Eleber

Package Leaflet: Information for the Patient

Eleber, 60 mg, Concentrate and Solvent for Solution for Infusion

Kabazitaxel

Read All of This Leaflet Carefully Before 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

• 1. What is Eleber and What is it Used For
• 2. Before You Use Eleber
• 3. How to Use Eleber
• 4. Possible Side Effects
• 5. How to Store Eleber
• 6. Contents of the Pack and Other Information

1. What is Eleber and What is it Used For

The Name of Your Medicine is Eleber. Its Common Name is Kabazitaxel. It Belongs to a Group of Medicines Called "Taxanes" Used to Treat Cancer.
Eleber is Used to Treat Prostate Cancer When the Disease Has Progressed After 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 Advice on This Medicine.

2. Before You Use Eleber

When Not to Use Eleber:

• If You are Allergic (Hypersensitive) to Kabazitaxel, Other Taxanes, Polysorbate 80, or Any of the Other Ingredients of the 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 Problems,
• If You Have Recently Received or Are Going to Receive a Yellow Fever Vaccine.

Do Not Use Eleber if Any of the Above Applies to You.
If You are Not Sure, Consult Your Doctor Before Using Eleber.

Warnings and Precautions

Before Each Administration of Eleber, Blood Tests are Performed to Check if the Number of Blood Cells and Liver and Kidney Function are Suitable for Administration of Eleber.
You Must Immediately Inform Your Doctor if:

• You Have a Fever. During Treatment with Eleber, There is a Risk of Decreased 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 Healthy White Blood Cell Count. In Patients with Low Blood Cell Counts, Life-Threatening Infections May Occur.

The Earliest Sign of Infection May be Fever, So if You Get a Fever, You Must Immediately Inform Your Doctor.

• You Have Had Any Previous Allergies. During Treatment with Eleber, Severe Allergic Reactions May Occur.
• You Have Severe or Prolonged Diarrhea, Nausea, or Vomiting. All These Symptoms Can Lead to Severe Dehydration. They May Also Require Treatment.
• You Have a Feeling of Tingling, Burning, or Reduced Sensation in Your Hands and Feet.
• You Have Any Gastrointestinal Bleeding, Change in Stool Color, or Abdominal Pain. If the Bleeding or Pain is Severe, Your Doctor May Stop the Treatment with Eleber. This is Because Eleber May Increase the Risk of Bleeding or Perforation of the Gut Wall.
• You Have Kidney Problems.
• You Have Yellowing of the Skin and Eyes, Dark Urine, Severe Nausea (Vomiting), or Because These May be Signs of Liver Problems.
• You Have a Significant Increase or Decrease in the Amount of Urine Passed in 24 Hours.
• You Have Blood in Your Urine.

You Must Immediately Inform Your Doctor if Any of the Above Applies to You.
Your Doctor May Reduce the Dose of Eleber or Stop the Treatment.

Eleber and Other Medicines

Tell Your Doctor, Pharmacist, or Nurse About All Medicines You are Taking Now or Have Recently Taken, Including Those You Have Bought Without a Prescription. This is Because Some Medicines May Affect the Way Eleber Works, or Eleber May Affect the Way Other Medicines Work. This Applies to the Following Medicines:

• 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) (Medicines to Lower Cholesterol in the Blood);
• Valsartan (Used to Treat High Blood Pressure);
• Repaglinide (Used to Treat Diabetes).

Before You Receive Any Vaccinations, Tell Your Doctor That You are Taking Eleber.

Pregnancy, Breast-Feeding, and Fertility

Eleber is Not Indicated for Use in Women.
You Should Use Condoms During Sexual Intercourse if Your Partner is Pregnant or May Become Pregnant. Eleber May be Present in Semen and May Affect the Fetus.
Men Taking Eleber Should Not Father a Child During and for Up to 4 Months After Treatment, and Before Starting Treatment, They Should Consult About Storing Their Sperm Because Eleber May Affect Fertility in Men.

