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Docefrez

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Docefrez




Docefrez Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Last reviewed on RxList 5/12/2015

Docefrez (docetaxel) is an antineoplastic (anticancer) drug used to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docefrez is also used to treat locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy and androgen independent metastatic prostate cancer. Docefrez or docetaxel (the drug brand name is Taxotere) is a generic form of Taxotere, available in Europe. The most common side effects Docefrez are weakness, tiredness, infections, hypersensitivity, muscle pain, nausea, diarrhea, vomiting, constipation, loss of appetite, anorexia, missed menstrual periods, temporary hair loss, fingernail or toenail changes, and skin reactions.

Docefrez (docetaxel) is available in 20 and 80 mg strength vials to be administered by intravenous drip over one hour. Doses are based on the disease process, the patient's size (in meters2), and calculated by personnel trained in the administration of potentially toxic medications. Note that most patients may need premedication with steroids before Docefrez is administered. Docefrez can cause fetal harm when administered to a pregnant woman. 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 Docefrez, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Severe side effects include death due to toxicity, hepatotoxicity, neutropenia, fluid retention, bleeding, skin blistering and hypersensitivity. The safety or effectiveness of Docefrez in pediatric population is unknown. There are over 200 drugs listed that may interact with Docefrez so the treating physician needs to know all medications the patient is currently taking.

Our Docefrez Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Docefrez in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • extreme weakness;
  • severe vomiting or diarrhea;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling of your ankles or feet, weight gain;
  • urinating less than usual or not at all;
  • redness or peeling of the skin on your hands and feet;
  • numbness, burning pain, or tingly feeling; or
  • redness, swelling, burning, irritation, or skin changes where the injection was given.

Less serious side effects may include:

  • feeling weak or tired;
  • mild nausea, vomiting, diarrhea, constipation, or loss of appetite;
  • muscle pain;
  • missed menstrual periods;
  • temporary hair loss; or
  • fingernail or toenail changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Docefrez (docetaxel)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Docefrez FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reactions from docetaxel are:

The most common adverse reactions across all docetaxel indications are 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. Incidence varies depending on the indication.

Adverse reactions are described for docetaxel according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Responding patients may not experience an improvement in performance status on therapy and may experience worsening. The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established.

Clinical Trial Experience

Breast Cancer

Monotherapy With Docetaxel For Locally Advanced Or Metastatic Breast Cancer After Failure Of Prior Chemotherapy

Docetaxel 100 mg/m² : Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received docetaxel administered at 100 mg/m² as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests; the subset of 965 patients with locally advanced or metastatic breast cancer, both previously treated and untreated with chemotherapy, who had normal baseline liver function tests; and an additional 61 patients with various tumor types who had abnormal liver function tests at baseline. These reactions were described using COSTART terms and were considered possibly or probably related to docetaxel. At least 95% of these patients did not receive hematopoietic support. The safety profile is generally similar in patients receiving docetaxel for the treatment of breast cancer and in patients with other tumor types (See Table 2).

Table 2 : Summary of Adverse Reactions in Patients Receiving Docetaxel at 100 mg/m²

Adverse Reaction All Tumor Types Normal LFTs*
n=2045%
All Tumor Types Elevated LFTs**
n=61%
Breast Cancer Normal LFTs*
n=965%
Hematologic
Neutropenia
  < 2000 cells/mm 96 96 99
  < 500 cells/mm³ 75 88 86
Leukopenia
  < 4000 cells/mm³ 96 98 99
  < 1000 cells/mm³ 32 47 44
Thrombocytopenia
  < 100,000 cells/mm 8 25 9
Anemia
  < 11 g/dL 90 92 94
  < 8 g/dL 9 31 8
Febrile Neutropenia*** 11 26 12
Septic Death Non-Septic Death
Infections 2 1 5 7 1 1
Any 22 33 22
Severe 6 16 6
Fever in Absence of Infection
Any 31 41 35
Severe 2 8 2
Hypersensitivity Reactions
Regardless of Premedication
Any 21 20 18
Severe 4 10 3
With 3-day Premedication n=92 n=3 n=92
Any 15 33 15
Severe 2 0 2
Fluid Retention
Regardless of Premedication
Any 47 39 60
Severe 7 8 9
With 3-day Premedication n=92 n=3 n=92
Any 64 67 64
Severe 7 33 7
Neurosensory
Any 49 34 58
Severe 4 0 6
Cutaneous
Any 48 54 47
Severe 5 10 5
Nail Changes
Any 31 23 41
Severe 3 5 4
Gastrointestinal
Nausea 39 38 42
Vomiting 22 23 23
Diarrhea 39 33 43
Severe 5 5 6
Stomatitis
Any 42 49 52
Severe 6 13 7
Alopecia 76 62 74
Asthenia
Any 62 53 66
Severe 13 25 15
Myalgia
Any 19 16 21
Severe 2 2 2
Arthralgia 9 7 8
Infusion Site Reactions 4 3 4
*Normal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
**Elevated Baseline LFTs: AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN
***Febrile Neutropenia: ANC grade 4 with fever > 38°>C with intravenous antibiotics and/or hospitalization

