Docetax

Docetax

docetaxel

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Docetaxel.
Indications/Uses
Breast Cancer: In combination with doxorubicin and cyclophosphamide, for the adjuvant treatment of patients with operable node-positive breast cancer and operable node-negative breast cancer.
In combination with doxorubicin for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic chemotherapy for this condition.
As monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Prior chemotherapy should have included an anthracycline or an alkylating agent.
In combination with trastuzumab, for the treatment of metastatic breast cancer whose tumors over express HER2 and without prior chemotherapy for metastatic disease.
In combination with capecitabine, for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Non-Small Cell Lung Cancer (NSCLC): As monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy.
In combination with cisplatin, for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.
Ovarian Cancer: For the treatment of patients with metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy.
Prostate Cancer: In combination with prednisone or prednisolone, for the treatment of patients with androgen independent (hormone-refractory) metastatic prostate cancer.
Gastric Cancer: In combination with cisplatin and 5-fluorouracil (5-FU), for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Squamous Cell Carcinoma of the Head and Neck (SCCHN): In combination with cisplatin and 5-FU, for the induction treatment of patients with locally advanced SCCHN.
As monotherapy, for the treatment of patients with recurrent and/or metastatic SCCHN after failure of previous chemotherapy.
Dosage/Direction for Use
Patients receiving docetaxel should be under the supervision of a physician experienced in the use of chemotherapeutic agents.
Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Premedication Regimen: Premedicate all patients (see as follows for prostate cancer) with oral corticosteroids such as dexamethasone 16 mg per day (8 mg twice daily) for 3 days starting one day before docetaxel administration in order to reduce the incidence and severity of fluid retention and hypersensitivity reactions. Antihistamines have not been shown to be useful in controlling fluid retention.
Prostate Cancer Patients: The pretreatment regimen for hormone-refractory metastatic prostate cancer (given the concurrent use of prednisone or prednisolone) is dexamethasone 8 mg at 12 hours, 3 hours, and 1 hour before docetaxel infusion.
General Dosing Information: Diluted docetaxel solution should be administered as a one-hour IV infusion under ambient temperature and lighting conditions.
Spilling of the solution during docetaxel IV infusion can cause irritation, local tissue necrosis, and/or thrombophlebitis. Immediately interrupt docetaxel administration and administer the remaining dose in another vein if extravasation occurs.
Other Dosing Consideration: Prophylactic Use of Granulocyte-Colony Stimulating Factor (G-CSF): Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities. In addition to G-CSF, the prophylactic use of antibiotics may provide additional benefit.
Recommended Docetaxel Dose: See Table 1.

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Dose Adjustments: During Treatment: General: Administer docetaxel therapy when neutrophil count is ≥1,500 cells/mm3.
Reduce docetaxel dose from 100 mg/m2 to 75 mg/m2 and/or 75 mg/m2 to 60 mg/m2 in patients who develop either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy.
If the patient continues to experience these reactions at 60 mg/m2, docetaxel therapy should be discontinued.
Breast Cancer: Patients who are dosed initially at 100 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, or severe or cumulative cutaneous reactions during docetaxel therapy should have the dosage adjusted from 100 mg/m2 to 75 mg/m2. If the patient continues to experience these reactions, the dosage should either be decreased from 75 mg/m2 to 55 mg/m2 or the treatment should be discontinued. Conversely, patients who are dosed initially at 60 mg/m2 and who do not experience febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during docetaxel therapy, may tolerate higher doses. Patients who develop ≥ grade 3 peripheral neuropathy should have docetaxel treatment discontinued entirely.
Combination therapy with docetaxel in the adjuvant treatment of breast cancer: Docetaxel in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is ≥1,500 cells/mm3. Patients who experience febrile neutropenia should receive G-CSF in all subsequent cycles. Patients who continue to experience this reaction should remain on G-CSF and have their docetaxel dose reduced to 60 mg/m2. Patients who experience grade 3 or 4 stomatitis should have their docetaxel dose decreased to 60 mg/m2. Patients who experience severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have their dosage of docetaxel reduced from 75 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, treatment should be discontinued.
