Caspofungin Sun 70 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Caspofungin SUN 70 mg powder for concentrate for

solution for infusion EFG

Caspofungin

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

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

Leaflet contents

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

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

What is Caspofungin SUN

Caspofungin SUN contains a medicine called caspofungin. It belongs to a group of medicines known as antifungals.

What Caspofungin SUN is used for

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

• Serious fungal infections in your tissues or organs (called "invasive candidiasis"). This infection is caused by fungal (yeast) cells called Candida. People who may develop this type of infection include those who have recently undergone surgery or those with weakened immune systems. Fever and chills that do not respond to antibiotic treatment are the most common symptoms of this type of infection.

• Fungal infections in your nose, sinuses, or lungs (called "invasive aspergillosis") when other antifungal treatments have not worked or have caused adverse effects. This infection is caused by molds called Aspergillus.

People who may develop this type of infection include those receiving chemotherapy, those who have undergone transplantation, and those with weakened immune systems.

• Suspected fungal infections when you have fever and a low white blood cell count that has not improved with antibiotic treatment. People at risk of developing a fungal infection include those who have recently undergone surgery or those with weakened immune systems.

How Caspofungin SUN works

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

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

Do not use Caspofungin SUN

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

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

Warnings and precautions

Talk to 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 cyclosporine (used to prevent organ transplant rejection or to suppress your immune system), as your doctor may need to carry out additional blood tests during treatment

• you have ever had any other medical problems.

If any of the above apply to you (or if 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 serious skin adverse reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Use of Caspofungin SUN with other medicines

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Caspofungin powder for concentrate for solution for infusion may affect how other medicines work. Likewise, other medicines may 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:

• cyclosporine or tacrolimus (used to prevent organ transplant rejection or to suppress your immune system), as your doctor may need to carry out additional blood tests during treatment

• certain anti-HIV medicines such as efavirenz or nevirapine

• phenytoin or carbamazepine (used to treat seizures)

• dexamethasone (a steroid)

• rifampicin (an antibiotic).

If any of the above apply to you (or if 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 during pregnancy if the potential benefit justifies the possible risks to the developing baby.

• Women receiving Caspofungin powder for concentrate for solution for infusion should not breastfeed.

Driving and using machines

There is no information suggesting that Caspofungin powder for concentrate for solution for infusion affects the ability to drive or operate machinery.

Caspofungin SUN contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., 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. Caspofungin SUN will be administered to you:

? once daily
? by slow injection into a vein (intravenous infusion)
? over approximately 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 appropriate. If you weigh more than 80 kg, you may require a different dose.

Children and adolescents

The dose for children and adolescents may differ from that 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, inform your doctor or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor or nurse immediately if you notice any of the following adverse effects, as you may require urgent medical treatment:

? Rash, itching, feeling of warmth, swelling of your face, lips or throat, or breathing difficulties: you may be experiencing a histamine-type reaction to the medicine.

? Difficulty breathing with wheezing or worsening of an existing rash: 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 serious respiratory problem that could lead to respiratory failure.

? Rash, skin peeling, sores in the mucous membranes, hives, large areas of skin peeling.

As with any prescription medicine, some adverse effects may be serious. Ask your doctor for further information.

Other adverse effects in adults include

Common: may affect up to 1 in 10 people:

? Decrease in haemoglobin (reduction 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 blood potassium levels

? Headache

? Vein inflammation

? Shortness of breath

? Diarrhoea, nausea or vomiting

? Changes in certain laboratory blood tests (such as increased values in some liver function tests)

? Itching, rash, skin redness or excessive sweating

? Joint pain

? Chills, fever

? Itching at the injection site.

Uncommon: may affect up to 1 in 100 people:

? Changes in certain laboratory blood tests (including blood clotting disorders, platelets, red blood cells and white blood cells)

? Loss of appetite, increased body fluid, imbalance in body salts, high blood sugar levels, low blood calcium levels, high blood calcium levels, low blood magnesium levels, increased levels of acid in the blood

? Disorientation, feeling nervous, inability to sleep

? Dizziness, reduced sensation or sensitivity (especially in the skin), restlessness, drowsiness, altered taste perception, tingling or numbness

? Blurred vision, increased tearing, swollen eyelid, yellowing of the whites of the eyes

? Sensation of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure

? Flushing, hot flushes, high blood pressure, low blood pressure, redness along a vein that is particularly sensitive to touch

? Muscle tightness around the airways, leading to wheezing or coughing, rapid breathing, breathlessness waking you up, low oxygen levels in the blood, abnormal breathing sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, sore throat

? Abdominal pain, upper abdominal pain, abdominal swelling, constipation, difficulty swallowing, dry mouth, indigestion, flatulence, gastric discomfort, swelling due to fluid accumulation around the abdomen

? Decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a medicine or chemical compound, 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 rest of the body

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

? Decreased kidney function, sudden loss of kidney function

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

? Increased blood pressure and changes in certain laboratory blood tests (such as kidney electrolyte tests and coagulation tests), increased levels of medicines you are taking that suppress the immune system.

? Chest discomfort, chest pain, sensation of body temperature change, general malaise, general pain, facial swelling, swelling of ankles, hands or feet, swelling, tenderness on palpation, feeling tired.

Adverse 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

? Fast heartbeat

? Flushing, low blood pressure

? Changes in certain laboratory blood tests (increased values in some liver function tests)

? Itching, rash

? Pain at the catheter site

? Chills

? Changes in certain laboratory blood tests

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the carton and vial after EXP. The expiry date is the last day of the month indicated.

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

Chemical and physical in-use stability has been demonstrated for up to 24 hours at temperatures not exceeding 25°C and at 5±3°C when reconstituted with water for injections.

