Caspofungin Fresenius Kabi

Package Leaflet: Information for the User

Caspofungin Fresenius Kabi, 70 mg, Powder for Concentrate for Solution for Infusion

Caspofungin

Read All of This Leaflet Carefully Before You Start Using This Medicine.

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

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

Caspofungin Fresenius Kabi Contains the Active Substance Caspofungin, Which Belongs to a Group of Antifungal Medicines.

What Caspofungin Fresenius Kabi Is Used For

Caspofungin Fresenius Kabi Is Used to Treat the Following Infections in Children, Adolescents, and Adults:

• Severe Fungal Infections of the Tissues and Organs (Invasive Candidiasis). This Is an Infection Caused by a Fungus Called Candida. People Who Are More Likely to Get This Type of Infection Include Those Who Have Just Had an Operation or Have a Weakened Immune System. The Most Common Symptoms of This Infection Are Fever and Chills That Do Not Respond to Antibiotic Treatment;
• Fungal Infections of the Nose, Sinuses, or Lungs (Invasive Aspergillosis), If Other Antifungal Medicines Have Not Worked or Have Caused Side Effects. These Infections Are Caused by a Fungus Called Aspergillus. People Who Are More Likely to Get This Type of Infection Include Those Who Are Having Chemotherapy, Have Had an Organ Transplant, or Have a Weakened Immune System;
• Suspected Fungal Infection in People with Fever and Low White Blood Cell Count, Whose Condition Has Not Improved with Antibiotic Treatment. People Who Are More Likely to Get a Fungal Infection Include Those Who Have Just Had an Operation or Have a Weakened Immune System.

How Caspofungin Fresenius Kabi Works

Caspofungin Fresenius Kabi Weakens the Fungal Cells and Inhibits Their Normal Growth. This Prevents the Spread of the Infection and Allows the Body's Natural Defense Mechanisms to Completely Eliminate It.

2. What You Need to Know Before You Use Caspofungin Fresenius Kabi

When Not to Use Caspofungin Fresenius Kabi

• If You Are Allergic to Caspofungin or Any of the Other Ingredients of This Medicine (Listed in Section 6).

If You Are Not Sure, Consult Your Doctor, Pharmacist, or Nurse Before Using the Medicine.

Warnings and Precautions

Before You Start Using Caspofungin Fresenius Kabi, Tell Your Doctor, Nurse, or Pharmacist:

• If You Are Allergic to Any Other Medicines;
• If You Have Ever Had Liver Problems - You May Need a Different Dose of the Medicine;
• If You Are Taking Cyclosporin (a Medicine to Prevent Organ Rejection or to Suppress the Immune System), as Your Doctor May Need to Monitor Your Blood Tests During Treatment;
• If You Have Ever Had Any Other Health Problems.

If Any of the Above Apply to You (or You Are Not Sure), Consult Your Doctor, Pharmacist, or Nurse Before Using Caspofungin Fresenius Kabi.

Caspofungin Fresenius Kabi and Other Medicines

Tell Your Doctor, Nurse, or Pharmacist About All the Medicines You Are Taking, Including Those You Have Bought Without a Prescription, Herbal Products, as Caspofungin Fresenius Kabi May Affect the Way They Work. Also, Some Other Medicines May Affect the Way Caspofungin Fresenius Kabi Works.

• Cyclosporin or Tacrolimus (Medicines to Prevent Organ Rejection or to Suppress the Immune System), as Your Doctor May Need to Monitor Your Blood Tests During Treatment;
• Certain Medicines Used to Treat HIV, Such as Efavirenz or Nevirapine;
• Phenytoin or Carbamazepine (Medicines Used to Treat Seizures);
• Dexamethasone (a Steroid Medicine);
• Rifampicin (an Antibiotic).

If Any of the Above Apply to You (or You Are Not Sure), Consult Your Doctor, Nurse, or Pharmacist Before Using Caspofungin Fresenius Kabi.

Pregnancy and Breast-Feeding

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant, or Are Planning to Have a Baby, Ask Your Doctor for Advice Before Using This Medicine.

• No Studies Have Been Done to Show Whether Caspofungin Fresenius Kabi Is Safe to Use in Pregnant Women. The Medicine Should Only Be Used in Pregnancy if the Potential Benefits Outweigh the Potential Risks to the Unborn Baby.
• Women Who Are Taking Caspofungin Fresenius Kabi Should Not Breast-Feed.

