Caspofungin Viatris

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Caspofungin Mylan, 70 mg, powder for concentrate for solution for infusion

Caspofungin

Read the contents of the leaflet carefully before using the medicine in a patient or their child, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Caspofungin Mylan and what is it used for
• 2. Important information before using Caspofungin Mylan
• 3. How to use Caspofungin Mylan
• 4. Possible side effects
• 5. How to store Caspofungin Mylan
• 6. Contents of the pack and other information

1. What is Caspofungin Mylan and what is it used for

What is Caspofungin Mylan

Caspofungin Mylan belongs to a group of medicines called antifungal medicines.

What is Caspofungin Mylan used for

Caspofungin is used to treat the following infections in children, adolescents, and adults:

• severe fungal infections of tissues and organs (called "invasive candidiasis"). This is an infection caused by fungi (yeast) called Candida. People who may develop this type of infection include patients who have recently had 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 (called "invasive aspergillosis"), if other antifungal medicines have not worked or have caused side effects. These infections are caused by a mold called Aspergillus. People who may develop this type of infection include patients undergoing chemotherapy, after organ transplantation, and with a weakened immune system.
• suspected fungal infection in people with fever and low white blood cell count, whose condition has not improved after antibiotic treatment. People who are at risk of developing a fungal infection include patients who have recently had surgery or have a weakened immune system.

How Caspofungin Mylan works

Caspofungin Mylan 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 Mylan

When not to use Caspofungin Mylan

• if the patient is allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).

In case of doubt before administering the medicine, consult a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting treatment with Caspofungin Mylan, discuss with your doctor, nurse, or pharmacist:

• if the patient is allergic to any medicines
• if the patient has ever had liver problems - a different dose of the medicine may be necessary
• if the patient is taking cyclosporin (a medicine used to prevent transplant rejection or to suppress the immune system), as the doctor may order additional blood tests during treatment
• if the patient has ever had any other medical problems

If any of the above statements apply to the patient (or the patient is unsure), before using Caspofungin Mylan, consult a doctor, pharmacist, or nurse.
Caspofungin Mylan may cause severe skin reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Caspofungin Mylan and other medicines

Tell your doctor, nurse, or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription, including herbal medicines, as Caspofungin Mylan may affect the way other medicines work. Also, some other medicines may affect the way Caspofungin Mylan works.
If the patient is taking any of the following medicines, tell their doctor, nurse, or pharmacist:

• cyclosporin or tacrolimus (medicines used to prevent transplant rejection or to suppress the immune system, as the doctor may order additional blood tests during treatment
• certain medicines used to treat HIV, such as efavirenz or nevirapine
• phenytoin or carbamazepine (used to treat seizures)
• dexamethasone (a steroid medicine)
• rifampicin (an antibiotic).

If any of the above statements apply to the patient (or the patient is unsure), before using Caspofungin Mylan, tell their doctor, nurse, or pharmacist.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or is breastfeeding, they should consult their doctor before using any medicine.

• No studies have been conducted on the use of Caspofungin Mylan in pregnant women. During pregnancy, the medicine should only be used if the potential benefits of treatment outweigh the potential risk to the unborn child.
• Women taking Caspofungin Mylan should not breastfeed.

Driving and using machines

There is no information to suggest that Caspofungin Mylan may affect the ability to drive or use machines.

Caspofungin Mylan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to use Caspofungin Mylan

Caspofungin Mylan will always be prepared and administered by medical professionals.
Caspofungin Mylan will be administered:

• once a day
• as a slow intravenous infusion (intravenous infusion)
• over a period of about 1 hour

The duration of treatment and the daily dose of Caspofungin Mylan will be determined by the treating doctor. They will monitor the effectiveness of the medicine in the patient. In patients with a body weight over 80 kg, a different dose may be necessary.

Children and adolescents

The dose for children and adolescents may be different from the dose used in adults.

