Taxotere

What preparations of docetaxel are available?

Injection Concentrate: 20 mg/0.5 ml, 80 mg/2 ml; Injection (Powder): 20 mg/vial, 80 mg/vial

How should I keep docetaxel stored?

Docetaxel concentrate should be stored between 2 C and 25 C (36 F to 77 F), and the powder should be stored between 2 C and 8 C (36 F and 46 F). They should be retained in their original package to protect them from light.

Docetaxel has caused severe (rarely fatal) allergic reactions and swelling (fluid retention/edema) even with the use of preventive medications. This drug must not be used in patients who have previously had an allergic reaction to it or to other medications containing polysorbate 80.

There is an increased risk of serious (possibly fatal) reactions in patients using docetaxel who have liver problems, patients receiving higher doses, and patients with non-small cell lung cancer who have received certain other chemotherapy drugs known as "platinums."

If you have a low white blood cell count or liver problems, notify your doctor before using docetaxel.

Seek immediate medical attention if you experience swelling, dizziness or fainting, difficulty breathing, irregular heartbeat, severe swelling of the abdomen, skin rash, easy bleeding or bruising, sores in the mouth or throat, or symptoms of infection such as fever and sore throat.

Your doctor will closely monitor you and your blood counts and liver tests while you are receiving docetaxel.

Before using docetaxel, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate 80, alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before receiving docetaxel, tell your doctor or pharmacist your medical history, especially of: liver problems, lung problems (e.g., pulmonary effusions), heart problems (e.g., congestive heart failure), weak immune system (e.g., neutropenia), blood problems (e.g., anemia, thrombocytopenia), blood pressure problems.Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.Use caution with sharp objects like razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.Wash your hands well to prevent the spread of infections.This medication and the pre-medications that you take before you take docetaxel may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages as they may aggravate some of the side effects and make your stomach and intestines more likely to bleed.Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially anemia, dizziness, diarrhea, infection, swelling, mouth sores, and weight loss.This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby. Consult your doctor before taking docetaxel and discuss the use of reliable birth control methods during therapy and for 3 months afterwards. If you become pregnant or think you may be pregnant, inform your doctor immediately.It is not known if this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Black Box Warnings

The drug should be administered under the supervision of an experienced cancer chemotherapy physician

Increased mortality reported in patients with liver impairment receiving higher doses, patients with non-small lung cancer, and a history of platinum-based chemotherapy receiving docetaxel as a single agent at a dose of 100 mg/m²

Patients with elevations in bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk of developing grade 4 neutropenia, febrile neutropenia, infections, severe neutropenia, severe stomatitis, and toxic death

Generally not given if bilirubin >ULN, or if SGOT and/or SGPT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN

Perform blood cell counts on all patients receiving docetaxel; if neutrophil count <1500 cells/mm3, do not administer

Severe hypersensitivity reactions, characterized by generalized rash/erythema, hypotension, and/or bronchospasm, or very rarely fatal anaphylaxis, reported in patients receiving the recommended 3-day dexamethasone premedication; discontinue infusion and administer appropriate therapy if hypersensitivity reaction occurs

Do not give docetaxel to patients with documented hypersensitivity to the drug or drugs formulated with polysorbate 80

Severe fluid retention may occur despite use of a 3-day dexamethasone premedication regimen; it may be characterized by poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites)

Contraindications

Hypersensitivity to docetaxel or polysorbate 80

Solid tumor with baseline ANC<1500/cu.mm

Cautions

Irritant; use caution

Treatment-related mortality higher in patients with hepatic impairment, those receiving higher doses, and in patients with NSCLC and history of prior platinum-based chemotherapy who receive docetaxel as a monotherapy at 100 mg/m²

Monitor for delayed myelodysplasia or myeloid leukemia in patients who received docetaxel injection concentrate, doxorubicin and cyclophosphamide

Coadministration with CYP3A4 inhibitors may increase exposure to docetaxel and should be avoided; consider docetaxel dose reduction if unable to avoid

Consider adjusting dose if cutaneous reactions like erythema of the extremities with edema followed by desquamation occur

