Caspofungin Viatris

PATIENT INFORMATION LEAFLET

Information leaflet for the user: Caspofungin Mylan, 50 mg, powder for concentrate for solution for infusion

Caspofungin Mylan

Caspofungin

Read all of this leaflet carefully before your patient or their child is given this medicine because it contains important information for them.

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

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

What Caspofungin Mylan is

Caspofungin Mylan is an antifungal medicine.

What Caspofungin Mylan is used for

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

• severe fungal infections of the tissues and organs (called “invasive candidiasis”). This is an infection caused by a fungus called Candida. People who are likely to get this type of infection include patients 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 (called “invasive aspergillosis”) when other antifungal medicines have not worked or have caused side effects. These infections are caused by a fungus called Aspergillus. People who are likely to get this type of infection include patients who are taking chemotherapy, have had an organ transplant, or have a weakened immune system.
• suspected fungal infection in people with fever and low white blood cell counts who have not responded to antibiotic treatment. People who are likely to get a fungal infection include patients who have just had an operation or have a weakened immune system.

How Caspofungin Mylan works

Caspofungin Mylan weakens the fungal cell and prevents it from growing normally. This stops the infection from spreading and allows the body's natural defenses to completely eliminate the infection.

2. What you need to know before Caspofungin Mylan is given

When not to use Caspofungin Mylan

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

If you are unsure, consult your doctor, pharmacist, or nurse before administering the medicine.

Warnings and precautions

Before Caspofungin Mylan is given, tell your doctor, pharmacist, or nurse:

• if your patient is allergic to any other medicines
• if your patient has ever had liver problems - they may need to be given a different dose
• if your patient is taking cyclosporin (a medicine used to prevent rejection of a transplanted organ or to suppress the immune system), as the doctor may need to monitor their blood tests during treatment
• if your patient has had any other medical problems in the past

If any of the above apply to your patient (or if you are not sure), tell their doctor, pharmacist, or nurse before Caspofungin Mylan is given. Caspofungin Mylan may cause severe skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Caspofungin Mylan with other medicines

Tell your doctor, pharmacist, or nurse about all the medicines your patient is taking, including those bought without a prescription, including herbal medicines. Caspofungin Mylan may affect the way other medicines work, and some other medicines may affect the way Caspofungin Mylan works.

• cyclosporin or tacrolimus (medicines used to prevent rejection of a transplanted organ or to suppress the immune system), as the doctor may need to monitor their blood tests during treatment
• some 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 apply to your patient (or if you are not sure), tell their doctor, pharmacist, or nurse before Caspofungin Mylan is given.

Pregnancy and breastfeeding

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

• No studies have been done on the use of Caspofungin Mylan in pregnant women. Caspofungin Mylan should only be used during pregnancy if the potential benefits to the mother outweigh the potential risks to the unborn baby.
• Women taking Caspofungin Mylan should not breastfeed.

Driving and using machines

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

Caspofungin Mylan contains sodium

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

3. How Caspofungin Mylan is given

Caspofungin Mylan will always be prepared and given by a healthcare professional.

Caspofungin Mylan will be given:

• once a day
• as a slow infusion into a vein (intravenous infusion)
• over about 1 hour

The length of treatment and the daily dose of Caspofungin Mylan will be decided by your doctor. They will monitor how well the medicine is working for your patient.

Children and adolescents

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

Overdose

If you think your patient has been given too much Caspofungin Mylan, tell their doctor or nurse immediately.

4. Possible side effects

Like all medicines, Caspofungin Mylan can cause side effects, although not everybody gets them.

If your patient experiences any of the following side effects, tell their doctor or nurse immediately, as they may need urgent medical attention:

• rash, itching, feeling of warmth, swelling of the face, lips, or throat, or difficulty breathing
• possible allergic 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 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 medicines, some side effects can be serious. Ask your doctor for more information.

Other side effects in adults include:

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 levels in the blood, low potassium levels in the blood
• headache
• vein inflammation
• shortness of breath
• diarrhea, nausea, or vomiting
• changes in some blood test results (including increased liver enzyme levels)
• 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 some blood test results (including blood clotting, platelet count, red blood cell count, and white blood cell count)
• loss of appetite, increased fluid in the body, imbalance of electrolytes 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
• confusion, feeling agitated, insomnia
• dizziness, numbness or tingling (especially of the skin), tremors, drowsiness, change in taste, feeling of numbness or tingling
• blurred vision, increased tear production, swelling of the eyelids, yellowing of the whites of the eyes (jaundice)
• 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 a vein, extremely sensitive to touch
• wheezing, cough, rapid breathing, shortness of breath that wakes you up from sleep, low oxygen levels 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, indigestion, gas, stomach upset, swelling of the abdomen due to fluid accumulation
• decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes (jaundice), chemical or drug-induced liver damage, liver problems
• abnormal skin changes, generalized itching, hives, skin rash, abnormal skin appearance, 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), vein inflammation at the injection site
• increased blood pressure and changes in some blood test results (including kidney function, electrolytes, and blood clotting), increased levels of immunosuppressive medicines
• feeling of discomfort in the chest, chest pain, feeling of changed body temperature, 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
• rapid heartbeat
• flushing, 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 side effects

If your patient experiences any side effects, tell their doctor, pharmacist, or nurse. Side effects can be reported to:

Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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.

