Hentaxel Special Precautions

Docetaxel for injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. Because severe hypersensitivity reactions may occur, relevant first aid facilities should be available. Main function index should be closely monitored during infusion.
In patients with abnormal hepatic function, patients on high-dose docetaxel and patients with non-small cell lung cancer previously treated with platinum-based chemotherapy, administered docetaxel at a dose of 100 mg/m², the incidence of death associated with treatment is increased.
All patients should be premedicated with oral corticosteroids eg, dexamethasone 16 mg/day for 4-5 days starting 1 day prior to docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Neutropenia is the most common adverse reaction. Frequent monitoring of leukocyte counts is essential during docetaxel therapy. Docetaxel should not be administered to patients until neutrophils return to be >1500 cells/mm³. If severe neutropenia (<500 cells/mm³ and duration of ≥7 days) occurs during docetaxel therapy, dosage decrease is recommended for the next cycle. If the problem recurs, dosing maybe tapered or therapy discontinued.
Hypersensitivity reactions may occur within a few minutes following initiation of a docetaxel infusion. If minor reactions eg, flushing or localized skin reactions occur, cessation of therapy may not be necessary. If severe reactions are observed, ie, blood pressure decreases by >20 mmHg, bronchospasm or eruption/erythema, immediate discontinuation of docetaxel may be required. Patients with a history of severe hypersensitivity reactions should not be rechallenged with docetaxel for injection.
During docetaxel therapy, peripheral neurotoxicity may occur. If it is severe, dosage decrease is recommended for next administration.
If observed cutaneous reactions include localized erythema of the extremities, edema and desquamation, therapy may be interrupted or discontinued.
Patients with liver function impairment: If serum transaminase (ALT and/or AST) is >1.5 times the upper limit of normal (ULN) concomitant with alkaline phosphatase >2.5 times ULN, there is a high-risk for severe adverse reactions, eg, toxicity, death, including lethal pyemia, GIT bleeding and febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia. Liver function tests should be conducted at baseline and before each chemotherapy cycle.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women using docetaxel for injection. If docetaxel for injection is used during pregnancy, or if the patient becomes pregnant while receiving Hentaxel, the patient should be apprised of the potential hazard to the fetus or potential risk for loss of pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with docetaxel.
Use in lactation: It is not known whether docetaxel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from docetaxel for injection, mothers should discontinue nursing prior to taking the drug.
Use in children: The safety and effectiveness of docetaxel in pediatric patients have not been established.