Hematologic Reactions

Reversible marrow suppression was the major dose-limiting toxicity of docetaxel [see WARNINGS AND PRECAUTIONS]. The median time to nadir was 7 days, while the median duration of severe neutropenia ( < 500 cells/mm³ ) was 7 days. Among 2045 patients with solid tumors and normal baseline LFTs, severe neutropenia occurred in 75.4% and lasted for more than 7 days in 2.9% of cycles.

Febrile neutropenia ( < 500 cells/mm³with fever > 38°C with intravenous antibiotics and/or hospitalization) occurred in 11% of patients with solid tumors, in 12.3% of patients with metastatic breast cancer, and in 9.8% of 92 breast cancer patients premedicated with 3-day corticosteroids.

Severe infectious episodes occurred in 6.1% of patients with solid tumors, in 6.4% of patients with metastatic breast cancer, and in 5.4% of 92 breast cancer patients premedicated with 3-day corticosteroids.

Thrombocytopenia ( < 100,000 cells/mm³ ) associated with fatal gastrointestinal hemorrhage has been reported.

Hypersensitivity Reactions

Severe hypersensitivity reactions have been reported [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. Minor events, including flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, or chills, have been reported and resolved after discontinuing the infusion and instituting appropriate therapy.

Fluid Retention

Fluid retention can occur with the use of DOCEFREZ [see BOXED WARNING, DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Cutaneous Reactions

Severe skin toxicity is discussed elsewhere in the label [see WARNINGS AND PRECAUTIONS]. Reversible cutaneous reactions characterized by a rash including localized eruptions, mainly on the feet and/or hands, but also on the arms, face, or thorax, usually associated with pruritus, have been observed. Eruptions generally occurred within 1 week after docetaxel infusion, recovered before the next infusion, and were not disabling.

Severe nail disorders were characterized by hypo-or hyperpigmentation, and occasionally by onycholysis (in 0.8% of patients with solid tumors) and pain.

Neurologic Reactions

Neurologic reactions are discussed elsewhere in the label [see WARNINGS AND PRECAUTIONS].

Gastrointestinal Reactions

Nausea, vomiting, and diarrhea were generally mild to moderate. Severe reactions occurred in 3-5% of patients with solid tumors and to a similar extent among metastatic breast cancer patients. The incidence of severe reactions was 1% or less for the 92 breast cancer patients premedicated with 3-day corticosteroids.

Severe stomatitis occurred in 5.5% of patients with solid tumors, in 7.4% of patients with metastatic breast cancer, and in 1.1% of the 92 breast cancer patients premedicated with 3-day corticosteroids.

Cardiovascular Reactions

Hypotension occurred in 2.8% of patients with solid tumors; 1.2% required treatment. Clinically meaningful events such as heart failure, sinus tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema, and hypertension occurred rarely. Seven of 86 patients (8.1%) of metastatic breast cancer patients receiving docetaxel 100 mg/m² in a randomized trial and who had serial left ventricular ejection fractions assessed developed deterioration of LVEF by ≥ 10% associated with a drop below the institutional lower limit of normal.

Infusion Site Reactions

Infusion site reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, or swelling of the vein.

Hepatic Reactions

In patients with normal LFTs at baseline, bilirubin values greater than the ULN occurred in 8.9% of patients. Increases in AST or ALT > 1.5 times the ULN, or alkaline phosphatase > 2.5 times ULN, were observed in 18.9% and 7.3% of patients, respectively. While on docetaxel, increases in AST and/or ALT > 1.5 times ULN concomitant with alkaline phosphatase > 2.5 times ULN occurred in 4.3% of patients with normal LFTs at baseline. Whether these changes were related to the drug or underlying disease has not been established.

Hematologic and Other Toxicity: Relation To Dose And Baseline Liver Chemistry Abnormalities

Hematologic and other toxicity is increased at higher doses and in patients with elevated baseline liver function tests (LFTs). In the following tables, adverse drug reactions are compared for three populations: 730 patients with normal LFTs given docetaxel at 100 mg/m² in the randomized and single arm studies of metastatic breast cancer after failure of previous chemotherapy; 18 patients in these studies who had abnormal baseline LFTs (defined as AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN); and 174 patients in Japanese studies given docetaxel at 60 mg/m² who had normal LFTs (see Tables 3 and 4).

