CASPOFUNGINA SUN 70 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before starting to use Caspofungin SUN

Do not use Caspofungin SUN

? if you are allergic to caspofungin or any of the other components of this medicine (listed in section 6).

If you are not sure, consult your doctor, pharmacist, or nurse before starting to use your medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Caspofungin powder for concentrate for solution for infusion if:

? you are allergic to any other medicine

? you have ever had liver problems; you may need a different dose of this medicine

? you are already taking cyclosporin (which is used to prevent organ transplant rejection or to cause suppression of your immune system), as your doctor will likely need to perform additional blood tests during treatment

? you have ever had any other medical problem.

If any of the above points apply to you (or you are not sure), consult your doctor, pharmacist, or nurse before starting to use Caspofungin powder for concentrate for solution for infusion.

Caspofungin may also cause severe skin reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Using Caspofungin SUN with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicine. This includes medicines obtained without a prescription, including herbal remedies. This is because Caspofungin powder for concentrate for solution for infusion may affect how other medicines work. Other medicines may also affect how Caspofungin powder for concentrate for solution for infusion works.

Tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:

? cyclosporin or tacrolimus (which are used to prevent organ transplant rejection or to cause suppression of your immune system), as your doctor will likely need to perform additional blood tests during treatment

? some anti-HIV medicines such as efavirenz or nevirapine

? phenytoin or carbamazepine (which are used to treat seizures)

? dexamethasone (a steroid)

? rifampicin (an antibiotic).

If any of the above points apply to you (or you are not sure), consult your doctor, pharmacist, or nurse before starting to use Caspofungin powder for concentrate for solution for infusion.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.

? Caspofungin powder for concentrate for solution for infusion has not been studied in pregnant women. It should only be used in pregnancy if the potential benefit justifies the potential risks to the developing baby.

? Women using Caspofungin powder for concentrate for solution for infusion should not breastfeed.

Driving and using machines

There is no information to suggest that Caspofungin powder for concentrate for solution for infusion affects the ability to drive or use machines.

Caspofungin SUN contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free"

3. How to use Caspofungin SUN

Caspofungin powder for concentrate for solution for infusion will always be prepared and administered by a healthcare professional. You will be given Caspofungin SUN:

? once a day

? by slow injection into a vein (intravenous infusion)

? for about 1 hour.

Your doctor will determine the duration of treatment and the amount of Caspofungin SUN to be administered each day. Your doctor will monitor whether the effect of the medicine is adequate. If you weigh more than 80 kg, you may need a different dose.

Children and adolescents

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

If you use more Caspofungin powder for concentrate for solution for infusion than you should

Your doctor will decide how much Caspofungin powder for concentrate for solution for infusion you need and for how long each day. If you are concerned that you may have been given too much Caspofungin powder for concentrate for solution for infusion, tell your doctor or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Tell your doctor or nurse immediately if you notice any of the following side effects, as you may need urgent medical treatment:

? rash, itching, feeling of heat, swelling of your face, lips, or throat, or difficulty breathing: you may be having a histamine reaction to the medicine.

? difficulty breathing with wheezing or worsening of a rash that already exists: you may be having an allergic reaction to the medicine.

? cough, severe breathing difficulties: if you are an adult and have invasive aspergillosis, you may experience a severe respiratory problem that could lead to respiratory failure.

? rash, skin peeling, blisters on the mucous membrane, hives, large areas of skin peeling.

As with any prescription medicine, 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:

? decrease in hemoglobin (decrease in the substance that carries oxygen in the blood), decrease in white blood cells

? decrease in albumin (a type of protein) in your blood, decrease in potassium or low potassium levels in the blood

? headache

? vein inflammation

? shortness of breath

? diarrhea, nausea, or vomiting

? changes in some laboratory blood tests (such as increased values of some liver tests)

? itching, rash, redness of the skin, or excessive sweating

? joint pain

? chills, fever

? itching at the injection site.

