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Details for: DOCETAXEL INJECTION

Company: SANDOZ CANADA INCORPORATED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02439336DOCETAXEL INJECTIONDOCETAXEL10 MG / MLSOLUTIONINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Docetaxel Injection is used as or for the:

  • adjuvant treatment of patients with operable nodepositive breast cancer in combination with doxorubicin and cyclophosphamide
  • advanced or metastatic breast cancer, as single agent, or in combination with doxorubicin; or in combination with capecitabine after failure of previous anti-cancer drugs
  • advanced or metastatic non small cell lung cancer, as single agent or in combination with platinum derivatives
  • metastatic ovarian cancer after failure of previous anticancer drugs
  • metastatic prostate cancer in combination with prednisone or prednisolone
  • recurrent or metastatic squamous cell carcinoma of the head and neck after failure of previous anti-cancer drugs
What it does

Here’s how Docetaxel Injection works: Every cell in your body contains a supporting structure (almost like a “skeleton”). If this “skeleton” is changed or damaged, the cell can’t grow or reproduce.

Docetaxel Injection makes the “skeleton” in cells unnaturally stiff. The cancer cells then can no longer grow or reproduce.

When it should not be used

Docetaxel Injection should not be used if:

  • you have had an allergic reaction to docetaxel or to polysorbate 80 or any of the other ingredients in the product;
  • you have a low white blood cell count (neutropenia);
  • you have a severe liver disease;
  • you are pregnant or breast-feeding.
What the medicinal ingredient is

The active ingredient in Docetaxel Injection is docetaxel

What the non-medicinal ingredients are

Citric acid, 279.5 mg/mL of 96% (v/v) ethanol, polyethylene glycol 300 and polysorbate 80.

What dosage form it comes in

Docetaxel Injection is available in vials as 10 mg/mL solution in three dosing formats: 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL.

Warnings and precautions

Serious Warnings and Precautions

Docetaxel Injection should be given under the supervision of a doctor experienced in the use of anti-cancer drugs.

There is a higher risk of developing severe adverse reactions, which may be life-threatening, in patients with liver disease. Docetaxel Injection should not be used if you have liver disease.

Docetaxel Injection should not be used in patients with white blood cell (neutrophil) counts of less than 1500 cells/mm3 .

Fatal cases of enterocolitis (inflammation of the digestive tract) have been reported.

Docetaxel Injection may cause severe life-threatening allergic reactions which require immediate discontinuation of the drug.

An increase in new (second) cancers has happened in people treated with Docetaxel Injection alone, or together with certain other anticancer treatments. This includes blood cancers, such as acute myeloid leukemia. No studies have been conducted to assess the carcinogenic potential of Docetaxel Injection.

Docetaxel Injection contains alcohol at levels that may cause you to feel drunk during and after treatment. Avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of docetaxel.

Precautions: Docetaxel Injection must be administered intravenously. Due to the osmolality of Docetaxel Injection, it is extremely important that the intravenous needle or catheter be properly positioned before any Docetaxel Injection is injected. Leakage into surrounding tissue during intravenous administration of Docetaxel Injection may cause considerable irritation, local tissue necrosis and/or thrombophlebitis. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should be introduced into another vein.

BEFORE you use Docetaxel Injection talk to your doctor if:

  • you are pregnant or planning to get pregnant
  • you have not taken your premedication as directed
  • you suffer from alcoholism (have problems with alcohol or drinking), liver disease, epilepsy or other medical conditions that may be affected by alcohol intake.
  • you have been previously treated with a medicine called paclitaxel and have had an allergic reaction to it.
  • you are already receiving treatments for cancer. Different types of cancer may develop from using Docetaxel Injection with certain other anticancer treatments.
  • you have kidney problems or high levels of uric acid in your blood. If after Docetaxel Injection infusion, you suffer from pain in your side, or reduced amount or darkening of urine, tell your doctor immediately."

Patients receiving Docetaxel Injection may experience:

