Caspofungin viatris

Package leaflet: Information for the user

Caspofungin Viatris, 70 mg, powder for solution for infusion concentrate
Caspofunginum
Please read all of this leaflet carefully before the medicine is given to the patient or their child, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor, nurse, or pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor, nurse, or pharmacist. See section 4.

Contents of the leaflet

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

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

What Caspofungin Viatris is
Caspofungin belongs to a group of medicines called antifungal agents.

What Caspofungin Viatris is used for
Caspofungin is used to treat the following fungal infections in children, adolescents, and adults:

• Severe fungal infections of tissues and organs (called "invasive candidiasis"). This infection is caused by fungi (yeasts) called Candida. Patients who may develop this type of infection include those 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 (called "invasive aspergillosis"), when other antifungal medicines have not worked or have caused side effects. These infections are caused by a mould called Aspergillus. Patients who may develop such infections include those receiving chemotherapy, organ transplant recipients, and those with 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. Patients at risk of developing fungal infection include those who have recently undergone surgery or have a weakened immune system.

How Caspofungin Viatris works
Caspofungin Viatris weakens fungal cells and inhibits their normal growth. This prevents the spread of infection and allows the body's natural defence mechanisms to completely eliminate it.

2. Important information before using Caspofungin Viatris

When not to use Caspofungin Viatris

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

If in doubt, consult a doctor, pharmacist, or nurse before administering the medicine.
Warnings and precautions
Before using Caspofungin Viatris, discuss 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 medicine may be required
• if the patient is taking cyclosporine (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 apply to the patient (or if the patient is unsure), consult a doctor, pharmacist, or nurse before using Caspofungin Viatris.
Caspofungin Viatris may cause serious skin reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Caspofungin Viatris and other medicines
Tell your doctor, nurse, or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines and herbal remedies, because Caspofungin Viatris may affect how other medicines work. Likewise, some other medicines may affect how Caspofungin Viatris works.
If the patient is taking any of the following medicines, inform the doctor, nurse, or pharmacist:

• cyclosporine 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 HIV medicines, such as efavirenz or nevirapine
• phenytoin or carbamazepine (used to treat seizures)
• dexamethasone (a steroid medicine)
• rifampicin (an antibiotic)

If any of the above apply to the patient (or if the patient is unsure), inform the doctor, nurse, or pharmacist before using Caspofungin Viatris.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, or if pregnancy is suspected, consult a doctor before using any medicine.

• Studies on the use of Caspofungin Viatris in pregnant women have not been conducted. Caspofungin Viatris should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.
• Women receiving Caspofungin Viatris should not breastfeed.

Driving and operating machinery
There is no information suggesting that Caspofungin Viatris may affect the ability to drive or operate machinery.
Caspofungin Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Caspofungin Viatris

Caspofungin Viatris will always be prepared and administered by trained medical personnel.
Caspofungin Viatris will be given:

• once daily
• by slow intravenous infusion (intravenous infusion)
• over approximately 1 hour

The duration of treatment and the daily dose of Caspofungin Viatris will be determined by the treating physician.
The physician will monitor the effectiveness of the medicine in the patient. A different dose may be required for patients with a body weight above 80 kg.
Children and adolescents
The dose intended for children and adolescents may differ from that used in adults.
Use of a higher than recommended dose of Caspofungin Viatris
The treating physician will decide what daily dose of Caspofungin Viatris the patient requires and how long treatment should last. However, if there is any concern that the patient may have received too high a dose of Caspofungin Viatris, immediate advice should be sought from the treating physician or nurse.
If you have any further doubts regarding the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following adverse reactions, you should
contact your doctor or nurse immediately, as immediate medical
assistance may be required:

• Rash, itching, feeling of warmth, swelling of the face, lips or throat, or difficulty breathing
  • possible occurrence of a histamine reaction to the medicine
• Difficulty breathing with wheezing or worsening rash – possible occurrence of an allergic reaction to the medicine
• Cough, severe breathing problems – in adult patients with invasive aspergillosis, severe breathing problems may occur, which may progress to respiratory failure
• Rash, skin peeling, mucosal ulcers, urticaria, extensive skin peeling.

As with all prescription medicines, some of these adverse reactions may be serious. You should consult your doctor for additional information.
Other adverse reactions observed in adults include:
Common: may affect up to 1 in 10 people:

• Decreased hemoglobin concentration (reduced concentration in blood of the substance transporting oxygen), decreased white blood cell count
• Decreased blood albumin concentration (a type of protein), decreased potassium concentration or low blood potassium levels
• Headache
• Phlebitis (inflammation of veins)
• Shortness of breath
• Diarrhea, nausea or vomiting
• Changes in results of certain blood laboratory tests (including increased values of certain liver function tests)
• Itching, rash, erythema, excessive sweating
• Joint pain
• Chills, fever
• Itching at the injection site

Uncommon: may affect up to 1 in 100 people:

