Generic Name: Docetaxel Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: D

Uses

What is Docetaxel used for?

Docetaxel is used to treat cancer (such as breast, lung, prostate, stomach, and head/neck cancer). Docetaxel is a member of a family of drugs called taxanes. This drug works by slowing cell growth.

How should I take Docetaxel?

This medication is given by injection into a vein by a health care professional, generally over 1 hour every 3 weeks or as directed by your doctor. The dosage and frequency is based on your medical condition and response to therapy.

Your doctor may prescribe pre-medications (e.g., corticosteroids such as dexamethasone) to prevent side effects like swelling (fluid retention/edema) and allergic reactions. These are generally started 1 day before treatment and continued for a total of 3 days. Carefully follow your doctor’s orders to prepare for your treatment. If you forget to take your pre-medication, or do not take it on schedule, tell your doctor or nurse before you receive your docetaxel treatment.

How do I store Docetaxel?

Docetaxel is best stored 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.

There may be different brands of Docetaxel that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Docetaxel down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using 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), 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.

This medication may make you dizzy or drowsy. It also contains alcohol, which can increase these symptoms and also make you feel drunk. Caution is advised if you have liver disease or any other condition that requires you to limit/avoid alcohol. Marijuana can also make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness for 1 to 2 hours after you receive this medication and until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

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.

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 right away.

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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Docetaxel during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Docetaxel. Docetaxel is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from 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), 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.

This medication may make you dizzy or drowsy. It also contains alcohol, which can increase these symptoms and also make you feel drunk. Caution is advised if you have liver disease or any other condition that requires you to limit/avoid alcohol. Marijuana can also make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness for 1 to 2 hours after you receive this medication and until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

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.

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 right away.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Docetaxel?

Pain or swelling at the injection site, nausea, vomiting, diarrhea, excessive tearing, fatigue, dizziness, drowsiness, feeling drunk, constipation, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be necessary to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve nausea and vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss and nail changes may occur. Normal hair growth and nail appearance should return after treatment has ended. However, in some cases, the hair loss may be permanent.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: swelling of the hands/feet/legs, unexplained weight gain, numbness or tingling of the hands or feet, muscle or joint pain, persistent weakness or fatigue, eye pain, irregular heartbeat, severe stomach pain, black or bloody stools, severe headache.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, vision changes (such as blurred vision, decreased vision, seeing flashes of light).

This medication can lower the body’s ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Docetaxel may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Docetaxel?

Docetaxel may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Docetaxel?

Docetaxel may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

 

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Docetaxel.

What is the dose of Docetaxel for an adult?

Usual Adult Dose for Non-Small Cell Lung Cancer

As a single agent after failure of prior platinum-based chemotherapy: 75 mg/m2 IV over 1 hour every 3 weeks

Chemotherapy-naive patients: 75 mg/m2 IV over 1 hour immediately followed by cisplatin 75 mg/m2 IV over 30 to 60 minutes; repeat every 3 weeks

Comments:

-Premedicate with oral corticosteroids (e.g., dexamethasone 8 mg 2 times a day) for 3 days starting 1 day prior to chemotherapy.

-Adjust dose as needed for toxicity.

-Patients should receive cisplatin premedication with antiemetics and hydration.

Uses:

-As monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

-In combination with cisplatin for unresectable, locally advanced or metastatic NSCLC in patients who have not previously received chemotherapy for this condition

Usual Adult Dose for Breast Cancer

-Single agent: 60 to 100 mg/m2 IV over 1 hour every 3 weeks

-Adjuvant: 75 mg/m2 IV over 1 hour administered 1 hour after doxorubicin 50 mg/m2 IV and cyclophosphamide 500 mg/m2 IV every 3 weeks for 6 cycles; prophylactic G-CSF may be used to mitigate the risk of hematological toxicities

Comments:

-Premedicate with oral corticosteroids (e.g., dexamethasone 8 mg 2 times a day) for 3 days starting 1 day prior to chemotherapy.

-Adjust dose as needed for toxicity.

Uses:

-As a single agent for locally advanced or metastatic breast cancer after failure of prior chemotherapy

-In combination with doxorubicin and cyclophosphamide for operable node-positive breast cancer

Usual Adult Dose for Gastric Cancer

75 mg/m2 IV over 1 hour followed by cisplatin 75 mg/m2 IV over 1 to 3 hours (both on Day 1 only), followed by fluorouracil 750 mg/m2 daily given as a 24-hour continuous IV infusion for 5 days, starting at the end of the cisplatin infusion; repeat every 3 weeks

Comments:

-Premedicate with oral corticosteroids (e.g., dexamethasone 8 mg 2 times a day) for 3 days starting 1 day prior to chemotherapy.

