Prospect: information for the user

CaspofunginStadafarma70 mg powder for concentrate for solution for infusion EFG

Read this prospect thoroughly before you or your child start using this medication, because it contains important information for you.

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

5Storage of CaspofunginStadafarma

6.Contents of the package and additional information

What is caspofungina

Caspofungina belongs to a group of medications known as antifungals.

What is caspofungina used for

Caspofungina 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 have 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 that have not improved with antibiotic treatment. Individuals who are at risk of developing a fungal infection include those who have recently undergone surgery or have a weakened immune system.

How caspofungina works

Caspofungina 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

?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 caspofungin if:

?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 caspofungin.

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

Other medications and Caspofungin Stadafarma

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications, including herbal remedies. This is because caspofungin may affect how other medications work. Other medications may also affect how caspofungin works.

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 your 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 caspofungin.

Pregnancy and breastfeeding

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

?Caspofungin has 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 taking caspofungin should not breastfeed.

Driving and operating machinery

There is no information to suggest that caspofungin affects your ability to drive or operate machinery.

Caspofungin Stadafarma contains sodium

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

CaspofunginaStadafarmawill always be prepared and administered by a healthcare professional. Caspofungina will be administered:

• once a day.
• through slow injection into a vein (intravenous infusion).
• for around 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 Stadafarma than you should

Your doctor will decide how much caspofungina you need and for how long each day. If you are concerned that you may have been given too much caspofungina, 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 – you may need urgent medical treatment:

• eruption, 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 an existing eruption: you may be having an allergic reaction to the medicine.
• cough, severe respiratory 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 ulcers, 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:

• 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 levels of potassium in the blood.
• headache.
• inflammation of the vein.
• shortness of breath.
• diarrhea, nausea, or vomiting.
• changes in some laboratory blood tests (such as increased values of some liver function tests).
• itching, eruption, redness of the skin, or excessive sweating.
• joint pain.
• chills, fever.
• itching at the injection site.

Rare: 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, increase in body fluid, electrolyte imbalance, high blood sugar, low calcium levels in the blood, high calcium levels in the blood, low magnesium levels in the blood, high levels of acid in the blood.
• disorientation, feeling of nerves, inability to sleep.
• feeling 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.
• 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 the touch.
• tension in the bands of muscle around the airways that leads to wheezing or cough, rapid breathing, shortness of breath that wakes you up, lack of oxygen 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 appearance 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), inflammation of the vein at the injection site.
• increase in blood pressure and alterations in some laboratory blood tests (such as kidney electrolyte tests and coagulation tests), increase in levels of medications 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

Other 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.
• flushing, low blood pressure.
• changes in some laboratory blood tests (increased values of some liver function tests).
• itching, eruption.
• pain at the catheter site.
• chills.
• changes in some laboratory blood tests.

Reporting of 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 of 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 first two numbers are the month; the next four numbers are the year). The expiration date is the last day of the month indicated.

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

Once caspofungin has been prepared, it should be used immediately. This is because it does not contain any component to prevent bacterial growth. Only a trained healthcare professional who has read the complete instructions should prepare the medication (see later "Instructions for reconstituting and diluting Caspofungin Stadafarma").

If the solution is not used immediately, it can be used within 24 hours when stored at a temperature equal to or less than 25 °C or within 48 hours when the bag (bottle) is stored in a refrigerator (2 to 8 °C) and is diluted in 9 mg/ml (0.9 %), 4.5 mg/ml (0.45 %), or 2.25 mg/ml (0.225 %) sodium chloride infusion solution, or with lactated Ringer's solution. If not used immediately, the storage times in use and conditions before 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 in controlled and validated aseptic conditions.

Do not use this medication if you observe any sign of discoloration or particles in suspension.

Medications 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.

Caspofungin Stadafarma Composition

-The active ingredient is caspofungin. Each vial of Caspofungin Stadafarma contains 70 mg of caspofungin (as acetate).

-The other components are sucrose, mannitol, concentrated hydrochloric acid (to adjust the pH), sodium hydroxide (to adjust the pH), and carbon dioxide (to adjust the pH).

Appearance of the product and contents of the package

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

The reconstituted solution is transparent.

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

Each package contains one vial of powder.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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

Netherlands

or

Hikma Italia S.p.A.

Viale Certosa, 10,

27100 Pavia

Italy

Last review date of this leaflet:May2023

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

This information is intended solely for doctors or healthcare professionals:

Instructions for reconstituting and diluting Caspofungin Stadafarma:

Reconstitution of caspofungin

DO NOT USE DILUENTS CONTAINING GLUCOSE, as caspofungin is not stable in diluents containing glucose. DO NOT MIX OR INFUSE CASPOFUNGIN CONCURRENTLY WITH ANY OTHER MEDICINE, as there are no data on the compatibility of caspofungin with other substances, additives, or intravenous pharmaceutical specialties. The reconstituted solution is transparent. The infusion solution should be visually inspected for solid particles or a change in color.

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of vials

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

The white to off-white lyophilized powder will dissolve completely. Gently mix until a transparent solution is obtained. The reconstituted solutions should 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 less than 25 °C.

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

The diluents for the final infusion solution are: 0.9% sodium chloride injection or Ringer lactate solution. The infusion solution is prepared by adding the appropriate amount of the reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced volume infusions in 100 ml may be used if 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

**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)

Preparation of the 70 mg/m2infusion 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

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

1. Wait for the refrigerated caspofungin vial to reach room temperature.

1. Aseptically, add 10.5 ml of injection water to this solution. a This reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25 °C. b This will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.

1. Extract the desired volume of the medicine from the vial equal to the calculated loading dose (Step 1). Transfer this volume (ml) c of reconstituted caspofungin aseptically to an IV bag or bottle that contains 250 ml of 0.9% sodium chloride injection or Ringer lactate solution. Alternatively, the volume (ml) c of reconstituted caspofungin can be added to a reduced volume of 0.9% sodium chloride injection or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution should be used within 24 hours if stored at a temperature equal to or less than 25 °C or within 48 hours if stored refrigerated between 2 and 8 °C.

Preparation of the 50 mg/m2infusion 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 dose calculated for the patient.

2.Wait for the refrigerated caspofungin vial to reach room temperature.

3.Aseptically, add 10.5 ml of injection water to this solution. a This reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25 °C. b This will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.

4.Extract the desired volume of the medicine from the vial equal to the calculated daily maintenance dose (Step 1). Transfer this volume (ml) c of reconstituted caspofungin aseptically to an IV bag or bottle that contains 250 ml of 0.9% sodium chloride injection or Ringer lactate solution. Alternatively, the volume (ml) c of reconstituted caspofungin can be added to a reduced volume of 0.9% sodium chloride injection or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution should be used within 24 hours if stored at a temperature equal to or less than 25 °C or within 48 hours if stored refrigerated between 2 and 8 °C.