Caspofungin Fresenius Kabi

Package Leaflet: Information for the User

Caspofungin Fresenius Kabi, 50 mg, Powder for Concentrate for Solution for Infusion

Caspofungin

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Table of Contents of the Package Leaflet

• 1. What is Caspofungin Fresenius Kabi and What is it Used For
• 2. Important Information Before Using 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 Package and Other Information

1. What is Caspofungin Fresenius Kabi and What is it Used For

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

What is Caspofungin Fresenius Kabi Used For

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

• Severe Fungal Infections of Tissues and Organs (Invasive Candidiasis). This Infection is Caused by a Fungus Called Candida. People Who May Develop this Type of Infection Include Patients Who Have Recently Undergone Surgery 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 May Develop this Type of Infection Include Patients Who Are Undergoing Chemotherapy, Have Had an Organ Transplant, or Have a Weakened Immune System;
• Suspected Fungal Infection in Patients with Fever and Low White Blood Cell Count, Whose Condition Has Not Improved with Antibiotic Treatment. People Who May Develop a Fungal Infection Include Patients Who Have Recently Undergone Surgery 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. Important Information Before Using Caspofungin Fresenius Kabi

When Not to Use Caspofungin Fresenius Kabi

• If the Patient is Allergic to Caspofungin or Any of the Other Ingredients of this Medicinal Product (Listed in Section 6).

If You Have Any Doubts Before Administering the Medicinal Product, Consult a Doctor, Pharmacist, or Nurse.

Warnings and Precautions

Before Starting Treatment with Caspofungin Fresenius Kabi, Discuss the Following with Your Doctor, Nurse, or Pharmacist:

• If the Patient is Allergic to Any Medicines;
• If the Patient Has Ever Had Liver Function Disorders - a Different Dose of the Medicinal Product May Be Necessary;
• If the Patient is Taking Cyclosporin (a Medicinal Product to Prevent Transplant Rejection or to Suppress the Immune System), as the Doctor May Prescribe Additional Blood Tests During Treatment;
• If the Patient Has Ever Had Any Other Health Disorders.

If Any of the Above Applies to the Patient (or is Suspected), Consult a Doctor, Pharmacist, or Nurse Before Using Caspofungin Fresenius Kabi.

Caspofungin Fresenius Kabi and Other Medicinal Products

Tell Your Doctor, Nurse, or Pharmacist About All Medicinal Products the Patient is Currently Taking or Has Recently Taken, as Well as Any Medicinal Products the Patient Plans to Take, Including Those Available Without a Prescription, Including Herbal Preparations, as Caspofungin Fresenius Kabi May Affect the Way Other Medicinal Products Work. Also, Some Other Medicinal Products May Affect the Way Caspofungin Fresenius Kabi Works.

• Cyclosporin or Tacrolimus (Medicinal Products to Prevent Transplant Rejection or to Suppress the Immune System), as the Doctor May Prescribe Additional Blood Tests During Treatment;
• Certain Medicinal Products Used to Treat HIV, Such as Efavirenz or Nevirapine;
• Phenytoin or Carbamazepine (Used to Treat Seizures);
• Dexamethasone (a Steroid Medicinal Product);
• Rifampicin (an Antibiotic).

If Any of the Above Applies to the Patient (or is Suspected), Consult a Doctor, Nurse, or Pharmacist Before Using Caspofungin Fresenius Kabi.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks She May be Pregnant, or Plans to Have a Child, She Should Consult a Doctor Before Using this Medicinal Product.

• No Studies Have Been Conducted on the Use of Caspofungin Fresenius Kabi in Pregnant Women. During Pregnancy, the Medicinal Product Should Only be Used if the Potential Benefits of Treatment Outweigh the Potential Risks to the Unborn Child.
• Women Taking Caspofungin Fresenius Kabi Should Not Breastfeed.

Driving and Using Machines

There is No Information to Suggest that Caspofungin Fresenius Kabi May Affect the Ability to Drive or Use Machines.

Caspofungin Fresenius Kabi Contains Sodium

The Medicinal Product Contains Less Than 1 mmol (23 mg) of Sodium per Vial, i.e., the Medicinal Product is Considered "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 Administered:

• Once a Day;
• By Slow Intravenous Infusion;
• Over a Period of About 1 Hour.

