Cabazitaxel Fresenius Kabi

Package Leaflet: Information for the Patient

Cabazitaxel Fresenius Kabi, 20 mg/ml, Concentrate for Solution for Infusion

Cabazitaxel

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• If You Get Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information:

• 1. What Is Cabazitaxel Fresenius Kabi and What Is It Used For
• 2. Important Information Before You Use Cabazitaxel Fresenius Kabi
• 3. How to Use Cabazitaxel Fresenius Kabi
• 4. Possible Side Effects
• 5. How to Store Cabazitaxel Fresenius Kabi
• 6. Contents of the Pack and Other Information

1. What Is Cabazitaxel Fresenius Kabi and What Is It Used For

The Name of Your Medicine Is Cabazitaxel Fresenius Kabi. The Common Name Is Cabazitaxel. It Belongs to a Group of Medicines Called "Taxanes" Used to Treat Cancer.
Cabazitaxel Fresenius Kabi Is Used to Treat Prostate Cancer When the Disease Has Progressed After Treatment with Other Chemotherapy. The Medicine Works by Stopping the Growth and Division of Cancer Cells.
Part of the Treatment Also Includes Taking a Corticosteroid (Prednisone or Prednisolone) by Mouth Every Day. You Should Ask Your Doctor for Information About This Medicine.

2. Important Information Before You Use Cabazitaxel Fresenius Kabi

When Not to Use Cabazitaxel Fresenius Kabi

• If You Are Allergic (Hypersensitive) to Cabazitaxel, Other Taxanes, or Polysorbate 80, or Any of the Other Ingredients of This Medicine (Listed in Section 6);
• If Your White Blood Cell Count Is Too Low (Neutrophil Count Less Than or Equal to 1500/mm^3);
• If You Have Severe Liver Function Disorders;
• If You Have Recently Received or Are Going to Receive a Live Vaccine Against Yellow Fever.

Do Not Use Cabazitaxel Fresenius Kabi If Any of the Above Applies to You. If You Are Not Sure, Talk to Your Doctor Before Using Cabazitaxel Fresenius Kabi.

Warnings and Precautions

Before Each Administration of Cabazitaxel Fresenius Kabi, Blood Tests Are Performed to Check If Your Blood Cell Count and Liver and Kidney Function Are Adequate.
Tell Your Doctor Immediately If:

• You Have a Fever. During Treatment with Cabazitaxel Fresenius Kabi, There Is a Risk of a Decrease in White Blood Cell Count. Your Doctor Will Check Your Blood and Monitor Your General Condition for Signs of Infection. They May Also Prescribe Other Medicines to Maintain a Normal White Blood Cell Count.
  In Patients with Low Blood Cell Counts, Life-Threatening Infections May Occur. The Earliest Sign of Infection May Be a Fever, So If You Get One, Tell Your Doctor Immediately.

Cabazitaxel Fresenius Kabi and Other Medicines

Tell Your Doctor, Pharmacist, or Nurse About All Medicines You Are Taking or Have Recently Taken, Including Those You Buy Without a Prescription. This Is Because Some Medicines May Affect the Way Cabazitaxel Fresenius Kabi Works or Cabazitaxel Fresenius Kabi May Affect the Way Other Medicines Work. In Particular, Tell Your Doctor If You Are Taking:

• Ketoconazole, Rifampicin (Used to Treat Infections);
• Carbamazepine, Phenobarbital, or Phenytoin (Used to Treat Epilepsy);
• St. John's Wort (Hypericum Perforatum) (Herbal Medicine for Depression and Other Conditions);
• Statins (Such as Simvastatin, Lovastatin, Atorvastatin, Rosuvastatin, or Pravastatin) (to Lower Blood Cholesterol);
• Valsartan (Used to Treat High Blood Pressure);
• Repaglinide (Used to Treat Diabetes).

Tell Your Doctor If You Are Going to Have Vaccinations. Cabazitaxel Fresenius Kabi May Affect the Way Vaccines Work.

