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Taxotere

Taxotere (docetaxel) is a cancer treatment drug manufactured and distributed by Sanofi-Aventis. The medication is used to treat a number of types of cancer, including breast cancer, non-small cell lung cancer, prostate cancer, head and neck cancer, and gastric adenocarcinoma. Potential side effects include permanent hair loss (alopecia), particularly in women who receive the drug as a part of a chemotherapy regimen to treat breast cancer. Some patients who have suffered permanent hair loss have sought counsel from attorneys to bring lawsuits against the manufacturer. They claim that they were not properly warned about the side effect or given sufficient information about alternatives.

Taxotere Recall

Although Taxotere has not been recalled by the FDA, the federal agency has received reports of adverse side effects such as permanent hair loss (alopecia) in women, reactions to the alcohol in Taxotere injections, cystoid macular edema (CME), and metabolism disorders such as hyponatremia. Potentially fatal respiratory side effects have also been reported, including dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis.

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Side Effects & Adverse Reactions

Among the most widespread side effects reported is permanent hair loss in women. The FDA reported in December 2015 that it had received reports of “permanent alopecia” related to Taxotere. Although the drug has proven to be effective in the treatment of breast cancer, it has left numerous patients with the unwanted side effect of permanent hair loss. Some patients have brought lawsuits based on allegations that they were not properly warned about the potential for permanent hair loss or properly advised about other effective treatment options that do not carry the same risk of hair loss.

Other known adverse reactions include: edema (fluid retention under the skin), infection, throat and mouth sores (stomatitis), congestion, constipation, anorexia, peeling of the skin (desquamation), and changes in the way things taste. Read more about Taxotere side effects and symptoms.

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FDA Safety Alerts

Adverse reactions to Taxotere (docetaxel) reported to the FDA include:

December 2015
ADVERSE REACTIONS
Postmarketing Experience
Cutaneous

  • Cases of permanent alopecia have been reported.

November 2014
WARNINGS AND PRECAUTIONS
Alcohol Content

  • Cases of intoxication have been reported with some formulations of docetaxel due to the alcohol content. The alcohol content in a dose of TAXOTERE Injection may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized. Consideration should be given to the alcohol content in TAXOTERE Injection on the ability to drive or use machines immediately after the infusion. Each administration of TAXOTERE Injection at 100 mg/m2 delivers 2.0 g/m2 of ethanol. For a patient with a BSA of 2.0 m2, this would deliver 4.0 grams of ethanol [see Description (11)]. Other docetaxel products may have a different amount of alcohol.

December 2013
WARNINGS AND PRECAUTIONS
Eye Disorders

  • Cystoid macular edema (CME) has been reported in patients treated with TAXOTERE, as well as with other taxanes. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. If CME is diagnosed, TAXOTERE treatment should be discontinued and appropriate treatment initiated. Alternative non-taxane cancer treatment should be considered.

ADVERSE REACTIONS
Postmarketing Experiences

  • Opthalmologic: Cases of cystoid macular edema (CME) have been reported in patients treated with TAXOTERE, as well as with other taxanes
  • Metabolism and nutrition disorders: cases of hyponatremia have been …

PATIENT INFORMATION
What are the possible side effects of TAXOTERE?

  • Cystoid Macular Edema (CME) is a painless eye disorder that can result in impaired vision.

June 2013
ADVERSE REACTIONS
Post-Marketing Experiences

  • 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.

May 2010
USE IN SPECIAL POPULATIONS
Pediatric Use

  • The overall safety profile of Taxotere in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.
  • Taxotere has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluoruracil (TCF).
  • Taxotere Monotherapy Taxotere monotherapy was evaluated in a dose-finding phase 1 trial in 61 pediatric patients (median age 12.5 years, range 1-22 years) with a variety of refractory solid tumors. The recommended dose was 125 mg/m2 as a 1-hour intravenous infusion every 21 days. The primary dose limiting toxicity was neutropenia.
  • The recommended dose for Taxotere monotherapy was evaluated in a phase 2 single-arm trial in 178 pediatric patient (median age 12 years, range 1-26 years) with a variety of recurrent/refractory solid tumors. Efficacy was not established with tumor response rates ranging from one complete response (CR) (0.6%) in a patient with undifferentiated sarcoma to four partial responses (2.2%) seen in one patient each with Ewing Sarcoma, neuroblastoma, osteosarcoma, and squamous cell carcinoma.
  • Taxotere in Combination Taxotere was studied in combination with cisplatin and 5-fluorouracil (TCF) versus cisplatin and 5-fluorouracil (CF) for the induction treatment of nasopharyngeal carcinoma (NPC) in pediatric patients prior to chemoradiation consolidation. Seventy-five patients…
  • Pharmacokinetics: Pharmacokinetic parameters for docetaxel were determined in 2 pediatric solid tumor trials.
    Following docetaxel administration…