The Duration of Treatment and the Daily Dose of Caspofungin Fresenius Kabi Will be Determined by the Treating Doctor, Who Will Monitor the Effectiveness of the Medicinal Product in the Patient. In Patients with a Body Weight Over 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 in Adult Patients.

Use of a Higher Than Recommended Dose of Caspofungin Fresenius Kabi

The Treating Doctor Will Decide What Daily Dose of Caspofungin Fresenius Kabi the Patient Needs and How Long the Treatment Should Last. However, if There is a Concern that the Patient Has Received Too High a Dose of Caspofungin Fresenius Kabi, Consult the Treating Doctor or Nurse Immediately.

4. Possible Side Effects

Like All Medicinal Products, Caspofungin Fresenius Kabi Can Cause Side Effects, Although Not Everybody Gets Them.

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

• Rash, Itching, Feeling of Heat, Swelling of the Face, Lips, or Throat, or Difficulty Breathing - Possible Histamine Reaction to the Medicinal Product;
• Difficulty Breathing, Wheezing, or Worsening Rash - Possible Allergic Reaction to the Medicinal Product;
• Cough, Severe Breathing Difficulties - in Adult Patients with Invasive Aspergillosis, Severe Breathing Difficulties May Occur, Which May Lead to Respiratory Failure;
• Rash, Peeling of the Skin, Ulcers of the Mucous Membranes, Hives, Peeling of the Skin Over a Large Area.

As with All Prescription Medicinal Products, Some Side Effects Can be Serious. Consult Your Doctor for More Information.

Other Side Effects in Adult Patients

Frequent: May Occur in More Than 1 in 10 Patients:

• Decreased Hemoglobin (Decreased Level of the Substance that Carries Oxygen in the Blood), 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;
• Shortness of Breath;
• Diarrhea, Nausea, or Vomiting;
• Changes in the Results of Some Blood Tests (Including Increased Values of Some Liver Tests);
• Itching, Rash, Redness of the Skin, or Excessive Sweating;
• Joint Pain;
• Chills, Fever;
• Itching at the Injection Site.

Less Frequent: May Occur in More Than 1 in 100 Patients:

• Changes in the Results of Some Blood Tests (Including Coagulation, Platelet Count, Red Blood Cell Count, and White Blood Cell Count);
• Lack of Appetite, Increased Fluid in the Body, Electrolyte Imbalance, High Blood Sugar, Low Calcium Levels in the Blood, High Calcium Levels in the Blood, Low Magnesium Levels in the Blood, Increased Acidity of the Blood;
• Disorientation, Feeling of Anxiety, Insomnia;
• Dizziness, Weakness, Numbness or Tingling (Especially of the Skin), Tremors, Drowsiness, Changes in Taste, Feeling of Numbness or Tingling;
• Blurred Vision, Increased Tear Production, Swelling of the Eyelids, Yellowing of the Whites of the Eyes;
• Feeling of Rapid or Irregular Heartbeat, Rapid Heartbeat, Irregular Heartbeat, Abnormal Heart Rhythm, Heart Failure;
• Redness of the Face, Hot Flashes, High Blood Pressure, Low Blood Pressure, Redness of the Skin Along the Vein, Extremely Sensitive to Touch;
• Wheezing, Cough, Rapid Breathing, Shortness of Breath, Waking Up with Shortness of Breath, Lack of Oxygen in the Blood, Abnormal Lung Sounds, Wheezing, Stuffy Nose, Cough, Sore Throat;
• Abdominal Pain, Pain in the Upper Abdomen, Bloating, Constipation, Difficulty Swallowing, Dry Mouth, Nausea, Gas, Stomach Upset, Swelling Due to Fluid Accumulation in the Abdominal Cavity;
• 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, Multiform 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 the Results of Some Blood Tests (Including Kidney Function, Electrolytes, and Coagulation), Increased Levels of Immunosuppressive Medicinal Products;
• Feeling of Discomfort in the Chest, Chest Pain, Feeling of Temperature Change, General Feeling of Illness, Generalized Pain, Swelling of the Face, Swelling of the Ankles, Hands, or Feet, Swelling, Tenderness, Feeling of Fatigue.

