Caspofungin Laboratorios Lorién

Package leaflet: Information for the user

Caspofungin Laboratorios Lorien 50 mg powder for concentrate for solution for infusion, 70 mg powder for concentrate for solution for infusion

Caspofungin
Generic medicine
Please read all of this leaflet carefully before this medicine is administered to you or your child, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Caspofungin Laboratorios Lorien is and what it is used for

What Caspofungin Laboratorios Lorien is
Caspofungin Laboratorios Lorien contains a medicine called caspofungin. This belongs to a group of medicines called antifungals.
What Caspofungin Laboratorios Lorien is used for
Caspofungin Laboratorios Lorien is used to treat the following infections in children, adolescents, and adults:

• Serious fungal infections in tissues and organs (called 'invasive candidiasis'). This infection is caused by fungal cells (yeasts) called Candida. People who may develop 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 antibiotics are the most common signs of this type of infection.
• Fungal infections of the nose, sinuses, or lungs (called 'invasive aspergillosis') when other antifungal treatments have not worked or have caused undesirable effects. This infection is caused by a mold called Aspergillus. People who may develop this type of infection include those undergoing chemotherapy, those who have had a transplant, and those with a weakened immune system.
• Suspected fungal infections: if you have fever and a low white blood cell count without improvement after antibiotic therapy. People at risk of developing a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

How Caspofungin Laboratorios Lorien works
Caspofungin Laboratorios Lorien weakens fungal cells and prevents the fungus from growing properly. This stops the spread of the infection and allows the body's natural defenses the opportunity to completely eliminate the infection.

2. What you should know before being given Caspofungin Laboratorios Lorien

Do not use Caspofungin Laboratorios Lorien

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Caspofungin Laboratorios Lorien 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 help prevent transplanted organ rejection or suppress the immune system) – as your doctor may need additional blood tests during treatment;
• you have ever had any other medical condition.

Caspofungin Laboratorios Lorien may cause severe skin reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Caspofungin Laboratorios Lorien
Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Caspofungin Laboratorios Lorien may interfere with the way some other medicines work. Likewise, some other medicines may interfere with the way Caspofungin Laboratorios Lorien works.
Tell your doctor, nurse, or pharmacist if you are taking any of the following medicines:

• cyclosporine or tacrolimus (used to help prevent transplanted organ rejection or suppress the immune system) – as your doctor may need additional blood tests during treatment;
• certain HIV medicines such as efavirenz or nevirapine;
• phenytoin or carbamazepine (used to treat seizures);
• dexamethasone (a steroid);
• rifampicin (an antibiotic).

If any of the conditions listed above apply to you (or if you are unsure), consult your doctor, nurse, or pharmacist before being given Caspofungin Laboratorios Lorien.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before being given this medicine.

• Caspofungin Laboratorios Lorien has not been studied in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.
• Women receiving Caspofungin Laboratorios Lorien must not breastfeed.

Driving and using machines
There is no information suggesting that Caspofungin Laboratorios Lorien has an effect on the ability to drive or use machinery.

3. How to use Caspofungin Laboratorios Lorien

Caspofungin Laboratorios Lorien must always be prepared and administered by a healthcare professional.
Caspofungin Laboratorios Lorien will be given to you:

• once daily
• as a slow injection into a vein (intravenous infusion)
• over approximately 1 hour.

Your doctor will determine how long your treatment will last and the daily amount of Caspofungin Laboratorios Lorien you will receive. Your doctor will monitor the effect of the medicine on you.
If your body weight is over 80 kg, you may require a different dose.
Children and adolescents
The dose for children and adolescents may differ from that for adults.
If you have been given more Caspofungin Laboratorios Lorien than you should have
Your doctor will decide the daily amount of Caspofungin Laboratorios Lorien you need and the duration of treatment. If you are concerned that you have been given too much Caspofungin Laboratorios Lorien, inform your doctor or nurse immediately.
If you have any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you notice any of the following side effects – you may need 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.
• breathing difficulties with wheezing or a worsening rash – you may be experiencing an allergic reaction to the medicine.
• cough, severe breathing difficulties – if you are an adult with invasive aspergillosis, you may be experiencing a serious respiratory problem that could lead to respiratory failure.
• rash, skin peeling, mouth sores, hives, large areas of scaly skin. As with any other prescription medicine, some side effects can be serious. For further information, consult your doctor.

Other side effects in adults include:
Common: may affect up to 1 in 10 people:

• decreased haemoglobin (reduction in the substance in the blood that carries oxygen), decreased white blood cells
• decreased blood albumin (a type of protein) in the blood, decreased potassium or low blood potassium levels
• headache
• inflammation of the vein
• shortness of breath
• diarrhoea, nausea, vomiting
• changes in certain blood test values (including increased values of certain liver parameters)
• itching, rash, skin redness or excessive sweating
• joint pain
• chills, fever
• injection site itching.