Risk of severe fluid retention even with dexamethasone

Women of childbearing potential should not become pregnant when receiving docetaxel injection concentrate; it causes fetal harm

Reactions including paresthesia, dysesthesia, and pain may occur; severe neurosensory symptoms require dose adjustment or discontinuation if persistent

Consider therapy discontinuation if severe asthenia occurs

Cystoid macular edema reported and requires treatment discontinuation

The diluent for docetaxel contains 13% ethanol; alcohol intoxication has been reported following IV infusion

Renal failure have been reported, the majority of these cases were associated with concomitant nephrotoxic drugs

Avoid pregnancy

Coadministration with doxorubicin and cyclophosphamide may increase incidence of heart failure compared to nondocetaxel regimens.

Pregnancy Category: D

Lactation: Not known if excreted in breast milk, do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Taxotere is a prescription anti-cancer medicine used to treat certain people with:

• breast cancer
• non-small cell lung cancer
• prostate cancer
• stomach cancer
• head and neck cancer

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ketoconazole
• ritonavir
• rifampin
• rifabutin

This is not a complete list of Taxotere drug interactions. Ask your doctor or pharmacist for more information.

 

Get emergency medical help if you have signs of an allergic reaction: hives, red skin rash; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden vision problems;

• extreme weakness, severe vomiting or diarrhea;

• redness or peeling of the skin on your hands and feet;

• numbness, burning pain, or tingly feeling;

• a feeling of being drunk--confusion, stumbling, extreme drowsiness;

• signs of infection--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• low red blood cells--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• low platelets in your blood--easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fluid retention--little or no urinating, swelling of your ankles or feet, rapid weight gain; or

• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Older adults may be more likely to have side effects from this medicine.

Common side effects may include:

• mild weakness;

• altered sense of taste;

• nausea, vomiting, loss of appetite;

• constipation, diarrhea;

• hair loss (may be permanent in some cases);

• muscle pain;

• mild skin rash; 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.

Metabolized by CYP3A4.1 84 85 86

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP3A.1 84 85 86

Potent CYP3A4 inhibitors: Possible pharmacokinetic interaction (increased exposure to docetaxel).1 84 85 86 Avoid concomitant use; if concomitant use cannot be avoided, consider reducing docetaxel dosage and carefully monitor for toxicity.1 84 85 86 Manufacturer recommends considering a 50% reduction in docetaxel dosage based on limited pharmacokinetic data for ketoconazole; however, clinical data not available for use of this adjusted dosage in patients receiving potent CYP3A4 inhibitors.1 84 85 86 (See Specific Drugs under Interactions.)

Specific Drugs

Drug	Interaction	Comments
Antifungals, azoles (itraconazole, ketoconazole, voriconazole)	Ketoconazole: Reduced clearance (by 49%) and increased exposure (by 2.2-fold) of docetaxel1 84 85 86 Itraconazole, voriconazole: Possible increased docetaxel exposure1 84 85 86	Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86
Cisplatin	Pharmacokinetic interaction unlikely1 84 85 86
CNS depressants (e.g., opiate analgesics, sedatives)	Possible additive CNS depressant effects with alcohol in docetaxel formulation90	Consider using docetaxel formulation with least amount of alcohol90
Corticosteroids (dexamethasone, prednisone)	No effect on docetaxel clearance1 84 85 86
Fluorouracil	Pharmacokinetic interaction unlikely1 84 86
HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)	Possible increased docetaxel exposure1 84 85 86	Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86
Macrolides (clarithromycin, telithromycin)	Possible increased docetaxel exposure1 84 85 86	Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86
Nefazodone	Possible increased docetaxel exposure1 84 85 86	Avoid concomitant use; if concomitant use cannot be avoided, consider 50% reduction in docetaxel dosage and monitor for toxicity1 84 85 86

In the U.S.

• Docefrez
• Taxotere

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Docetaxel injection is used to treat breast cancer, non-small cell lung cancer, head and neck cancer, gastric (stomach) cancer, and prostate cancer. Docetaxel might be used together with other cancer medicines.

Docetaxel belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by docetaxel, other unwanted effects will also occur.

This medicine is to be given only by or under the direct supervision of your doctor.

