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.
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.
Questions & Answers
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.
Sanofi-Aventis, the manufacturer of Taxotere (docetaxel) is facing lawsuits from female patients who have suffered permanent hair loss, also known as “alopecia.” The plaintiffs claim that they did not receive proper warnings about the risk of permanent hair loss associated with the drug, and did not receive proper information about alternative treatments that do not carry the same risks. → Learn more about the pending taxotere lawsuits and settlements
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.
- 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.
- 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.
- 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 ...
- Cystoid Macular Edema (CME) is a painless eye disorder that can result in impaired vision.
- 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.
- 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...
- 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
- 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
- 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.
- 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.
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)
- 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)]
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
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.
TAXOTERE in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.
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.
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).
There is currently no drug history available for this drug.
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:
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.