Table 3 : Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m² with Normal or Elevated Liver Function Tests or 60 mg/m² with Normal Liver Function Tests

Adverse Reaction Docetaxel 100 mg/m² Docetaxel 60 mg/m²
Normal LFTs*
n=730 %
Elevated LFTs**
n=18 %
Normal LFTs*
n=174 %
Neutropenia
Any < 2000 cells/mm³ 98 100 95
Grade 4 < 500 cells/mm³ 84 94 75
Thrombocytopenia
Any < 100,000 cells/mm 11 44 14
Grade 4 < 20,000 cells/mm³ 1 17 1
Anemia < 11 g/dL 95 94 65
Infection***
Any 23 39 1
Grade 3 and 4 7 33 0
Febrile Neutropenia****
By Patient 12 33 0
By Course 2 9 0
Septic Death 2 6 1
Non-Septic Death 1 11 0
*Normal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
**Elevated Baseline LFTs: AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN
***Incidence of infection requiring hospitalization and/or intravenous antibiotics was 8.5% (n=62) among the 730 patients with normal LFTs at baseline; 7 patients had concurrent grade 3 neutropenia, and 46 patients had grade 4 neutropenia.
****Febrile Neutropenia: For 100 mg/m², ANC grade 4 and fever > 38°C with intravenous antibiotics and/or hospitalization; for 60 mg/m², ANC grade 3/4 and fever > 38.1°C

Table 4: Non-Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m² with Normal or Elevated Liver Function Tests or 60 mg/m² with Normal Liver Function Tests

Adverse Reaction Docetaxel 100 mg/m² Docetaxel 60 mg/m²
Normal LFTs*
n=730%
Elevated LFTs**
n=18%
Normal LFTs*
n=174%
Acute Hypersensitivity Reaction Regardless of Premedication
Any 13 6 1
Severe 1 0 0
Fluid Retention*** Regardless of Premedication
Any 56 61 13
Severe 8 17 0
Neurosensory
Any 57 50 20
Severe 6 0 0
Myalgia 23 33 3
Cutaneous
Any 45 61 31
Severe 5 17 0
Asthenia
Any 65 44 66
Severe 17 22 0
Diarrhea
Any 42 28 NA
Severe 6 11
Stomatitis
Any 53 67 19
Severe 8 39 1
*Normal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
** Elevated Baseline Liver Function: AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN
***Fluid Retention includes (by COSTART): edema (peripheral, localized, generalized, lymphedema, pulmonary edema, and edema otherwise not specified) and effusion (pleural, pericardial, and ascites); no premedication given with the 60 mg/m² dose
NA = not available

In the three-arm monotherapy trial, TAX313, which compared docetaxel 60 mg/m², 75 mg/m² and 100 mg/m² in advanced breast cancer, grade 3/4 or severe adverse reactions occurred in 49.0% of patients treated with docetaxel 60 mg/m² compared to 55.3% and 65.9% treated with 75 mg/m² and 100 mg/m² respectively. Discontinuation due to adverse reactions was reported in 5.3% of patients treated with 60 mg/m² vs. 6.9% and 16.5% for patients treated at 75 mg/m² and 100 mg/m² respectively. Deaths within 30 days of last treatment occurred in 4.0% of patients treated with 60 mg/m² compared to 5.3% and 1.6% for patients treated at 75 mg/m² and 100 mg/m² respectively.

The following adverse reactions were associated with increasing docetaxel doses: fluid retention (26%, 38%, and 46% at 60 mg/m², 75 mg/m², and 100 mg/m² respectively), thrombocytopenia (7%, 11%, and 12% respectively), neutropenia (92%, 94%, and 97% respectively), febrile neutropenia (5%, 7%, and 14% respectively), treatment-related grade 3/4 infection (2%, 3%, and 7% respectively) and anemia (87%, 94%, and 97% respectively).

Lung Cancer

Monotherapy With Docetaxel For Unresectable, Locally Advanced Or Metastatic NSCLC Previously Treated With Platinum-Based Chemotherapy

Docetaxel 75 mg/m²: Treatment emergent adverse drug reactions are shown in Table 5. Included in this table are safety data for a total of 176 patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who were treated in two randomized, controlled trials. These reactions were described using NCI Common Toxicity Criteria regardless of relationship to study treatment, except for the hematologic toxicities or where otherwise noted.