Pregnancy, Breast-Feeding, and Fertility

Cabazitaxel Fresenius Kabi Is Not Indicated for Use in Women.
Male Patients Should Use Condoms During Sexual Intercourse If Their Partner Is Pregnant or Could Become Pregnant. Cabazitaxel Fresenius Kabi May Be Present in Semen and May Affect the Fetus. Male Patients Should Not Father a Child During and for Up to 4 Months After Treatment with Cabazitaxel Fresenius Kabi and Should Seek Advice on Sperm Preservation Before Starting Treatment Because Cabazitaxel Fresenius Kabi May Alter Fertility in Men.

Driving and Using Machines

During Treatment with Cabazitaxel Fresenius Kabi, You May Feel Tired or Dizzy. Do Not Drive or Operate Machines Until These Effects Have Worn Off.

Cabazitaxel Fresenius Kabi Contains Ethanol (Alcohol)

This Medicine Contains 395 Mg of Ethanol (Alcohol) in 1 Ml, Which Is Equivalent to 39.5% V/V. The Amount of Alcohol in 2.25 Ml of the Dose Is Equivalent to 23 Ml of Beer or 9 Ml of Wine.
A Small Amount of Alcohol in This Medicine Will Not Have a Noticeable Effect. If You Are Alcohol-Dependent, Have Liver Disease, or Have Epilepsy, You Should Consult Your Doctor or Pharmacist Before Taking This Medicine.

3. How to Use Cabazitaxel Fresenius Kabi

Instructions for Use

Before You Are Given Cabazitaxel Fresenius Kabi, You Will Be Given Medicines to Reduce the Risk of Allergic Reactions.

• Cabazitaxel Fresenius Kabi Is Given by a Doctor or Nurse.
• Cabazitaxel Fresenius Kabi Must Be Diluted Before Administration. This Leaflet Contains Practical Information for Doctors, Nurses, and Pharmacists on Handling Cabazitaxel Fresenius Kabi and How to Administer It.
• Cabazitaxel Fresenius Kabi Is Given in a Hospital as an Intravenous Infusion Over About 1 Hour.
• Part of the Treatment Also Includes Taking a Corticosteroid (Prednisone or Prednisolone) by Mouth Every Day.

Dose and Frequency of Administration

• The Usual Dose Depends on Your Body Surface Area. Your Doctor Will Calculate Your Body Surface Area in Square Meters (M^2) and Determine the Dose to Be Given Based on This.
• The Infusion Is Usually Given Every 3 Weeks.

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
Your Doctor Should Discuss the Possible Side Effects with You and Explain the Risks and Benefits of the Treatment.

Tell Your Doctor Immediately If You Notice Any of the Following Serious Side Effects:

• Fever (High Temperature). This Is a Common Side Effect (May Affect Up to 1 in 10 People).
• Severe Loss of Fluids (Dehydration). This Is a Common Side Effect (May Affect Up to 1 in 10 People). Dehydration Can Occur Due to Severe or Prolonged Diarrhea, Fever, or Vomiting.
• Severe Stomach Pain or Stomach Pain That Does Not Go Away. These Symptoms May Occur If You Have a Hole in Your Stomach, Esophagus, or Intestine (Perforation of the Gastrointestinal Tract). This Can Be Life-Threatening.

Tell Your Doctor Immediately If You Notice Any of These Symptoms.

Other Side Effects:

Very Common(May Affect More Than 1 in 10 People):

• Decrease in Red Blood Cell Count (Anemia) or White Blood Cell Count (Important for Fighting Infections);
• Decrease in Platelet Count (Which Increases the Risk of Bleeding);
• Lack of Appetite (Anorexia);
• Stomach Upset, Including Nausea, Vomiting, Diarrhea, or Constipation;
• Back Pain;
• Blood in the Urine;
• Feeling Tired, Weak, or Lacking Energy.