Docetaxel in combination with capecitabine: See Table 2.

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Non-small Cell Lung Cancer: Monotherapy with docetaxel for NSCLC treatment after failure of prior platinum-based chemotherapy: Patients who are dosed initially at 75 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or other grade 3/4 non-hematological toxicities during docetaxel treatment should have treatment withheld until resolution of the toxicity and then resumed at 55 mg/m2. Patients who develop ≥ grade 3 peripheral neuropathy should have docetaxel treatment discontinued entirely.
Combination therapy with docetaxel for chemotherapy-naive NSCLC: For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm3, in patients who experience febrile neutropenia, and in patients with serious non-hematologic toxicities, the docetaxel dosage in subsequent cycles should be reduced to 65 mg/m2. In patients who require a further dose reduction, a dose of 50 mg/m2 is recommended. For cisplatin dosage adjustments, see product's labeling information.
Prostate Cancer: Combination therapy with docetaxel for hormone-refractory metastatic prostate cancer: Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3. For patients who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have the dosage of docetaxel reduced from 75 to 60 mg/m2. Treatment should be discontinued if the patient continues to experience these reactions at 60 mg/m2.
Gastric or Head and Neck Carcinoma: Docetaxel in combination with cisplatin and fluorouracil in gastric cancer or head and neck cancer: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur, docetaxel dose should be reduced from 60 to 45 mg/m2. In case of grade 4 thrombocytopenia, the docetaxel dose should be reduced from 75 to 60 mg/m2. Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3. Discontinue treatment if these toxicities persist. (See Table 3.)

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Special Populations: Patients with Hepatic Impairment: Adjust doses based on levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) as indicated in the Table 4: See Table 4.

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Use in the Elderly: No special dose adjustment is recommended. In combination with capecitabine, capecitabine dose should be reduced (For capecitabine dosage adjustments, see product's labeling information).
Contraindications
Hypersensitivity to docetaxel, polysorbate 80, or any component of the product.
Baseline neutrophil count <1,500 cells/mm3.
Severe liver impairment.
Pregnant or breastfeeding women.
Contraindications for other drugs (e.g., doxorubicin, cyclophosphamide, capecitabine, and prednisone) also apply when such drugs are combined with docetaxel.
Warnings
Toxic Deaths, Hepatotoxicity, Neutropenia, Hypersensitivity Reactions, and Fluid Retention: The incidence of treatment-related mortality associated with docetaxel therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma, and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m2.
Docetaxel should not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 x ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death. Bilirubin, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of docetaxel therapy.
Docetaxel therapy should not be given to patients with neutrophil counts of <1,500 cells/mm3. In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood cell counts should be performed on all patients receiving docetaxel.
Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received a 3-day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy. Docetaxel must not be given to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80.
Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).
Special Precautions
General: All patients should be premedicated with an oral corticosteroid such as dexamethasone prior to docetaxel administration to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Toxic Deaths: Docetaxel has been associated with deaths considered possibly or probably related to treatment in patients with metastatic breast cancer. These were patients who are previously treated or untreated, with normal baseline liver function and those with various tumor types who had abnormal baseline liver function. Almost half of the accounted deaths occurred during the first cycle with sepsis as the major cause.
Deaths were also reported in patients with locally advanced or metastatic NSCLC who had a history of prior platinum-based chemotherapy.
Acute Myeloid Leukemia: In clinical trials, treatment-related acute myeloid leukemia (AML) or myelodysplasia have occurred in patients receiving docetaxel, doxorubicin and cyclophosphamide. These patients require hematological follow-up.
Fluid Retention: Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Hematological Effects: Perform frequent peripheral blood cell counts on all patients receiving docetaxel. Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level of >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3. A 25% reduction in the dose of docetaxel is recommended during subsequent cycles following severe neutropenia (<500 cells/mm3) lasting 7 days or more, febrile neutropenia, or a grade 4 infection in a docetaxel cycle.
In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF. Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection). Patients receiving TCF should be closely monitored.
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis. Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection). Patients receiving TAC should be closely monitored.
Neutropenia (<2,000 neutrophils/mm3) occurs in all patients given 60 mg/m2 to 100 mg/m2 of docetaxel and grade 4 neutropenia (<500 cells/mm3) occurs in 85% of patients given 100 mg/m2 and 75% of patients given 60 mg/m2. Frequent monitoring of blood counts is, therefore, essential so that dose can be adjusted. Docetaxel should not be administered to patients with neutrophils <1,500 cells/mm3.
Hypersensitivity Reactions: Patients should be observed closely for hypersensitivity reactions, particularly during the first and second infusions. Hypersensitivity reactions may occur within a few minutes after initiation of a docetaxel infusion. If minor reactions (e.g., flushing or localized skin reactions) occur, interruption of therapy is not required. However, severe reactions (e.g., severe hypotension, bronchospasm or generalized rash/erythema) require immediate discontinuation of docetaxel and appropriate therapy. Patients who have developed severe hypersensitivity reactions should not be rechallenged with docetaxel.
Neurologic Effects: Severe neurosensory symptoms (e.g., paresthesia, dyesthesia, pain) were observed in metastatic breast cancer patients, and resulted in treatment discontinuation. When these symptoms occur, dosage must be adjusted. If symptoms persist, treatment should be discontinued. Patients who experienced neurotoxicity in clinical trials and for whom follow-up information on the complete resolution of the event was available had spontaneous reversal of symptoms with a median of 9 weeks from onset (range: 0 to 106 weeks). Severe peripheral motor neuropathy mainly manifested as distal extremity weakness were also reported.
Cutaneous Reactions: Localized skin erythema of the extremities (palms of the hands and soles of the feet) with edema followed by desquamation has been observed. Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported.
Asthenia: Severe asthenia has been reported in metastatic breast cancer patients and has led to treatment discontinuation. Symptoms of fatigue and weakness which may be associated with deterioration of performance status in patients with progressive disease may last for a few days up to several weeks.
Hepatic Impairment: Docetaxel therapy should not be given to patients with combined abnormalities of transaminases and alkaline phosphatase.
Respiratory Disorders: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis, and respiratory failure have been reported and may be associated with fatal outcome. Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated. Interruption of docetaxel therapy is recommended until diagnosis is available. Early use of supportive care measures may help improve the condition. The benefit of resuming docetaxel treatment must be carefully evaluated.
Cardiovascular Disorder: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following chemotherapy containing anthracycline (doxorubicin or epirubicin). This may be moderate to severe and has been associated with death.
Patients who are candidates for treatment with docetaxel in combination with trastuzumab should undergo baseline cardiac assessment. Cardiac function should be further monitored during treatment (e.g., every three months) to help identify patients who may develop cardiac dysfunction.
Symptoms of congestive heart failure (CHF) should be monitored in patients during therapy and follow-up period. The risk of CHF has been shown to be higher during the first year after treatment of node positive breast cancer in patients treated with TAC regimen.
Eye Disorder: Cystoids macular edema has been reported in patients treated with docetaxel. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case cystoids macular edema is diagnosed, docetaxel should be discontinued and appropriate treatment initiated.
Alcohol Content: The alcohol content in the dose of docetaxel injection may affect the central nervous system. Patients should be advised to avoid or minimize alcohol intake if they are taking docetaxel since there have been reports of cases of intoxication with some formulations of docetaxel.
Effects on ability to drive and use machines: Because of the alcohol content in a dose of docetaxel, this may impair a patient's ability to drive or use machines immediately after infusion.