Table 5 : Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy*

Adverse Reaction Docetaxel 75 mg/m²
n=176 %
Best Supportive Care
n=49 %
Vinorelbine/ Ifosfamide
n=119 %
Neutropenia
Any 84 14 83
Grade 3/4 65 12 57
Leukopenia
Any 84 6 89
Grade 3/4 49 0 43
Thrombocytopenia
Any 8 0 8
Grade 3/4 3 0 2
Anemia
Any 91 55 91
Grade 3/4 9 12 14
Febrile
Neutropenia** 6 NA† 1
Infection
Any 34 29 30
Grade 3/4 10 6 9
Treatment Related Mortality 3 NA† 3
Hypersensitivity Reactions
Any 6 0 1
Grade 3/4 3 0 0
Fluid Retention
Any 34 ND†† 23
Severe 3 3
Neurosensory
Any 23 14 29
Grade 3/4 2 6 5
Neuromotor
Any 16 8 10
Grade 3/4 5 6 3
Skin
Any 20 6 17
Grade 3/4 1 2 1
Gastrointestinal
Nausea
Any 34 31 31
Grade 3/4 5 4 8
Vomiting
Any 22 27 22
Grade 3/4 3 2 6
Diarrhea
Any 23 6 12
Grade 3/4 3 0 4
Alopecia 56 35 50
Asthenia
Any 53 57 54
Severe*** 18 39 23
Stomatitis
Any 26 6 8
Grade 3/4 2 0 1
Pulmonary
Any 41 49 45
Grade 3/4 21 29 19
Nail Disorder
Any 11 0 2
Severe*** 1 0 0
Myalgia
Any 6 0 3
Severe*** 0 0 0
Arthralgia
Any 3 2 2
Severe*** 0 0 1
Taste Perversion
Any 6 0 0
Severe*** 1 0 0
*Normal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
**Febrile Neutropenia: ANC grade 4 with fever > 38°C with intravenous antibiotics and/or hospitalization
***COSTART term and grading system
†Not Applicable;
†† Not Done

Combination Therapy With Docetaxel In Chemotherapy-Naïve Advanced Unresectable Or Metastatic NSCLC

Table 6 presents safety data from two arms of an open label, randomized controlled trial (TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity Criteria except where otherwise noted.

Table 6 : Adverse Reactions Regardless of Relationship to Treatment in Chemotherapy-Nave Advanced Non-Small Cell Lung Cancer Patients Receiving Docetaxel in Combination with Cisplatin

  Docetaxel 75 mg/m + Cisplatin 75 mg/m²
n=406 %
Vinorelbine 25 mg/m + Cisplatin 100 mg/m²
n=396 %
Neutropenia
Any 91 90
Grade 3/4 74 78
Febrile Neutropenia 5 5
Thrombocytopenia
Any 15 15
Grade 3/4 3 4
Anemia
Any 89 94
Grade 3/4 7 25
Infection
Any 35 37
Grade 3/4 8 8
Fever in absence of infection
Any 33 29
Grade 3/4 < 1 1
Hypersensitivity Reaction*
Any 12 4
Grade 3/4 3 < 1
Fluid Retention**
Any 54 42
All severe or life-threatening events 2 2
Pleural effusion
Any 23 22
All severe or life-threatening events 2 2
Peripheral edema
Any 34 18
All severe or life-threatening events < 1 < 1
Weight gain
Any 15 9
All severe or life-threatening events < 1 < 1
Neurosensory
Any 47 42
Grade 3/4 4 4
Neuromotor
Any 19 17
Grade 3/4 3 6
Skin
Any 16 14
Grade 3/4 < 1 1
Nausea
Any 72 76
Grade 3/4 10 17
Vomiting
Any 55 61
Grade 3/4 8 16
Diarrhea
Any 47 25
Grade 3/4 7 3
Anorexia**
Any 42 40
All severe or life-threatening events 5 5
Stomatitis
Any 24 21
Grade 3/4 2 1
Alopecia
Any 75 42
Grade 3 < 1 0
Asthenia**
Any 74 75
All severe or life-threatening events 12 14
Nail Disorder**
Any 14 < 1
All severe events < 1 0
Myalgia**
Any 18 12
All severe events < 1 < 1
* Replaces NCI term “ Allergy”
** COSTART term and grading system

Deaths within 30 days of last study treatment occurred in 31 patients (7.6%) in the docetaxel+cisplatin arm and 37 patients (9.3%) in the vinorelbine+cisplatin arm. Deaths within 30 days of last study treatment attributed to study drug occurred in 9 patients (2.2%) in the docetaxel+cisplatin arm and 8 patients (2.0%) in the vinorelbine+cisplatin arm. The second comparison in the study, vinorelbine+cisplatin versus docetaxel+carboplatin (which did not demonstrate a superior survival associated with DOCEFREZ, [see Clinical Studies]) demonstrated a higher incidence of thrombocytopenia, diarrhea, fluid retention, hypersensitivity reactions, skin toxicity, alopecia and nail changes on the docetaxel+carboplatin arm, while a higher incidence of anemia, neurosensory toxicity, nausea, vomiting, anorexia and asthenia was observed on the vinorelbine+cisplatin arm.