Common(May Affect Up to 1 in 10 People):

• Taste Disorders;
• Shortness of Breath;
• Cough;
• Stomach Pain;
• Temporary Hair Loss (in Most Cases, Normal Hair Growth Should Return);
• Joint Pain;
• Urinary Tract Infection;
• Lack of White Blood Cells Associated with Fever and Infection;
• Feeling of Numbness, Tingling, Burning, or Reduced Sensation in Hands and Feet;
• Dizziness;
• Headache;
• Decrease or Increase in Blood Pressure;
• Discomfort in the Stomach, Heartburn, or Belching;
• Stomach Pain;
• Hemorrhoids;
• Muscle Cramps;
• Pain When Urinating or Frequent Urination;
• Urinary Incontinence;
• Kidney Disease or Kidney Function Disorders;
• Mouth Ulcers or Lip Ulcers;
• Infections or Risk of Infections;
• Increased Blood Sugar (Glucose) Levels;
• Insomnia;
• Confusion;
• Anxiety;
• Abnormal Sensation, Loss of Sensation, or Pain in Hands and Feet;
• Difficulty Maintaining Balance;
• Fast or Irregular Heartbeat;
• Blood Clots in the Legs or Lungs;
• Sudden Redness of the Skin;
• Mouth or Throat Pain;
• Bleeding from the Rectum;
• Discomfort, Weakness, or Muscle Pain;
• Swelling of the Feet or Legs;
• Chills;
• Nail Disorders (Change in Nail Color; Nails May Separate).

Uncommon(May Affect Up to 1 in 100 People):

• Decreased Potassium Levels in the Blood;
• Ringing in the Ears;
• Feeling of Heat;
• Redness of the Skin;
• Urinary Bladder Inflammation, Which May Occur If You Have Had Radiotherapy Before (Radiation Cystitis).

Frequency Not Known(Frequency Cannot Be Estimated from the Available Data):

• Non-Infectious Interstitial Lung Disease (Lung Inflammation Causing Cough and Difficulty Breathing).

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet.
Side Effects Can Be Reported to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You Can Also Report Side Effects Directly to the Marketing Authorization Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Cabazitaxel Fresenius Kabi

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton and on the Vial After "EXP". The Expiry Date Refers to the Last Day of That Month.
There Are No Special Storage Conditions for This Medicine.
After Opening
Each Vial Is for Single Use Only and Should Be Used Immediately After Opening. In Other Cases, the User Is Responsible for the Storage Conditions.
After Final Dilution in the Infusion Bag/Bottle
Chemical and Physical Stability of the Infusion Solution Has Been Demonstrated for 8 Hours at Temperatures Between 15°C and 30°C (Including 1 Hour of Infusion Time) and for 48 Hours Under Refrigerated Conditions (Including 1 Hour of Infusion Time) in Non-PVC Infusion Bags.
From a Microbiological Point of View, the Infusion Solution Should Be Used Immediately. In Other Cases, the User Is Responsible for the Storage Conditions and the Storage Time Should Not Normally Be Longer Than 24 Hours at 2°C-8°C Unless the Dilution Has Been Made in Controlled and Validated Aseptic Conditions.
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Cabazitaxel Fresenius Kabi Contains

• The Active Substance Is Cabazitaxel. 1 Ml of the Concentrate Contains 20 Mg of Cabazitaxel. Each Vial with 3 Ml of Concentrate Contains 60 Mg of Cabazitaxel.
• The Other Ingredients Are Polysorbate 80, Anhydrous Ethanol, and Citric Acid (See Section 2 "Cabazitaxel Fresenius Kabi Contains Alcohol").

What Cabazitaxel Fresenius Kabi Looks Like and Contents of the Pack

Cabazitaxel Fresenius Kabi Is a Concentrate for Solution for Infusion.
The Concentrate Is a Clear, Colorless to Pale Yellow Solution.
Cabazitaxel Fresenius Kabi Is Available in a 6 Ml Colorless Glass Vial with a Capacity of 3 Ml of Concentrate, in a Cardboard Box.
Pack Size:
Each Box Contains One Single-Use Vial.

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Importer

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
For Further Information, Contact the Marketing Authorization Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134, 02-305 Warsaw
Phone: +48 22 345 67 89

This Medicine Is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Leaflet:28.11.2024
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Information Intended for Healthcare Professionals Only:

PRACTICAL INFORMATION FOR DOCTORS AND HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL FRESENIUS KABI, 20 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION

The Following Information Is a Supplement to Sections 3 and 5 for the User.
Read the Entire Procedure Before Preparing the Infusion Solution.

Incompatibilities

Do Not Mix This Medicine with Other Medicines Except Those Used for Dilution.
Cabazitaxel Fresenius Kabi, 20 Mg/Ml, Concentrate for Solution for Infusion Does Not Require Prior Dilution with a Solvent and Is Ready for Addition to the Infusion Solution.

