Loading…
DOCETAXEL is a brand name for Docetaxel, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Breast Cancer: • Docetaxel Injection USP in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. The effectiveness of docetaxel in combination with doxorubicin and cyclophosphamide (TAC) is based on improved disease-free…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Premedication Regimen (see below for prostate cancer): In order to reduce the incidence and severity of fluid retention, all patients should be pretreated with oral corticosteroids. g. 8 mg BID), for 3 days starting one day prior to each Docetaxel Injection USP administration.
Antihistamines have not been shown to be useful in controlling fluid retention. PrDocetaxel Injection USP – Product Monograph Page 7 of 74 Premedication Regimen for Prostate Cancer: For prostate cancer, given the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg at 12 hours, 3 hours and 1 hour before the Docetaxel Injection USP infusion.
Prophylactic Use of Antibiotics:
In order to reduce the incidence of febrile neutropenia and infections, the prophylactic use of antibiotics is recommended to patients treated for head and neck cancer. The treatment should consist of oral fluoroquinolone antibiotics, or equivalent oral or intravenous antibiotics, for 10 days starting on day 5 of each cycle of Docetaxel Injection USP administration.
Prophylactic Use of G-CSF:
Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities. 2 Recommended Dose and Dosage Adjustment. In addition to G-CSF, the prophylactic use of antibiotics may provide additional benefit. 2 Recommended Dose and Dosage Adjustment Metastatic Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, and Squamous Cell Carcinoma of the Head and Neck: The recommended dosage of Docetaxel Injection USP is 100 mg/m2 administered as a one-hour infusion every 3 weeks.
When used in combination, Docetaxel Injection USP is administered at the recommended dosage of 75 mg/m2.
Prostate Cancer:
The recommended dosage of Docetaxel Injection USP is 75 mg/m2 administered as a one-hour infusion every 3 weeks. Concomitant treatment with prednisone or prednisolone 5 mg orally twice daily is administered continuously.
Adjuvant Treatment of Operable Node-Positive Breast Cancer:
The Docetaxel Injection USP dose is 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 courses.
). All patients treated with docetaxel- containing regimens should be monitored for second primary malignancies (see 8 ADVERSE REACTIONS). Docetaxel has been shown to be mutagenic in the in vitro chromosome aberration test in CHO- K1 cells and in the in vivo micronucleus test in the mouse.
The carcinogenic potential of docetaxel has not been studied. However, given that docetaxel is unequivocally genotoxic, it should be presumed to be a human carcinogen (see 16 NON- CLINICAL TOXICOLOGY). 5 Post-Market Adverse Drug Reactions).
Baseline cardiac assessment is recommended.
Endocrine and Metabolism Tumor Lysis Syndrome:
Tumor lysis syndrome, including fatal cases, has been reported in patients treated with docetaxel. e. those with renal impairment, hyperuricemia, bulky tumor) should be closely monitored in order to properly manage this syndrome. Correction of dehydration and treatment of high uric acid levels are recommended prior to initiation of treatment.
Fluid Retention Severe fluid retention has been reported following docetaxel therapy. Therefore, patients should be premedicated with oral corticosteroids prior to each Docetaxel Injection USP administration to reduce the incidence and severity of fluid retention (see 4 DOSAGE AND ADMINISTRATION).
Patients with preexisting severe fluid retention such as pleural effusion, pericardial effusion and ascites should be closely monitored from the first dose for the possible PrDocetaxel Injection USP – Product Monograph Page 14 of 74 exacerbation of the effusions.
Gastrointestinal Caution is recommended for patients with neutropenia, who are particularly at risk for developing gastrointestinal complications. Enterocolitis could develop at any time, and could lead to death as early as on the first day of onset.
2 Breast-feeding 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 6 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 3 Reconstitution ....................................................................................................... 4 Administration .......................................................................................................
5 Missed dose........................................................................................................... 11 5 OVERDOSAGE.............................................................................................................
