Taro-Docetaxel: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Taro-Docetaxel is used as or for the:

• adjuvant treatment of patients with operable node-positive 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 (Xeloda®) 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 anti-cancer 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 Taro-Docetaxel 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.

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

When it should not be used:

Taro-Docetaxel 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 Taro-Docetaxel is docetaxel.

What the nonmedicinal ingredients are:

The non-active ingredients are polysorbate 80, citric acid (anhydrous) and ethanol (anhydrous).

What dosage forms it comes in:

Taro-Docetaxel is available in a concentrated solution for injection, packaging in a vial of 20 mg/mL, 80 mg/4 mL or 160 mg/8 mL

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

BEFORE your Taro-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, liver disease or epilepsy.

• 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 Taro-Doxetaxel with certain other anticancer treatments.
• you have kidney problems or high levels of uric acid in your blood. If after Taro-Doxetaxel infusion, you suffer from pain in your side, or reduced amount or darkening of urine, tell your doctor immediately.

Patients receiving Taro-Docetaxel 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 Taro-Docetaxel. 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 Taro-Docetaxel 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, non-Hodgkin 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 Taro-Doxetaxel.
  • 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 Taro-Docetaxel. This may impair your ability to drive or use machinery.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Taro-Docetaxel 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.

PROPER USE OF THIS MEDICATION

How often will I get treated with Taro-Docetaxel?

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

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

What do I need to do before each Taro-Docetaxel treatment?

The administration of Taro-Docetaxel requires you to take medication before each treatment begins. Every time you receive Taro-Docetaxel, 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 Taro-Docetaxel 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 Taro-Docetaxel treatment.

Overdose:

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, Taro-Docetaxel may have side effects. Most of the side effects that occur with Taro-Docetaxel 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 Taro-Docetaxel, cause a temporary drop in neutrophils (a condition known as neutropenia); however, most people receiving Taro-Docetaxel 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. So 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 Taro-Docetaxel. 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 Taro-

Docetaxel 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 Taro-Docetaxel 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 Taro-Docetaxel treatment, and disappears again before the next treatment. The rash is rarely serious, and it is rare for a patient to discontinue Taro-Docetaxel 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 Taro-Docetaxel 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 Taro-Docetaxel. 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.

When Taro-Docetaxel is used in combination with capecitabine (Xeloda®), 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.

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

HOW TO STORE IT

Store the unopened vials between 15 °C to 25 °C. Retain in the original package to protect from light.

Keep out of reach and sight of children.

Reporting Side Effects

MORE INFORMATION

Your doctor, pharmacist and nurse are always your best source of information about your condition and treatment. If you have additional questions or concerns, be sure to ask them.

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.taro.ca or by contacting the sponsor,

Taro Pharmaceuticals Inc., at: 1-800-268-1975

Taro Pharmaceuticals Inc.

130 East Drive

Brampton, Ontario L6T 1C1

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last revised: August 10, 2021