-Adjust dose as needed for toxicity.

-Patients should receive cisplatin premedication with antiemetics and hydration.

Use: In combination with cisplatin and fluorouracil for advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, in patients who have not received prior chemotherapy for advanced disease

Usual Adult Dose for Head and Neck Cancer

Induction therapy of locally advanced inoperable SCCHN:

-Day 1: 75 mg/m2 IV over 1 hour followed by cisplatin 75 mg/m2 IV over 1 hour, on Day 1, followed by fluorouracil 750 mg/m2 as a continuous IV infusion daily for 5 days

-Administer this regimen every 3 weeks for 4 cycles.

-Following chemotherapy, patients should receive radiotherapy.

Induction therapy for locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN:

-Day 1: 75 mg/m2 IV over 1 hour followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour IV infusion, followed by fluorouracil 1000 mg/m2/day as a continuous IV infusion from Day 1 to Day 4

-Repeat therapy every 3 weeks for 3 cycles.

-Following chemotherapy, patients should receive radiotherapy.

Comments:

-Premedicate with oral corticosteroids (e.g., dexamethasone 8 mg orally 2 times a day) for 3 days starting 1 day prior to chemotherapy.

-Adjust dose as needed for toxicity.

-Patients should receive cisplatin premedication with antiemetics and hydration.

-Prophylaxis for neutropenic infections should be administered; during clinical trials, all patients received prophylactic antibiotics.

Use: In combination with cisplatin and fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Usual Adult Dose for Prostate Cancer

75 mg/m2 IV over 1 hour every 3 weeks; prednisone 5 mg orally 2 times a day is administered continuously

Comments:

-For hormone-refractory metastatic prostate cancer, because of the concurrent use of prednisone, the recommended premedication regimen is dexamethasone 8 mg orally, at 12 hours, 3 hours, and 1 hour before docetaxel.

Use: In combination with prednisone for androgen independent (hormone refractory) metastatic prostate cancer

Liver Dose Adjustments

-Patients with bilirubin greater than the upper limit of normal (ULN) should not receive this drug.

-Patients with AST and/or ALT greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN should not receive this drug.

Gastric or Head and Neck Cancer – In Combination with Cisplatin and Fluorouracil

The following dose adjustments were used during clinical trials:

-For AST/ALT elevations greater than 12.5 x ULN to less than or equal to 5 x ULN and alkaline phosphatase (AP) elevations of 2.5 x ULN or less: docetaxel dose reduced by 20%

-For AST/ALT elevations greater than 1.5 x ULN to less than or equal to 5 x ULN and AP elevations greater than 2.5 x ULN to less than or equal to 5 x ULN: docetaxel dose reduced by 20%

-For AST or ALT elevations greater than 5 X ULN and/or AP elevations greater than 5 x ULN: docetaxel was stopped.

Dose Adjustments

Do not administer until neutrophil count recovers to a level greater than 1500 cells/mm3 and platelets recover to a level greater than 100,000 cells/mm3.

Hematologic Toxicity:

-Following severe neutropenia (less than 500 cells/mm3) lasting 7 days or more, febrile neutropenia, or a grade 4 infection during a cycle; reduce docetaxel dose by 25% in subsequent cycles.

Breast Cancer – Monotherapy:

-For patients initially dosed at 100 mg/m2 and experiencing febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during therapy, reduce dose to 75 mg/m2; if these reactions persist, consider a further reduction to 55 mg/m2 or treatment discontinuation.

-For patients initiated at 60 mg/m2 who do not develop toxicity, higher doses may be tolerated.

-For patients developing grade 3 or greater peripheral neuropathy, treatment should be discontinued entirely.

Breast Cancer – Combination with Doxorubicin and Cyclophosphamide

-Patients experiencing febrile neutropenia should receive G-CSF in all subsequent cycles; for persistent febrile neutropenia, patients should remain on G-CSF and reduce their docetaxel dose to 60 mg/m2.

-For grade 3 or 4 stomatitis: Reduce docetaxel dose to 60 mg/m2.

-For severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms: Reduce dose to 60 mg/m2; if reactions persist at 60 mg/m2, treatment should be discontinued.

Non-small Cell Lung Cancer (NSCLC) – Monotherapy:

-For patients initially dosed at 75 mg/m2 and experiencing febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or other grade 3 or 4 nonhematologic toxicities: withhold treatment until resolution of the toxicity and then resume at 55 mg/m2.