Side Effects in Children and Adolescents

Very Frequent: May Occur in More Than 1 in 10 Patients:

• Fever.

Frequent: May Occur in More Than 1 in 10 Patients:

• Headache;
• Rapid Heartbeat;
• Sudden Redness of the Face, Low Blood Pressure;
• Changes in the Results of Some Blood Tests (Increased Values of Some Liver Tests);
• Itching, Rash;
• Pain at the Injection Site;
• Chills;
• Changes in the Results of Some Blood Tests.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor, Nurse, or Pharmacist. Side Effects Can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, See Contact Details Below.

5. How to Store Caspofungin Fresenius Kabi

Keep the Medicinal Product Out of the Sight and Reach of Children.

Do Not Use this Medicinal Product After the Expiry Date Stated on the Carton and Vial After "EXP".

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

Store in a Refrigerator (2°C to 8°C).

After Preparation, Caspofungin Fresenius Kabi Should be Used Immediately, as it Does Not Contain Any Preservatives. The Medicinal Product Should Only be Prepared by Trained Medical Personnel Who Have Read All the Instructions (See Below "Instructions for the Preparation of Caspofungin Fresenius Kabi").

Prepared 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 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 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 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 Solution for Infusion.

Caspofungin Fresenius Kabi Does Not Contain Preservatives. Chemical and Physical Stability Has Been Demonstrated for 24 Hours at a Temperature Up to 25°C Before Administration. From a Microbiological Point of View, the Product Should be Used Immediately. If Not Used Immediately, the Responsibility for the Storage Conditions and Duration Lies with the Healthcare Professional. The Storage Time Should Not Exceed 24 Hours at a Temperature of 2°C to 8°C, Provided That Reconstitution and Dilution Are Carried Out Under Controlled, Validated Aseptic Conditions.

Do Not Use this Medicinal Product if the Vial is Visibly Damaged.

Medicinal Products Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicinal Products No Longer Required. This Will Help Protect the Environment.

6. Contents of the Package and Other Information

What Caspofungin Fresenius Kabi Contains

• The Active Substance is Caspofungin. Each Vial of Caspofungin Fresenius Kabi Contains 50 mg of Caspofungin (as Caspofungin Acetate). The Final Concentration of the Reconstituted Solution Will be 5.2 mg/ml.
• The Other Ingredients are Sucrose, Mannitol, Acetic Acid, Sodium Hydroxide (to Adjust the pH) (See Section 2 "Important Information Before Using Caspofungin Fresenius Kabi").

What Caspofungin Fresenius Kabi Looks Like and Contents of the Package

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

The Package 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 More 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 Powder for Concentrate for Solution for Infusion

Germany:

Caspofungin Fresenius Kabi 50 mg Powder for Concentrate for Solution for Infusion

France:

Caspofungine Fresenius Kabi 50 mg Powder for Solution for Infusion

Italy:

Caspofungin Fresenius Kabi

Ireland:

Caspofungin Fresenius Kabi 50 mg Powder for Concentrate for Solution for Infusion

Poland:

Caspofungin Fresenius Kabi

Spain:

Caspofungina Fresenius Kabi 50 mg Powder for Concentrate for Solution for Infusion

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

Information Intended for Healthcare Professionals Only:

Instructions for the Preparation 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 MEDICINAL PRODUCTS, as There is No Information on the Compatibility of Caspofungin Fresenius Kabi with Other Intravenously Administered Medicinal Products. The Solution for Infusion Should be Inspected for Particulate Matter and Discoloration.

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

INSTRUCTIONS FOR ADMINISTERING CASPOFUNGIN FRESenIUS KABI TO ADULT PATIENTS

Step 1: Reconstitution of the Vial Contents

To Reconstitute the Powder, Remove the Vial from the Refrigerator and Allow it to Reach Room Temperature. Then, Using Aseptic Technique, Add 10.5 ml of Water for Injections. The Final Concentration of the Reconstituted Solution Will be 5.2 mg/ml.