Use Taxotere as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• A steroid drug like dexamethasone will be given before this medicine to lower side effects. Talk with the doctor. Tell the doctor if the steroid drug is not used as your doctor has told you.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Mechanism of Action

Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells. Docetaxel's binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use.

Human Pharmacokinetics

Absorption: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20 mg/m2 to 115 mg/m2 in phase 1 studies. The area under the curve (AUC) was dose proportional following doses of 70 mg/m2 to 115 mg/m2 with infusion times of 1 to 2 hours. Docetaxel's pharmacokinetic profile is consistent with a three-compartment pharmacokinetic model, with half-lives for the α, β, and γ phases of 4 min, 36 min, and 11.1 hr, respectively. Mean total body clearance was 21 L/h/m2.

Distribution: The initial rapid decline represents distribution to the peripheral compartments and the late (terminal) phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment. Mean steady state volume of distribution was 113 L. In vitro studies showed that docetaxel is about 94% protein bound, mainly to α1-acid glycoprotein, albumin, and lipoproteins. In three cancer patients, the in vitro binding to plasma proteins was found to be approximately 97%. Dexamethasone does not affect the protein binding of docetaxel.

Metabolism: In vitro drug interaction studies revealed that docetaxel is metabolized by the CYP3A4 isoenzyme, and its metabolism may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4 [see Drug Interactions (7)].

Elimination: A study of 14C-docetaxel was conducted in three cancer patients. Docetaxel was eliminated in both the urine and feces following oxidative metabolism of the tert-butyl ester group, but fecal excretion was the main elimination route. Within 7 days, urinary and fecal excretion accounted for approximately 6% and 75% of the administered radioactivity, respectively. About 80% of the radioactivity recovered in feces is excreted during the first 48 hours as 1 major and 3 minor metabolites with very small amounts (less than 8%) of unchanged drug.

Effect of Age: A population pharmacokinetic analysis was carried out after Taxotere treatment of 535 patients dosed at 100 mg/m2. Pharmacokinetic parameters estimated by this analysis were very close to those estimated from phase 1 studies. The pharmacokinetics of docetaxel were not influenced by age.

Effect of Gender: The population pharmacokinetics analysis described above also indicated that gender did not influence the pharmacokinetics of docetaxel.

Hepatic Impairment: The population pharmacokinetic analysis described above indicated that in patients with clinical chemistry data suggestive of mild to moderate liver impairment (AST and/or ALT >1.5 times ULN concomitant with alkaline phosphatase >2.5 times ULN), total body clearance was lowered by an average of 27%, resulting in a 38% increase in systemic exposure (AUC). This average, however, includes a substantial range and there is, at present, no measurement that would allow recommendation for dose adjustment in such patients. Patients with combined abnormalities of transaminase and alkaline phosphatase should not be treated with Taxotere. Patients with severe hepatic impairment have not been studied. [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]

Effect of Race: Mean total body clearance for Japanese patients dosed at the range of 10 mg/m2 to 90 mg/m2 was similar to that of European/American populations dosed at 100 mg/m2, suggesting no significant difference in the elimination of docetaxel in the two populations.

Effect of Ketoconazole: The effect of ketoconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of docetaxel was investigated in 7 cancer patients. Patients were randomized to receive either docetaxel (100 mg/m2 intravenous) alone or docetaxel (10 mg/m2 intravenous) in combination with ketoconazole (200 mg orally once daily for 3 days) in a crossover design with a 3-week washout period. The results of this study indicated that the mean dose-normalized AUC of docetaxel was increased 2.2-fold and its clearance was reduced by 49% when docetaxel was co-administration with ketoconazole [see Dosage and Administration (2.7) and Drug-Drug Interactions (7)].