Driving and Using Machines

There Is No Information to Suggest That Caspofungin Fresenius Kabi Affects the Ability to Drive or Use Machines.

Caspofungin Fresenius Kabi Contains Sodium

The Medicine Contains Less Than 1 Mmol (23 Mg) of Sodium per Vial, Which Means It Is Essentially Sodium-Free.

3. How to Use Caspofungin Fresenius Kabi

Caspofungin Fresenius Kabi Is Always Prepared and Administered by a Healthcare Professional. Caspofungin Fresenius Kabi Will Be Given:

• Once a Day;
• As a Slow Injection into a Vein (Intravenous Infusion);
• Over About 1 Hour.

The Duration of Treatment and the Daily Dose of Caspofungin Fresenius Kabi Will Be Determined by Your Doctor. They Will Monitor the Effectiveness of the Medicine and Your Response to It. For Patients Weighing More Than 80 Kg, a Different Dose May Be Necessary.

Use in Children and Adolescents

The Dose for Children and Adolescents May Be Different from the Dose Used for Adult Patients.

Overdose of Caspofungin Fresenius Kabi

Your Doctor Will Decide What Dose of Caspofungin Fresenius Kabi You Need and How Long You Need to Take It. However, If You Think You Have Been Given Too Much Caspofungin Fresenius Kabi, Tell Your Doctor or Nurse Immediately.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

If You Get Any of the Following Side Effects, Tell Your Doctor or Nurse Immediately, as You May Need Urgent Medical Attention:

• Rash, Itching, Feeling of Warmth, Swelling of the Face, Lips, or Throat, or Difficulty Breathing - Possible Signs of a Histamine Reaction to the Medicine;
• Difficulty Breathing, Wheezing, or Severe Rash - Possible Signs of an Allergic Reaction to the Medicine;
• Cough, Severe Breathing Problems - in Adults with Invasive Aspergillosis, Severe Breathing Problems May Occur, Which May Lead to Respiratory Failure;
• Rash, Skin Peeling, Ulcers of the Mucous Membranes, Hives, Skin Peeling Over a Large Area.

As with All Prescription Medicines, Some Side Effects Can Be Serious. Ask Your Doctor for More Information.

Other Side Effects in Adults

Common: May Affect Up to 1 in 10 People:

• Decreased Hemoglobin (Decreased Red Blood Cell Count), Decreased White Blood Cell Count;
• Decreased Albumin (a Type of Protein) in the Blood, Decreased Potassium or Low Potassium Levels in the Blood;
• Headache;
• Phlebitis (Inflammation of the Veins);
• Shortness of Breath;
• Diarrhea, Nausea, or Vomiting;
• Changes in Some Blood Test Results (Including Increased Liver Enzyme Levels);
• Itching, Rash, Redness of the Skin, or Increased Sweating;
• Joint Pain;
• Chills, Fever;
• Itching at the Injection Site.

Uncommon: May Affect Up to 1 in 100 People:

• Changes in Some Blood Test Results (Including Blood Clotting, Platelet Count, Red or White Blood Cell Count);
• Loss of Appetite, Increased Fluid Retention, Electrolyte Imbalance, High Blood Sugar, Low Calcium Levels, High Calcium Levels, Low Magnesium Levels;
• Disorientation, Feeling Anxious, Sleep Disturbances;
• Dizziness, Weakness, Tingling, or Numbness (Especially of the Skin), Tremors, Drowsiness, Change in Taste, Feeling of Tingling or Numbness;
• Blurred Vision, Increased Tear Production, Swelling of the Eyelids, Yellowing of the Whites of the Eyes;
• Feeling of Rapid or Irregular Heartbeat, Fast Heartbeat, Irregular Heartbeat, Abnormal Heart Rhythm, Heart Failure;
• Flushing, Hot Flushes, High Blood Pressure, Low Blood Pressure, Redness of the Skin Along the Vein, Extreme Sensitivity to Touch;
• Wheezing, Severe Breathing Problems, Fast Breathing, Shortness of Breath, Abnormal Lung Sounds, Wheezing, Stuffy Nose, Cough, Sore Throat;
• Abdominal Pain, Pain in the Upper Abdomen, Bloating, Constipation, Difficulty Swallowing, Dry Mouth, Indigestion, Gas, Stomach Upset, Swelling Due to Fluid Build-Up in the Abdomen;
• Decreased Bile Flow, Enlarged Liver, Yellowing of the Skin and/or Whites of the Eyes, Chemical or Medicinal Liver Damage, Liver Function Disorders;
• Abnormal Skin Changes, Generalized Itching, Hives, Multiforme Erythema, Abnormal Skin Appearance, Presence of Red, Often Itchy Spots on the Hands and Feet, and Sometimes on the Face and Rest of the Body;
• Back Pain, Pain in the Arms or Legs, Bone Pain, Muscle Pain, Muscle Weakness;
• Worsening of Kidney Function, Sudden Worsening of Kidney Function;
• Pain at the Injection Site, Changes at the Injection Site (Redness, Hardening, Pain, Swelling, Irritation, Rash, Hives, Fluid Leaking from the Catheter into the Tissues), Phlebitis at the Injection Site;
• Increased Blood Pressure and Changes in Some Blood Test Results (Including Kidney Function, Electrolytes, and Blood Clotting), Increased Levels of Medicines That Weaken the Immune System;
• Feeling of Discomfort in the Chest, Chest Pain, Feeling of Temperature Change