Driving and Using Machines

During Treatment with Eleber, You May Feel Tired or Dizzy. In This Case, Do Not Drive or Operate Machines, or Use Tools Until These Symptoms Have Gone Away.

Eleber Contains Ethanol (Alcohol)

The Medicine Contains 542.4 mg of Ethanol (Alcohol) in Each Vial of Solvent. The Amount in One Dose of the Medicine is Equivalent to Less Than 10 ml of Beer or 4 ml of Wine.
The Small Amount of Alcohol in This Medicine Will Not Cause Any Noticeable Effects.

3. How to Use Eleber

Instructions for Use

Before You Receive Eleber, You Will be Given Medicines to Reduce the Risk of Allergic Reactions.

• Eleber is Given by a Doctor or Nurse.
• Eleber Must be Properly Prepared (Diluted) Before Administration. This Leaflet Contains Practical Information for Doctors, Nurses, and Pharmacists on Handling Eleber and How to Administer it.
• Eleber is Given in a Hospital as an Intravenous Infusion (Drip) Over About 1 Hour into One of Your Veins.
• 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, Eleber 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.

You Must Immediately Consult a Doctor if You Experience Any of the Following Side Effects:

• Fever (High Body Temperature). This is a Common Side Effect (May Affect Up to 1 in 10 People).
• Severe Loss of Fluid from the Body (Dehydration). This is a Common Side Effect (May Affect Up to 1 in 10 People). Dehydration May Occur Due to Severe or Prolonged Diarrhea, Fever, or Vomiting.
• Severe Abdominal Pain or Abdominal Pain That Does Not Go Away. These Symptoms May Occur if You Have a Perforated Stomach, Esophagus, or Intestine (Perforation of the Gastrointestinal Tract). This May Lead to Death.

You Must Immediately Inform Your Doctor if Any of the Above Applies to You.

Other Side Effects:

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

• Decreased Number of Red Blood Cells (Anemia) or White Blood Cells (Important for Fighting Infections)
• Decreased Number of Platelets (Which Increases the Risk of Bleeding)
• Lack of Appetite (Anorexia)
• Irritation of the Stomach, 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):

• Changes in Taste
• Shortness of Breath
• Cough
• Abdominal 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
• Decreased or Increased 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 Problems
• Mouth or Lip Ulcers
• Infections or Risk of Infections
• High Blood Sugar Levels
• Insomnia
• Confusion
• Feeling of 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
• Feeling of Heat or Flushing of the Skin
• Mouth or Throat Pain
• Bleeding from the Rectum
• Muscle Discomfort, Pain, or Weakness
• Swelling of the Feet or Legs
• Chills
• Nail Disorders (Change in Nail Color; Nails May Detach)

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

• Low Potassium Levels in the Blood
• Ringing in the Ears
• Feeling of Hot Skin
• Redness of the Skin
• Urinary Bladder Inflammation, Which May Occur if You Have Previously Undergone Radiotherapy (Radiation-Induced Cystitis).

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

• Non-Infectious Interstitial Pneumonia (Pneumonia 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. You Can Also Report Side Effects Directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
You Can Also Report Side Effects 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 Eleber

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 Vial Label After "EXP". The Expiry Date Refers to the Last Day of the Month.
Information on the Storage and Shelf Life of Eleber After Dilution and Preparation for Use is Described in the Section "PRACTICAL INFORMATION FOR DOCTORS AND HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF ELEBER".
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 Eleber Contains

• The Active Substance is Kabazitaxel. One ml of Concentrate Contains 40 mg of Kabazitaxel. Each Vial of Concentrate Contains 60 mg of Kabazitaxel.
• The Other Ingredients are: Polysorbate 80 and Citric Acid in the Concentrate and Ethanol 96% and Water for Injection in the Solvent (See Section 2 "Eleber Contains Alcohol").

Note: Both the Vial of Eleber 60 mg/1.5 ml Concentrate (Fill Volume: 73.2 mg Kabazitaxel/1.83 ml) and the Vial of Solvent (Fill Volume: 5.67 ml) Contain an Overfill to Account for Losses During Preparation. This Overfill Ensures That After Dilution with the Entire Contents of the Accompanying Solvent, the Resulting Solution Contains 10 mg/ml of Kabazitaxel.