Uncommon: may affect up to 1 in 100 people:

? changes in some laboratory blood tests (including blood coagulation disorders, platelets, red blood cells, and white blood cells)

? loss of appetite, increase in body fluid, imbalance of body salts, high blood sugar, low calcium levels in the blood, high calcium levels in the blood, low magnesium levels in the blood, increase in the level of medicines you are taking that weaken the immune system

? disorientation, feeling nervous, inability to sleep

? feeling dizzy, decreased sensations or sensitivity (especially in the skin), agitation, feeling sleepy, change in the way things taste, tingling, or numbness

? blurred vision, increased tearing, swollen eyelid, yellowing of the white part of the eyes

? feeling of rapid or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure

? flushing, hot flashes, high blood pressure, low blood pressure, redness along a vein that is very sensitive to touch

? tension in the muscle bands around the airways, leading to wheezing or cough, rapid breathing rate, shortness of breath that wakes you up, lack of oxygen in the blood, abnormal breathing sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, sore throat

? abdominal pain, pain in the upper abdomen, abdominal swelling, constipation, difficulty swallowing, dry mouth, indigestion, gas, stomach upset, swelling due to fluid accumulation around the abdomen

? decrease in bile flow, increase in liver size, yellowing of the skin and/or the white part of the eyes, liver injury caused by a medicine or chemical, liver disorder

? abnormal skin tissue, generalized itching, hives, rash of varying appearance, abnormal skin, red spots, often with itching, on arms and legs and sometimes on the face and the rest of the body

? back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness

? loss of kidney function, sudden loss of kidney function

? pain at the catheter site, symptoms at the injection site (redness, hard lump, pain, swelling, irritation, rash, hives, fluid leakage from the catheter to the tissue), vein inflammation at the injection site

? increase in blood pressure and changes in some laboratory blood tests (such as kidney electrolyte tests and coagulation tests), increase in levels of medicines you are taking that weaken the immune system

? chest discomfort, chest pain, feeling of change in body temperature, feeling generally unwell, general pain, swelling of the face, swelling of the ankles, hands, or feet, swelling, pain on palpation, 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

? flushing, low blood pressure

? changes in some laboratory blood tests (increased values of some liver tests)

? itching, rash

? pain at the catheter site

? chills

? changes in some laboratory blood tests

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Caspofungin SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and vial after EXP. The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Chemical and physical stability in-use has been demonstrated for up to 24 hours at a temperature of 25°C or below and 5±3°C when reconstituted with water for injections.

This is because it does not contain any component to prevent the growth of bacteria. If not used immediately, the in-use storage times and conditions before use are the responsibility of the user.

Chemical and physical stability in-use of the diluted infusion solution to the patient has been demonstrated for up to 48 hours between 2 and 8°C and at room temperature (25°C), when diluted with sodium chloride 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%) solution for infusion or Ringer's lactate solution.

From a microbiological point of view, unless the opening/reconstitution/dilution method eliminates the risk of microbiological contamination, the product should be used immediately.

Only a trained healthcare professional who has read the complete instructions should prepare the medicine (see "Instructions for reconstituting and diluting Caspofungin SUN" below).

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. Container Content and Additional Information

Composition of Caspofungin SUN

The active ingredient is caspofungin.

Each vial of Caspofungin SUN contains 70 mg of caspofungin (as acetate).

After reconstitution in 10.5 ml of water for injectable preparations, 1 ml of concentrate contains 7.2 mg of caspofungin.

The other components are sucrose, mannitol, glacial acetic acid, and sodium hydroxide.

Appearance of the Product and Container Content

Caspofungin SUN is a sterile, white to off-white lyophilized powder.

Each container contains a 10-ml vial of powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer:

Pharmathen S.A.

Dervenakion str., Pallini, Attiki

153 51, Greece

Phamadox Healthcare Ltd

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

ELPEN Pharmaceutical CO., INC

Marathonos Ave. 95,

Pikermi Attiki

19009 Greece

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel: + 34 93 342 78 90

This medicinal product is authorized in the following EEA Member States with the following names:

DK/H/2569/001-002/DC

Denmark Caspofungin SUN 50 mg powder for concentrate for solution for infusion, solution Caspofungin SUN 70 mg powder for concentrate for solution for infusion, solution

Spain Caspofungin SUN 50 mg powder for concentrate for solution for perfusion EFG Caspofungin SUN 70 mg powder for concentrate for solution for perfusion EFG

France Caspofungine SUN 50 mg, powder for solution to be diluted for perfusion Caspofungine SUN 70 mg, powder for solution to be diluted for perfusion

Italy Caspofungin SUN

Germany Caspofungin SUN 50 mg powder for concentrate for solution for infusion Caspofungin SUN 70 mg powder for concentrate for solution for infusion

United Kingdom Caspofungin 50 mg powder for concentrate for solution for infusion Caspofungin 70 mg powder for concentrate for solution for infusion