  • Fluid retention. Your doctor will prescribe you medication to reduce the risk of having severe fluid retention.
  • Low blood cell count: Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to go to all your appointments. Your doctor may decide to reduce your dose if your white blood cell count is low.
  • Allergic reactions: Allergic reactions may occur within a few minutes following the initiation of Docetaxel Injection. Severe allergic reactions with severe rash, difficulty in breathing (bronchospasm), low blood pressure (hypotension) may occur. Your doctor will prescribe you medication to reduce the risk of having an allergic reaction.
  • Nerve pain (peripheral neurotoxicity): Some people feel this pain as numbness, tingling, or burning in their hands and feet. This nerve pain is rarely severe and usually goes away after treatment is completed. In some cases, your doctor may decide to reduce your dose or stop your treatment.
  • Rash: This usually occurs on the feet and hands, but may also appear on the arms, face or body. The rash is rarely serious, and it is rare for a patient to discontinue Docetaxel Injection therapy because of rash or other skin problems. In some cases, your doctor may decide to reduce your dose.
  • An increase in new (second) cancers, including acute myeloid leukemia, myelodysplastic syndrome, nonHodgkin lymphoma (types of blood cancer) and renal cancer, may occur in patients who are treated with docetaxel alone or together with certain other anticancer treatments. These cancers may occur years after treatment with Docetaxel Injection.
  • Tumor lysis syndrome, which may have the following symptoms: nausea, vomiting, confusion, delirium, seizures, pain in your side, reduced amount of urine, or darkening of urine. If this happens, contact your doctor immediately, as it can cause life-threatening kidney failure and heart problems.
  • Severe skin problems: symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash, and you may also have flu-like symptoms such as fever, chills, or muscle aches. The rash may be red, scaly and widespread with bumps under the skin (including your skin folds, trunk and upper extremities) and you may have blisters accompanied by fever. If you develop severe skin reactions, tell your doctor immediately.
  • Feeling drunk or intoxicated: you may feel the effects of the alcohol contained in Docetaxel Injection for one to two hours after infusion. This may impair your ability to drive or use machinery. Avoid driving, operating machinery or doing other activities that are dangerous or require skill one to two hours after you receive treatment with Docetaxel Injection
Interactions with this medication

Drugs that may interact with Docetaxel Injection include, but are not limited to:

  • cyclosporine
  • terfenadine
  • ketoconazole
  • erythromycin
  • protease inhibitors (e.g. ritonavir, indinavir, nelfinavir, saquinavir)
  • itraconazole
  • clarithromycin
  • nefazodone
  • telithromycin
  • voriconazole
  • pain relievers
  • sleep aids, such as diazepam or other medicines called “benzodiazepines”.

Tell your doctor if you are taking any medicine which has been prescribed for you or which you bought without a prescription.

Tell your health care professional about all the medicines you are currently taking, as the alcohol in Docetaxel Injection may affect other medicines you are using.

Proper use of this medication

MUST BE DILUTED BEFORE USE

How often will I get treated with Docetaxel Injection?

Docetaxel Injection is usually given in a 1-hour intravenous (IV) dose every 21 days. Every patient is different; your doctor will determine what dose of Docetaxel Injection is right for you and how often you should receive it.

Your doctor may prescribe Docetaxel Injection either alone or in combination with other anti-cancer drugs, such as doxorubicin, cyclophosphamide, platinum derivatives (cisplatin, carboplatin), capecitabine, prednisone or prednisolone.

What do I need to do before each Docetaxel Injection treatment?

The administration of Docetaxel Injection requires you to take medication before each treatment begins. Every time you receive Docetaxel Injection, you will be asked to take some premedication; the purpose of this premedication is to reduce the fluid retention you may experience during treatment. Usually, the premedication consists of corticosteroid pills that are taken orally one day before each Docetaxel Injection treatment, on the same day of each treatment, and one day after each treatment. Your doctor or nurse will tell you exactly what premedication you need to take and for how long.

Your doctor may also decide to give you other medications to reduce the risk of infection.

If you forget to take your premedication as directed, make sure to tell your doctor or nurse before you get your Docetaxel Injection treatment.

Overdose

If you think you have taken too much Docetaxel Injection, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss an appointment, call your doctor for instructions.

Side effects and what to do about them

Like many anti-cancer drugs, Docetaxel Injection may have side effects. Most of the side effects that occur with Docetaxel Injection are manageable. Occasionally, it is necessary to stop the treatment. If you do experience side effects, your doctor can give you a number of medications and explain techniques to help make you feel more comfortable.

The most common side effects are:

  • Nausea, diarrhea, vomiting
  • Fatigue
  • Stomatitis: sores in the mouth
  • Nail changes
  • Low white blood cell count (neutropenia)
  • Fever
  • Hair Loss
  • Weakness
  • Rash
  • Nerve pain
  • Fluid retention
  • Swelling at the injection site

Side effects with unknown frequencies are:

  • Inflammation of muscles.

Low White Blood Cell Count: Your white blood cells protect your body against infection. There are three types of white blood cells; the most important in preventing infections are cells called neutrophils. Many anti-cancer drugs, including Docetaxel Injection, cause a temporary drop in neutrophils (a condition known as neutropenia); however, most people receiving Docetaxel Injection do not develop infections, even when they have neutropenia. Your doctor will be checking routinely your white blood count and will alert you if your white count is low.

