel. DOCETAXEL SPC is availble in United Arab Emirates.
Farmaco UAE drug index information on DOCETAXEL SPC Concentrate for Solution for Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.