Label: information for the user

Cancidas 50mg powder for concentrate for solution for infusion

Cancidas 70mg powder for concentrate for solution for infusion

caspofungina

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 section4.

What is Cancidas

Cancidas contains a medication called caspofungin. This belongs to a group of medications known as antifungals.

What is Cancidas used for

Cancidas 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.

People who may be at risk for 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 fungi called Aspergillus.

People who may be at risk for this type of infection include those receiving 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. People who are at risk of developing a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

How Cancidas works

Cancidas 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 Cancidas

• If you are allergic to caspofungin or any of the other components of this medication (listed in section6).

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 Cancidas 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 toprevent organ transplant rejectionor to cause a suppression of 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 Cancidas.

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

Other Medications and Cancidas

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 Cancidas may affect how other medications work. Also, other medications may affect how Cancidas works.

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

• Ciclosporin or tacrolimus (used toprevent organ transplant rejectionor to cause a suppression of your immune system), as your doctor may need to perform additional blood tests during treatment
• Some HIV medications such as efavirenz or nevirapina
• Phenitoin 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 Cancidas.

Pregnancy and Breastfeeding

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

• Cancidas 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 using Cancidas should not breastfeed.

Driving and Operating Machinery

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

Cancidas Contains Sodium

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

Cancidas will always be prepared and administered by a healthcare professional.

Cancidas will be administered to you:

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

Your doctor will determine the duration of treatment and the amount of Cancidas to be administered each day. Your doctor will monitor if the medication's effect is adequate. If you weigh more than 80 kg, you may need a different dose.

Use in children and adolescents

The dosage for children and adolescents may be different from that for adults.

If you use more Cancidas than you should

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

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

Like all medicines, this medicine can 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.
• coughs, 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 can be serious. Ask your doctor for more information.

Other side effects in adults include:

Frequent: can affect up to 1in every10people:

• 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
• Phlebitis (inflammation of the vein)
• Shortness 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.

Rare: can affect up to 1in every100people:

• 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, low calcium levels in the blood, high calcium levels in the blood, low magnesium levels in the blood, increased acid levels in the blood
• Disorientation, feeling of nerves, unable to sleep
• Feeling of dizziness, decreased sensations or sensitivity (especially in the skin), restlessness, feeling of sleep, 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
• Rubor, hot flashes, high blood pressure, low blood pressure, redness along a very sensitive vein,
• Tension in the muscle bands around the airways, leading to wheezing or coughing, 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, abdominal swelling, constipation, difficulty swallowing, dry mouth, indigestion, gas, 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 medication or chemical compound, liver disorder
• Abnormal skin tissue, generalized itching, rashes, varied-looking 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
• Renal function loss, sudden loss of renal 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), venous inflammation at the injection site
• Increased blood pressure and alterations in some laboratory blood tests (such as kidney function tests and coagulation tests), increased levels of medications you are taking that weaken the immune system.
• Chest discomfort, chest pain, feeling of temperature change, feeling generally unwell, general pain, facial swelling, ankle, hand, or foot swelling, swelling, pain on palpation, feeling of fatigue.

Other side effects in children and adolescents

Very frequent:can affect more than1in every10people:

• Fever

Frequent:can affect up to1in every10people:

• 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 of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV.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 on the vial (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 Cancidas has been prepared, it should be used immediately. This is because it does not contain any component to prevent the growth of bacteria. Only a trained healthcare professional who has read the complete instructions should prepare the medication (see further on “Instructions for reconstituting and diluting Cancidas”).

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

Composition of Cancidas

• The active ingredient is caspofungin.

Cancidas 50mg powder for concentrate for solution for infusion

Each vial of Cancidas contains 50mg of caspofungin.

Cancidas 70mg powder for concentrate for solution for infusion

Each vial of Cancidas contains 70mg of caspofungin.

• The other components are sucrose, mannitol (E‑421), glacial acetic acid and sodium hydroxide (see section2. What you need to know before you start using Cancidas).

