Drug Safety-related Labeling Changes (SrLC)

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TAXOTERE (NDA-020449)

(DOCETAXEL)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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01/18/2023 (SUPPL-86)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.12 Embryo-Fetal Toxicity

Additions and revisions underlined:

Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of TAXOTERE. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of TAXOTERE [see Use in Specific Populations (8.1, 8.3)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes to table; please refer to label

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Additions and revisions underlined:

Based on findings in animals, TAXOTERE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating TAXOTERE.

Contraception Females

Based on genetic toxicity findings, advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of TAXOTERE.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Advise patients to avoid becoming pregnant while receiving this drug. Advise female patients of reproductive potential to use effective contraceptives during treatment and for 2 months after the last dose of TAXOTERE. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of TAXOTERE [see Warnings and Precautions (5.12), and Use in Specific Populations (8.1, 8.3)].

Patient Information

Additions and revisions underlined:

• Females who are able to become pregnant:

  • Your healthcare provider will check to see if you are pregnant before you start treatment with TAXOTERE.

  • You should use effective birth control (contraception) during treatment with TAXOTERE and for 2 months after the last dose.

    Males with female partners who are able to become pregnant should use effective birth control during treatment with TAXOTERE and for 4 months after the last dose.

05/15/2020 (SUPPL-84)

Approved Drug Label (PDF)

5 Warnings and Precautions

Tumor Lysis Syndrome

(Newly added section)

Tumor lysis syndrome has been reported with docetaxel [see Adverse Reactions (6.2)]. Patients at risk of tumor lysis syndrome (e.g., with renal impairment, hyperuricemia, bulky tumor) should be closely monitored prior to initiating TAXOTERE and periodically during treatment.

Correction of dehydration and treatment of high uric acid levels are recommended prior to initiation of treatment.

6 Adverse Reactions

Post marketing experience

(Additions and/or revisions underlined)

Metabolism and nutrition disorders: electrolyte imbalance, including hyponatremia,

hypokalemia, hypomagnesemia, and hypocalcemia. Tumor lysis syndrome, sometimes fatal.

myositis.

Ophthalmologic: conjunctivitis, lacrimation or lacrimation with or without conjunctivitis,

cystoid macular edema (CME). Excessive tearing which may be attributable to lacrimal duct

obstruction. Transient visual disturbances (flashes, flashing lights, scotomata), typically

occurring during drug infusion and reversible upon discontinuation of the infusion, in association

with hypersensitivity reactions.

Second primary malignancies: second primary malignancies, including AML, MDS, NHL, and

renal cancer [see Warnings and Precautions (5.7)].

Musculoskeletal disorder: myositis.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

Tumor Lysis Syndrome

(Newly added subsection)

Advise patients of the potential risk of tumor lysis syndrome and to immediately report any signs

or symptoms associated with this event (nausea, vomiting, confusion, shortness of breath,

seizure, irregular heartbeat, dark or cloudy urine, reduced amount of urine, unusual tiredness,

muscle cramps) to their healthcare provider. Advise patients of the importance of keeping

scheduled appointment for blood work or other laboratory tests and of drinking adequate fluids

to avoid dehydration. [see Warnings and Precautions (5.14)].

12/17/2019 (SUPPL-83)

Approved Drug Label (PDF)

Boxed Warning

(Additions and/or revisions underlined)

Treatment-related mortality associated with TAXOTERE 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 TAXOTERE as a single agent at a dose of 100 mg/m2.

Avoid the use of TAXOTERE in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of TAXOTERE.

Do not administer TAXOTERE to patients with neutrophil counts of <1500 cells/mm3. Monitor blood counts frequently as neutropenia may be severe and result in infection.

Do not administer TAXOTERE to patients who have a history of severe hypersensitivity reactions to TAXOTERE or to other drugs formulated with polysorbate 80. Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the TAXOTERE infusion and administration of appropriate therapy.

Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. 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).

5 Warnings and Precautions

5.2     Hepatic Impairment

(Additions and/or revisions underlined)

Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death.

Avoid TAXOTERE in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN.

For patients with isolated elevations of transaminase >1.5 × ULN, consider TAXOTERE dose modifications.

Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of TAXOTERE therapy.

5.3     Hematologic Effects

(Additions and/or revisions underlined)

Perform frequent peripheral blood cell counts on all patients receiving TAXOTERE. Do not retreat patients with subsequent cycles of TAXOTERE until neutrophils recover to a level >1500 cells/mm3. Avoid retreating patients until platelets recover to a level >100,000 cells/mm3.

