Label: information for the user

Caspofungin SUN 50 mg powder for concentrate for solution for infusion EFG

Caspofungin

Read this label carefully before you or your child start using this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

5Storage of Caspofungin SUN

6.Contents of the package and additional information

What is Caspofungina SUNSUN

Caspofungina SUN contains a medication called caspofungina. This belongs to a group of medications known as antifungals.

What is Caspofungina SUN used for

Caspofungina powder for concentrate for solution for infusion is used to treat the following fungal infections in children, adolescents, and adults:

•severe fungal infections in tissues or organs (designated as “invasive candidiasis”). This infection is caused by fungal cells (yeast) called Candida. Individuals who may be susceptible to this type of infection include those who have recently undergone surgery or those with a weakened immune system. Fever and chills that do not respond to antibiotic treatment are the most common symptoms of this type of infection.

•fungal infections in the nose, nasal sinuses, or lungs (designated as “invasive aspergillosis”) if other antifungal treatments have not worked or have caused adverse effects. This infection is caused by molds called Aspergillus.

Individuals who may be susceptible to this type of infection include those undergoing chemotherapy, those who have undergone a transplant, and those with a weakened immune system.

•presumed fungal infections if you have fever and a low white blood cell count, which have not improved with antibiotic treatment. Individuals who are at risk of developing a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

How Caspofungina SUN works

Caspofungina powder for concentrate for solution for infusion makes fungal cells fragile and prevents the fungus from growing properly. This prevents the infection from spreading and gives the body's natural defenses the opportunity to completely eliminate the infection.

No use Caspofungina SUN

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

If you are unsure, consult your doctor, pharmacist, or nurse before starting to use your medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Caspofunginapowder for concentrate for solution for infusionif:

• you are allergic to any other medication.
• you have ever had liver problems; you may need a different dose of this medication.
• you are already taking ciclosporin (used to prevent organ transplant rejection or to suppress your immune system), as your doctor may need to perform additional blood tests during treatment.
• you have ever had any other medical condition.

If any of the above points apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before starting to use Caspofunginapowder for concentrate for solution for infusion.

Caspofungina may also cause severe skin reactions, such as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET).

Use of Caspofungina SUN with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription, including herbal remedies.

This is because Caspofunginapowder for concentrate for solution for infusionmay affect how other medications work. Other medications may also affect how Caspofunginapowder for concentrate for solution for infusionworks.

Inform your doctor, pharmacist, or nurse if you are taking any of the following medications:

• ciclosporin or tacrolimus (used to prevent organ transplant rejection or to suppress your immune system), as your doctor may need to perform additional blood tests during treatment.
• some HIV medications such as efavirenz or nevirapina.
• phenytoin or carbamazepine (used to treat seizures).
• dexamethasone (a steroid).
• rifampicin (an antibiotic).

If any of the above points apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before starting to use Caspofunginapowder 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 medication.

• Caspofunginapowder for concentrate for solution for infusionhas not been studied in pregnant women. It should only be used during pregnancy if the potential benefits outweigh the possible risks to the developing fetus.
• Women using Caspofunginapowder for concentrate for solution for infusionshould not breastfeed.

Driving and operating machinery

There is no information to suggest that Caspofungina powder for concentrate for solution for infusion affects your ability to drive or operate machinery.

Caspofungina SUN contains sodium

This medication contains less than 1mmol of sodium (23mg) per vial; it is essentially “sodium-free”

Caspofungina powder for concentrate for infusion solution will always be prepared and administered by a healthcare professional. Caspofungina powder for concentrate for infusion solution will be administered to you:

• once a day.
• through slow injection into a vein (intravenous infusion).
• for about 1 hour.

Your doctor will determine the duration of treatment and the amount of Caspofungina to be administered each day. Your doctor will monitor if the effect of the medication 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 adult dose.

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

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

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• eruption, itching, sensation 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 an existing eruption: 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.
• eruption, skin peeling, mucous membrane lesions, rashes, large areas of skin peeling

As with any prescription medication, some side effects may be serious. Ask your doctor for more information.

Other side effects in adults include:

Frequent: may affect up to 1 in 10 people:

• Decreased hemoglobin (decrease in the substance that carries oxygen in the blood), decreased white blood cells.
• Decreased albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood.
• Headache.
• Vein inflammation.
• Lack of breath.
• Diarrhea, nausea, or vomiting.
• Changes in some laboratory blood tests (such as increased values for some liver function tests).
• Itching, eruption, redness of the skin, or excessive sweating.
• Joint pain.
• Chills, fever.
• Itching at the injection site.

