Docetaxel

What is Docetaxel?

• Docetaxel (Taxotere) is a microtubule inhibitor used alone or with other drugs to treat Breast cancer, Non-small cell lung cancer, Prostate cancer, Squamous cell carcinoma of the head and neck, and Stomach adenocarcinoma or gastroesophageal junction adenocarcinoma.

Docetaxel

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What are the uses of this medicine?

Docetaxel (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

How does this medicine work?

• Docetaxel (doe" se tax' el) is a complex diterpenoid molecule that contains a central 8-member taxane ring. Docetaxel is a semisynthetic analogue of paclitaxel and was initially isolated from the needles of the European Yew tree (Taxus baccata).
• It is a potent antineoplastic agent and its mechanism of action appears to be mediated by its binding to microtubulin, which is important in the mitototic phase of cell division.
• The binding of docetaxel prevents the disassembly of the cytoskeletal microtubules, preventing cell division and leading to cell death.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• severe allergic reaction to:
• docetaxel, the active ingredient in Docetaxel Injection or
• any other medicines that contain polysorbate 80.
• have a low white blood cell count.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• antifungals such as itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend)
• clarithromycin (Biaxin)
• HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• medications containing alcohol (Nyquil, elixirs, others)
• medications for pain
• nefazodone
• sleeping pills
• telithromycin (no longer available in US; Ketek).

Is this medicine FDA approved?

• Docetaxel was approved for use in the United States in 1996 and it remains an important agent in the therapy of several neoplasms including breast, gastric, prostate, head and neck, and non-small cell lung cancer.

How should this medicine be used?

• Premedicate with oral corticosteroids.

Recommended dosage: Breast Cancer:

• locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent.
• BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles.

Non-Small Cell Lung Cancer:

• after platinum therapy failure: 75 mg/m2 single agent
• chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2

Prostate Cancer:

• 75 mg/m2 with 5 mg prednisone twice a day continuously

Gastric Adenocarcinoma:

• 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr intravenous infusion (days 1 to 5), starting at end of cisplatin infusion

Head and Neck Cancer:

• Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): 75 mg/m2 followed by cisplatin 75 mg/m2 intravenously (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr intravenous infusion (days 1 to 5), starting at end of cisplatin infusion; for 4 cycles (2.5)
• Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): 75 mg/m2 followed by cisplatin 100 mg/m2 intravenously (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr intravenous infusion (days 1 to 4); for 3 cycles

Administration:

• Docetaxel Injection will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
• Docetaxel Injection is usually given every 3 weeks.
• Your doctor will decide how long you will receive treatment with docetaxel injection.
• Your doctor will check your blood cell counts and other blood tests during your treatment with docetaxel injection to check for side effects of docetaxel injection.
• 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 docetaxel injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Docetaxel Injection: Multipl-dose vial 160 mg/8 mL

This medicine is available in fallowing brand namesː

• Taxotere

What side effects can this medication cause?

The most common side effects of this medicine 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 docetaxel injection administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin
• tissue damage if docetaxel injection leaks out of the vein into the tissues

Docetaxel Injection may cause serious side effects including:

• death
• Serious allergic reactions
• affect your blood cells
• severe fluid retention
• Acute Myeloid Leukemia (AML)
• Other Blood Disorders
• Skin Reactions
• Neurologic Symptoms
• Vision Problems

What special precautions should I follow?

• 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 patients who received docetaxel, doxorubicin and cyclophosphamide, monitor for delayed myelodysplasia or myeloid leukemia.
• Localized erythema of the extremities with edema followed by desquamation has been observed. Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe skin toxicity may require dose adjustment.
• Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent.
• Cystoid macular edema (CME) has been reported and requires treatment discontinuation. If CME is diagnosed, Docetaxel Injection treatment should be discontinued and appropriate treatment initiated. Alternative non-taxane cancer treatment should be considered.
• Severe asthenia may occur and may require treatment discontinuation.
• The alcohol content in a dose of Docetaxel Injection may affect the central nervous system. This may include impairment of a patient’s ability to drive or use machines immediately after infusion.
• Fetal harm can occur when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant when receiving Docetaxel Injection.
• Patients with combined abnormalities of transaminases and alkaline phosphatase should not be treated with Docetaxel Injection.
• Perform frequent peripheral blood cell counts on all patients receiving Docetaxel Injection.
• Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions. 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 Docetaxel Injection .
• Severe fluid retention has been reported following docetaxel therapy. Patients developing peripheral edema may be treated with standard measures, e.g., salt restriction, oral diuretic(s).

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• bone marrow suppression, peripheral neurotoxicity, and mucositis

Management of overdosage:

• There is no known antidote for docetaxel overdosage.
• In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored.
• Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings in animals, Docetaxel injection can cause fetal harm when administered to a pregnant woman.
• Docetaxel Injection can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Docetaxel Injection in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: docetaxel anhydrous, USP
• Inactive ingredients include: anhydrous citric acid, polysorbate 80 and dehydrated alcohol

Who manufactures and distributes this medicine?

Manufactured for:

• Mylan Institutional LLC
• Rockford, IL 61103 U.S.A.

Manufactured By:

• Mylan Laboratories Limited
• Bangalore, India.

What should I know about storage and disposal of this medication?

• Store between 15° and 25°C (59° and 77°F). Retain in the original package to protect from light.
• Freezing does not adversely affect the product.
• After initial puncture, Docetaxel Injection, USP multiple-dose vials are stable for 28 days when stored at room temperature, with protection from light.

• Dailymed label info on Docetaxel
• FDA Docetaxel

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