• Changes in results of certain blood laboratory tests (including blood coagulation, platelet count, red blood cells and white blood cells)
• Loss of appetite, increased body fluids, electrolyte imbalance, high blood sugar, low blood calcium, increased blood calcium, low blood magnesium, increased blood acidity
• Disorientation, feeling of restlessness, inability to sleep
• Dizziness, reduced sensation or sensitivity (especially of the skin), tremor, drowsiness, altered taste, tingling or numbness sensations
• Blurred vision, increased tear production, eyelid swelling, yellowing of the sclera (whites of the eyes)
• Sensation of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
• Facial flushing, hot flushes, high blood pressure, low blood pressure, redness along the vein pathway, extreme sensitivity to touch
• Bronchospasm causing wheezing or cough, rapid breathing, shortness of breath waking from sleep, low oxygen levels in blood, abnormal breath sounds, crackles in lungs, wheezing, nasal congestion, cough, sore throat
• Abdominal pain, epigastric pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, flatulence, stomach discomfort, swelling due to fluid accumulation in the abdominal cavity
• Reduced bile flow, enlarged liver, yellowing of the skin and/or sclera (whites of the eyes), chemical or drug-induced liver injury, liver function disorders
• Abnormal skin changes, generalized itching, urticaria, polymorphic rash, abnormal skin appearance, presence of red, often itchy spots on hands and legs, sometimes on the face and other parts of the body
• Spinal pain, pain in arms or legs, bone pain, muscle pain, muscle weakness
• Impaired kidney function, sudden worsening of kidney function
• Pain at catheter site, injection site reactions (redness, hardening, pain, swelling, irritation, rash, urticaria, leakage of fluid from catheter into tissues), phlebitis at injection site
• Increased blood pressure and changes in results of certain blood laboratory tests (including tests assessing kidney function, electrolytes and blood coagulation), increased concentrations of immunosuppressive drugs
• Feeling of discomfort in the chest, chest pain, sensation of body temperature change, general malaise, generalized pain, facial swelling, ankle, hand or foot swelling, swelling, tenderness, feeling of fatigue

Adverse reactions 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 facial flushing, low blood pressure
• Changes in results of certain blood laboratory tests (increased values of certain liver function tests)
• Itching, rash
• Pain at cannula insertion site
• Chills
• Changes in results of certain blood laboratory tests

Reporting of adverse reactions
If any adverse effects occur, including any not listed
in this leaflet, you should inform your doctor, nurse or pharmacist. Adverse reactions
can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Caspofungin Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial (the first two digits indicate the month; the following four digits indicate the year). The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C to 8°C).
After preparation, Caspofungin Viatris should be used immediately, as it contains no preservatives to inhibit bacterial growth. The medicine must be prepared only by trained healthcare professionals who have read all instructions (see below, "Instructions for reconstitution and dilution of Caspofungin Viatris medicinal product").
If not used immediately, the solution may be used within 24 hours if stored at a temperature of 25°C or lower, or within 48 hours if stored in an infusion bag (bottle) in a refrigerator (2°C to 8°C), after dilution with sodium chloride injection solutions at concentrations of 9 mg/mL (0.9%), 4.5 mg/mL (0.45%), or 2.25 mg/mL (0.225%), or with lactated Ringer's solution. If the medicine is not used immediately, the user is responsible for storage time and conditions. The storage time should not exceed 24 hours at 2°C to 8°C, unless reconstitution and dilution were carried out under controlled, validated aseptic conditions.
Do not use the solution if any discoloration or visible particulate matter is observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Caspofungin Viatris contains

• The active substance is caspofungin. Each vial of Caspofungin Viatris contains 70 mg of caspofungin as caspofungin acetate.
• Other components are: sucrose, mannitol, hydrochloric acid concentrated (for pH adjustment), sodium hydroxide (for pH adjustment), and carbon dioxide (for pH adjustment).

What Caspofungin Viatris looks like and contents of the pack
Caspofungin Viatris is a sterile, white or off-white, hygroscopic powder. The solution after
reconstitution is clear.
Caspofungin Viatris is available in 10 mL vials made of colourless glass (Type I), closed with a
bromobutyl rubber stopper and an aluminium flip-off seal with an orange plastic flip-off cap,
packaged in a cardboard box.
Each pack contains one vial of powder.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer/Importer
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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400

Information intended exclusively for healthcare professionals:
Instructions for reconstitution and dilution of the medicinal product Caspofungin Viatris:

Reconstitution of the medicinal product Caspofungin Viatris
DO NOT USE ANY SOLUTIONS CONTAINING GLUCOSE, as the medicinal product Caspofungin Viatris is not stable in solutions containing glucose. DO NOT MIX OR ADMINISTER IN THE SAME INFUSION WITH OTHER MEDICINAL PRODUCTS, as there are no data regarding concomitant administration of Caspofungin Viatris with other intravenous active substances, excipients, or medicinal products.
The prepared solution should be clear. The infusion solution should be inspected visually for particulate matter and discoloration.