Patients with Renal Impairment: Patients with bilirubin >ULN, AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN should not receive docetaxel.
The alcohol content in docetaxel injection should be taken into account when given to patients with hepatic impairment.
Carcinogenicity, Mutagenicity, Impairment of Fertility: No studies have been conducted to fully assess docetaxel's long-term carcinogenic potential. However, based on its pharmacodynamic mechanism of action, docetaxel may be a carcinogen.
Docetaxel has been shown to be clastogenic in the in vitro chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse, but did not induce mutagenicity in the Ames test or the CHO/HPRT gene mutation assays.
In non-clinical studies, docetaxel has genotoxic effects and may alter male fertility. Thus, men being treated with docetaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.
Use in Children: The safety and efficacy of docetaxel in children, one month to less than 18 years old, as monotherapy or in combination have not been established. The overall safety profile of docetaxel in children receiving monotherapy or TCF was consistent with the known safety profile in adults.
The alcohol content in docetaxel injection should be taken into account when given to pediatric patients.
Use in Elderly: Certain toxicities associated with docetaxel therapy may occur more frequently and with greater severity in the elderly patients particularly those with poor performance status, or otherwise non-life threatening indolent disease (such as relatively asymptomatic metastatic disease limited to the bone). Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and the drug therapy observed in the elderly, caution is advised in dose selection for geriatric patients.
Use In Pregnancy & Lactation
Use in Pregnancy: Docetaxel can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. In animal studies of rabbits and rats, docetaxel has been shown to be both embryotoxic and fetotoxic and reduce fertility in rats.
There are no adequate and well-controlled studies in pregnant women using docetaxel. If docetaxel is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patients should be informed of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with docetaxel.
Use in Lactation: Docetaxel is lipophilic but it is not known whether it is distributed into human milk. Breastfeeding must be discontinued for the duration of docetaxel therapy because of the potential for adverse reactions in breastfeeding infants.
Females and Males of Reproductive Potential: During treatment with docetaxel, an effective method of contraception should be used.
Adverse Reactions
The most common adverse effects of docetaxel are infection, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.
Infections and infestations: Sepsis, bronchopneumonia, lower respiratory tract infection, conjunctivitis, otitis media.
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Cancer pain, acute myeloid leukemia, myelodysplastic syndrome.
Blood and lymphatic system disorders: Lymphedema, lower limb edema, neutropenic infection, peripheral lymphedema, neutropenic enterocolitis, leukopenia, disseminated intravascular coagulation (DIC), jaundice, myelosuppression.
Immune system disorders: Allergic reaction, erythema multiforme, Stevens-Johnson syndrome, bronchospasm, fatal anaphylaxis.
Endocrine disorders: Amenorrhea, irregular menstruation.
Metabolism and nutrition disorders: Edema, hyponatremia, dehydration, respiratory failure, peripheral edema.
Psychiatric disorders: Confusion, insomnia, somnolence.
Nervous system disorders: Paresthesia, dysesthesia, burning sensation, dizziness, seizure, transient loss of consciousness, headache, hypoesthesia, peripheral sensory neuropathy, peripheral motor neuropathy.
Eye disorders: Lacrimation disorder, tearing which may be attributable to lacrimal duct obstruction, visual disturbances (flashes, flashing lights, scotomata).
Ear and labyrinth disorders: Hearing disorders, hearing loss.
Cardiac disorders: Chest pain, congestive heart failure, tachycardia, sinus tachycardia, supraventricular tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema, myocardial ischemia, atrial fibrillation, palpitations, chest tightness, dyspnea, myocardial infarction, arrhythmia, cardiac failure, dilated cardiomyopathy.
Vascular disorders: Hypotension, postural hypotension, hypertension, syncope, vasodilation, superficial and deep vein thrombosis, thrombophlebitis, hot flashes, ischemic colitis, hemorrhoids, hemorrhage, flushing, anaphylactic shock, epistaxis, venous thromboembolic event.
