Caspofungin Stadafarma 50 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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 effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What is caspofungin

Caspofungin belongs to a group of medicines called antifungals.

What caspofungin is used for

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

• Serious fungal infections in 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 the 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 organ transplantation, and those with weakened immune systems.

• Presumed 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 works

Caspofungin weakens fungal cells 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 using Caspofungin Stadafarma

Do not use caspofungin

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

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using caspofungin if:

• you are allergic to any other medicine

• you have ever had liver problems; you may require 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 perform additional blood tests during treatment

• you have ever had any other medical condition.

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

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

Other medicines and Caspofungin Stadafarma

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 may affect how other medicines work. Likewise, other medicines may affect how caspofungin 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 perform 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 unsure), consult your doctor, pharmacist, or nurse before starting to use caspofungin.

Pregnancy and breastfeeding

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

• Caspofungin 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 must not breastfeed.

Driving and using machines

There is no information suggesting that caspofungin affects the ability to drive or operate machinery.

Caspofungin Stadafarma contains sodium

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

3. How to use Caspofungin Stadafarma

Caspofungin will always be prepared and administered by a healthcare professional. Caspofungin 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 to be administered each day. Your doctor will monitor whether the medicine's effect is adequate. 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 the adult dose.

If you use more Caspofungin Stadafarma than you should

Your doctor will decide how much caspofungin you need and for how long each day. If you are concerned that you may have received too much caspofungin, inform your doctor or nurse immediately.

In case of overdose or accidental ingestion, consult 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 will experience them.

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

• Rash, itching, feeling of warmth, swelling of the face, lips or throat, or breathing difficulties: you may be experiencing a histamine 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:

• Decreased hemoglobin (reduction 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.
• Inflammation of the vein.
• Shortness of breath.
• Diarrhea, nausea, or vomiting.
• Changes in certain laboratory blood tests (such as increased values in some liver function tests).
• Itching, rash, skin redness, or increased 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 magnesium levels in the blood, increased levels of acids in the blood.
• Disorientation, feeling nervous, inability to sleep.
• Dizziness, decreased sensations or sensitivity (especially in the skin), restlessness, drowsiness, altered taste, 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 very sensitive to touch.
• Tightness in the muscle bands around the airways leading to wheezing or coughing, rapid breathing rate, shortness of breath causing awakening, low oxygen levels in the blood, abnormal breathing sounds, crackling lung sounds, wheezing, nasal congestion, cough, sore throat.
• Abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, gas, 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 drug or chemical compound, liver disorder.
• Abnormal skin tissue, generalized itching, hives, rash with variable appearance, abnormal skin, red spots, often itchy, on arms and legs and sometimes on the face and other parts 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 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 medications 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 upon palpation, feeling of fatigue.

Other 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.
• Rapid 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Stadafarma

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 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 (between 2 °C and 8 °C).

Once caspofungin has been prepared, it should be used immediately. This is because it contains no components to prevent bacterial growth. Only a trained healthcare professional who has read the complete instructions should prepare the medicine (see below “Instructions for reconstitution and dilution of Caspofungin Stadafarma”).

If not used immediately, the solution can be used within 24 hours when stored at a temperature not exceeding 25 °C, or within 48 hours when the bag (bottle) is stored refrigerated (2 to 8 °C) and diluted with 9 mg/ml (0.9 %), 4.5 mg/ml (0.45 %), or 2.25 mg/ml (0.225 %) sodium chloride solution for infusion, or with lactated Ringer's solution. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours between 2 and 8 °C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.

Do not use this medicine if you notice any signs of discoloration or particles in suspension.

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

6. Contents of the pack and other information

Composition of Caspofungin Stadafarma

• The active substance is caspofungin. Each vial contains 50 mg of caspofungin (as acetate).
• The other components are sucrose, mannitol, concentrated hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), carbon dioxide (to adjust pH).

Appearance of the product and contents of the pack

Caspofungin Stadafarma is a sterile, compact, white to off-white powder.

The reconstituted solution is clear and transparent.

Caspofungin Stadafarma is available in 10 ml glass vials with a grey stopper and an aluminum seal with a red "flip-off" plastic cap.

Each pack contains one vial of powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park

Paola

PLA 3000

Malta

or

SAG Manufacturing S.L.U

Ctra. N-I, Km 36. San Agustín de Guadalix

28750, Madrid

Spain

or

Galenicum Health S.L.U

Sant Gabriel, 50

08950 Esplugues de Llobregat (Barcelona)

Spain

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijstraat 31-E

4814 NE Breda

The Netherlands

or

Hikma Italia S.p.A.

Viale Certosa, 10,

27100 Pavia

Italy

Date of latest revision of this leaflet: May 2023

Detailed 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/

This information is intended only for healthcare professionals:

Instructions for reconstituting and diluting Caspofungin Stadafarma:

Reconstitution of Caspofungin St

DO NOT USE DILUENTS CONTAINING GLUCOSE, as caspofungin is not stable in diluents containing glucose. DO NOT MIX OR CO-ADMINISTER caspofungin WITH ANY OTHER MEDICATION, as compatibility data with other substances, additives, or intravenous pharmaceutical specialties are not available. The infusion solution must be visually inspected for the presence of solid particles or discoloration.

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of the vials

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

The white to off-white lyophilized compact powder will dissolve completely. Gently mix until a clear, transparent solution is obtained. Reconstituted solutions must be visually inspected for the presence of solid particles or discoloration. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25 °C.

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

The diluents for the final infusion solution are: sodium chloride solution for injection or lactated Ringer's 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, 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

DOSE*	Volume of reconstituted caspofungin to transfer to an intravenous bag or vial	Standard preparation (reconstituted caspofungin added to 250 ml) final concentration	Reduced volume infusion (reconstituted caspofungin added to 100 ml) final concentration
50 mg	10 ml	0.20 mg/ml	-
50 mg in reduced volume	10 ml	-	0.47 mg/ml
35 mg for moderate hepatic impairment (from a 50 mg vial)	7 ml	0.14 mg/ml	-
35 mg for moderate hepatic impairment (from a 50 mg vial) in reduced volume	7 ml	-	0.34 mg/ml

*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

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

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

1. Allow the refrigerated caspofungin vial to reach room temperature.

2. Aseptically add 10.5 ml of Water for Injections.a The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C.b This will result in a final caspofungin concentration of 5.2 mg/ml in the vial.

3. 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 into an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted caspofungin may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or lactated Ringer's solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2 to 8°C.

Preparation of the 50 mg/m² infusion for pediatric patients >3 months (using a 50 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.

1. Allow the refrigerated caspofungin vial to reach room temperature.

2. Aseptically add 10.5 ml of Water for Injections.a The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C.b This will result in a final caspofungin concentration of 5.2 mg/ml in the vial.

3. 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 into an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted caspofungin may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or lactated Ringer's solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2 to 8°C.

Reconstitution Notes : The white to off-white 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 precipitate. Caspofungin is formulated to deliver the full vial dose stated in the package insert (50 mg) when 10 mL is withdrawn from the vial.