Using a higher dose of Caspofungin Mylan than recommended

The treating doctor will decide what daily dose of Caspofungin Mylan 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 Mylan, they should immediately consult their doctor or nurse.
If you have any further questions about using this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice 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 histamine reaction to the medicine
• difficulty breathing with wheezing or worsening rash - possible allergic reaction to the medicine
• cough, severe breathing difficulties - in adults with invasive aspergillosis, severe breathing difficulties may occur, which can 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 medicines, some side effects may be serious. Consult your doctor for further information.
Other side effects that occur in adults include
Common: may affect up to 1 in 10 people:

• Decreased hemoglobin levels (decreased levels of the substance that carries oxygen in the blood), decreased white blood cell count

Decreased albumin levels (a type of protein) in the blood, decreased potassium levels or low potassium levels in the blood

• Headache
• Phlebitis
• Shortness of breath
• Diarrhea, nausea, or vomiting
• Changes in the results of some blood laboratory tests (including increased values of some liver tests)
• Itching, rash, redness, excessive sweating
• Joint pain
• Chills, fever
• Itching at the injection site

Uncommon: may affect up to 1 in 100 people:

• Changes in the results of some blood laboratory tests (including blood clotting, platelet count, red blood cell count, and white blood cell count)
• Loss of appetite, increased fluid levels, imbalance of salt levels in the body, high blood sugar levels, 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 agitation, 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 (sclera)
• Feeling of rapid or irregular heartbeat, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
• Flushing, hot flashes, high blood pressure, low blood pressure, redness of the skin along the vein, extremely sensitive to touch
• Constriction of the airways causing wheezing or cough, rapid breathing, shortness of breath that wakes you up from sleep, lack of oxygen in the blood, abnormal breathing sounds, crackling in the lungs, 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 (jaundice), chemical or drug-induced liver damage, liver function disorders
• Abnormal skin changes, generalized itching, hives, polymorphic rash, abnormal skin appearance, presence of red, often itchy patches 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 leakage from the catheter into the tissues), phlebitis at the injection site
• Increased blood pressure and changes in the results of some blood laboratory tests (including those evaluating kidney function, electrolytes, and blood clotting), increased levels of immunosuppressive medicines
• Feeling of discomfort in the chest, chest pain, feeling of changes in body temperature, general malaise, 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 common:may affect more than 1 in 10 people:

• Fever

Common:may affect up to 1 in 10 people:

• Headache
• Rapid heartbeat
• Sudden flushing, low blood pressure
• Changes in the results of some blood laboratory tests (increased values of some liver tests)
• Itching, rash
• Pain at the injection site
• Chills
• Changes in the results of some blood laboratory tests

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, nurse, or pharmacist. Side effects can be reported directly to:
Department of Post-Marketing Surveillance of Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Caspofungin Mylan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial (the first two digits indicate the month; the next four digits indicate the year). The expiry date refers to the last day of the month.
Store in a refrigerator (2°C to 8°C).
After preparation, use Caspofungin Mylan 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 Mylan").
If not used immediately, the solution may be used within 24 hours if stored at a temperature of 25°C or below or within 48 hours if stored in an infusion bag (bottle) in a refrigerator at a temperature of 2°C to 8°C, after dilution of the solution with sodium chloride injection solution at a concentration of 9 mg/mL (0.9%), 4.5 mg/mL (0.45%), or 2.25 mg/mL (0.225%) or Ringer's solution with lactate for injection. If not used immediately, the storage time and conditions are the responsibility of the user. The storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless reconstitution and dilution took place under controlled, validated aseptic conditions.
Do not use the solution if it is discolored or contains visible particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Caspofungin Mylan contains

• The active substance is caspofungin. Each vial of Caspofungin Mylan contains 70 mg of caspofungin as caspofungin acetate
• The other ingredients are: sucrose, mannitol, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), and carbon dioxide (to adjust pH)

What Caspofungin Mylan looks like and contents of the pack

Caspofungin Mylan is a sterile, white or almost white, compact powder. The solution after preparation is clear.
Caspofungin Mylan is available in 10 mL vials made of colorless glass (type I), closed with a stopper made of bromobutyl rubber and an aluminum flip-off cap with an orange, plastic flip-off cap, in a cardboard box.
Each pack contains one vial of powder.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer/Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Viatris Santé
1 rue de Turin
69007 Lyon
France
SAG Manufacturing, S.L.U.
Ctra. N-I, Km 36. San Agustín de Guadalix
28750, Madrid
Spain
Galenicum Health, S.L.U
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe
Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
Hikma Italia S.p.A.
Viale Certosa, 10
27100, Pavia (PV)
Italy
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Mylan Healthcare Sp. z o.o.
Phone: +48 22 54 66 400

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Instructions for reconstitution and dilution of Caspofungin Mylan:

Reconstitution of Caspofungin Mylan

DO NOT USE ANY SOLUTIONS CONTAINING GLUCOSE, as Caspofungin Mylan is not stable in solutions containing glucose. DO NOT MIX OR ADMINISTER IN THE SAME INFUSION WITH OTHER MEDICINES, as there are no data on the co-administration of Caspofungin Mylan with other intravenous substances, excipients, or other medicinal products.
The prepared solution is clear. The infusion solution should be inspected for particulate matter and discoloration.

