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Indications & Uses
Docetaxel Trihydrate (sold as Docetaxel HEXAL) is a microtubule inhibitor. It is used for breast cancer (BC), either as a single agent for locally advanced or metastatic BC after chemotherapy has failed, or with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC. For non-small cell lung cancer (NSCLC), Docetaxel Trihydrate is given alone when locally advanced or metastatic NSCLC has not responded to platinum therapy. It is given with cisplatin for unresectable, locally advanced or metastatic NSCLC that has not been treated before. For metastatic castration-resistant prostate cancer (CRPC), it is combined with prednisone. Gastric adenocarcinoma (GC) is another use, where it goes with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction. The last use is squamous cell carcinoma of the head and neck (SCCHN), where Docetaxel Trihydrate is combined with cisplatin and fluorouracil as induction treatment of locally advanced SCCHN.
Pharmacology
Docetaxel is an antineoplastic medicine. It works by disrupting the microtubule network inside cells, which the cells need for mitosis and for their normal functions between divisions. Docetaxel helps tubulin assemble into stable microtubules and, at the same time, stops those microtubules from breaking down. It also binds to free tubulin, so the critical concentration of tubulin inside the cell goes down.
Because polymerization of the microtubules is promoted, they form bundles that don't function normally, and the microtubules become stabilised. The result is that mitosis in the cells is inhibited. When Docetaxel binds to microtubules, the number of protofilaments in the bound microtubules does not change, and in this it differs from other spindle poisons.
In vitro, Docetaxel was found to be cytotoxic against various murine and human tumor cell lines, and against freshly excised human tumor cells in clonogenic assays. It was also found to be active on a number of cell lines that overexpress the p-glycoprotein, which is encoded by the multidrug resistant gene.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Docetaxel should be given in a facility that can manage possible complications such as anaphylaxis. It goes in intravenously (IV) over 1 hr, every 3 weeks. Don't use PVC equipment. Use only a 21 gauge needle to withdraw docetaxel from the vial.
BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 as a single agent.
BC adjuvant: 75 mg/m2, given 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2, every 3 weeks for 6 cycles.
NSCLC after platinum therapy failure: 75 mg/m2 as a single agent.
NSCLC, chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2.
HRPC: 75 mg/m2 with 5 mg prednisone twice a day, continuously.
GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only), then fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1 to 5), starting at the end of the cisplatin infusion.
SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), then fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1 to 5), starting at the end of the cisplatin infusion. This is given for 4 cycles.
SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), then fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1 to 4). This is given for 3 cycles.
All patients need premedication with oral corticosteroids. Adjust the dose as needed.
Side Effects
Across all the conditions docetaxel is used for, the most common side effects 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. How often each one occurs depends on the indication, so the side effects are described separately for each indication. Clinical trials are run under very different conditions, so the rates seen in the trials of one drug can't be compared directly with the rates in the trials of another drug. They also may not match the rates seen in everyday practice.
Cautions & Contraindications
Warnings & Precautions
Docetaxel Trihydrate should be given under the supervision of a physician experienced in the use of antineoplastic agents. There is a higher risk of severe adverse reactions, including toxic death and fatal gastrointestinal hemorrhage, in patients with hepatic impairment. Docetaxel Trihydrate therapy should not be given to patients whose neutrophil counts are less than 1,500 cells/mm3. Fatal cases of enterocolitis have been reported, including ischemic colitis, colitis and neutropenic enterocolitis. Severe hypersensitivity reactions can also occur, and they may be fatal. If one happens, Docetaxel Trihydrate must be stopped immediately, so patients should be closely monitored. Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel Trihydrate.
Contraindications
Docetaxel must not be given to patients whose neutrophil count is below 1500 cells/mm3. It must also not be given to anyone with a history of severe hypersensitivity reactions to docetaxel, or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred.
Pregnancy & Breastfeeding
Animal reproduction studies and the way docetaxel works both point to a risk: docetaxel can harm the unborn baby when it is given to a pregnant woman. No one knows whether docetaxel passes into human breast milk, or what it does to milk production or to a breastfed child. Studies of docetaxel in breastfeeding animals have not been done.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
A few cases of overdosage with docetaxel have been reported. There is no known antidote. If an overdose happens, the patient should be kept in a specialised unit and their vital functions watched closely. Worsening of the usual adverse events can be expected.
The main complications to expect are bone marrow suppression, peripheral neurotoxicity and mucositis. The patient should get therapeutic G-CSF as soon as possible after the overdose is discovered. Other symptomatic measures should be taken as needed.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Docetaxel Trihydrate at a temperature between 2°C and 25°C, and protect it from light. Freezing doesn't harm the product.
Common questions about Docetaxel HEXAL 20 mg
What is Docetaxel HEXAL 20 mg IV Infusion?
Docetaxel HEXAL 20 mg IV Infusion is a medicine that contains Docetaxel Trihydrate. It is made by Nevian Lifescience PLC. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Docetaxel HEXAL used for?
Docetaxel Trihydrate (sold as Docetaxel HEXAL) is a microtubule inhibitor. It is used for breast cancer (BC), either as a single agent for locally advanced or metastatic BC after chemotherapy has failed, or with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.
What are the side effects of Docetaxel HEXAL?
Across all the conditions docetaxel is used for, the most common side effects 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. How often each one occurs depends on the indication, so the side effects are described separately for each indication.
Can I take Docetaxel HEXAL during pregnancy or while breastfeeding?
Animal reproduction studies and the way docetaxel works both point to a risk: docetaxel can harm the unborn baby when it is given to a pregnant woman. No one knows whether docetaxel passes into human breast milk, or what it does to milk production or to a breastfed child. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Docetaxel HEXAL?
A few cases of overdosage with docetaxel have been reported. There is no known antidote. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Docetaxel HEXAL?
Keep Docetaxel Trihydrate at a temperature between 2°C and 25°C, and protect it from light. Freezing doesn't harm the product.
Do I need a prescription for Docetaxel HEXAL?
Docetaxel HEXAL is a prescription (Rx) medicine. Take it as your doctor advises.