5.5     Hypersensitivity Reactions

(Additions and/or revisions underlined)

Monitor patients closely for hypersensitivity reactions, especially during the first and second infusions. Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or fatal anaphylaxis, have been reported in patients premedicated with 3 days of corticosteroids. Severe hypersensitivity reactions require immediate discontinuation of the TAXOTERE infusion and aggressive therapy. Do not rechallenge patients with a history of severe hypersensitivity reactions with TAXOTERE.

5.8     Cutaneous Reactions

(Additions and/or revisions underlined)

Localized erythema of the extremities with edema followed by desquamation has been observed. In case of severe skin toxicity, an adjustment in dosage is recommended. The discontinuation rate due to skin toxicity was 1.6% (15/965) for metastatic breast cancer patients. Among 92 breast cancer patients premedicated with 3-day corticosteroids, there were no cases of severe skin toxicity reported and no patient discontinued TAXOTERE due to skin toxicity.

Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with docetaxel treatment. Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Permanent treatment discontinuation should be considered in patients who experience SCARs.

6 Adverse Reactions

6.2     Postmarketing Experience

(Additions and/or revisions underlined)

The following adverse reactions have been identified from clinical trials and/or postmarketing surveillance. Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a whole: diffuse pain, chest pain, radiation recall phenomenon, injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) at the site of previous extravasation.

Cutaneous: cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, scleroderma-like changes (usually preceded by peripheral lymphedema), severe palmar-plantar erythrodysesthesia and permanent alopecia have been reported.

Hearing: ototoxicity, hearing disorders and/or hearing loss have been reported, including during use with other ototoxic drugs.

Hypersensitivity: anaphylactic shock with fatal outcome in patients who received premedication. Severe hypersensitivity reactions with fatal outcome have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.

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

8 Use in Specific Populations

8.6     Hepatic Impairment

(Additions and/or revisions underlined)

Avoid TAXOTERE in patients with bilirubin >ULN and patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN.

06/06/2019 (SUPPL-80)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly titled subsection with added information underlined:

5.7 Second Primary Malignancies (replaces Treatment-related acute myeloid leukemia (AML) Myelodysplasia)

Second primary malignancies, notably acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Non-Hodgkin’s Lymphoma (NHL), and renal cancer, have been reported in patients treated with docetaxel-containing regimens. These adverse reactions may occur several months or years after docetaxel-containing therapy.

Treatment-related AML or MDS has occurred in … In TAC-treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires hematological follow-up. Monitor patients for second primary malignancies.

6 Adverse Reactions

Second Primary Malignancies replaces Acute Myeloid Leukemia in the bulleted line listing.

6.2 Postmarketing Experience

Addition of the following:

Second primary malignancies: second primary malignancies, including AML, MDS, NHL, and renal cancer, have been reported in patients treated with TAXOTERE-containing regimens.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

What are the possible side effects of TAXOTERE?

TAXOTERE may cause serious side effects including death.

• Risk of new cancers. An increase in new (second) cancers has happened in people treated with TAXOTERE together with certain other anticancer treatments. This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Non-Hodgkin’s Lymphoma (NHL), and kidney cancer.

  • Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with TAXOTERE.

Your healthcare provider will check you for new cancers during and after your treatment with TAXOTERE.

PATIENT COUNSELING INFORMATION

Extensively changed; please refer to label for complete information.

06/06/2019 (SUPPL-82)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.13 Embryo-Fetal Toxicity

Based on findings from animal reproduction studies and its mechanism of action, TAXOTERE can cause fetal harm when administered to a pregnant woman. Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to initiating TAXOTERE. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of TAXOTERE. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of TAXOTERE.

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

PLLR conversion; please refer to label for complete information.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

Before you receive TAXOTERE, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. TAXOTERE can harm your unborn baby. You should not become pregnant during treatment with TAXOTERE. Tell your healthcare provider if you become pregnant or you think you may be pregnant during treatment with TAXOTERE.   Females who are able to become pregnant:

  • Your healthcare provider will check to see if you are pregnant before you start treatment with TAXOTERE.

  • You should use effective birth control (contraception) during treatment with TAXOTERE and for 6 months after the last dose.

Males with female partners who are able to become pregnant should use effective birth control during treatment with TAXOTERE and for 3 months after the last dose.

Talk to your healthcare provider if you have questions about birth control options that are right for you.

• are breastfeeding or plan to breastfeed. It is not known if TAXOTERE passes into your breast milk. Do not breastfeed during treatment with TAXOTERE and for 1 week after the last dose.

The most common side effects of TAXOTERE include:

TAXOTERE may affect fertility in males. Talk to your healthcare provider if this is a concern for you.