Shelf Life and Special Precautions for Storage

Regarding the Packaging of Cabazitaxel Fresenius Kabi, 20 Mg/Ml, Concentrate for Solution for Infusion
This Medicine Does Not Require Special Storage Conditions.
After Opening
Each Vial Is for Single Use Only and Should Be Used Immediately After Opening. In Other Cases, the User Is Responsible for the Storage Conditions.
After Final Dilution in the Infusion Bag/Bottle
Chemical and Physical Stability of the Infusion Solution Has Been Demonstrated for 8 Hours at Temperatures Between 15°C and 30°C (Including 1 Hour of Infusion Time) and for 48 Hours Under Refrigerated Conditions (Including 1 Hour of Infusion Time) in Non-PVC Infusion Bags.
From a Microbiological Point of View, the Infusion Solution Should Be Used Immediately. In Other Cases, the User Is Responsible for the Storage Conditions and the Storage Time Should Not Normally Be Longer Than 24 Hours at 2°C-8°C Unless the Dilution Has Been Made in Controlled and Validated Aseptic Conditions.

Precautions for Handling and Administration

As with Other Cytotoxic Medicines, Handle Cabazitaxel Fresenius Kabi and Prepare Its Solutions with Care, Using Equipment That Minimizes Exposure to the Medicine, Personal Protective Equipment (Such as Gloves), and Procedures for Preparing the Medicine for Use.
In Case of Contact with the Skin or Mucous Membranes, Wash the Affected Area Immediately with Soap and Water.

Steps for Preparation

Do Not Use Cabazitaxel Fresenius Kabi with Other Medicines Containing Cabazitaxel of Different Concentrations. Cabazitaxel Fresenius Kabi Contains 20 Mg/Ml of Cabazitaxel (At Least 3 Ml of the Delivered Volume).
Each Vial Is for Single Use Only and Should Be Used Immediately. Any Unused Solution Should Be Discarded.
To Administer the Prescribed Dose, More Than One Vial of Cabazitaxel Fresenius Kabi May Be Needed.
The Dilution Process Must Be Carried Out Under Aseptic Conditions.

Step 1

Using a Syringe with a Graduated Scale and a Needle Attached, Draw Up the Required Volume of Cabazitaxel Fresenius Kabi (Containing 20 Mg/Ml of Cabazitaxel) Under Aseptic Conditions.

For Example, a Dose of 45 Mg of Cabazitaxel Requires the Administration of 2.25 Ml of Cabazitaxel Fresenius Kabi.

Step 2

Inject Into a Sterile Bag Containing 5% Glucose Solution or 9 Mg/Ml (0.9%) Sodium Chloride Solution for Infusion. The Concentration of the Infusion Solution Should Be Between 0.10 Mg/Ml and 0.26 Mg/Ml.

Step 3

Remove the Syringe and Mix the Contents of the Bag or Bottle for Infusion by Gently Rocking It. The Infusion Solution Is a Clear, Colorless Solution.

Step 4

As with Other Medicines for Intravenous Administration, the Prepared Infusion Solution Should Be Inspected Visually for Particulate Matter or Discoloration Prior to Administration.
The Infusion Solution Is Supersaturated and May Crystallize Over Time. In This Case, the Solution Should Not Be Used and Should Be Discarded.

The Infusion Solution Should Be Used Immediately After Preparation. Information on Shelf Life and Special Precautions for Storage Is Given Above.
Any Unused Medicine or Waste Materials Used to Prepare, Dilute, and Administer the Medicine Should Be Disposed of in Accordance with Hospital Procedures for Cytotoxic Medicines and Local Regulations for the Disposal of Hazardous Waste.

Method of Administration

Cabazitaxel Fresenius Kabi Is Administered as a 1-Hour Intravenous Infusion.
During Administration of the Medicine, It Is Recommended to Use a Filter with a Nominal Pore Size of 0.22 Microns (Also Known as 0.2 Microns).
Do Not Use PVC Infusion Bags or Polyurethane Infusion Sets for the Preparation and Administration of Cabazitaxel Fresenius Kabi.