Respiratory, thoracic and mediastinal disorders: Pulmonary embolism, cough, pharyngitis, acute respiratory distress syndrome, interstitial lung disease, pulmonary fibrosis, rhinitis, lung infiltration, altered sense of smell, pleural effusion, radiation pneumonitis, non-cardiac chest pain.
Gastrointestinal disorders: Oral candidiasis, dry mouth, stomatitis, abdominal pain, esophagitis, esophageal ulcer, dysphagia, odynophagia, gastrointestinal pain/cramping, heartburn, gastrointestinal bleeding, gastrointestinal perforation, colitis, intestinal obstruction, ileus, duodenal ulcer, sore throat, abdominal distention, enteritis, ulceration of lips, tongue and oral cavity, dyspepsia.
Hepatobiliary disorders: Hepatitis, hepatic failure, hepatic coma, hepatotoxicity.
Skin and subcutaneous tissue disorders: Bullous eruptions, hand and foot syndrome, nail discoloration, onycholysis, rash/desquamation, dermatitis, dry skin, rash with or without pruritus, hyperpigmentation, erythema, dryness of skin, erythrodysesthesia.
Musculoskeletal and connective tissue disorders: Pain in limb, bone pain, chills, cutaneous lupus erythematosus, scleroderma-like changes, back pain, arthralgia.
Renal and urinary disorders: Renal failure, renal insufficiency.
Reproductive system and breast disorders: Amenorrhea.
General disorders and administration site conditions: Fever, treatment related mortality, fatigue, multi-organ failure, drug fever, inflammation, extravasation, lethargy, septic death, non-septic death, fever in absence of infection.
Investigations: ECG abnormalities, weight loss, weight gain, increased serum creatinine, decreased hemoglobin, prothrombin level decreased, increased serum levels of AST, ALT, bilirubin and alkaline phosphatase, left ventricular ejection fraction (LVEF) deterioration, abnormal liver function test.
Injury, poisoning and procedural complications: Radiation recall phenomenon, phlebitis, toxic epidermal necrolysis, skin toxicity, cystoid macular edema, ototoxicity, hematologic toxicity, neuromotor toxicity, neurocortical toxicity, neurocerebellar toxicity, infusion site reaction.
Drug Interactions
Drugs that induce, inhibit or are metabolized by CYP450 3A4: In vitro studies have shown that docetaxel metabolism may be modified by concomitant administration of compounds that induce, inhibit or are metabolized by CYP450 3A such as cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin. Caution should be exercised when treating patients with these drugs as concomitant therapy since there is a potential for a significant interaction.
Concomitant use of potent CYP3A4 inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) with docetaxel should be avoided. If such concomitant use cannot be avoided, a dose-adjustment of docetaxel may be suitable, with careful monitoring for toxicity, should be considered.
Ketoconazole: The mean dose-normalized AUC of docetaxel was increased 2.2-fold and its clearance was reduced by 49% when docetaxel was co-administered with ketoconazole.
In vitro plasma protein binding of docetaxel was not affected by dexamethasone, erythromycin, salicylate, sulfamethoxazole, diphenhydramine, propranolol, propafenone, phenytoin, and sodium valproate. The binding of digoxin was not affected by docetaxel. Dexamethasone did not affect protein binding of docetaxel.
Pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their concomitant use.
Carboplatin: There is limited data on the interaction between docetaxel and carboplatin. When combined with docetaxel, the clearance of carboplatin was about 50% higher than the values previously reported for carboplatin monotherapy.
Prednisone: There is no statistically significant effect of prednisone on the pharmacokinetics of docetaxel.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.
Presentation/Packing
Form
Docetax infusion conc 20 mg/0.5 mL
Packing/Price
(+ 1.5 mL vial diluent) 1's
Form
Docetax infusion conc 80 mg/2 mL
Packing/Price
(+ 6 mL vial diluent) 1's
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