Appearance of the product and contents of the container

Cancidas is a compact, sterile, white to off-white powder.

Each container contains a vial of powder.

Holder of the marketing authorization and responsible for manufacturing

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

Last update of the summary of product characteristics:

This information is intended solely for healthcare professionals:

Instructions for reconstituting and diluting CANCIDAS:

Reconstitution of CANCIDAS

DO NOT USE DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in glucose-containing diluents.DO NOT MIX OR INFUSE CANCIDAS CONCURRENTLY WITH ANY OTHER MEDICAMENT, as there are no data on the compatibility of CANCIDAS with other substances, additives or intravenous pharmaceutical specialties.The infusion solution must be visually inspected for particulate matter or a change in color.

CANCIDAS 50mg powder for concentrate for solution for infusion

Instructions for use in adult patients (50mg vial)

Paso 1 Reconstitution of the vials

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

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

Paso 2 Addition of reconstituted CANCIDAS 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 250ml infusion bag or bottle. Infusion bags or bottles of reduced volume (100ml) may be used, if medically necessary, for daily doses of 50mg or 35mg. Do not use if the solution is turbid or has precipitated.

VIAL of 50mg: PREPARATION OF THE INFUSION SOLUTION IN ADULTS

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

Instructions for use in pediatric patients (50mg vial)

Calculation of body surface area (SC) for pediatric dosing

Before preparing the infusion, calculate the patient's body surface area (SC) using the following formula: (Mosteller formula[1])

Preparation of the 70mg/m2infusion solution for pediatric patients >3months (using a 50mg vial)

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)X70mg/m2=loading dose

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

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

3.Add 10.5ml of water for injection asetically.aThis reconstituted solution can be stored for up to 24hours at a temperature equal to or below 25°C.bThis will result in a final concentration of caspofungin in the vial of 5.2mg/ml.

4.Withdraw from the vial a volume of the medication equal to the calculated loading dose (Step1). Transfer asetically this volume (ml)cof reconstituted CANCIDAS to an IV bag or bottle that contains 250ml of sodium chloride injection or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted CANCIDAS can be added to a reduced volume of sodium chloride injection or Ringer lactate solution, without exceeding a final concentration of 0.5mg/ml. This infusion solution must be used within 24hours if stored at a temperature equal to or below 25°C or within 48hours if stored refrigerated between 2 and 8°C.

Preparation of the 50mg/m2infusion solution for pediatric patients >3months (using a 50mg 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)X50mg/m2=daily maintenance dose

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

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

3.Add 10.5ml of water for injection asetically.aThis reconstituted solution can be stored for up to 24hours at a temperature equal to or below 25°C.bThis will result in a final concentration of caspofungin in the vial of 5.2mg/ml.

4.Withdraw from the vial a volume of the medication equal to the calculated daily maintenance dose (Step1). Transfer asetically this volume (ml)cof reconstituted CANCIDAS to an IV bag or bottle that contains 250ml of sodium chloride injection or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted CANCIDAS can be added to a reduced volume of sodium chloride injection or Ringer lactate solution, without exceeding a final concentration of 0.5mg/ml. This infusion solution must be used within 24hours if stored at a temperature equal to or below 25°C or within 48hours if stored refrigerated between 2 and 8°C.

CANCIDAS 70mg powder for concentrate for solution for infusion

Instructions for use in adult patients (70mg vial)

Paso 1 Reconstitution of the vials

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

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

Paso 2 Addition of reconstituted CANCIDAS 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 250ml infusion bag or bottle. Infusion bags or bottles of reduced volume (100ml) may be used, if medically necessary, for daily doses of 50mg or 35mg. Do not use if the solution is turbid or has precipitated.

VIAL of 70mg: PREPARATION OF THE INFUSION SOLUTION IN ADULTS

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

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

Instructions for use in pediatric patients (70mg vial)

Calculation of body surface area (SC) for pediatric dosing

Before preparing the infusion, calculate the patient's body surface area (SC) using the following formula: (Mosteller formula[2])

Preparation of