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Dissolving the vial contents
To dissolve the powder, allow the sealed vial to reach room temperature, then aseptically add 10.5 mL of Water for Injections. The concentration of the resulting concentrate will be 7.2 mg/mL.
Gently swirl the vial to dissolve the white or almost white, hygroscopic, lyophilized powder into a clear solution. The solution should be inspected visually for particulate matter and discoloration. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C.

Step 2 Adding the dissolved medicinal product Caspofungin Viatris to the patient's infusion solution
The following solutions may be used to prepare the final infusion solution: Sodium Chloride Injection or Ringer's Lactate Solution. The infusion solution should be prepared by aseptically adding the appropriate volume of the prepared concentrate (as shown in the table below) to a 250 mL infusion bag or bottle. A daily dose of 50 mg or 35 mg, if indicated, may be administered in a reduced infusion volume of 100 mL. Do not use the solution if cloudiness or precipitation occurs.

PREPARATION OF INFUSION SOLUTION FOR ADULTS

* To dissolve the contents of each vial, use 10.5 mL of diluent.
** If a 70 mg vial is not available, a 70 mg dose can be obtained from two vials of 50 mg each.
INSTRUCTIONS FOR USE IN CHILDREN AND ADOLESCENTS
Calculation of body surface area (BSA) for dose determination in children and adolescents
Before preparing the infusion, calculate the patient's body surface area using the following formula (Mosteller formula):

Preparation of intravenous infusion containing a dose of 70 mg/m² for children and adolescents aged >3 months (using a vial containing 70 mg of medicinal product)

1. Determine the actual loading dose for children and adolescents based on body surface area (calculated as described above) using the following equation: BSA (m²) × 70 mg/m² = loading dose. The maximum loading dose administered on day 1 of therapy should not exceed 70 mg, regardless of the calculated dose for the individual patient.
2. Remove the Caspofungin Viatris 70 mg medicinal product vial from the refrigerator and allow it to warm to room temperature.
3. Under aseptic conditions, add 10.5 mL of water for injection. The prepared solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This results in a final concentration of caspofungin of 7.2 mg/mL in the vial.
4. Withdraw from the vial the volume of medicinal product corresponding to the calculated loading dose (step 1). Under aseptic conditions, transfer this volume (mL) of diluted Caspofungin Viatris 70 mg medicinal product into an intravenous infusion bag (or bottle) containing 250 mL of 0.9%, 0.45%, or 0.225% sodium chloride injection or lactated Ringer's injection. Alternatively, the specified volume (mL) of diluted Caspofungin Viatris 70 mg medicinal product may be added to a smaller volume of 0.9%, 0.45%, or 0.225% sodium chloride injection or lactated Ringer's injection, provided that the final concentration does not exceed 0.5 mg/mL. The ready-to-use infusion solution should be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if stored refrigerated at 2°C to 8°C.

Preparation of intravenous infusion containing a dose of 50 mg/m² for children and adolescents aged >3 months (using a vial containing 70 mg of medicinal product)

1. Determine the actual daily maintenance dose for children and adolescents based on body surface area (calculated as described above) using the following equation: BSA (m²) × 50 mg/m² = daily maintenance dose. The daily maintenance dose should not exceed 70 mg, regardless of the calculated dose for the individual patient.
2. Remove the Caspofungin Viatris 70 mg medicinal product vial from the refrigerator and allow it to warm to room temperature.
3. Under aseptic conditions, add 10.5 mL of water for injection. The prepared solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This results in a final concentration of caspofungin of 7.2 mg/mL in the vial.
4. Withdraw from the vial the volume of medicinal product corresponding to the calculated daily maintenance dose (step 1). Under aseptic conditions, transfer this volume (mL) of diluted Caspofungin Viatris 70 mg medicinal product into an intravenous infusion bag (or bottle) containing 250 mL of 0.9%, 0.45%, or 0.225% sodium chloride injection or lactated Ringer's injection. Alternatively, the specified volume (mL) of diluted Caspofungin Viatris 70 mg medicinal product may be added to a smaller volume of 0.9%, 0.45%, or 0.225% sodium chloride injection or lactated Ringer's injection, provided that the final concentration does not exceed 0.5 mg/mL. The ready-to-use infusion solution should be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if stored refrigerated at 2°C to 8°C.

Notes on preparation of the medicinal product:
a The white or almost white compact substance should dissolve completely. Gently mix the contents until a clear solution is obtained.
b The prepared solution should be inspected visually for particulate matter and discoloration prior to administration. If the solution is cloudy or contains precipitate, it should not be administered.
c The Caspofungin Viatris medicinal product is formulated so that the full dose stated on the vial label (70 mg) can be recovered by withdrawing 10 mL of solution from the vial.