Effect of Combination Therapies:

• Dexamethasone: Docetaxel total body clearance was not modified by pretreatment with dexamethasone.
• Cisplatin: Clearance of docetaxel in combination therapy with cisplatin was similar to that previously observed following monotherapy with docetaxel. The pharmacokinetic profile of cisplatin in combination therapy with docetaxel was similar to that observed with cisplatin alone.
• Cisplatin and Fluorouracil: The combined administration of docetaxel, cisplatin and fluorouracil in 12 patients with solid tumors had no influence on the pharmacokinetics of each individual drug.
• Prednisone: A population pharmacokinetic analysis of plasma data from 40 patients with hormone-refractory metastatic prostate cancer indicated that docetaxel systemic clearance in combination with prednisone is similar to that observed following administration of docetaxel alone.
• Cyclophosphamide and Doxorubicin: A study was conducted in 30 patients with advanced breast cancer to determine the potential for drug-drug-interactions between docetaxel (75 mg/m2), doxorubicin (50 mg/m2), and cyclophosphamide (500 mg/m2) when administered in combination. The coadministration of docetaxel had no effect on the pharmacokinetics of doxorubicin and cyclophosphamide when the three drugs were given in combination compared to coadministration of doxorubicin and cyclophosphamide only. In addition, doxorubicin and cyclophosphamide had no effect on docetaxel plasma clearance when the three drugs were given in combination compared to historical data for docetaxel monotherapy.

How Supplied

One-vial Taxotere (Injection Concentrate)

Taxotere Injection Concentrate is supplied in a single use vial as a sterile, pyrogen-free, non-aqueous solution.

Taxotere 20 mg/mL           (NDC 0075-8003-01)

Taxotere (docetaxel) Injection Concentrate 20 mg/1 mL: 20 mg docetaxel in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.

The vial is in a blister pack in one carton.

Taxotere 80 mg/4 mL           (NDC 0075-8004-04)

Taxotere (docetaxel) Injection Concentrate 80 mg/4 mL: 80 mg docetaxel in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.

The vial is in a blister pack in one carton.

Storage

Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.

Handling and Disposal

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

See FDA-Approved Patient Labeling

• Taxotere may cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug. Women of childbearing potential should use effective contraceptives if receiving Taxotere [see Warnings and Precautions (5.12) and Use in Specific Populations (8.1)].
• Obtain detailed allergy and concomitant drug information from the patient prior to Taxotere administration.
• 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.
• Instruct patients to immediately report signs of a hypersensitivity reaction.
• Tell patients to watch for signs of fluid retention such as peripheral edema in the lower extremities, weight gain and dyspnea.
• Explain the significance of routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever.
• Instruct patients to report myalgia, cutaneous, or neurologic reactions.
• Explain to patients the possible effects of the alcohol content in Taxotere Injection, including possible effects on the central nervous system. Patients in whom alcohol should be avoided or minimized should consider the alcohol content of Taxotere Injection. Alcohol could impair their ability to drive or use machines immediately after infusion.
• Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration.

Patient Information

Taxotere (TAX-O-TEER)
(docetaxel) Injection Concentrate
Intravenous Infusion

Read this Patient Information before you receive your first treatment with Taxotere and each time before you are treated. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Taxotere?

Taxotere can cause serious side effects, including death.

1. The chance of death in people who receive Taxotere is higher if you:
   • have liver problems
   • receive high doses of Taxotere
   • have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
2. Taxotere can affect your blood cells. Your doctor should do routine blood tests during treatment with Taxotere. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your doctor may not treat you with Taxotere until you have enough white blood cells. People with low white blood counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your doctor's instructions for how often to take your temperature while taking Taxotere. Call your doctor right away if you have a fever.
3. Serious allergic reactions can happen in people who take Taxotere. Serious allergic reactions are medical emergencies that can lead to death and must be treated right away.

   Tell your doctor right away if you have any of these signs of a serious allergic reaction:

   • trouble breathing
   • sudden swelling of your face, lips, tongue, throat, or trouble swallowing
   • hives (raised bumps), rash, or redness all over your body
4. Your body may hold too much fluid (severe fluid retention) during treatment with Taxotere. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each Taxotere treatment. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your Taxotere treatment if you forget to take the corticosteroid dose or do not take it as your doctor tells you.

What is Taxotere?

Taxotere is a prescription anti-cancer medicine used to treat certain people with:

• breast cancer
• non-small cell lung cancer
• prostate cancer
• stomach cancer
• head and neck cancer

It is not known if Taxotere is effective in children.

Who should not receive Taxotere?