ADVERSE REACTIONS
Post-marketing Experiences

  • Cutaneous: Scleroderma-like changes usually preceded by peripheral lymphedema
  • Renal: renal failure have been reported, the majority of these cases were associated with concomitant nephrotoxic drugs

DRUG INTERACTIONS

The exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4.  Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of Taxotere and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with Taxotere, close monitoring for toxicity and a Taxotere dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided

Safety Announcement
[[6-20-2014] The U.S. Food and Drug Administration (FDA) is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment.  We are revising the labels of all docetaxel drug products to warn about this risk.  Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications.

Patients should be aware that docetaxel may cause them to become intoxicated from the alcohol it contains.  Patients should avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of docetaxel.  In addition, some medications, such as pain relievers and sleep aids, may interact with the alcohol in the docetaxel infusion and worsen the intoxicating effects.

Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer.  Several forms of docetaxel are currently marketed, including generics and the brand-name products Taxotere, Docefrez, and Docetaxel Injection.  The various products contain different amounts of alcohol, which is used to dissolve the active ingredients so docetaxel can be given intravenously (see Docetaxel Formulations and Alcohol Content).  Health care professionals should be aware of the differences in formulations in order to monitor and counsel patients appropriately.

Facts about docetaxel

  • A prescription chemotherapy drug used to treat different types of cancer, including breast, prostate, stomach, head and neck cancers, and non-small cell lung cancer
  • Marketed as generics and also under the brand-names Taxotere, Docefrez, and Docetaxel Injection
  • Given as an infusion into the vein in a physician’s office or a medical facility capable of managing possible complications

Additional Information for Patients

  • Docetaxel contains alcohol, which affects the central nervous system and can impair your ability to drive or use machinery for one to two hours after infusion.
  • Before receiving docetaxel, tell your health care professional if you have problems with alcohol or drinking, have liver disease or other medical conditions that may be affected by alcohol intake.
  • Avoid driving, operating machinery or doing other activities that are dangerous or require skill one to two hours after you receive treatment with docetaxel.
  • Tell your health care professional about all the medicines you are currently taking, as the alcohol in docetaxel may affect other medicines you are using.
  • Notify your health care professional immediately if you experience any of the following symptoms while receiving an intravenous infusion of docetaxel and for one to two hours after treatment: symptoms of being drunk, confusion, stumbling, or becoming very sleepy.
  • Report any side effects from docetaxel to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

Additional Information for Health Care Professionals

  • Cases of intoxication have been reported with some formulations of docetaxel due to the alcohol (ethanol) content.
  • The alcohol content in a dose of docetaxel may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized, including patients with hepatic impairment.
  • Take into consideration the alcohol content in docetaxel on patients’ ability to drive or use machines one to two hours after the infusion.
  • Consider a docetaxel formulation with the lowest possible alcohol content for patients who experience adverse reactions.
  • Slowing the infusion rate during administration may help resolve symptoms of alcohol intoxication.
  • Monitor patients for signs of alcohol intoxication during and after treatment.
  • Counsel patients about the possible effects of the alcohol content in docetaxel, including possible effects on the central nervous system.
  • Report adverse events involving docetaxel to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

Data Summary

A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature identified three cases of alcohol intoxication associated with docetaxel.1  There was a strong temporal association between the docetaxel infusion and symptoms of alcohol intoxication in the cases.  Two patients experienced alcohol intoxication during the infusion and one patient experienced it within 24 hours of drug administration.  In one case, the symptoms of alcohol intoxication were transient.  In another case, the symptoms resolved in time for the patient to finish his treatment using a slower infusion rate.  In two of the three cases, the reporters planned to use a different docetaxel formulation with lower alcohol content for future treatments.