2 Breast-feeding) and − patients with severe liver impairment. • Docetaxel Injection USP should not be used in patients with baseline neutrophil counts of <1,500 cells/mm3. Contraindications for other drugs also apply when combined with Docetaxel Injection USP: • Contraindications for Xeloda® (capecitabine) also apply to the capecitabine plus Docetaxel Injection USP combination (Please refer to Xeloda® Product Monograph).
• Contraindications to prednisone also apply to the combination with Docetaxel Injection USP (Please refer to Product Monograph for prednisone). • Contraindications to doxorubicin and cyclophosphamide also apply to their combination with Docetaxel Injection USP (Please refer to Product Monographs for doxorubicin and cyclophosphamide).
PrDocetaxel Injection USP – Product Monograph Page 6 of 74
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Geriatrics:
Based on the population pharmacokinetics, there are no special instructions for the use in the elderly (see 7 WARNINGS AND PRECAUTIONS). Dosing Adjustment Patients with Neutropenia, Cutaneous Reactions or Peripheral Neuropathy: Careful monitoring of neutrophil counts is an essential part of Docetaxel Injection USP therapy.
Docetaxel Injection USP should not be administered until the neutrophil count is at least 1,500 cells/ mm3. Patients who experience febrile neutropenia, severe neutropenia (neutrophil <500 cells/mm3 for more than one week), severe or cumulative cutaneous reaction, or severe neurosensory signs and/or symptoms during Docetaxel Injection USP therapy should have the dosage of Docetaxel Injection USP reduced from 100 mg/m2 to 75 mg/m2.
When Docetaxel Injection USP is given in combination, the dose of Docetaxel Injection USP should be reduced from 75 mg/m2 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.
Alternatively, prophylactic G-CSF may be used PrDocetaxel Injection USP – Product Monograph Page 8 of 74 in patients with either prior febrile neutropenia or severe infection in order to maintain dose intensity (see 7 WARNINGS AND PRECAUTIONS).
Patients who receive adjuvant therapy for breast cancer and 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 Injection USP dose reduced to 60 mg/m2.
If G-CSF is not used, the Docetaxel Injection USP dose should be reduced from 75 to 60 mg/m2. Patients who experience grade 3 or 4 stomatitis should have their dose decreased from 75 to 60 mg/m2.
Patients with Hepatic Impairment:
Docetaxel Injection USP should not be used in patients with serum bilirubin > ULN. 5 x ULN. The amount of ethanol in Docetaxel Injection USP should be taken into account when given to patients with hepatic impairment (see 7 WARNINGS AND PRECAUTIONS).
Concomitant use with a potent CYP3A4 inhibitor: if systemic administration of a potent CYP3A4 inhibitor cannot be avoided, a dose reduction of Docetaxel Injection USP should be considered and close monitoring for toxicity is recommended (see 7 WARNINGS AND PRECAUTIONS, General and 9 DRUG INTERACTIONS).
PrDocetaxel Injection USP – Product Monograph Page 9 of 74 Docetaxel Injection USP in Combination with Capecitabine Table 1: Recommended Dose Modifications for Combination Therapy with Capecitabine Grade 2 Grade 3 Grade 4 1st appearance Interrupt treatment until resolved to grade 0-1 then continue at same doses with prophylaxis where possible.
Grade 3 at time Docetaxel Injection USP treatment due: interrupt treatment and delay for a maximum of two weeks until grade 0-1 then continue at 75% of original capecitabine dose and at 55 mg/m2 of Docetaxel Injection USP with prophylaxis where possible.
If no recovery to grade 0-1 within two weeks delay, patient will stop Docetaxel Injection USP therapy but may restart capecitabine at 75% of original capecitabine dose when grade 0-1. Grade 3 occurring between cycles with recovery to grade 0-1 by the time the next treatment due: continue at 75% of original capecitabine dose and at 55 mg/m2 of Docetaxel Injection USP with prophylaxis where possible.