The White or Almost White, Compact, Freeze-Dried Powder Will Completely Dissolve. Gently Shake the Contents to Obtain a Clear Solution. The Reconstituted Solution Should be Inspected for Particulate Matter and Discoloration.

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

To Prepare the Final Solution for Infusion, the Following Solutions Can be Used: Sodium Chloride 9 mg/ml (0.9%) Solution for Injection or Ringer's Solution with Lactate for Injection. The Solution for Infusion Should be Prepared by Adding the Appropriate Volume of the Reconstituted Concentrate (as Shown in the Table Below) to an Intravenous Bag or Bottle Containing 250 ml of the Solution. The Daily Dose of 50 mg or 35 mg, if Appropriate, Can be Administered in a Reduced Infusion Volume of 100 ml.

PREPARATION OF THE INFUSION SOLUTION FOR ADULT PATIENTS

* To Reconstitute the Contents of Each Vial, 10.5 ml of Water for Injections Should be Used.

INSTRUCTIONS FOR ADMINISTERING CASPOFUNGIN FRESenIUS KABI TO CHILDREN AND ADOLESCENTS

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

Preparation of the Intravenous Infusion Containing a Dose of 70 mg/m² for Children and Adolescents

• 1. Determine the Actual Loading Dose for Children and Adolescents Based on the Body Surface Area (Calculated as Above) Using the Following Equation: BSA (m²) x 70 mg/m² = Loading Dose. The Maximum Loading Dose on Day 1 Should Not Exceed 70 mg, Regardless of the Calculated Dose for the Patient.
• 2. Remove the Vial from the Refrigerator and Allow it to Reach Room Temperature.
• 3. Using Aseptic Technique, Add 10.5 ml of Water for Injections. The Reconstituted Solution Can be Stored for Up to 24 Hours at a Temperature Up to 25°C. This Will Result in a Caspofungin Concentration of 5.2 mg/ml.
• 4. From the Vial, Withdraw the Volume of the Reconstituted Caspofungin Fresenius Kabi Equivalent to the Calculated Loading Dose (Step 1).

Using Aseptic Technique, 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%) Solution for 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 Solution for Injection or Ringer's Solution with Lactate, Without Exceeding a Final Concentration of 0.5 mg/ml. The Prepared Infusion Solution Should be Used Within 24 Hours if Stored at a Temperature Up to 25°C or Within 48 Hours if Stored in a Refrigerator at a Temperature of 2°C to 8°C.

Preparation of the Intravenous Infusion Containing a Dose of 50 mg/m² for Children and Adolescents

• 1. Determine the Actual Daily Maintenance Dose for Children and Adolescents Based on the Body Surface Area (Calculated as Above) Using the Following Equation: BSA (m²) x 50 mg/m² = Daily Maintenance Dose. The Daily Maintenance Dose Should Not Exceed 70 mg, Regardless of the Calculated Dose for the Patient.
• 2. Remove the Vial from the Refrigerator and Allow it to Reach Room Temperature.
• 3. Using Aseptic Technique, Add 10.5 ml of Water for Injections. The Reconstituted Solution Can be Stored for Up to 24 Hours at a Temperature Up to 25°C. This Will Result in a Caspofungin Concentration of 5.2 mg/ml.
• 4. From the Vial, Withdraw the Volume of the Reconstituted Caspofungin Fresenius Kabi Equivalent to the Calculated Daily Maintenance Dose (Step 1). Using Aseptic Technique, 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%) Solution for 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 Solution for Injection or Ringer's Solution with Lactate, Without Exceeding a Final Concentration of 0.5 mg/ml. The Prepared Infusion Solution Should be Used Within 24 Hours if Stored at a Temperature Up to 25°C or Within 48 Hours if Stored in a Refrigerator at a Temperature of 2°C to 8°C.

Notes on the Preparation of the Medicinal Product:

The White or Almost White, Compact, Freeze-Dried Powder Should Completely Dissolve. Gently Shake the Contents to Obtain a Clear Solution.

The Reconstituted Solution Should be Inspected for Particulate Matter and Discoloration Before Dilution and Before Administration. If the Solution is Cloudy or Contains Particulate Matter, Do Not Administer.