Poland Caspofungin Ranbaxy 50 mg, powder for concentrate for solution for infusion Caspofungin Ranbaxy 70 mg, powder for concentrate for solution for infusion

Romania Caspofungina Terapia 50mg powder for concentrate for perfusion solution Caspofungina Terapia 70mg powder for concentrate for perfusion solution

Date of the last revision of this leaflet: January 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

____________________________________________________________________

This information is intended exclusively for healthcare professionals:

Instructions for reconstituting and diluting CASPOFUNGINA SUN:

Reconstitution of CASPOFUNGINA SUN

DO NOT USE DILUENTS CONTAINING GLUCOSE, as CASPOFUNGINA SUN is not stable in diluents containing glucose. DO NOT MIX OR INFUSE CASPOFUNGINA SUN WITH ANY OTHER MEDICINE, as there are no data available on the compatibility of CASPOFUNGINA SUN with other substances, additives, or intravenous pharmaceutical products.

The infusion solution should be inspected visually for particulate matter or color change.

Caspofungina SUN 70 mg powder for concentrate for solution for perfusion

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of the vials

To reconstitute the powder, bring the vial to room temperature and add aseptically 10.5 ml of water for injectable preparations. The concentration of the reconstituted vials will be 7.2 mg/ml.

The compact white to off-white lyophilized powder will dissolve completely. Mix gently until a clear solution is obtained. The reconstituted solutions should be inspected visually for particulate matter or color change. The reconstituted solution may be stored for up to 24 hours at a temperature of 25°C or below or at 5 ± 3°C.

Step 2 Addition of reconstituted Caspofungina SUN to the patient's infusion solution

The diluents for the final infusion solution are: sodium chloride injection solution or Ringer's lactate solution. The infusion solution is prepared by adding aseptically the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250-ml infusion bag or bottle. Reduced-volume infusions of 100 ml may be used, if medically necessary, for daily doses of 50 mg or 35 mg.

Do not use if the solution is cloudy or has precipitated.

PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

*10.5 ml should be used for the reconstitution of all vials

**If the 70-mg vial is not available, the 70-mg dose can be prepared from two 50-mg vials

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Calculation of body surface area (BSA) for pediatric dosing

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

___________________

BSA (m2) = √ Height (cm) x weight (kg)

3600

Preparation of the 70 mg/m2 infusion for pediatric patients >3 months (using a 70-mg vial)

1. Determine the actual loading dose to be used in the pediatric patient using the patient's BSA (as calculated above) and 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.

1. Wait for the refrigerated Caspofungina SUN vial to reach room temperature.

1. Add aseptically 10.5 ml of water for injectable preparations. This reconstituted solution can be stored for up to 24 hours at a temperature of 25°C or below or at 5 ± 3°C.

This will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.

1. Withdraw from the vial a volume of the medication equal to the calculated loading dose (Step 1). Transfer aseptically this volume (ml) of reconstituted Caspofungina SUN to an intravenous bag (or bottle) containing 250 ml of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution. Alternatively, the volume (ml) of reconstituted Caspofungina SUN can be added to a reduced volume of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution should be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Preparation of the 50 mg/m2 infusion for pediatric patients >3 months (using a 70-mg vial)

1. Determine the actual daily maintenance dose to be used in the pediatric patient using the patient's BSA (as calculated above) and 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.

1. Wait for the refrigerated Caspofungina SUN vial to reach room temperature.

1. Add aseptically 10.5 ml of water for injectable preparations. This reconstituted solution can be stored for up to 24 hours at a temperature of 25°C or below or at 5 ± 3°C.

This will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.

1. Withdraw from the vial a volume of the medication equal to the calculated daily maintenance dose (Step 1). Transfer aseptically this volume (ml) of reconstituted Caspofungina SUN to an intravenous bag (or bottle) containing 250 ml of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution. Alternatively, the volume (ml) of reconstituted Caspofungina SUN can be added to a reduced volume of sodium chloride injection solution 0.9%, 0.45%, or 0.225%, or Ringer's lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution should be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C)

Preparation Notes:

• The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained.

• Inspect the reconstituted solution visually for particulate matter or color change during reconstitution and before infusion. Do not use if the solution is cloudy or has precipitated.

• Caspofungina SUN is formulated to provide the full dose of the vial as stated in the package insert (70 mg) when 10 ml is withdrawn from the vial.