What Eleber Looks Like and Contents of the Pack

Eleber is a Concentrate and Solvent for Solution for Infusion (Sterile Concentrate). The Concentrate is a Clear, Colorless to Pale Yellow, Viscous Solution.
The Solvent is a Clear, Colorless Solution.
One Pack of Eleber Contains:

• One Vial of Colorless Glass Type I, Closed with a Chlorobutyl Rubber Stopper Covered with a Fluoropolymer, with an Aluminum Flip-Off Seal, Containing 1.5 ml (Nominal Volume) of Concentrate.
• One Vial of Colorless Glass Type I, Closed with a Chlorobutyl Rubber Stopper Covered with a Fluoropolymer, with an Aluminum Flip-Off Seal, Containing 4.5 ml (Nominal Volume) of Solvent.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Importer:
Pharmadox Healthcare Ltd.
Kordin Industrial Park KW20A
PLA 3000 Paola
Malta

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Bulgaria: Елебер 60 mg концентрат и разтворител за инфузионен разтвор
Croatia: Eleber 60 mg koncentrat i otapalo za otopinu za infuziju
Estonia: Eleber
Iceland: Eleber
Lithuania: Eleber 60 mg koncentratas ir tirpiklis infuziniam tirpalui
Latvia: Eleber 60 mg koncentrāts un šķīdinātājs infūziju šķīduma pagatavošanai
Poland: Eleber
Czech Republic: Eleber
Romania: Eleber 60 mg concentrat și solvent pentru soluție perfuzabilă
Slovakia: Eleber 60 mg koncentrát a rozpúšťadlo na infúzny roztok
Slovenia: Eleber 60 mg koncentrat in vehikel za raztopino za infundiranje
Hungary: Eleber 60 MG KONCENTRÁTUM ÉS OLDÓSZER OLDATOS INFÚZIÓHOZ

For Further Information on This Medicinal Product, Please Contact the Local Representative of the Marketing Authorization Holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Phone: +48 22 375 92 00
[Logo of the Marketing Authorization Holder]
Date of Last Revision of the Leaflet:November 2023

Information Intended for Healthcare Professionals Only:

PRACTICAL INFORMATION FOR DOCTORS AND HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF ELEBER, 60 mg, CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Introduction

The Following Information is a Supplement to Sections 3 and 5 for the User.
Before Preparing the Infusion Solution, Read the Entire Description of the Procedure Below.

Incompatibilities

Do Not Mix This Medicinal Product with Other Medicinal Products Except Those Used for Dilution.

Shelf Life and Special Precautions for Storage

Regarding the Packaging of Eleber, 60 mg, Concentrate and Solvent
No Special Precautions for Storage.

After Opening

The Vials of Concentrate and Solvent Must be Used Immediately After Opening. Otherwise, the User is Responsible for the Storage Conditions and Duration.
From a Microbiological Point of View, the Two-Step Dilution Process Must be Carried Out Under Controlled and Aseptic Conditions (See Below "Precautions for Handling and Administration").

After Initial Dilution

After Initial Dilution of the Eleber 60 mg Concentrate Using the Entire Contents of the Accompanying Solvent, the Chemical and Physical Stability of the Solution Has Been Demonstrated for 30 Minutes at Room Temperature.