This is because it contains no component to prevent bacterial growth. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user.

In-use chemical and physical stability of the diluted solution for infusion has been demonstrated for 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%) for infusion or Ringer's lactate solution.

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

The medicine should only be prepared by a trained healthcare professional who has read the complete instructions (see below “Instructions for reconstituting and diluting Caspofungin SUN”).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Caspofungin SUN

• The active substance is caspofungin.

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

After reconstitution with 10.5 ml of water for injections, 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 contents of the pack

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

Each pack contains one vial of powder (10 ml).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The 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 under the following names:

DK/H/2569/001-002/DC

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

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

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

Italy Caspofungin SUN

Germany Caspofungin SUN 50 mg powder for a concentrate for solution for infusion
Caspofungin SUN 70 mg powder for a 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, proszek do sporzadzania koncentratu do sporzadzania roztworu do infuzji
Caspofungin Ranbaxy 70 mg, proszek do sporzadzania koncentratu do sporzadzania roztworu do infuzji

Romania Caspofungina Terapia 50 mg pulbere pentru concentrat pentru solutie perfuzabila
Caspofungina Terapia 70 mg pulbere pentru concentrat pentru solutie perfuzabila

Date of the most recent review of this summary: January 2023

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

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This information is intended for healthcare professionals only:

Instructions for reconstitution and dilution of CASPOFUNGIN SUN:

Reconstitution of CASPOFUNGIN SUN

DO NOT USE DILUENTS CONTAINING GLUCOSE, as CASPOFUNGIN SUN is not stable in diluents containing glucose. DO NOT MIX OR CO-ADMINISTER CASPOFUNGIN SUN WITH ANY OTHER MEDICATION, as compatibility data with other substances, additives, or intravenous pharmaceutical products are not available.

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

Caspofungin SUN 70 mg powder for concentrate for infusion solution

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of vials

To reconstitute the powder, allow the vial to reach room temperature and aseptically add 10.5 ml of water for injections. The concentration of the reconstituted vial will be 7.2 mg/ml.

The compact, white to off-white lyophilized powder will dissolve completely. Gently mix until a clear solution is obtained. Reconstituted solutions should be inspected visually for particulate matter or discoloration. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25 °C or at 5 ± 3 °C.

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

Suitable diluents for the final infusion solution are: sodium chloride solution for injection or Ringer's lactate solution. The infusion solution is prepared by aseptically adding 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, when medically necessary, for daily doses of 50 mg or 35 mg.

Do not use if the solution is cloudy or precipitate is present.

PREPARATION OF INFUSION SOLUTION IN ADULTS

DOSE*	Volume of reconstituted Caspofungin SUN to transfer to an intravenous bag or vial	Standard preparation (Reconstituted Caspofungin SUN added to 250 ml) final concentration	Reduced volume infusion (Reconstituted Caspofungin SUN added to 100 ml) final concentration
70 mg	10 ml	0.28 mg/ml	Not recommended
70 mg (from two 50 mg vials)**	14 ml	0.28 mg/ml	Not recommended
35 mg for moderate hepatic impairment (from one 70 mg vial)	5 ml	0.14 mg/ml	0.34 mg/ml

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

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

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for Pediatric Dosing

Prior to preparing the infusion, calculate the patient's body surface area (BSA) using the following formula: (Mosteller Formula)

___________________

BSA (m²) = √ Height (cm) × Weight (kg)
          3600

Preparation of 70 mg/m² Infusion for Pediatric Patients >3 Months (using a 70 mg vial)

1. Determine the actual loading dose to be administered to the pediatric patient using the patient’s BSA (as calculated above) and the following equation:
   BSA (m²) × 70 mg/m² = loading dose
   The maximum loading dose on Day 1 must not exceed 70 mg, regardless of the calculated dose for the patient.

2. Allow the refrigerated Caspofungin SUN vial to reach room temperature.

3. Aseptically add 10.5 ml of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25 °C or at 5 ± 3 °C.b
   This will result in a final caspofungin concentration of 7.2 mg/ml in the vial.

4. Withdraw from the vial a volume of medication equal to the calculated loading dose (Step 1). Aseptically transfer this volume (ml)c of reconstituted Caspofungin SUN into an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted Caspofungin SUN may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's solution, provided the final concentration does not exceed 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 (25 °C).

Preparation of 50 mg/m² Infusion for Pediatric Patients >3 Months (using a 70 mg vial)

1. Determine the actual daily maintenance dose to be administered to the pediatric patient using the patient’s BSA (as calculated above) and the following equation:
   BSA (m²) × 50 mg/m² = daily maintenance dose
   The daily maintenance dose must not exceed 70 mg, regardless of the calculated dose for the patient.

2. Allow the refrigerated Caspofungin SUN vial to reach room temperature.

3. Aseptically add 10.5 ml of Water for Injections.a This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25 °C or at 5 ± 3 °C.b
   This will result in a final caspofungin concentration of 7.2 mg/ml in the vial.

4. Withdraw from the vial a volume of medication equal to the calculated daily maintenance dose (Step 1). Aseptically transfer this volume (ml)c of reconstituted Caspofungin SUN into an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted Caspofungin SUN may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's solution, provided the final concentration does not exceed 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 (25 °C).

Preparation Notes:

• The white to off-white lyophilized cake will completely dissolve. Gently mix until a clear solution is obtained.

• Visually inspect the reconstituted solution for the presence of particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or contains precipitates.

• Caspofungin SUN is formulated to deliver the full labeled vial dose (70 mg) when 10 ml are withdrawn from the vial.