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Note: This document contains side effect information about docetaxel. Some of the dosage forms listed on this page may not apply to the brand name Taxotere.
Applies to docetaxel: intravenous solution
Intravenous route (Solution)
Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based therapy receiving docetaxel at 100 mg/m(2). Docetaxel should generally not be given to patients with bilirubin greater than the ULN, or to patients with AST or ALT greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN; these patients are at increased risk for developing severe or life-threatening toxicities. Monitor LFTs prior to each treatment cycle. Docetaxel therapy should not be given to patients with neutrophil counts of less than 1500 cells/mm(3); obtain frequent blood counts to monitor for neutropenia. Severe hypersensitivity reactions, including fatal anaphylaxis, have been reported in patients who received dexamethasone premedication. Use is contraindicated in patients with a severe hypersensitivity to docetaxel or polysorbate 80. Severe fluid retention may occur.
Along with its needed effects, docetaxel (the active ingredient contained in Taxotere) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking docetaxel:
Some side effects of docetaxel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
incidence not known
Applies to docetaxel: intravenous powder for injection, intravenous solution
The most common adverse reactions across all indications include infections, 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.
Very common (10% or more): Neutropenia (99%), leukopenia (99%), thrombocytopenia (39%), anemia (94%)
Common (1% to 10%): Hemorrhage
Postmarketing reports: Bleeding episodes, disseminated intravascular coagulation (DIC)
The major dose-limiting toxicity of this drug is reversible marrow suppression. In clinical trials, the median time to nadir was 7 days, and the median duration of severe neutropenia (less than 500 cells/mm3) was 7 days.
Hematologic toxicity is increased at higher doses and in patients with elevated baseline liver function tests.
Very common (10% or more): Hypersensitivity (33%)
Common (1% to 10%): Severe hypersensitivity
Frequency not reported: Flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, chills
Postmarketing reports: Anaphylactic shock
Severe hypersensitivity reactions have been reported. Minor events, including flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, or chills have been reported and after discontinuation of the infusion and instituting treatment as necessary, have resolved.
Very common (10% or more): Fluid retention (60%)
Common (1% to 10%): Severe fluid retention, hypotension, lymphedema, phlebitis, hypertension
Rare (less than 0.1%): Heart failure, sinus tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema
Postmarketing reports: Atrial fibrillation, deep vein thrombosis, ECG abnormalities, pulmonary embolism, syncope, tachycardia, myocardial infarction, chest pain
Very common (10% or more): Alopecia (98%), cutaneous reactions (54%), nail changes (41%)
Common (1% to 10%): Severe cutaneous reactions, severe nail changes, rash
Rare (less than 0.1%): Onycholysis
Postmarketing reports: Very rare cases of cutaneous lupus erythematosus, rare cases of bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Scleroderma-like changes usually preceded by peripheral lymphedema, severe hand and foot syndrome, radiation recall
Cutaneous reactions including severe skin toxicity has been reported. Reversible cutaneous reactions include rash mainly on the feet and/or hands, or on the arms, face, or thorax. This is usually accompanied by pruritus. Eruptions generally occur within 1 week of receiving the drug and resolve before the next infusion.
Very common (10% or more): Neurosensory events (58%), dizziness (16%), headache, hypoesthesia
Common (1% to 10%): Severe neurosensory events
Uncommon (0.1% to 1%): Somnolence
Frequency not reported: Paresthesia, dysesthesia, neuromotor weakness,
Postmarketing reports: Confusion, seizures or transient loss of consciousness
Postmarketing reports: Acute myeloid leukemia, myelodysplasic syndrome
The cumulative risk of developing treatment-related acute myeloid leukemia appears to be similar to the risk observed for other anthracyclines/cyclophosphamide containing adjuvant breast chemotherapy regimens.
Among patients with normal liver function tests at baseline, elevations in bilirubin occurred in 8.9%, increases in AST or ALT to greater than 1.5 times the upper limit of normal (1.5 x ULN), or increases in alkaline phosphatase to greater than 2.5 x ULN occurred in 18.9% and 7.3%, respectively. Increases in AST and/or ALT to greater than 1.5 x ULN concurrently with alkaline phosphatase elevations to greater than 2.5 x ULN occurred in 4.3% of patients. It is unknown whether these changes were drug related or related to the underlying disease condition.
Very common (10% or more): Transaminase elevations, (19%)
Common (1% to 10%): Bilirubin elevations, alkaline phosphatase elevations, transaminase elevations in combination with alkaline phosphatase elevations
Postmarketing reports: Hepatitis
Considering all tumor types, stomatitis has been reported in 42% of patients with normal LFTs at baseline and 49% of patients with elevated LFTs. Severe stomatitis has been reported in 6% of patients with normal LFTs at baseline and 13% of patients with elevated LFTs. Stomatitis appears to be dose dependent.
Very common (10% or more): Stomatitis (52%), nausea (42%), vomiting (23%), diarrhea (43%), constipation (25%), esophagitis/dysphagia/odynophagia (16%)
Common (1% to 10%): Severe gastrointestinal events, severe stomatitis, gastrointestinal pain and cramping, dry mouth
Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, severe abdominal pain, severe esophagitis
Postmarketing reports: Duodenal ulcer, gastrointestinal hemorrhage, gastrointestinal perforation, ischemic colitis, colitis, intestinal obstruction, ileus, neutropenic enterocolitis, dehydration
Very common (10% or more): Asthenia (up to 66%), severe asthenia (up to 25%), febrile neutropenia (up to 26%), fever in absence of infection (up to 47%)
Common (1% to 10%): Non-septic death, impaired hearing
Postmarketing reports: Ototoxicity, hearing disorders
Infusion reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, or swelling of the vein.
Common (1% to 10%): Infusion site reactions
Frequency not reported: Hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, swelling of the vein
Very common (10% or more): Lacrimation disorder (11%)
Common (1% to 10%): Conjunctivitis
Postmarketing reports: Cystoid macular edema, transient visual disturbances occurring during drug infusion and in association with hypersensitivity reactions (have been reversible upon discontinuation of the infusion)
Very common (10% or more): Cough, rhinorrhea, pharyngolaryngeal pain
Common (1% to 10%): Epistaxis, pneumonia, dyspnea
Postmarketing reports: Acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis, rare cases of radiation pneumonitis in patients receiving concomitant radiotherapy
Postmarketing reports: Renal insufficiency and renal failure (majority of these cases associated with concomitant nephrotoxic drugs)
Very common (10% or more): Weight gain (15%), weight loss (21%)
Common (1% to 10%): Anorexia
Postmarketing reports: Hyponatremia
Very common (10% or more): Myalgia (33%)
Common (1% to 10%): Severe myalgia, arthralgia, bone pain, back pain
Very common (10% or more): Infections (33%)
Common (1% to 10%): Severe infections, septic death, oral candidiasis
Very common (10% or more): Insomnia
Very common (10% or more): Amenorrhea (62%)
Common (1% to 10%): Menstrual irregularities
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