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Manufacturer Warnings

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
See full prescribing information for complete boxed warning

  • Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving TAXOTERE at 100 mg/m2 (5.1)
  • Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle (8.6)
  • Should not be given if neutrophil counts are < 1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia (4)
  • Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of TAXOTERE and administration of appropriate therapy (5.4)
  • Contraindicated if history of severe hypersensitivity reactions to TAXOTERE or to drugs formulated with polysorbate 80 (4)
  • Severe fluid retention may occur despite dexamethasone (5.5)

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

The incidence of treatment-related mortality associated with TAXOTERE 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 TAXOTERE as a single agent at a dose of 100 mg/m2[see Warnings and Precautions (5.1)].

TAXOTERE should not be given to 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 grade 4 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 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 TAXOTERE therapy [see Warnings and Precautions (5.2)].

TAXOTERE therapy should not be given to patients with neutrophil counts of <1500 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 TAXOTERE [see Warnings and Precautions (5.3)].

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 TAXOTERE infusion and administration of appropriate therapy [see Warnings and Precautions (5.4)]. TAXOTERE must not be given to patients who have a history of severe hypersensitivity reactions to TAXOTERE or to other drugs formulated with polysorbate 80 [see Contraindications (4)].

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) [see Warnings and Precautions (5.5)].

WARNINGS AND PRECAUTIONS
5.1 Toxic Deaths

Breast Cancer

TAXOTERE administered at 100 mg/m2 was associated with deaths considered possibly or probably related to treatment in 2.0% (19/965) of metastatic breast cancer patients, both previously treated and untreated, with normal baseline liver function and in 11.5% (7/61) of patients with various tumor types who had abnormal baseline liver function (AST and/or ALT >1.5 times ULN together with AP >2.5 times ULN). Among patients dosed at 60 mg/m2, mortality related to treatment occurred in 0.6% (3/481) of patients with normal liver function, and in 3 of 7 patients with abnormal liver function. Approximately half of these deaths occurred during the first cycle. Sepsis accounted for the majority of the deaths.

Non-Small Cell Lung Cancer

TAXOTERE administered at a dose of 100 mg/m2 in patients with locally advanced or metastatic non-small cell lung cancer who had a history of prior platinum-based chemotherapy was associated with increased treatment-related mortality (14% and 5% in two randomized, controlled studies). There were 2.8% treatment-related deaths among the 176 patients treated at the 75 mg/m2 dose in the randomized trials. Among patients who experienced treatment-related mortality at the 75 mg/m2 dose level, 3 of 5 patients had an ECOG PS of 2 at study entry [see Dosage and Administration (2.2), Clinical Studies (14)].

5.2 Hepatic Impairment

Patients with combined abnormalities of transaminases and alkaline phosphatase should not be treated with TAXOTERE [see Boxed Warning, Use in Specific Populations (8.6), Clinical studies (14)].

5.3 Hematologic Effects

Perform frequent peripheral blood cell counts on all patients receiving TAXOTERE. Patients should not be retreated with subsequent cycles of TAXOTERE until neutrophils recover to a level >1500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.

A 25% reduction in the dose of TAXOTERE 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 TAXOTERE cycle [see Dosage and Administration (2.7)].

Neutropenia (<2000 neutrophils/mm3) occurs in virtually all patients given 60 mg/m2 to 100 mg/m2 of TAXOTERE 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. TAXOTERE should not be administered to patients with neutrophils <1500 cells/mm3.

Febrile neutropenia occurred in about 12% of patients given 100 mg/m2 but was very uncommon in patients given 60 mg/m2. Hematologic responses, febrile reactions and infections, and rates of septic death for different regimens are dose related [see Adverse Reactions (6.1), Clinical Studies (14)].

Three breast cancer patients with severe liver impairment (bilirubin >1.7 times ULN) developed fatal gastrointestinal bleeding associated with severe drug-induced thrombocytopenia. In gastric cancer patients treated with docetaxel in combination with cisplatin and fluorouracil (TCF), febrile neutropenia and/or neutropenic infection occurred in 12% of patients receiving G-CSF compared to 28% who did not. Patients receiving TCF should be closely monitored during the first and subsequent cycles for febrile neutropenia and neutropenic infection [see Dosage and Administration (2.7), Adverse Reactions (6)].

5.4 Hypersensitivity Reactions

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 premedicated 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.

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 [see Dosage and Administration (2.6)].