-Patients developing a grade 3 or greater peripheral neuropathy should have docetaxel treatment discontinued entirely.

Non-small Cell Lung Cancer (NSCLC) – Combination Therapy:

-For patients initially dosed at 75 mg/m2 in combination with cisplatin and experiencing a platelet nadir count of less than 25,000 cells/mm3, febrile neutropenia, and/or serious nonhematologic toxicities, reduce docetaxel dose in subsequent cycles to 65 mg/m2. A further dose reduction to 50 mg/m2 may be undertaken if necessary. See prescribing information for cisplatin dose adjustments.

Prostate Cancer:

-Patients experiencing febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or moderate neurosensory signs and/or symptoms should have their docetaxel dose to 60 mg/m2; if patient continues to experience these reactions at 60 mg/m2, treatment should be discontinued.

Gastric or Head and Neck Cancer – In Combination with Cisplatin and Fluorouracil:

-For febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days, initiate G-CSF and continue G-CSF in subsequent cycles; if an episode of febrile neutropenia, prolonged neutropenia, or neutropenic infection occurs despite G-CSF use, reduce docetaxel dose to 60 mg/m2; if subsequent episodes of complicated neutropenia occur, the docetaxel dose should be reduced to 45 mg/m2.

-Grade 4 thrombocytopenia: reduce docetaxel dose to 60 mg/m2; platelets should recover to a level greater than 100,000 cells/mm3 prior to retreatment.

-Treatment should be discontinued if neutrophils do not recover to greater than 1500 cells/mm3 and platelets do not recover to greater than 100,000 cells/mm3.

The recommended dose modifications for GI toxicities in patients treated with docetaxel in combination with cisplatin and fluorouracil are as follows:

Diarrhea grade 3:

For the first episode, reduce the dose of fluorouracil by 20%.

For the second episode, also reduce the docetaxel dose by 20%.

Diarrhea grade 4:

For the first episode, reduce the dose of both docetaxel and fluorouracil by 20%.

For the second episode, discontinue treatment.

Stomatitis grade 3:

For the first episode, reduce the dose of fluorouracil by 20%.

For the second episode, stop fluorouracil only, at all subsequent cycles.

For the third episode, reduce the dose of docetaxel by 20%.

Stomatitis grade 4:

For the first episode, stop fluorouracil only, at all subsequent cycles.

For the second episode, reduce the dose of docetaxel by 20%.

Cisplatin Dose Modifications and Delays used in the Gastric Cancer Study:

-Grade 2 peripheral neuropathy: Reduced cisplatin dose by 20%

-Grade 3 peripheral neuropathy: Discontinued treatment

-Grade 3 ototoxicity: Discontinued treatment

-Nephrotoxicity: Determined CrCl prior to each cycle; for CrCl 60 mL/min or greater, provided full cisplatin dose; for CrCl 40 to 59 mL/min, cisplatin dose was reduced by 50% (if CrCl at end of cycle was greater than 60 mL/min, full cisplatin dose reinstituted at next cycle; if no recovery then cisplatin was omitted from next cycle); for CrCl less than 40 mL/min, omitted cisplatin from treatment cycle (if CrCl remained less than 40 mL/min at the end of the cycle then cisplatin was discontinued; if CrCl was greater than 40 mL/min to less than 60 mL/min at end of cycle then a 50% cisplatin dose was given at the next cycle; if CrCl was greater than 60 mL/min at the end of cycle then a full cisplatin dose was given at next cycle)

-For other cisplatin dosage adjustments, see cisplatin prescribing information.

Fluorouracil Dose Modifications and Delays used in the Gastric Cancer Study:

-Grade 2 or greater plantar-palmar toxicity: stop fluorouracil until recovered, then reduce dose by 20%

-Grade 3 toxicities except alopecia and anemia: delay chemotherapy until resolution to grade 1 or less (maximum delay should be 2 weeks from planned date of infusion), recommence if medically appropriate.

-For other fluorouracil dosage adjustments, see fluorouracil prescribing information.

Strong CYP450 3A4 Inhibitors:

-Avoid use of concomitant strong CYP450 3A4 inhibitors; if concomitant use is unavoidable, consider a 50% dose reduction of docetaxel

What is the dose of Docetaxel for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Docetaxel available?

Docetaxel is available in the following dosage forms and strengths:

  • Intravenous solution,
  • Intravenous powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Docetaxel, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 31, 2018 | Last Modified: August 31, 2018