After Final Dilution in the Infusion Bag and/or Bottle

The Chemical and Physical Stability of the Infusion Solution Has Been Demonstrated for 8 Hours at Room Temperature (15°C - 30°C), Including the 1-Hour Infusion Time, and for 24 Hours Under Refrigerated Conditions, Including the 1-Hour Infusion Time.
From a Microbiological Point of View, the Infusion Solution Should be Used Immediately After Preparation. Otherwise, the User is Responsible for the Storage Conditions and Duration, and the Storage Time Should Not Normally Exceed 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, Caution Should be Exercised When Handling Eleber and Preparing Its Solutions, Taking Into Account the Use of Equipment That Minimizes Exposure to the Medicinal Product, Personal Protective Equipment (e.g., Gloves), and Procedures for the Preparation of the Medicinal Product for Use.
In Case of Contact with the Skin, at Any Stage of Handling, the Affected Area Should be Washed Immediately with Soap and Water. In Case of Contact with the Mucous Membranes, the Affected Area Should be Rinsed Immediately with Water.
Eleber Should Only be Prepared and Administered by Personnel Trained in the Handling of Cytotoxic Substances. Pregnant Women in the Personnel Should Not Handle the Medicinal Product.

Steps for Preparation

Before Mixing and Diluting, Read the Entire Section Carefully. The Preparation of Eleber Before Administration Requires TWOSteps of Dilution. Follow the Instructions Below.

Step 1: Initial Dilution of the Concentrate for Solution for Infusion Using the Accompanying Solvent.

Step 1.1

Inspect the Vial of Concentrate and the Vial of Solvent Carefully. The Concentrate and Solvent Solutions Should be Clear.

Step 1.2

Using a Syringe with a Needle Attached, With Asepsis, Withdraw the Entire Contents of the Accompanying Solvent, Turning the Vial Upside Down.

Step 1.3

Inject the Entire Contents of the Solvent into the Corresponding Vial of Concentrate.
To Minimize Foam Formation During the Injection of the Solvent, Direct the Needle onto the Inner Wall of the Concentrate Vial and Inject Slowly.
After the First Dilution, the Resulting Solution Contains 10 mg/ml of Kabazitaxel.

Mixture of Concentrate and Solvent
10 mg/ml

Step 1.4

Remove the Syringe and Needle and Mix Gently by Hand by Repeatedly Inverting Until a Clear and Homogeneous Solution is Obtained. This May Take About 45 Seconds.

Step 1.5

Let the Solution Stand for About 5 Minutes and Then Check if the Solution is Homogeneous and Clear.
Persistence of Foam After This Time is a Normal Phenomenon.
The Resulting Mixture of Concentrate and Solvent Contains Kabazitaxel at a Concentration of 10 mg/ml (at Least 6 ml of Solution to be Administered). The Second Dilution Should be Performed Immediately (Within 1 Hour) as Described in the Section "Step 2".

Step 2: Second (Final) Dilution of the Infusion Solution

Step 2.1

With Asepsis, Transfer the Required Volume of the Mixture of Concentrate and Solvent (Kabazitaxel Concentration 10 mg/ml) Using a Syringe with Gradations and a Needle Attached. For Example, a Dose of 45 mg of Eleber Will Require 4.5 ml of the Mixture of Concentrate and Solvent Prepared as Described in Step 1.

Mixture of Concentrate and Solvent
10 mg/ml

Mixture of Concentrate and Solvent
10 mg/ml

Step 2.2

Inject into a Sterile Bag Made of a Material Other Than PVC, 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 2.3

Remove the Syringe and Mix the Contents of the Bag or Bottle for Infusion by Hand, Performing a Rocking Motion.

Step 2.4

As with Any Medicinal Product for Parenteral Administration, the Resulting Infusion Solution Should be Inspected Visually for Particulate Matter and Discoloration Prior to Administration. Since the Infusion Solution is Supersaturated, it May Crystallize Over Time. In This Case, the Solution Must Not be Used and Should be Discarded.
The Infusion Solution Should be Used Immediately After Preparation. However, the Storage Time of the Prepared Solution May be Longer Under Certain Conditions Described Above in the Section "Shelf Life and Special Precautions for Storage".

Administration

Eleber is Administered as an Intravenous Infusion Over 1 Hour.
During Administration of Eleber, it is Recommended to Use a Filter with a Nominal Pore Size of 0.22 Microns (Also Known as 0.2 Microns) Attached to the Infusion Set.
Do Not Use Infusion Bags Made of PVC and Polyurethane Infusion Sets.