5. How to store Caspofungin Mylan

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 (the first two digits indicate the month; the next four digits indicate the year). The expiry date refers to the last day of that 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 healthcare professionals who have read the instructions (see below: “Instructions for the reconstitution and dilution of Caspofungin Mylan”).

If not used immediately, the solution may be stored for up to 24 hours at a temperature not above 25°C or for up to 48 hours in a refrigerator (at 2°C to 8°C) in an infusion bag (bottle) after dilution with sodium chloride injection or Ringer’s lactate injection.

Do not use the solution if it is cloudy or contains particles.

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 Mylan contains

• The active substance is caspofungin. Each vial of Caspofungin Mylan contains 50 mg of caspofungin as caspofungin acetate.
• The other ingredients are sucrose, mannitol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and carbon dioxide (for pH adjustment).

What Caspofungin Mylan looks like and contents of the pack

Caspofungin Mylan is a white or almost white powder. The solution is clear.

Caspofungin Mylan is available in 10 mL vials of glass (type I), closed with a bromobutyl rubber stopper and an aluminum flip-off seal with a red 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

Date of last revision of the leaflet

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Information for healthcare professionals only:

Instructions for the reconstitution and dilution of Caspofungin Mylan:

Reconstitution of Caspofungin Mylan

DO NOT USE ANY GLUCOSE CONTAINING SOLUTIONS, as Caspofungin Mylan is not stable in glucose-containing solutions. DO NOT MIX OR ADMINISTER WITH OTHER MEDICINES, as there are no data available on the co-administration of Caspofungin Mylan with other intravenous medicinal products or diluents.

The reconstituted solution should be clear. The infusion solution should be inspected for particulate matter and discoloration prior to administration.

INSTRUCTIONS FOR ADMINISTERING CASPOFUNGIN MYLAN TO ADULT PATIENTS

Step 1 Reconstitution of the vial contents

To reconstitute the powder, remove the vial from the refrigerator and let it reach room temperature. Then, using aseptic technique, add 10.5 mL of water for injection to the vial. The final concentration will be 5.2 mg/mL.

The white or almost white, compact, lyophilized powder should dissolve completely. Gently mix the contents until a clear solution is obtained.

Step 2 Addition of 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 or Ringer’s lactate injection. The infusion solution should be prepared by adding the appropriate volume of the reconstituted Caspofungin Mylan (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 ADULTS

* To reconstitute the contents of each vial, 10.5 mL of water for injection should be used.

INSTRUCTIONS FOR ADMINISTERING CASPOFUNGIN MYLAN TO CHILDREN AND ADOLESCENTS

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

Preparation of the infusion solution containing a dose of 70 mg/m² for children and adolescents over 3 months of age (using a 50 mg vial of Caspofungin Mylan)

• 1. Determine the actual loading dose to be given to children and adolescents based on their 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 individual patient.
• 2. Remove the vial from the refrigerator and let it reach room temperature.
• 3. Using aseptic technique, add 10.5 mL of water for injection to the vial. The reconstituted solution can be stored for up to 24 hours at a temperature not above 25°C. The final concentration will be 5.2 mg/mL.

• 4. Withdraw the volume of reconstituted Caspofungin Mylan (Step 1) equal to the calculated loading dose (based on the patient’s BSA) from the vial. Using aseptic technique, add this volume (mL) of reconstituted Caspofungin Mylan to an intravenous bag or bottle containing 250 mL of sodium chloride injection or Ringer’s lactate injection. Alternatively, the calculated volume (mL) of reconstituted Caspofungin Mylan can be added to a smaller volume of sodium chloride injection or Ringer’s lactate injection, not 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 above 25°C or within 48 hours if stored in a refrigerator at 2°C to 8°C.

Preparation of the infusion solution containing a dose of 50 mg/m² for children and adolescents over 3 months of age (using a 50 mg vial of Caspofungin Mylan)

• 1. Determine the actual daily maintenance dose to be given to children and adolescents based on their 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 individual patient.
• 2. Remove the vial from the refrigerator and let it reach room temperature.
• 3. Using aseptic technique, add 10.5 mL of water for injection to the vial. The reconstituted solution can be stored for up to 24 hours at a temperature not above 25°C. The final concentration will be 5.2 mg/mL.
• 4. Withdraw the volume of reconstituted Caspofungin Mylan (Step 1) equal to the calculated daily maintenance dose (based on the patient’s BSA) from the vial. Using aseptic technique, add this volume (mL) of reconstituted Caspofungin Mylan to an intravenous bag or bottle containing 250 mL of sodium chloride injection or Ringer’s lactate injection. Alternatively, the calculated volume (mL) of reconstituted Caspofungin Mylan can be added to a smaller volume of sodium chloride injection or Ringer’s lactate injection, not 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 above 25°C or within 48 hours if stored in a refrigerator at 2°C to 8°C.

Notes on preparation:

aThe compact, white or almost white powder should dissolve completely. Gently mix the contents until a clear solution is obtained.

bThe reconstituted solution should be inspected for particulate matter and discoloration prior to administration and during infusion. If the solution is cloudy or contains particles, do not administer.

cCaspofungin Mylan is formulated to provide the full dose of 50 mg, as stated on the vial label, when 10 mL of the reconstituted solution is withdrawn from the vial.