Discontinue capecitabine and Docetaxel Injection USP treatment unless treating physician considers it to be in the best interest of the patient to continue with capecitabine monotherapy at 50% of original dose. 2nd appearance of same […]
5 Post-Market Adverse Drug Reactions). Hematologic Neutropenia is the most frequently reported adverse event. Neutrophil nadirs occurred at a median of 7 days, but this interval may be shorter in heavily pretreated patients. Docetaxel Injection USP therapy should not be administered until the neutrophil count is over 1,500 cells/mm3.
In order to monitor the occurrence of myelotoxicity, it is recommended that frequent blood cell counts be performed on all patients receiving Docetaxel Injection USP. Patients should not be retreated with subsequent cycles of Docetaxel Injection USP until neutrophils recover to a level of >1,500 cells/mm³.
In cases of severe neutropenia (<500 cells/mm3) for seven days or more during a course of Docetaxel Injection USP therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate systematic measures are recommended (see 4 DOSAGE AND ADMINISTRATION).
5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths, including sepsis and gastrointestinal hemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
The severe or life-threatening complications have been reported in these patients at subclinical doses. 5 x ULN. Liver function tests (LFTs) should be measured at baseline and before each cycle. The amount of ethanol in Docetaxel Injection USP should be taken into account when given to patients with hepatic impairment (see 7 WARNINGS AND PRECAUTIONS, Neurologic).
Immune Hypersensitivity Reactions:
Severe hypersensitivity reactions characterized by severe hypotension, bronchospasm, generalized rash/erythema or very rarely fatal anaphylaxis have been reported in patients who received premedication. 4% (5 of 1260) of patients. Severe symptoms resolve after discontinuation of the infusion and administration of appropriate therapy.
PrDocetaxel Injection USP – Product Monograph Page 15 of 74 Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions. Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of Docetaxel Injection USP, thus facilities for the treatment of hypotension and bronchospasm should be available.
Severe reactions require immediate discontinuation of Docetaxel Injection USP and aggressive therapy. Patients who have developed severe hypersensitivity reactions should not be rechallenged with Docetaxel Injection USP. If minor reactions such as flushing or localized skin reactions occur, therapy with Docetaxel Injection USP does not have to be discontinued.
All patients should be premedicated with an oral corticosteroid prior to the initiation of the infusion of Docetaxel Injection USP (see 4 DOSAGE AND ADMINISTRATION). Patients who have previously experienced a hypersensitivity reaction to paclitaxel may develop a potentially fatal hypersensitivity reaction to Docetaxel Injection USP.
Neurologic The development of severe peripheral neurotoxicity is infrequent and requires a reduction in dose (see 4 DOSAGE AND ADMINISTRATION). If symptoms persist, treatment should be discontinued.
Alcohol content:
Docetaxel […]
11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 11 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations................................................................................................
1 Pregnant Women ............................................................................................ 2 Breastfeeding .................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 17 8 ADVERSE REACTIONS .................................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 5 Post-Market Adverse Reactions ............................................................................ 36 9 DRUG INTERACTIONS .................................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions......................................................................... 40 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics ......................................................................................... 3 Pharmacokinetics ............................................................................................ 41 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
42 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 43 13 PHARMACEUTICAL INFORMATION ............................................................................. 44 14 CLINICAL TRIALS .........................................................................................................
44 15 MICROBIOLOGY ......................................................................................................... 55 16 NON-CLINICAL TOXICOLOGY ......................................................................................
55 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 64 PATIENT MEDICATION INFORMATION ................................................................................... 65 PrDocetaxel Injection USP – Product Monograph Page 4 of 74 PrDOCETAXEL INJECTION USP Docetaxel Sterile Solution, 10 mg/mL, for Intravenous Infusion Must be diluted directly in infusion solution Antineoplastic Agent PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Breast Cancer: • Docetaxel Injection USP in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
The effectiveness of docetaxel in combination with doxorubicin and cyclophosphamide (TAC) is based on improved disease-free survival and overall survival in comparison to the combination of fluorouracil, doxorubicin and cyclophosphamide (FAC).
However, the positive […]