Body, General Feeling of Being Unwell, Generalized Pain, Swelling of the Face, Swelling of the Ankles, Hands, or Feet, Swelling, Tenderness, Feeling of Tiredness.

Side Effects in Children and Adolescents

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

• Fever.

Common: May Affect Up to 1 in 10 People:

• Headache;
• Fast Heartbeat;
• Sudden Redness of the Face, Low Blood Pressure;
• Changes in Some Blood Test Results (Including Increased Liver Enzyme Levels);
• Itching, Rash;
• Pain at the Injection Site;
• Chills;
• Changes in Some Blood Test Results.

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 Regulatory Authority. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Caspofungin 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 Vial After EXP.

The Expiry Date Refers to the Last Day of That Month.

Store in a Refrigerator (2°C to 8°C).

After Reconstitution, the Medicine Should Be Used Immediately, as It Does Not Contain Any Preservatives. The Medicine Should Only Be Prepared by Trained Medical Personnel Who Have Read the Instructions (See Below "Instructions for Reconstitution and Dilution of Caspofungin Fresenius Kabi").

Reconstituted Concentrate: Should Be Used Immediately. Stability Studies Have Shown That the Concentrate for Solution for Infusion Can Be Stored for 24 Hours If the Vials Are Stored at a Temperature of Up to 25°C and Water for Injections Is Used for Reconstitution.

Chemical and Physical Stability Has Been Demonstrated for 24 Hours If the Vials Are Stored at a Temperature of Up to 25°C and Water Is Used for Reconstitution.

Diluted Solution: Should Be Used Immediately. Stability Studies Have Shown That the Product Can Be Used Within 24 Hours If Stored at a Temperature of Up to 25°C or Within 48 Hours If the Infusion Bag (Bottle) Is Stored in a Refrigerator (2°C to 8°C), and a Solution of Sodium Chloride 9 Mg/Ml (0.9%), 4.5 Mg/Ml (0.45%), or 2.25 Mg/Ml (0.225%) or Ringer's Solution with Lactate Is Used to Prepare the Infusion Solution.

Caspofungin Fresenius Kabi Does Not Contain Preservatives. Chemical and Physical Stability Has Been Demonstrated for 24 Hours at a Temperature of Up to 25°C Before Administration.

From a Microbiological Point of View, the Product Should Be Used Immediately. If Not Used Immediately, the Storage Time and Conditions Are the Responsibility of the User.

The Storage Time Should Not Exceed 24 Hours at 2°C to 8°C, Provided That Reconstitution and Dilution Are Carried Out in Controlled, Validated Aseptic Conditions.

Do Not Use This Medicine If the Vial Is Damaged.

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 Caspofungin Fresenius Kabi Contains

• The Active Substance Is Caspofungin. Each Vial of Caspofungin Fresenius Kabi Contains 70 Mg of Caspofungin (as Caspofungin Acetate). The Final Concentration of the Reconstituted Solution Will Be 7.2 Mg/Ml.
• The Other Ingredients Are Sucrose, Mannitol, Acetic Acid, Sodium Hydroxide (for pH Adjustment) (See Section 2 "Important Information Before Using Caspofungin Fresenius Kabi").