Less frequent: may affect up to 1 in 100 people:

• Changes in some laboratory blood tests (including blood clotting disorders, platelets, red blood cells, and white blood cells).
• Loss of appetite, increased body fluid, electrolyte imbalance, high blood sugar levels, low calcium levels in the blood, low magnesium levels in the blood, high blood acidity levels.
• Disorientation, nervousness, inability to sleep.
• Sensation of dizziness, decreased sensations or sensitivity (especially in the skin), agitation, feeling of sleepiness, change in the way things taste, tingling or numbness.
• Blurred vision, increased tearing, swollen eyelid, yellow discoloration of the white part of the eyes.
• Sensation of rapid or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure.
• Rubor, hot flashes, high blood pressure, low blood pressure, redness along a vein that is very sensitive to the touch.
• Tension in the bands of muscle around the airways that leads to wheezing or cough, rapid breathing rate, lack of breath that wakes you up, low oxygen levels in the blood, abnormal respiratory sounds, crepitant sounds in the lungs, wheezing, nasal congestion, cough, sore throat.
• Abdominal pain, upper abdominal pain, swelling, constipation, difficulty swallowing, dry mouth, indigestion, gas passing, stomach discomfort, swelling due to fluid accumulation around the abdomen.
• Decreased bile flow, enlarged liver, yellow discoloration of the skin and/or white part of the eyes, liver damage caused by a drug or chemical compound, liver disorder.
• Abnormal skin tissue, generalized itching, rashes, varied eruption, abnormal skin, red patches, often with itching, on arms and legs and sometimes on the face and 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, eruption, rashes, fluid leakage from the catheter into the tissue), vein inflammation at the injection site.
• Increased blood pressure and alterations in some laboratory blood tests (such as kidney electrolyte tests and coagulation tests), increased levels of medications you are taking that weaken the immune system.
• Chest discomfort, chest pain, sensation of temperature change in the body, feeling generally unwell, general pain, facial swelling, ankle, hand, or foot swelling, swelling, pain on palpation, feeling of fatigue

Side effects in children and adolescents

Very frequent:may affect more than 1 in 10 people:

• Fever.

Frequent:may affect up to 1 in 10 people:

• Headache.
• Rapid heartbeat.
• Rubor, low blood pressure.
• Changes in some laboratory blood tests (increased values for some liver function tests).
• Itching, eruption.
• Pain at the catheter site.
• Chills.
• Changes in some laboratory blood tests.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

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

Chemical and physical stability has been demonstrated for up to 24 hours at a temperature equal to or less than 25ºC and at 5±3ºC when reconstituted with water for injectable preparations.

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

Chemical and physical stability has been demonstrated for the diluted solution for patient infusion for 48 hours between 2 and 8ºC and at room temperature (25ºC), when diluted with sodium chloride solution 9 mg/ml (0.9%), 4.5 mg/ml (0.45%) or 2.25 mg/ml (0.225%) for infusion or Ringer 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 medication (see later "Instructions to reconstitute and dilute Caspofungin SUN").

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Caspofungin SUN

?The active ingredient is caspofungin.

Each vial of Caspofungin SUN contains 50 mg of caspofungin (as acetate).

Tras reconstitución en 10,5 ml de agua para preparaciones inyectables, 1 ml de concentrado contiene 5,2 mgde caspofungina.

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

Aspect of the product and content of the package

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

Cada envase contiene un vial of powder (10 ml).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible for manufacturing:

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

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

This medication is authorized in the following Member States of the EEA with the following names:

DK/H/2569/001-002/DC

DenmarkCaspofungin SUN 50 mg powder for concentrate for solution for infusion, opløsning
Caspofungin SUN 70 mg powder for concentrate for solution for infusion, opløsning

SpainCaspofungin SUN 50 mg powder for concentrate for solution for infusion EFG

Caspofungin SUN 70 mg powder for concentrate for solution for infusion EFG

FranceCaspofungine SUN 50 mg, poudre pour solution à diluer pour perfusion
Caspofungine SUN 70mg, poudre pour solution à diluer pour perfusion