INSTRUCTIONS FOR ADMINISTERING THE MEDICINE 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, in a sterile manner, add 10.5 mL of water for injection. The resulting concentration will be: 7.2 mg/mL.
The white or almost white, compact powder should dissolve completely. Gently mix the contents until a clear solution is obtained. The prepared solution can be stored for up to 24 hours at a temperature not exceeding 25°C.

Step 2 Addition of the reconstituted Caspofungin Mylan to the infusion solution for the patient

To prepare the final infusion solution, the following solutions can be used: sodium chloride injection solution or Ringer's solution with lactate for injection. The infusion solution should be prepared by adding the appropriate volume of the reconstituted concentrate (as shown in the table below) to an infusion bag or bottle containing 250 mL of the solution. The daily dose of 50 mg or 35 mg, if indicated, can be administered in a reduced volume of 100 mL. Do not use the solution if it is cloudy or contains particulate matter.

PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

* To reconstitute the contents of each vial, use 10.5 mL of water for injection.
** If a 70 mg vial is not available, a dose of 70 mg can be obtained from two vials of 50 mg.

INSTRUCTIONS FOR ADMINISTERING THE MEDICINE TO CHILDREN AND ADOLESCENTS

Calculating the body surface area (BSA) to determine the dose in children and adolescents

Before preparing the infusion, calculate the patient's body surface area using the following formula (Mosteller's formula):

Preparing an intravenous infusion containing a dose of 70 mg/m² for children and adolescents over 3 months of age (using a vial containing 70 mg of the medicinal product)

• 1. Determine the actual loading dose used in 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 administered on day 1 of therapy should not exceed 70 mg, regardless of the dose calculated for the individual patient.
• 2. Remove the Caspofungin Mylan vial from the refrigerator and allow it to reach room temperature.
• 3. In a sterile manner, add 10.5 mL of water for injection. The resulting concentration will be: 7.2 mg/mL. The white or almost white, compact powder should dissolve completely. Gently mix the contents until a clear solution is obtained. The prepared solution can be stored for up to 24 hours at a temperature not exceeding 25°C.
• 4. From the vial, withdraw the volume of the medicinal product equivalent to the calculated loading dose (step 1). In a sterile manner, add this volume (mL) of reconstituted Caspofungin Mylan to an infusion bag or bottle containing 250 mL of sodium chloride injection solution at a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection. Alternatively, the volume (mL) of reconstituted Caspofungin Mylan can be added to a smaller volume of sodium chloride injection solution at a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection, 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 not exceeding 25°C or within 48 hours if stored in a refrigerator at a temperature of 2°C to 8°C.

Preparing an intravenous infusion containing a dose of 50 mg/m² for children and adolescents over 3 months of age (using a vial containing 70 mg of the medicinal product)

• 1. Determine the actual daily maintenance dose used in 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 dose calculated for the individual patient.
• 2. Remove the Caspofungin Mylan vial from the refrigerator and allow it to reach room temperature.
• 3. In a sterile manner, add 10.5 mL of water for injection. The resulting concentration will be: 7.2 mg/mL. The white or almost white, compact powder should dissolve completely. Gently mix the contents until a clear solution is obtained. The prepared solution can be stored for up to 24 hours at a temperature not exceeding 25°C.
• 4. From the vial, withdraw the volume of the medicinal product equivalent to the calculated daily maintenance dose (step 1). In a sterile manner, add this volume (mL) of reconstituted Caspofungin Mylan to an infusion bag or bottle containing 250 mL of sodium chloride injection solution at a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection. Alternatively, the volume (mL) of reconstituted Caspofungin Mylan can be added to a smaller volume of sodium chloride injection solution at a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection, 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 not exceeding 25°C or within 48 hours if stored in a refrigerator at a temperature of 2°C to 8°C.

Notes on preparation:
aThe white or almost white, compact powder should dissolve completely. Gently mix the contents until a clear solution is obtained.
bThe prepared solution should be inspected for particulate matter or discoloration before administration. If the solution is cloudy or contains visible particles, do not administer it.
cCaspofungin Mylan is prepared to allow for the complete dose stated on the vial label (70 mg) to be withdrawn from the vial after reconstitution.