Cabazitaxel for Injection by Sandoz

The recommended adult dose of cabazitaxel varies according to body size. It is generally calculated as 20 mg per metre squared of body surface area, a calculation based on body weight and height. Depending on how well this medication is tolerated, your doctor may reduce the dose to reduce the severity of side effects.

Cabazitaxel is usually injected into a vein through a site on the skin that has been prepared for this purpose. It is often scheduled to be given over a one-hour period once every 3 weeks.

Cabazitaxel is always given under the supervision of a doctor. Very careful handling of this medication is required. It is always administered in a hospital or similar setting with access to sterile equipment for preparation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive cabazitaxel, contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each mL of clear, colourless-to-pale-yellow viscous solution contains 10 mg of cabazitaxel (anhydrous). Nonmedicinal ingredients: 260 mg polysorbate 80, 4.5 mg citric acid anhydrous, 198 mg ethanol absolute, and 560 mg polyethylene glycol 300.

Do not take cabazitaxel if you:

• are allergic to cabazitaxel or any ingredients of the medication

• have low white blood cell counts

• have severely decreased liver function

• are currently receiving live vaccines

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back, joint, or muscle pain

• change in sense of taste

• constipation

• cough

• decreased appetite

• diarrhea

• dizziness

• hair loss

• headache

• heartburn

• low blood pressure

• tingling, burning, numbness, or pain in the hands, arms, feet, or legs

• mouth sores

• muscle spasms

• nausea

• tiredness

• vomiting

• weakness

• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain

• extreme weakness or fatigue

• low blood pressure

• persistent vomiting or diarrhea

• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)

• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)

• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)

• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• signs of gastrointestinal toxicity (e.g., abdominal pain, tenderness, fever, persistent constipation and diarrhea)

• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of bleeding in the stomach (e.g., bloody, black, or  tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• symptoms of lung problems (e.g., difficulty breathing, shortness of breath, cough, fatigue)

**Some people may experience side effects other than those listed. **Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

**Anemia: **Cabazitaxel may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth control: People with partners who are or may become pregnant should use reliable birth control during treatment and for 6 months after the last dose, to avoid exposing the partner to cabazitaxel.

**Bleeding: ** Cabazitaxel may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Drowsiness/reduced alertness: Cabazitaxel may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Heart rhythm: Cabazitaxel can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: As well as killing cancer cells, cabazitaxel can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections.  Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. It may also cause a decrease in liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung problems: Cabazitaxel can cause lung problems. If you experience difficulty breathing or shortness of breath while you are taking this medication, contact your doctor immediately.

Stomach problems: Rarely, cabazitaxel, can cause perforation (holes) in the stomach or intestines. If you experience severe abdominal pain, fever, vomiting, or black and tarry stools, contact your doctor immediately.

Pregnancy: Cabazitaxel may be harmful to the unborn baby if this medication is used during pregnancy. For this reason, this medication should not be used during pregnancy and a reliable form of birth control should be used. If you become pregnant while taking this medication, contact your doctor immediately.

**Breast-feeding: **This medication may pass into breast milk. If you are breast-feeding and taking cabazitaxel, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 18.

Seniors: People over the age of 65 years, may be more at risk of side effects from this medication.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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