What Caspofungin Fresenius Kabi Looks Like and Contents of the Pack

Caspofungin Fresenius Kabi Is a White or Almost White, Compact, Freeze-Dried Powder in a Glass Vial with a Grey Rubber Stopper and a Yellow Aluminium Flip-Off Cap, in a Cardboard Box.

The Pack Contains 1 Vial of Powder.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Polska Sp. z o.o.

Al. Jerozolimskie 134

02-305 Warsaw

Poland

Manufacturer

Famar Health Care Services Madrid S.A.U.

Avda. Leganés, 62, Alcorcón

28923 Madrid

Spain

For Further Information, Contact the Marketing Authorisation Holder:

Fresenius Kabi Polska Sp. z o.o.

Al. Jerozolimskie 134, 02-305 Warsaw

Phone: +48 22 345 67 89

This Medicinal Product Is Authorised in the Member States of the European Economic Area Under the Following Names:

Austria:

Caspofungin Fresenius Kabi 50 Mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Germany:

Caspofungin Fresenius Kabi 50 Mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

France:

Caspofungine Fresenius Kabi 50 Mg Poudre pour solution à diluer pour perfusion

Italy:

Caspofungin Fresenius Kabi

Ireland:

Caspofungin Fresenius Kabi 70 Mg Powder for Concentrate for Solution for Infusion

Poland:

Caspofungin Fresenius Kabi

Spain:

Caspofungina Fresenius Kabi 50 Mg Polvo para concentrado para solución para perfusión

Date of Last Revision of the Leaflet: ---------------------------------------------------------------------

Information Intended for Healthcare Professionals Only:

Instructions for Reconstitution and Dilution of Caspofungin Fresenius Kabi:

Reconstitution of Caspofungin Fresenius Kabi

DO NOT USE ANY SOLUTIONS CONTAINING GLUCOSE, as Caspofungin Fresenius Kabi Is Not Stable in Solutions Containing Glucose. DO NOT MIX OR ADMINISTER IN THE SAME INFUSION WITH OTHER MEDICINES, as There Are No Data Available on the Compatibility of Caspofungin Fresenius Kabi with Other Intravenous Medicinal Products. The Infusion Solution Should Be Inspected Visually for Particulate Matter or Discoloration.

Any Unused Product or Waste Material Should Be Disposed of in Accordance with Local Requirements.

INSTRUCTIONS FOR ADMINISTRATION OF CASPOFUNGIN FRESNIUS KABI TO ADULT PATIENTS

Step 1: Reconstitution of the Vial

To Reconstitute the Powder, Allow the Vial to Reach Room Temperature, Then Aseptically Add 10.5 Ml of Water for Injections. The Final Concentration of the Reconstituted Solution Will Be 7.2 Mg/Ml.

The White or Almost White, Compact, Freeze-Dried Powder Will Dissolve Completely. Gently Shake the Vial Until the Solution Is Clear. The Reconstituted Solution Should Be Inspected Visually for Particulate Matter or Discoloration. The Reconstituted Solution Can Be Stored for Up to 24 Hours at a Temperature of Up to 25°C.

Step 2: Addition of the Reconstituted Caspofungin Fresenius Kabi to the Infusion Solution

To Prepare the Final Infusion Solution, the Following Solutions Can Be Used: Sodium Chloride 9 Mg/Ml (0.9%) Injection, Sodium Chloride 4.5 Mg/Ml (0.45%) Injection, Sodium Chloride 2.25 Mg/Ml (0.225%) Injection, or Ringer's Solution with Lactate for Injection. The Infusion Solution Should Be Prepared by Aseptically Adding the Appropriate Volume of the Reconstituted Caspofungin Fresenius Kabi (as Shown in the Table Below) to an Intravenous Bag or Bottle Containing 250 Ml of the Infusion Solution.

PREPARATION OF THE INFUSION SOLUTION FOR ADULT PATIENTS

* To Reconstitute the Contents of Each Vial, 10.5 Ml of Water for Injections Should Be Added.

** If 70 Mg Vials Are Not Available, a 70 Mg Dose Can Be Prepared from Two 50 Mg Vials.

INSTRUCTIONS FOR ADMINISTRATION OF CASPOFUNGIN FRESNIUS KABI TO CHILDREN AND ADOLESCENTS

Calculation of Body Surface Area (BSA) to Determine the Dose for Children and Adolescents

Preparation of the Intravenous Infusion Containing a Dose of 70 Mg/M² for Children and Adolescents Aged >3 Months (Using a 70 Mg Vial)

• 1. Determine the Actual Dose to Be Used for Children and Adolescents Based on the Body Surface Area (Calculated as Above) Using the Following Equation: BSA (M²) x 70 Mg/M² = Dose. The Maximum Dose on Day 1 Should Not Exceed 70 Mg, Regardless of the Calculated Dose for the Individual Patient.
• 2. Remove the Vial from the Refrigerator and Allow It to Reach Room Temperature.
• 3. Aseptically Add 10.5 Ml of Water for Injections. The Reconstituted Solution Can Be Stored for Up to 24 Hours at a Temperature of Up to 25°C. This Will Result in a Final Concentration of 7.2 Mg/Ml.
• 4. From the Vial, Withdraw the Volume of the Reconstituted Caspofungin Fresenius Kabi Equal to the Calculated Dose (Step 1). Aseptically Add This Volume (Ml) of the Reconstituted Caspofungin Fresenius Kabi to an Intravenous Bag or Bottle Containing 250 Ml of Sodium Chloride 9 Mg/Ml (0.9%), 4.5 Mg/Ml (0.45%), or 2.25 Mg/Ml (0.225%) Injection or Ringer's Solution with Lactate for Injection. Alternatively, the Calculated Volume (Ml) of the Reconstituted Caspofungin Fresenius Kabi Can Be Added to a Smaller Volume of Sodium Chloride 9 Mg/Ml (0.9%), 4.5 Mg/Ml (0.45%), or 2.25 Mg/Ml (0.225%) Injection or Ringer's Solution with Lactate for Injection, Without Exceeding a Final Concentration of 0.5 Mg/Ml. The Final Infusion Solution Should Be Used Within 24 Hours If Stored at a Temperature of Up to 25°C or Within 48 Hours If Stored in a Refrigerator at 2°C to 8°C.

Preparation of the Intravenous Infusion Containing a Dose of 50 Mg/M² for Children and Adolescents Aged >3 Months (Using a 70 Mg Vial)

• 1. Determine the Actual Daily Dose to Be Used for Children and Adolescents Based on the Body Surface Area (Calculated as Above) Using the Following Equation: BSA (M²) x 50 Mg/M² = Daily Dose. The Daily Dose Should Not Exceed 70 Mg, Regardless of the Calculated Dose for the Individual Patient.
• 2. Remove the Vial from the Refrigerator and Allow It to Reach Room Temperature.
• 3. Aseptically Add 10.5 Ml of Water for Injections. The Reconstituted Solution Can Be Stored for Up to 24 Hours at a Temperature of Up to 25°C. This Will Result in a Final Concentration of 7.2 Mg/Ml.
• 4. From the Vial, Withdraw the Volume of the Reconstituted Caspofungin Fresenius Kabi Equal to the Calculated Daily Dose (Step 1). Aseptically Add This Volume (Ml) of the Reconstituted Caspofungin Fresenius Kabi to an Intravenous Bag or Bottle Containing 250 Ml of Sodium Chloride 9 Mg/Ml (0.9%), 4.5 Mg/Ml (0.45%), or 2.25 Mg/Ml (0.225%) Injection or Ringer's Solution with Lactate for Injection. Alternatively, the Calculated Volume (Ml) of the Reconstituted Caspofungin Fresenius Kabi Can Be Added to a Smaller Volume of Sodium Chloride 9 Mg/Ml (0.9%), 4.5 Mg/Ml (0.45%), or 2.25 Mg/Ml (0.225%) Injection or Ringer's Solution with Lactate for Injection, Without Exceeding a Final Concentration of 0.5 Mg/Ml. The Final Infusion Solution Should Be Used Within 24 Hours If Stored at a Temperature of Up to 25°C or Within 48 Hours If Stored in a Refrigerator at 2°C to 8°C.

Notes on Preparation:

The White or Almost White, Compact, Freeze-Dried Powder Should Dissolve Completely. Gently Shake the Vial Until the Solution Is Clear.

The Reconstituted Solution Should Be Inspected Visually for Particulate Matter or Discoloration Before Administration. If the Solution Is Cloudy or Contains Particulate Matter, It Should Not Be Administered.

Caspofungin Fresenius Kabi Is Prepared to Allow the Full Dose, as Indicated on the Vial Label (70 Mg), to Be Withdrawn from the Vial (10 Ml).