Uncommon: may affect up to 1 in 100 people:

• changes in certain blood test values (including blood clotting disorders, platelets, red blood cells and white blood cells)
• loss of appetite, increased body fluid, electrolyte imbalance, high blood sugar levels, low blood calcium levels, low blood magnesium levels, increased levels of acids in the blood
• disorientation, feeling nervous, inability to sleep
• dizziness, decreased sensation or sensitivity (especially of the skin), tremor, 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
• hot flushes, flushing, high blood pressure, low blood pressure, redness of a vein that is extremely painful to pressure
• narrowing of the muscular bands in the airways causing shortness of breath or cough, rapid breathing, shortness of breath waking the patient, reduced oxygen in the blood, abnormal breathing sounds, rubbing sound in the lungs, dyspnoea, nasal congestion, cough, sore throat
• abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to fluid accumulation in the abdomen
• decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver damage due to a medicine or chemical causes, liver disorder
• abnormal skin tissue, generalized itching, hives, various types of skin rash, abnormal skin, red spots often itchy on the arms and legs and sometimes on the face and other parts of the body
• back pain, pain in arms or legs, bone pain, muscle pain, muscle weakness
• loss of kidney function, sudden loss of kidney function
• catheter site pain, injection site reactions (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from catheter into tissue), inflammation of the vein at injection site
• increased blood pressure and changes in certain blood test values (including renal electrolytes and coagulation parameters), increased levels of medicines you are taking that suppress the immune system
• chest discomfort, chest pain, sensation of body temperature changes, feeling of general malaise, general pain, facial swelling, swelling of ankles, hands or feet, swelling, hypersensitivity, feeling of fatigue.

Side 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 blood test values (increased values in certain liver tests)
• itching, rash
• catheter site pain
• chills
• changes in certain blood test values.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, nurse or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Laboratorios Lorien

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
Store and transport in a refrigerator (from 2°C to 8°C).
Once Caspofungin Laboratorios Lorien has been prepared, it must be used immediately. This is because it does not contain ingredients to prevent bacterial growth. Only a trained healthcare professional who has read the complete instructions should prepare this medicine (see below "Instructions for reconstitution and dilution of Caspofungin Laboratorios Lorien").
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Caspofungin Laboratorios Lorien contains

• The active substance is caspofungin. Each vial of Caspofungin Laboratorios Lorien 50 mg contains 50 mg of caspofungin. Each vial of Caspofungin Laboratorios Lorien 70 mg contains 70 mg of caspofungin. After reconstitution, each ml of concentrate contains 5.2 mg of caspofungin. After reconstitution, each ml of concentrate contains 7.2 mg of caspofungin.
• The other excipients are sucrose, mannitol (E421), succinic acid (E363), and sodium hydroxide (to adjust pH) (E524).

Description of the appearance of Caspofungin Laboratorios Lorien and package contents
Caspofungin Laboratorios Lorien is a compact white to off-white powder.
Each pack contains one vial of powder.
Marketing Authorization Holder
Laboratorios Lorien S.L., C/ Séneca 10, bajos 2ª, 08006 Barcelona, Spain
Manufacturer
Laboratori Fundació DAU, C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain
This Patient Information Leaflet was last approved in February 2018.

The following information is intended for healthcare professionals only:

Instructions for reconstituting and diluting Caspofungin Laboratorios Lorien 50 mg:
Reconstitution of Caspofungin Laboratorios Lorien
DO NOT USE DILUENTS CONTAINING DEXTROSE because Caspofungin Laboratorios Lorien is
not stable in diluents containing dextrose. DO NOT MIX OR ADMINISTER CASPOFUNGIN
LABORATORIOS LORIEN THROUGH THE SAME INTRAVENOUS LINE AS OTHER
MEDICATIONS, as compatibility data with other substances, additives, or intravenous
medications are not available. Visually inspect the infusion solution for the presence of
particles or discoloration.
Step 1 Reconstitution of conventional vials
To reconstitute the powder, bring the vial to room temperature and aseptically add
10.5 ml of water for injections. The concentration of the reconstituted vial will be 5.2 mg/ml.
The white to off-white lyophilized powder must be completely dissolved.
Gently swirl until a clear, colorless to slightly yellow solution is obtained. Reconstituted solutions should be visually inspected for the presence of particles or discoloration. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C.
Step 2 Addition of reconstituted CASPOFUNGIN LABORATORIOS LORIEN
to the patient's infusion solution
Diluents suitable for the final infusion solution are: sodium chloride solution for injections
or Ringer's lactate solution. The infusion solution is prepared by aseptically adding the
appropriate volume of the reconstituted concentrate (as shown in the following table) to a
250 ml infusion bag or bottle. If medically necessary, reduced infusion volumes of 100 ml
may be used for daily doses of 50 mg or 35 mg/day. Do not use if the solution is cloudy or contains precipitates.
PREPARATION OF THE INFUSION SOLUTION IN ADULTS