Do not receive Taxotere if you:

• have had a severe allergic reaction to:
  • docetaxel, the active ingredient in Taxotere, or
  • any other medicines that contain polysorbate 80. Ask your doctor or pharmacist if you are not sure.

  See "What is the most important information I should know about Taxotere?" for the signs and symptoms of a severe allergic reaction.

• have a low white blood cell count.

What should I tell my doctor before receiving Taxotere?

Before you receive Taxotere, tell your doctor if you:

• are allergic to any medicines. See "Who should not receive Taxotere?" Also, see the end of this leaflet for a complete list of the ingredients in Taxotere.
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant. Taxotere can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Taxotere passes into your breast milk. You and your doctor should decide if you will receive Taxotere or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taxotere may affect the way other medicines work, and other medicines may affect the way Taxotere works.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How will I receive Taxotere?

• Taxotere will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
• Taxotere is usually given every 3 weeks.
• Your doctor will decide how long you will receive treatment with Taxotere.
• Your doctor will check your blood cell counts and other blood tests during your treatment with Taxotere to check for side effects of Taxotere.
• Your doctor may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving Taxotere.

What are the possible side effects of Taxotere?

Taxotere may cause serious side effects including death.

• See "What is the most important information I should know about Taxotere?"
• Acute Myeloid Leukemia (AML), a type of blood cancer, can happen in people who take Taxotere along with certain other medicines.
• Other Blood Disorders. Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Taxotere.
• Skin Reactions including redness and swelling of your arms and legs with peeling of your skin.
• Neurologic Symptoms including numbness, tingling, or burning in your hands and feet.
• Vision Problems including blurred vision or loss of vision.
• Taxotere Injection contains alcohol. The alcohol content in Taxotere Injection may impair your ability to drive or use machinery right after receiving Taxotere Injection. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive Taxotere Injection treatment.

The most common side effects of Taxotere include:

• changes in your sense of taste
• feeling short of breath
• constipation
• decreased appetite
• changes in your fingernails or toenails
• swelling of your hands, face or feet
• feeling weak or tired
• joint and muscle pain
• nausea and vomiting
• diarrhea
• mouth or lips sores
• hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.
• rash
• redness of the eye, excess tearing
• skin reactions at the site of Taxotere administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin.
• tissue damage if Taxotere leaks out of the vein into the tissues

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Taxotere. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about Taxotere

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about Taxotere. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Taxotere that is written for health professionals.

For more information, call 1-800-633-1610

What are the ingredients in Taxotere?

Active ingredient: docetaxel

Inactive ingredients include: ethanol and polysorbate 80

Every three-week injection of Taxotere for breast, non-small cell lung and stomach, and head and neck cancers

Take your oral corticosteroid medicine as your doctor tells you.

Oral corticosteroid dosing:

Day 1 Date:_________ Time: ______ AM _______ PM

Day 2 Date:_________ Time: ______ AM _______ PM (Taxotere Treatment Day)

Day 3 Date:_________ Time: ______ AM _______ PM

Every three-week injection of Taxotere for prostate cancer

Take your oral corticosteroid medicine as your doctor tells you.

Oral corticosteroid dosing:

Date: _________ Time: ___________

Date: _________ Time: ___________ (Taxotere Treatment Day)

Time: ___________

This Patient Information has been approved by the U.S. Food and Drug Administration.

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

Revised: 12/2015
© 2015 sanofi-aventis U.S. LLC

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have any signs of an allergic reaction to Taxotere: hives, red skin rash; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden vision problems;

• extreme weakness, severe vomiting or diarrhea;

• redness or peeling of the skin on your hands and feet;

• numbness, burning pain, or tingly feeling;

• a feeling of being drunk - confusion, stumbling, extreme drowsiness;

• signs of infection - fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• low red blood cells - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• low platelets in your blood - easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fluid retention - little or no urinating, swelling of your ankles or feet, rapid weight gain; or

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Older adults may be more likely to have side effects from this medicine.

Common Taxotere side effects may include:

• mild weakness;

• altered sense of taste;

• nausea, vomiting, loss of appetite;

• constipation, diarrhea;

• hair loss (may be permanent in some cases);

• muscle pain;

• mild skin rash; 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.