Fever is one of the most common signs of infection. If you have a fever, make sure to tell your doctor or nurse immediately.

Hair Loss: Loss of the hair (including eyebrows, eyelashes, pubic hair, underarm hair and the hair on your head), which is known as alopecia, occurs in most patients taking Docetaxel Injection. Hair loss may happen shortly after treatment has begun. Your hair should grow back once you’ve finished the treatment. However, some patients may experience permanent hair loss. In the meantime, your doctor or nurse can probably refer you to a special store that carries turbans and wigs specifically for patients with cancer.

Weakness: Many patients receiving Docetaxel Injection experience a feeling of weakness during their treatment. If weakness is accompanied by joint or muscle pain, make sure to tell your doctor or nurse; your doctor can prescribe pain medication to help make you feel more comfortable.

Rash: Patients on Docetaxel Injection may develop a rash. This usually occurs on the feet and hands, but may also appear on the arms, face or body. The rash generally appears within a week after each Docetaxel Injection treatment, and disappears again before the next treatment. The rash is rarely serious, and it is rare for a patient to discontinue Docetaxel Injection therapy because of rash or other skin problems.

Severe skin problems: symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. The rash may be red, scaly and widespread with bumps under the skin (including your skin folds, trunk and upper extremities) and you may have blisters accompanied by fever. If you develop severe skin reactions, tell your doctor immediately.

Nerve Pain: Patients receiving Docetaxel Injection may experience nerve pain; some people feel this pain as numbness, tingling, or burning in their hands and feet. This nerve pain is rarely severe and usually goes away after treatment is completed. However, if you are bothered by nerve pain, make sure to tell your doctor or nurse; your doctor can prescribe pain medication to help make you feel more comfortable.

Fluid Retention: Fluid retention can occur in patients receiving Docetaxel Injection. It may begin as swelling on the legs. Your doctor will prescribe medication, which is important for you to take to reduce the likelihood that the fluid retention will be serious or cause your treatment to be discontinued.

Blurred vision: In case of vision problems, you should have a complete eye and vision examination. If cystoid macular edema (blurred vision due to swelling of the retina within the eye) is diagnosed, your doctor may stop your treatment.

Intoxication: Notify your health care professional immediately if you experience any of the following symptoms while receiving an intravenous infusion of Docetaxel Injection and for one to two hours after treatment: symptoms of being drunk, confusion, stumbling, or becoming very sleepy.

When Docetaxel Injection is used in combination with capecitabine, the frequency of side effects may differ. In particular, the risk of developing a rash of the hands and feet is increased. You should refer to your doctor for more details.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
Muscle pain   ✔  
Nerve pain such as numbness, tingling, or burning in their hands and feet   ✔  
Weakness ✔    
Uncommon
Allergic reactions such as trouble breathing, tightness in the throat, rash, hives, swelling of the lips or tongue or low blood pressure   ✔  
Fever or signs of infection, like redness or swelling at the injection site, a cough that brings up mucus, or a sore throat   ✔  
Cardiac problems with symptoms such as: chest pain, rapid or irregular heartbeat, dizziness, nausea, shortness of breath, loss of consciousness   ✔  
Liver problems such as loss of appetite, dark urine, light-colored stools, yellowing of the skin or eyes   ✔  
Kidney problems   ✔  
Persistent vomiting or diarrhea; abdominal pain.   ✔  
Visual disturbances   ✔  
New (second) cancers, including acute myeloid leukemia, myelodysplastic syndrome, nonHodgkin lymphoma and renal cancer     ✔
Unknown frequency
Electrolyte imbalance: weakness, confusion, muscle pain or cramps, irregular heartbeat   ✔  
Redness, swelling, itching at the site of a previous infusion following later treatment.   ✔  
Severe skin reaction, blistering, peeling or bleeding, red, scaly rash with bumps under the skin, which may be accompanied by flu-like symptoms   ✔  
Pain in your side, reduced amount of urine, darkening of urine.   ✔  
Muscle inflammation   ✔  

This is not a complete list of severe side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.

How to store

The unopened vials should be stored between 2°C and 25°C in their original packaging. Protect from light.

Docetaxel Injection infusion solutions, if stored between 2°C and 25°C are stable for 4 hours. Fully prepared Docetaxel Injection infusion solution (in either 0.9% sodium chloride solution or 5% dextrose solution) should be used within 4 hours (including the 1 hour IV administration).

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about Docetaxel Injection:

This leaflet was prepared by Sandoz Canada Inc.

Last revised: November 17, 2020

Date modified: