Prospect: information for the user

Caspofungina Hikma 50 mg powder for concentrate for solution for infusion EFG

Caspofungina Hikma 70 mg powder for concentrate for solution for infusion EFG

Caspofungina

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

• Keep this prospect, 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 prospect. See section 4.

5Storage of Caspofungina Hikma

6.Contents of the package and additional information

What is Caspofungina Hikma

Caspofungina Hikma contains a medicine called caspofungina. This belongs to a group of medicines called antifungals.

What caspofungina is used for

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

•severe fungal infections in tissues or organs (designated “invasive candidiasis”). This infection is caused by fungal cells (yeast) called Candida. People who may be at risk of 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 “invasive aspergillosis”) if other antifungal treatments have not worked or have caused side effects. This infection is caused by fungi called Aspergillus.

People who may be at risk of 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, which have not improved with antibiotic treatment. People who are at risk of fungal infection include those who have recently undergone surgery or those with 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 Hikma

• 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 Caspofungina Hikma

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 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 treatment.
• Some HIV medications such as efavirenz or nevirapine.
• 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 Caspofungina.

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.

• 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 using caspofungin should not breastfeed.

Driving and Operating Machinery

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

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

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

Your doctor will determine the duration of treatment and the amount of Caspofungina to be administered each day. Your doctor will monitor whether the effect of the medication 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 Caspofungina Hikma 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 Toxicology 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 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.
• 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 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 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: can 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 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), restlessness, 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, abdominal swelling, constipation, difficulty swallowing, dry mouth, indigestion, gas passing, stomach discomfort, swelling due to accumulation of fluid around the abdomen.
• decrease in bile flow, enlargement of the 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 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, leakage of fluid 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 function 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:can affect more than 1 in 10 people:

• fever.

Frequent:can 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 (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 Caspofungina Hikma 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 "Instructions for reconstituting and diluting Caspofungina Hikma" later).

If not used immediately, the solution can be stored for up to 24 hours at 25 ° C or less or for 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8 ° C) and 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 lactated Ringer's solution. If not used immediately, the storage times and conditions before use are the responsibility of the user and are normally not to exceed 24 hours between 2 and 8 ° C, unless reconstitution and dilution have taken place in validated controlled aseptic conditions.

Do not use the solution if you notice signs of discoloration or particles in suspension.

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.This will help protect the environment.

Composition of Caspofungin Hikma

• The active ingredient is caspofungin.

Caspofungin Hikma 50 mg powder for concentrate for solution for infusion EFG.

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

Caspofungin Hikma 70 mg powder for concentrate for solution for infusion EFG.

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

• The other components are sucrose, mannitol, hydrochloric acid (to adjust the pH), sodium hydroxide (to adjust the pH), carbon dioxide (to adjust the pH) (see section 2. What you need to know before starting to use Caspofungin Hikma).

Appearance of the product and contents of the pack

Caspofungin Hikma is a compact, sterile, white to off-white powder. The reconstituted solution is transparent.

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

10 ml glass vial type I with bromobutyl stopper and plastic cap with red aluminum band.

Caspofungin Hikma 70 mg powder for concentrate for solution for infusion EFG.

10 ml glass vial type I with bromobutyl stopper and plastic cap with orange aluminum band.

Cada envase contiene un vial de polvo.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.º 8, 8A e 8B – Fervença

2705-906 Terrugem SNT

Portugal

Tel.: ++351 21 960 84 10

Fax: ++351 21 961 51 02

E-mail: [email protected]

Responsible for manufacturing

Pharmadox healthcare, ltd

KW20A Kordin Industrial Park, Paola

PLA 3000Malta

Galenicum Health, S.L.U.

Sant Gabriel, 50Esplugues de Llobregat 08950

Barcelona, España

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36

San Agustín de Guadalix, 28750,

Madrid, España

Hikma Italia S.p.A.

Viale Certosa, 10,

27100, Pavia (PV),

Italia

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

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

España

Last review date of this leaflet: JULIO 2020

This information is intended only for healthcare professionals:

Instructions for reconstituting and dilutingCaspofungin Hikma:

Reconstitution of caspofungin hikma

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 MEDICAMENT, as no data are available on the compatibility of CASPOFUNGIN with other substances, additives or intravenous pharmaceutical specialties. The infusion solution must be visually inspected for particulate matter or a change in color.

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

Instructions for use in adult patients(vial 50 mg)

Step 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 vial will be 5.2 mg/ml.

The compact 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 particulate matter 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.

Step 2 Addition of caspofungin 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 following table) to a 250 ml infusion bag or bottle. Perfusions of reduced volume in 100 ml may be used, if medically necessary, for doses of 50 mg or 35 mg. Do not use if the solution is turbid or has precipitated.

Vial 50 mg: PREPARATION OF THE INFUSION SOLUTION IN ADULT PATIENTS

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

Instructions for use in pediatric patients (vial 50 mg)

Calculation of body surface area (SC) for pediatric dosing

Before preparing the infusion, calculate the body surface area (SC) of the patient using the following formula: (Mosteller formula)

SC (m2)=

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

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

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

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.
2. 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

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

1. Extract from the vial a volume of the medication equal to the calculated loading dose (Step 1). Transfer asetically this volume (ml)cof caspofungin reconstituted to an IV bag or bottle that contains 250 ml of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% sodium chloride injection, or Ringer lactate solution. Alternatively, the volume (ml)cof caspofungin reconstituted can be added to a reduced volume of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% 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 below 25°C or within 48 hours if stored refrigerated between 2 and 8°C.

Preparation of the 50 mg/m2infusion 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 SC of the patient (as calculated above) and the following equation:

SC (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.

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

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

1. Extract from the vial a volume of the medication equal to the calculated daily maintenance dose (Step 1). Transfer asetically this volume (ml)cof caspofungin reconstituted to an IV bag or bottle that contains 250 ml of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% sodium chloride injection, or Ringer lactate solution. Alternatively, the volume (ml)cof caspofungin reconstituted can be added to a reduced volume of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% 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 below 25°C or within 48 hours if stored refrigerated between 2 and 8°C.

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

Instructions for use in adult patients(vial70 mg)

Step 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 vial will be 7.2 mg/ml.

The compact 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 particulate matter 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.

Step 2 Addition of Caspofungin 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 following table) to a 250 ml infusion bag or bottle. Perfusions of reduced volume in 100 ml may be used, if medically necessary, for doses of 50 mg or 35 mg. Do not use if the solution is turbid or has precipitated.

70 mg vial: PREPARATION OF THE INFUSION SOLUTION IN ADULT PATIENTS

*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 (70 mg vial)

Calculation of body surface area (SC) for pediatric dosing

Before preparing the infusion, calculate the body surface area (SC) of the patient using the following formula: (Mosteller formula)

SC (m2)=

Preparation of the 70 mg/m2infusion solution 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 SC of the patient (as calculated above) and the following equation:

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

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.
2. 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

bThis will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.

1. Extract from the vial a volume of the medication equal to the calculated loading dose (Step 1). Transfer asetically this volume (ml)cof caspofungin reconstituted to an IV bag or bottle that contains 250 ml of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% sodium chloride injection, or Ringer lactate solution. Alternatively, the volume (ml)cof caspofungin reconstituted can be added to a reduced volume of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% 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 below 25°C or within 48 hours if stored refrigerated between 2 and 8°C.

Preparation of the 50 mg/m2infusion solution 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 SC of the patient (as calculated above) and the following equation:

SC (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.

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

bThis will result in a final concentration of caspofungin in the vial of 7.2 mg/ml.

1. Extract from the vial a volume of the medication equal to the calculated daily maintenance dose (Step 1). Transfer asetically this volume (ml)cof caspofungin reconstituted to an IV bag or bottle that contains 250 ml of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% sodium chloride injection, or Ringer lactate solution. Alternatively, the volume (ml)cof caspofungin reconstituted can be added to a reduced volume of 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% 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 below 25°C or within 48 hours if stored refrigerated between 2 and 8°C.