5.5 Fluid Retention

Severe fluid retention has been reported following TAXOTERE therapy. Patients should be premedicated with oral corticosteroids prior to each TAXOTERE administration to reduce the incidence and severity of fluid retention [see Dosage and Administration (2.6)]. Patients with pre-existing effusions should be closely monitored from the first dose for the possible exacerbation of the effusions.

When fluid retention occurs, peripheral edema usually starts in the lower extremities and may become generalized with a median weight gain of 2 kg.

Among 92 breast cancer patients premedicated with 3-day corticosteroids, moderate fluid retention occurred in 27.2% and severe fluid retention in 6.5%. The median cumulative dose to onset of moderate or severe fluid retention was 819 mg/m2. Nine of 92 patients (9.8%) of patients discontinued treatment due to fluid retention: 4 patients discontinued with severe fluid retention; the remaining 5 had mild or moderate fluid retention. The median cumulative dose to treatment discontinuation due to fluid retention was 1021 mg/m2. Fluid retention was completely, but sometimes slowly, reversible with a median of 16 weeks from the last infusion of TAXOTERE to resolution (range: 0 to 42+ weeks). Patients developing peripheral edema may be treated with standard measures, e.g., salt restriction, oral diuretic(s).

5.6 Acute Myeloid Leukemia

Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use in adjuvant therapy for breast cancer. In the adjuvant breast cancer trial (TAX316) AML occurred in 3 of 744 patients who received TAXOTERE, doxorubicin and cyclophosphamide (TAC) and in 1 of 736 patients who received fluorouracil, doxorubicin and cyclophosphamide [see Clinical Studies (14.2)]. In TAC-treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires hematological follow-up.

5.7 Cutaneous Reactions

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 [see Dosage and Administration (2.7)]. 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.

5.8 Neurologic Reactions

Severe neurosensory symptoms (e.g. paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients, and resulted in treatment discontinuation in 6.1%. When these symptoms occur, dosage must be adjusted. If symptoms persist, treatment should be discontinued [see Dosage and Administration (2.7)]. 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 occurred in 4.4% (42/965).

5.9 Eye Disorders

Cystoid macular edema (CME) has been reported in patients treated with TAXOTERE. Patients with impaired vision should undergo a prompt and comprehensive ophthalmologic examination. If CME is diagnosed, TAXOTERE treatment should be discontinued and appropriate treatment initiated. Alternative non-taxane cancer treatment should be considered.

5.10 Asthenia

Severe asthenia has been reported in 14.9% (144/965) of metastatic breast cancer patients but has led to treatment discontinuation in only 1.8%. Symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease.

5.11 Alcohol Content

Cases of intoxication have been reported with some formulations of docetaxel due to the alcohol content. The alcohol content in a dose of TAXOTERE Injection may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized. Consideration should be given to the alcohol content in TAXOTERE Injection on the ability to drive or use machines immediately after the infusion. Each administration of TAXOTERE Injection at 100 mg/m2 delivers 2.0 g/m2 of ethanol. For a patient with a BSA of 2.0 m2, this would deliver 4.0 grams of ethanol [see Description (11)]. Other docetaxel products may have a different amount of alcohol.

5.12 Use in Pregnancy

TAXOTERE can cause fetal harm when administered to a pregnant woman. Docetaxel caused embryofetal toxicities including intrauterine mortality when administered to pregnant rats and rabbits during the period of organogenesis. Embryofetal effects in animals occurred at doses as low as 1/50 and 1/300 the recommended human dose on a body surface area basis.

There are no adequate and well-controlled studies in pregnant women using TAXOTERE. If TAXOTERE is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with TAXOTERE [see Use in Specific Populations (8.1)].

ADVERSE REACTIONS

The most serious adverse reactions from TAXOTERE are:

  • Toxic Deaths [see Boxed Warning, Warnings and Precautions (5.1)]
  • Hepatotoxicity [see Boxed Warning, Warnings and Precautions (5.2)]
  • Neutropenia [see Boxed Warning, Warnings and Precautions (5.3)]
  • Hypersensitivity [see Boxed Warning, Warnings and Precautions (5.4)]
  • Fluid Retention [see Boxed Warning, Warnings and Precautions (5.5)]
  • Acute Myeloid Leukemia [see Warnings and Precautions (5.6)]
  • Cutaneous Reactions [see Warnings and Precautions (5.7)]
  • Neurologic Reactions [see Warnings and Precautions (5.8)]
  • Eye Disorders [see Warnings and Precautions (5.9)]
  • Asthenia [see Warnings and Precautions (5.10)]
  • Alcohol Intoxication [see Warnings and Precautions (5.11)]

The most common adverse reactions across all TAXOTERE 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 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.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

1.1 Breast Cancer

TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.

TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

1.2 Non-Small Cell Lung Cancer

TAXOTERE as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.

TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.

1.3 Prostate Cancer

TAXOTERE in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

1.4 Gastric Adenocarcinoma

TAXOTERE in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

1.5 Head and Neck Cancer

TAXOTERE in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

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History

There is currently no drug history available for this drug.

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Other Information

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:

Chemical Structure

Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14• 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water.

One-vial TAXOTERE (Injection Concentrate)

TAXOTERE (docetaxel) Injection Concentrate is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration.

Each mL contains 20 mg docetaxel (anhydrous) in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution.

TAXOTERE is available in single use vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous).

TAXOTERE Injection Concentrate requires NO prior dilution with a diluent and is ready to add to the infusion solution.

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Sources

  • http://www.fda.gov/Drugs/DrugSafety/ucm401752.htm
  • http://products.sanofi.us/taxotere/taxotere.html
  • http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm212079.htm
  • http://www.fda.gov/Drugs/DrugSafety/ucm401752.htm
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    For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration (2.7)].

    Administer in a facility equipped to manage possible complications (e.g. anaphylaxis).

    2.1 Breast Cancer For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of TAXOTERE is 60 mg/m2 to 100 mg/m2 administered intravenously over 1 hour every 3 weeks. For the adjuvant treatment of operable node-positive breast cancer, the recommended TAXOTERE dose is 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities [see Dosage and Administration (2.7)]. 2.2 Non-Small Cell Lung Cancer For treatment after failure of prior platinum-based chemotherapy, TAXOTERE was evaluated as monotherapy, and the recommended dose is 75 mg/m2 administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized, controlled trials [see Boxed Warning, Dosage and Administration (2.7), Warnings and Precautions (5), Clinical Studies (14)]. For chemotherapy-naïve patients, TAXOTERE was evaluated in combination with cisplatin. The recommended dose of TAXOTERE is 75 mg/m2 administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m2 over 30–60 minutes every 3 weeks [see Dosage and Administration (2.7)]. 2.3 Prostate Cancer For hormone-refractory metastatic prostate cancer, the recommended dose of TAXOTERE is 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously [see Dosage and Administration (2.7)]. 2.4 Gastric Adenocarcinoma For gastric adenocarcinoma, the recommended dose of TAXOTERE is 75 mg/m2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m2, as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration [see Dosage and Administration (2.7)]. 2.5 Head and Neck Cancer

    Patients must receive premedication with antiemetics, and appropriate hydration (prior to and after cisplatin administration). Prophylaxis for neutropenic infections should be administered. All patients treated on the TAXOTERE containing arms of the TAX323 and TAX324 studies received prophylactic antibiotics.

    Induction chemotherapy followed by radiotherapy (TAX323)
    For the induction treatment of locally advanced inoperable SCCHN, the recommended dose of TAXOTERE is 75 mg/m2 as a 1 hour intravenous infusion followed by cisplatin 75 mg/m2 intravenously over 1 hour, on day one, followed by fluorouracil as a continuous intravenous infusion at 750 mg/m2 per day for five days. This regimen is administered every 3 weeks for 4 cycles. Following chemotherapy, patients should receive radiotherapy. [see Dosage and Administration (2.7)]. Induction chemotherapy followed by chemoradiotherapy (TAX324)
    For the induction treatment of patients with locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN, the recommended dose of TAXOTERE is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3 hour infusion, followed by fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4. This regimen is administered every 3 weeks for 3 cycles. Following chemotherapy, patients should receive chemoradiotherapy [see Dosage and Administration (2.7)]. 2.6 Premedication Regimen

    All patients should be premedicated with oral corticosteroids (see below for prostate cancer) such as dexamethasone 16 mg per day (e.g., 8 mg twice daily) for 3 days starting 1 day prior to TAXOTERE administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.4)].

    For hormone-refractory metastatic prostate cancer, given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the TAXOTERE infusion [see Warnings and Precautions (5.4)].