Prostate Cancer

Combination Therapy With Docetaxel In Patients With Prostate Cancer

The following data are based on the experience of 332 patients, who were treated with docetaxel 75 mg/m every 3 weeks in combination with prednisone 5 mg orally twice daily (see Table 7).

Table 7 : Clinically Important Treatment Emergent Adverse Reactions (Regardless of Relationship) in Patients with Prostate Cancer who Received Docetaxel in Combination with Prednisone (TAX327)

Adverse Reaction Docetaxel 75 mg/m every 3 weeks + prednisone 5 mg twice daily
n=332 %
Mitoxantrone 12 mg/m every 3 weeks + prednisone 5 mg twice daily
n=335 %
Any Grade 3/4 Any Grade 3/4
Anemia 67 5 58 2
Neutropenia 41 32 48 22
Thrombocytopenia 3 1 8 1
Febrile neutropenia 3 N/A 2 N/A
Infection 32 6 20 4
Epistaxis 6 0 2 0
Allergic Reactions 8 1 1 0
Fluid Retention* 24 1 5 0
Weight Gain* 8 0 3 0
Peripheral Edema* 18 0 2 0
Neuropathy Sensory 30 2 7 0
Neuropathy Motor 7 2 3 1
Rash/Desquamation 6 0 3 1
Alopecia 65 N/A 13 N/A
Nail Changes 30 0 8 0
Nausea 41 3 36 2
Diarrhea 32 2 10 1
Stomatitis/Pharyngitis 20 1 8 0
Taste Disturbance 18 0 7 0
Vomiting 17 2 14 2
Anorexia 17 1 14 0
Cough 12 0 8 0
Dyspnea 15 3 9 1
Cardiac left ventricular function 10 0 22 1
Fatigue 53 5 35 5
Myalgia 15 0 13 1
Tearing 10 1 2 0
Arthralgia 8 1 5 1
*Related to treatment

Post-Marketing Experiences

The following adverse reactions have been identified from clinical trials and/or post-marketing surveillance. Because they are reported from a population of unknown size, precise estimates of frequency cannot be made.

Body as a whole: diffuse pain, chest pain, radiation recall phenomenon.

Cardiovascular: atrial fibrillation, deep vein thrombosis, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, tachycardia, myocardial infarction.

Cutaneous: very rare cases of cutaneous lupus erythematosus and rare cases of bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Scleroderma-like changes usually preceded by peripheral lymphedema. In some cases multiple factors may have contributed to the development of these effects. Severe hand and foot syndrome has been reported.

Gastrointestinal: abdominal pain, anorexia, constipation, duodenal ulcer, esophagitis, gastrointestinal hemorrhage, gastrointestinal perforation, ischemic colitis, colitis, intestinal obstruction, ileus, neutropenic enterocolitis and dehydration as a consequence to gastrointestinal events have been reported.

Hematologic: bleeding episodes. Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported. Cases of acute myeloid leukemia and myelodysplasic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.

Hypersensitivity: rare cases of anaphylactic shock have been reported. Very rarely these cases resulted in a fatal outcome in patients who received premedication.

Hepatic: rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.

Neurologic: confusion, rare cases of seizures or transient loss of consciousness have been observed, sometimes appearing during the infusion of the drug.

Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or without conjunctivitis. Excessive tearing which may be attributable to lacrimal duct obstruction has been reported. Rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during drug infusion and in association with hypersensitivity reactions have been reported. These were reversible upon discontinuation of the infusion. Cases of cystoid macular edema (CME) have been reported in patients treated with DOCEFREZ.

Hearing: rare cases of ototoxicity, hearing disorders and/or hearing loss have been reported, including cases associated with other ototoxic drugs.

Respiratory: dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis have rarely been reported and may be associated with fatal outcome. Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.

Renal: renal insufficiency and renal failure have been reported, the majority of these cases were associated with concomitant nephrotoxic drugs.

Metabolism and nutrition disorders: cases of hyponatremia have been reported.

Read the entire FDA prescribing information for Docefrez (docetaxel)

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