PATIENT COUNSELING INFORMATION

Addition of the following information:

Embryo-Fetal Toxicity

TAXOTERE can cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this drug. Advise female patients of reproductive potential to use effective contraceptives during treatment and for 6 months after the last dose of TAXOTERE. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of TAXOTERE.

Lactation

Advise women not to breastfeed during TAXOTERE treatment and for 1 week after the last dose.

Infertility

Advise males of reproductive potential that TAXOTERE may impair fertility.

10/05/2018 (SUPPL-79)

Approved Drug Label (PDF)

4 Contraindications

4 CONTRAINDICATIONS

(Additions and/or revisions are underlined)

TAXOTERE is contraindicated in patients with:

• neutrophil counts of <1500 cells/mm3.

• a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred.

5 Warnings and Precautions

5.4 Enterocolitis and Neutropenic Colitis

(Newly added subsection)

Enterocolitis and neutropenic colitis (typhlitis) have occurred in patients treated with TAXOTERE alone and in combination with other chemotherapeutic agents, despite the co- administration of G-CSF. Caution is recommended for patients with neutropenia, particularly at risk for developing gastrointestinal complications. Enterocolitis and neutropenic enterocolitis may develop at any time, and could lead to death as early as the first day of symptom onset.

Monitor patients closely from onset of any symptoms of gastrointestinal toxicity. Inform patients to contact their healthcare provider with new, or worsening symptoms of gastrointestinal toxicity.

5.5 Hypersensitivity Reactions

(Additions and/or revisions are underlined)

Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions. Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients pre-medicated with 3 days of corticosteroids. Severe hypersensitivity reactions require immediate discontinuation of the TAXOTERE infusion and aggressive therapy. Patients with a history of severe hypersensitivity reactions should not be rechallenged with TAXOTERE.

 

Patients who have previously experienced a hypersensitivity reaction to paclitaxel may develop a hypersensitivity reaction to docetaxel that may include severe or fatal reactions such as anaphylaxis. Monitor patients with a previous history of hypersensitivity to paclitaxel closely during initiation of TAXOTERE therapy. Hypersensitivity reactions may occur within a few minutes following initiation of a TAXOTERE infusion. If minor reactions such as flushing or localized skin reactions occur, interruption of therapy is not required. All patients should be premedicated with an oral corticosteroid prior to the initiation of the infusion of TAXOTERE.

6 Adverse Reactions

6 ADVERSE REACTIONS

(Additions and/or revisions are underlined)

The most serious adverse reactions from TAXOTERE are:

• Toxic Deaths

• Hepatic Impairment

• Hematologic Effects

• Enterocolitis and Neutropenic Colitis

• Hypersensitivity Reactions

• Fluid Retention

• Acute Myeloid Leukemia

• Cutaneous Reactions

• Neurologic Reactions

• Eye Disorders

• Asthenia

• Alcohol Content

...

6.1 Clinical Trials Experience

(Additions and/or revisions are underlined)

 ….

Fever and infection

During the treatment period, fever in the absence of infection was seen in 46.5% of TAC-treated patients and in 17.1% of FAC-treated patients. Grade 3/4 fever in the absence of infection was seen in 1.3% and 0% of TAC and FAC-treated patients respectively. Infection was seen in 39.4% of TAC-treated patients compared to 36.3% of FAC-treated patients. Grade 3/4 infection was seen in 3.9% and 2.2% of TAC-treated and FAC-treated patients respectively. There were no septic deaths in either treatment arm during the treatment period.

Gastrointestinal reactions

In addition to gastrointestinal reactions reflected in the table above, 7 patients in the TAC arm were reported to have colitis/enteritis/large intestine perforation versus one patient in the FAC arm. Five of the 7 TAC-treated patients required treatment discontinuation; no deaths due to these events occurred during the treatment period.

Cardiovascular reactions

More cardiovascular reactions were reported in the TAC arm versus the FAC arm during the treatment period: arrhythmias, all grades (6.2% vs 4.9%), and hypotension, all grades (1.9% vs 0.8%). Twenty-six (26) patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm developed CHF during the study period. All except one patient in each arm were diagnosed with CHF during the follow-up period. Two (2) patients in TAC arm and 4 patients in FAC arm died due to CHF. The risk of CHF was higher in the TAC arm in the first year, and then was similar in both treatment arms.

Adverse reactions during the follow-up period (median follow-up time of 8 years)

In study TAX316, the most common adverse reactions that started during the treatment period and persisted into the follow-up period in TAC and FAC patients are described below (median follow-up time of 8 years).