    2.7 Dosage Adjustments During Treatment

    Breast Cancer

    Patients who are dosed initially at 100 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, or severe or cumulative cutaneous reactions during TAXOTERE 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 1 week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during TAXOTERE therapy may tolerate higher doses. Patients who develop ≥grade 3 peripheral neuropathy should have TAXOTERE treatment discontinued entirely.

    Combination Therapy with TAXOTERE in the Adjuvant Treatment of Breast Cancer

    TAXOTERE 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 TAXOTERE dose reduced to 60 mg/m2. Patients who experience grade 3 or 4 stomatitis should have their TAXOTERE dose decreased to 60 mg/m2. Patients who experience severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during TAXOTERE therapy should have their dosage of TAXOTERE reduced from 75 mg/m2 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, treatment should be discontinued.

    Non-Small Cell Lung Cancer

    Monotherapy with TAXOTERE 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 TAXOTERE 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 TAXOTERE treatment discontinued entirely.

    Combination therapy with TAXOTERE for chemotherapy-naïve NSCLC

    For patients who are dosed initially at TAXOTERE 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 TAXOTERE 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 manufacturers' prescribing information.

    Prostate Cancer

    Combination therapy with TAXOTERE for hormone-refractory metastatic prostate cancer

    TAXOTERE should be administered when the neutrophil count is ≥1,500 cells/mm3. 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 TAXOTERE therapy should have the dosage of TAXOTERE 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.

    Gastric or Head and Neck Cancer

    TAXOTERE in combination with cisplatin and fluorouracil in gastric cancer or head and neck cancer

    Patients treated with TAXOTERE in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In both studies, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days. If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the TAXOTERE dose should be reduced from 75 mg/m2 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur the TAXOTERE dose should be reduced from 60 mg/m2 to 45 mg/m2. In case of grade 4 thrombocytopenia the TAXOTERE dose should be reduced from 75 mg/m2 to 60 mg/m2. Patients should not be retreated with subsequent cycles of TAXOTERE 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 Warnings and Precautions (5.3)].

    Recommended dose modifications for toxicities in patients treated with TAXOTERE in combination with cisplatin and fluorouracil are shown in Table 1.

    Table 1 - Recommended Dose Modifications for Toxicities in Patients Treated with TAXOTERE in Combination with Cisplatin and Fluorouracil Toxicity Dosage adjustment Diarrhea grade 3 First episode: reduce fluorouracil dose by 20%.
    Second episode: then reduce TAXOTERE dose by 20%. Diarrhea grade 4 First episode: reduce TAXOTERE and fluorouracil doses by 20%.
    Second episode: discontinue treatment. Stomatitis/mucositis grade 3 First episode: reduce fluorouracil dose by 20%.
    Second episode: stop fluorouracil only, at all subsequent cycles.
    Third episode: reduce TAXOTERE dose by 20%. Stomatitis/mucositis grade 4 First episode: stop fluorouracil only, at all subsequent cycles.
    Second episode: reduce TAXOTERE dose by 20%.

    Liver dysfunction:

    In case of AST/ALT >2.5 to ≤5 × ULN and AP ≤2.5 × ULN, or AST/ALT >1.5 to ≤5 × ULN and AP >2.5 to ≤5 × ULN, TAXOTERE should be reduced by 20%.

    In case of AST/ALT >5 × ULN and/or AP >5 × ULN TAXOTERE should be stopped.

    The dose modifications for cisplatin and fluorouracil in the gastric cancer study are provided below:

    Cisplatin dose modifications and delays

    Peripheral neuropathy: A neurological examination should be performed before entry into the study, and then at least every 2 cycles and at the end of treatment. In the case of neurological signs or symptoms, more frequent examinations should be performed and the following dose modifications can be made according to NCIC-CTC grade:

    Grade 2: Reduce cisplatin dose by 20%. Grade 3: Discontinue treatment.

    Ototoxicity: In the case of grade 3 toxicity, discontinue treatment.

    Nephrotoxicity: In the event of a rise in serum creatinine ≥grade 2 (>1.5 x normal value) despite adequate rehydration, CrCl should be determined before each subsequent cycle and the following dose reductions should be considered (see Table 2).

    For other cisplatin dosage adjustments, also refer to the manufacturers' prescribing information.