ItalyCaspofungin SUN

GermanyCaspofungin SUN 50 mg Powder for a concentrate for the preparation of an infusion solution

Caspofungin SUN 70 mg Powder for a concentrate for the preparation of an infusion solution

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

PolandCaspofungin Ranbaxy 50 mg, proszek do sporzadzania koncentratu do sporzadzania roztworu do infuzji

Caspofungin Ranbaxy 70 mg, proszek do sporzadzania koncentratu do sporzadzania roztworu do infuzji

RomaniaCaspofungina Terapia 50mg pulbere pentru concentrat pentru solutie perfuzabila

Caspofungina Terapia 70mg pulbere pentru concentrat pentru solutie perfuzabila

Date of the last review of this leaflet: January 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely 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 CONCURRENTLY WITH ANY OTHER MEDICAMENT, as there are no data on the compatibility of CASPOFUNGINA SUN with other substances, additives or intravenous pharmaceutical specialties.

The infusion solution must be visually inspected for solid particles or a change in color.

Caspofungina SUN 50 mg powder for concentrate for solution for infusion

Instructions for use in adult patients

Paso 1 Reconstitution of the vials

To reconstitute the powder, bring the vial to room temperature and add asetically 10.5 ml of water for injection. The concentration of the reconstituted vials will be 5.2 mg/ml.

The lyophilized powder of white to off-white color will dissolve completely. Gently mix until a transparent solution is obtained. The reconstituted solutions must be visually inspected for solid particles or a change in color. The reconstituted solution can be stored for a maximum of 24 hours at a temperature equal to or below 25 °C or at 5 ± 3ºC.

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

The diluents for the final infusion solution are: sodium chloride injection or Ringer lactate solution. The infusion solution is prepared by adding asetically the appropriate amount of the 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 in case medically necessary, for daily doses of 50 mg or 35 mg.

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

PREPARATION OF THE INFUSION SOLUTION IN ADULTS

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

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

CALCULATION OF BODY SURFACE AREA (BSA) FOR PEDIATRIC DOSING

Before preparing the infusion, calculatethe 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 SOLUTION FOR PEDIATRIC PATIENTS >3 MONTHS (USING A 50 MG VIAL)UTILIZING A VIAL OF 50 MG)

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

SC (m2) X 70 mg/m2 = loading dose

The maximum loading dose on day 1 must not exceed 70 mg regardless of the dose calculated for the patient.

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

3. Asetically, add 10.5 ml of water for injection.aThis reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25 °C or at 5 ± 3ºC.b

This will result in a final concentration of caspofungin in the vial of 5.2 mg/ml.

4. Extract from the vial a volume of medication equal to the calculated loading dose (Step 1).

Transfer asetically this volume (ml)cof Caspofungina SUN reconstituted to an IV bag or bottle that contains 250 ml of sodium chloride injection or Ringer lactate solution. Alternatively, the volume (ml)cof Caspofungina SUN reconstituted can be added to a reduced volume of sodium chloride injection or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8 °C or at room temperature (25ºC).

PREPARATION OF THE 50 MG/M2 INFUSION SOLUTION FOR PEDIATRIC PATIENTS >3 MONTHS (USING A 50 MG VIAL)

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

SC (m2) X 50 mg/m2 = daily maintenance dose

The daily maintenance dose must not exceed 70 mg regardless of the dose calculated for the patient.

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

3. Asetically, add 10.5 ml of water for injection.aThis reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25 °C or at 5 ± 3ºC.b

This will result in a final concentration of caspofungin in the vial of 5.2 mg/ml.

4. Extract from the vial a volume of medication equal to the calculated daily maintenance dose.

Transfer asetically this volume (ml)cof Caspofungina SUN reconstituted to an IV bag or bottle that contains 250 ml of sodium chloride injection or Ringer lactate solution. Alternatively, the volume (ml)cof Caspofungina SUN reconstituted can be added to a reduced volume of sodium chloride injection or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8 °C or at room temperature (25ºC).

NOTES FOR PREPARATION:

a.The white to off-white powder will dissolve completely. Gently mix until a transparent solution is obtained.

b.Visually inspect the reconstituted solution for solid particles or a change in color during reconstitution and before infusion. Do not use if the solution is turbid or has precipitated.

c.Caspofungina SUN is formulated to provide the full dose of the vial as indicated in the product information (50 mg) when 10 ml is extracted from the vial.