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Careful Administration (Docetaxel should be administrated with care in the following patients.): Patients with bone-marrow suppression [Bone-marrow suppression may worsen and severe infection, etc. may concomitantly occur].
Patients with interstitial pneumonia or pulmonary fibrosis [Symptoms may worsen].
Patients with liver disorder [Blood concentration of this drug may increase and adverse reactions may be enhanced.] (see Other Precautions as follows).
Patients with renal disorder [Renal disorder may worsen].
Patients with edema [Edema may worsen].
Patients who may become pregnant (see Important Precautions as follows).
Important Precautions: Since serious bone-marrow suppression occur frequently, be cautious about the following: (1) Adequate observation of the patient's condition such as frequent laboratory testing (blood test, etc.) should be performed. If any abnormality is observed, take proper measures such as dose reduction or withholding.
(2) Pay extra attention to the onset of infection and check the presence or absence of symptoms such as neutropenia, elevated CRP, and fever. If the infection occurs or worsens, immediately take proper measures such as administration of antibiotics (In a clinical study in Japanese patients conducted by another company, the incidence of infection was higher in patients with prostate cancer [70 mg/m2] comparing with patients with other types of cancer [70 mg/m2]).
Since efficacy on focus of brain metastasis has not yet been established, consider other treatments regarding focus of brain metastasis.
Since serious symptoms of irritation due to this drug may appear, patients should be adequately observed especially at the first and second administration of this drug. Since symptoms of irritation may appear within few minutes after starting administration of this drug, patients should be adequately observed for 1 hour after starting administration of this drug with frequent monitoring of vital signs (such as blood pressure and pulse rate), etc. If serious symptoms of irritation (such as dyspnea, bronchospasm, decreased blood pressure, chest pressure sensation, and rash) should be observed, immediately stop administration of this drug and take appropriate measures. This drug should not be re-administered to patients who have developed serious symptoms of irritation. (See Other Precautions as follows and Clinically significant adverse reactions under Adverse Reactions.)
Adequate observation about cardiocirculatory system should be performed (Occasionally, cardiac failure, decreased blood pressure, arrhythmia, palpitation, etc. may occur).
Since embryotoxicity (such as embryonic resorption, fetal death, growth retardation), and findings indicating teratogenicity were observed in animal studies (rats), be cautious about the following: (1) Confirm before starting administration that the patient is not pregnant.
(2) As a general rule, this drug should not be administered to patients who may become pregnant. If this drug is administered by necessity, give sufficient explanation that this drug can cause obstruction in maintenance of pregnancy and development of fetus and instruct to use contraception without fail.
(3) If pregnancy is confirmed or suspected while the patients are on this drug, discontinue administration immediately.
Testicular toxicity has been observed in animal studies (mice, rats, dogs). If this drug must be administered to patients of reproductive age, consider about the effects on gonad.
Other Precautions: Premedication in other countries: In Europe and the United States, where the daily maximum dose of docetaxel is 100mg/m2, incidence and seriousness of edema are higher. Therefore, premedication with adrenal corticosteroid for relieving edema and symptoms of irritation is performed. As a premedication, it is considered to be desirable to administer medicine such as dexamethasone (16 mg/day, 8 mg twice daily) orally as a single agent for 3 days from 1 day before starting docetaxel. However, deaths due to serious hypersensitivity (anaphylactic shock) in patients with premedication have been reported.
In addition, there is the following report regarding edema: When docetaxel 100mg/m2 was intravenously infused at a three-week interval, incidence of edema increased when cumulative dose (median) of 818.9mg/m2 or more was administered in previously mentioned patients with premedication, and 489.7mg/m2 or more in patients without premedication.
After discontinuation of docetaxel, edema gradually improves. Edema develops from lower extremities and it may become generalized with increase of body weight by 3 kg or more, but it is not accompanied by acute oliguria or hypotension. Dehydration and pulmonary edema have been infrequently reported.
Administration to patients with abnormal hepatic function in other countries: In other countries, when docetaxel 100mg/m2 was intravenously infused at a three-week interval, enhancement and worsening of serious adverse reactions were observed when docetaxel was administered in patients with increased transaminase (more the 1.5 times of upper limit of normal) with increased blood alkaline phosphatase level (more the 2.5 times of upper limit of normal), and in patients with increased blood bilirubin (exceeding upper limit of normal). Reported adverse reactions include grade 4 neutropenia, febrile neutropenia, infection, serious thrombocytopenia, serious stomatitis, and skin symptoms such as peeling of skin. It was warned that risk of treatment-related death would increase.
Occurrence of acute leukemia and myelodysplastic syndrome (MDS) were reported in patients who concomitantly received this drug and other antineoplastics or radiation therapy.
Among mutagenicity tests, positive results in both of chromosomal aberration assay using cultivated cell line from Chinese hamster ovary (CHO-K1) and micronucleus test using mice have been obtained.
In a phase II clinical study in Japan conducted by another company, with the administration method of 35 mg/m2 once weekly (35 mg/m2 once daily, administered on Days 1, 8, 15, repeated every 4 week) against non-small cell lung cancer, interstitial pneumonia was noted in 6 patients among 48 patients. (Unapproved dosage and administration).
**In the overseas clinical trial of postoperative adjuvant chemotherapy for breast cancer patients conducted by another company, cases of continuous hair loss in patients administrated with the combination of docetaxel and other antineoplastic agent were reported at the end of observation period (incidence rate 3.9%(29/744), median of observation period 96 months).
Use in the Elderly: Be cautious about adverse reactions and pay attention to dosage interval and dose. If any adverse reactions occur, take proper measures such as withholding or extending dosage interval. [Elderly patients generally have reduced physiological function.]
Use in Children: The safety of this drug in low birth weight infants, neonates, infants, toddlers, and children has not yet been established (no clinical experience).