    Table 2 – Dose Reductions for Evaluation of Creatinine Clearance Creatinine clearance result before next cycle Cisplatin dose next cycle CrCl = Creatinine clearance CrCl ≥60 mL/min Full dose of cisplatin was given. CrCl was to be repeated before each treatment cycle. CrCl between 40 and 59 mL/min Dose of cisplatin was reduced by 50% at subsequent cycle. If CrCl was >60 mL/min at end of cycle, full cisplatin dose was reinstituted at the next cycle.

    If no recovery was observed, then cisplatin was omitted from the next treatment cycle. CrCl <40 mL/min Dose of cisplatin was omitted in that treatment cycle only.

    If CrCl was still <40 mL/min at the end of cycle, cisplatin was discontinued.

    If CrCl was >40 and <60 mL/min at end of cycle, a 50% cisplatin dose was given at the next cycle.

    If CrCl was >60 mL/min at end of cycle, full cisplatin dose was given at next cycle.

    Fluorouracil dose modifications and treatment delays

    For diarrhea and stomatitis, see Table 1.

    In the event of grade 2 or greater plantar-palmar toxicity, fluorouracil should be stopped until recovery. The fluorouracil dosage should be reduced by 20%.

    For other greater than grade 3 toxicities, except alopecia and anemia, chemotherapy should be delayed (for a maximum of 2 weeks from the planned date of infusion) until resolution to grade ≤1 and then recommenced, if medically appropriate.

    For other fluorouracil dosage adjustments, also refer to the manufacturers' prescribing information.

    Combination Therapy with Strong CYP3A4 inhibitors:

    Avoid using concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole). There are no clinical data with a dose adjustment in patients receiving strong CYP3A4 inhibitors. Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require co-administration of a strong CYP3A4 inhibitor. [see Drug Interactions (7), Clinical Pharmacology (12.3)].

    2.8 Administration Precautions

    TAXOTERE is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing TAXOTERE solutions. The use of gloves is recommended. Please refer to [see How Supplied/ Storage and Handling (16.3)].

    If TAXOTERE Injection Concentrate, initial diluted solution, or final dilution for infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. If TAXOTERE Injection Concentrate, initial diluted solution, or final dilution for infusion should come into contact with mucosa, immediately and thoroughly wash with water.

    Contact of the TAXOTERE concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, the final TAXOTERE dilution for infusion should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.

    One-vial TAXOTERE (Injection Concentrate)

    TAXOTERE Injection Concentrate requires NO prior dilution with a diluent and is ready to add to the infusion solution.

    Please follow the preparation instructions provided below.

    2.9 Preparation and Administration

    DO NOT use the two-vial formulation (Injection Concentrate and diluent) with the one-vial formulation.

    One-vial TAXOTERE (Injection Concentrate)

    TAXOTERE Injection Concentrate (20 mg/mL) requires NO prior dilution with a diluent and is ready to add to the infusion solution. Use only a 21 gauge needle to withdraw TAXOTERE from the vial because larger bore needles (e.g., 18 and 19 gauge) may result in stopper coring and rubber particulates.

    TAXOTERE vials should be stored between 2 and 25°C (36 and 77°F). If the vials are stored under refrigeration, allow the appropriate number of vials of TAXOTERE Injection Concentrate vials to stand at room temperature for approximately 5 minutes before use. Using only a 21 gauge needle, aseptically withdraw the required amount of TAXOTERE injection concentrate (20 mg docetaxel/mL) with a calibrated syringe and inject via a single injection (one shot) into a 250 mL infusion bag or bottle of either 0.9% Sodium Chloride solution or 5% Dextrose solution to produce a final concentration of 0.3 mg/mL to 0.74 mg/mL.
    If a dose greater than 200 mg of TAXOTERE is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL TAXOTERE is not exceeded. Thoroughly mix the infusion by gentle manual rotation. As with all parenteral products, TAXOTERE should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and container permit. If the TAXOTERE dilution for intravenous infusion is not clear or appears to have precipitation, it should be discarded. TAXOTERE infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

    The TAXOTERE dilution for infusion should be administered intravenously as a 1-hour infusion under ambient room temperature (below 25°C) and lighting conditions.

    2.10 Stability

    TAXOTERE final dilution for infusion, if stored between 2°C and 25°C (36°F and 77°F) is stable for 6 hours. TAXOTERE final dilution for infusion (in either 0.9% Sodium Chloride solution or 5% Dextrose solution) should be used within 6 hours (including the 1 hour intravenous administration).

    In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C and 8°C (36 and 46°F).

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