Nervous system disorders

In study TAX316, peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2%) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.

Skin and subcutaneous tissue disorders

In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%). At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).

Reproductive system and breast disorders

In study TAX316, amenorrhea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%). Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients (11.7%).

General disorders and administration site conditions

In study TAX316, peripheral edema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%). At the end of the follow-up period (actual median follow-up time of 8 years), peripheral edema was ongoing in 19 TAC patients (2.6%) and 4 FAC patients (0.5%).

In study TAX316, lymphedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%). At the end of the follow-up period (actual median follow-up time of 8 years), lymphedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).

In study TAX316, asthenia that started during the treatment period and persisted into the follow- up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%). At the end of the follow-up period (actual median follow-up time of 8 years), asthenia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).

Acute myeloid leukemia (AML)/myelodysplastic syndrome

AML occurred in the adjuvant breast cancer trial (TAX316). The cumulative risk of developing treatment-related AML at median follow-up time of 8 years in TAX316 was 0.4% for TAC- treated patients and 0.1% for FAC-treated patients. One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).

Myelodysplastic syndrome occurred in 2 of 744 (0.3%) patients who received TAC and in 1 of 736 (0.1%) patients who received FAC. AML occurs at a higher frequency when these agents are given in combination with radiation therapy.

…

 

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

The following adverse reactions have been identified from clinical trials and/or postmarketing 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, injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) at the site of previous extravasation.

Cardiovascular: atrial fibrillation, deep vein thrombosis, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, tachycardia, myocardial infarction. Ventricular arrhythmia including ventricular tachycardia has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/or cyclophosphamide, and may be associated with fatal outcome.

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. Cases of permanent alopecia have been reported.

Gastrointestinal: enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, has been reported with a potential fatal outcome. Abdominal pain, anorexia, constipation, duodenal ulcer, esophagitis, gastrointestinal hemorrhage, gastrointestinal perforation, intestinal obstruction, ileus, and dehydration as a consequence to gastrointestinal events have been reported.

…

Hypersensitivity: rare cases of anaphylactic shock have been reported. Very rarely these cases resulted in a fatal outcome in patients who received premedication. Hypersensitivity reactions with potential fatal outcome have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.

…

Metabolism and nutrition disorders: electrolyte imbalance, including cases of hyponatremia, hypokalemia, hypomagnesemia, and hypocalcemia has been reported.

 

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Bone Marrow Suppression

Explain the significance of routine blood cell counts. Thus, it is important that periodic assessment of their blood count be performed to detect the development of neutropenia, thrombocytopenia and/ or anemia. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever.

Gastrointestinal Events, Eye Disorders

Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, excessive tearing and/or vision disturbances are associated with docetaxel administration. Tell patients to immediately report abdominal pain or tenderness, and/or diarrhea, with or without fever, any vision changes.

Hypersensitivity Reactions

Obtain detailed allergy information from the patient prior to TAXOTERE administration. Instruct patients to immediately report signs of a hypersensitivity reaction. Ask patients whether they have previously received paclitaxel therapy, and if they have experienced a hypersensitivity reaction to paclitaxel.

Fluid Retention

Tell patients to watch for signs of fluid retention such as peripheral edema in the lower extremities, weight gain and dyspnea and instruct patients to immediately report them.

Myalgia, Cutaneous Reactions, Neurologic Reactions, Local Site Reactions, Fatigue, Alopecia

Instruct patients to report myalgia, neurologic reactions, or infusion site reactions. Explain to patients that side effects such as fatigue and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration.

Cardiac disorders

Tell patients to report any irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting.

Importance of Corticosteroids

Explain the significance of oral corticosteroids such as dexamethasone administration to the patient to help facilitate compliance. Instruct patients to report if they were not compliant with oral corticosteroid regimen.

Alcohol Content in TAXOTERE Injection

patients the possible effects of the alcohol content in TAXOTERE Injection, including possible effects on the central nervous system.

Ability to Drive or Operate Machines

Explain to patients that TAXOTERE Injection may impair their ability to drive or operate machines due to its side effects or due to the alcohol content of TAXOTERE Injection. Advise them not to drive or use machines if they experience these side effects during treatment.

Drug Interactions

Inform patients about the risk of drug interactions and the importance of providing a list of prescription and non-prescription drugs to their healthcare provider.

Embryo-Fetal Toxicity

TAXOTERE may cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug. Advise female patients of childbearing potential to use effective contraceptives during treatment.

Other

PATIENT INFORMATION

(Significant changes have been made, please refer to the label)