*10.5 ml must be used to reconstitute all vials
INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS
Calculation of Body Surface Area (BSA) for Pediatric Dosing
Before preparing the infusion, calculate the patient's body surface area (BSA)
using the following formula (Mosteller Formula):
𝐵𝑆𝐴 (𝑚²) = √Height (𝑐𝑚) × Weight (𝑘𝑔)
Preparation of the 70 mg/m² Infusion for Pediatric Patients Aged > 3 Months
(using a 50 mg vial)

1. Determine the appropriate loading dose for pediatric patients 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 Laboratorios Lorien 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 temperatures not exceeding 25°C. This will yield a final concentration of caspofungin of 5.2 mg/ml in the vial.
4. Withdraw from the vial the volume (ml) corresponding to the calculated loading dose (Step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Laboratorios Lorien into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections. Alternatively, the volume (ml) of reconstituted Caspofungin Laboratorios Lorien may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at temperatures not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.

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

1. Determine the appropriate daily maintenance dose for 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 Laboratorios Lorien 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 temperatures not exceeding 25°C. This will yield a final concentration of caspofungin of 5.2 mg/ml in the vial.
4. Withdraw from the vial the volume (ml) corresponding to the calculated daily maintenance dose (Step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Laboratorios Lorien into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections. Alternatively, the volume (ml) of reconstituted Caspofungin Laboratorios Lorien may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at temperatures not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.

Notes on Preparation:
a. The white to off-white powder will dissolve completely. Gently swirl until a clear, colorless to slightly yellow solution is obtained.
b. Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and before infusion. Do not use if the solution is cloudy or contains precipitates.
c. Caspofungin Laboratorios Lorien is formulated to deliver the full labeled dose (50 mg) when 10 ml are withdrawn from the vial.
Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)
Instructions for Reconstituting and Diluting Caspofungin Laboratorios Lorien 70 mg:
Reconstitution of CASPOFUNGIN LABORATORIOS LORIEN
DO NOT USE DILUENTS CONTAINING DEXTROSE because CASPOFUNGIN
LABORATORIOS LORIEN is not stable in diluents containing glucose. DO NOT
MIX OR ADMINISTER CASPOFUNGIN LABORATORIOS LORIEN IN THE
SAME INTRAVENOUS LINE WITH ANY OTHER MEDICINE, as compatibility data with other substances, additives, or intravenous drugs are not available.
Visually inspect the infusion solution for particulate matter or discoloration.
INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1 Reconstitution of Conventional 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 white to off-white lyophilized powder must be completely dissolved. Gently swirl until a clear, colorless to slightly yellow solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or discoloration. This reconstituted solution may be stored for up to 24 hours at temperatures not exceeding 25°C.
Step 2 Addition of Reconstituted CASPOFUNGIN LABORATORIOS LORIEN
to the Patient's Infusion Solution
The diluents for the final infusion solution are: Sodium Chloride solution for Injections or Lactated Ringer's solution. The infusion solution is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the following table) to a 250 ml infusion bag or bottle. For medical reasons, reduced infusion volumes down to 100 ml may be used for daily doses of 50 mg or 35 mg/day. Do not use if the solution is cloudy or contains precipitates.
PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

* 10.5 ml must be used to reconstitute all vials
**If the 70 mg vial is not available, the 70 mg dose can be prepared using 2 vials of 50 mg
INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS
Calculation of Body Surface Area (BSA) for pediatric dosing
Before preparing the infusion, calculate the patient's body surface area (BSA) using the following formula: (Mosteller Formula)
𝐵𝑆𝐴 (𝑚²) = √Height (cm) × Weight (kg)
Preparation of 70 mg/m² infusion for pediatric patients aged > 3 months
(using one 70 mg vial)

1. Determine the appropriate loading dose for pediatric patients using the patient’s BSA (calculated as 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 Laboratorios Lorien vial to reach room temperature.
3. Aseptically add 10.5 ml of Water for Injections. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will result in a final caspofungin concentration of 7.2 mg/ml in the vial.
4. Withdraw from the vial the volume (ml) corresponding to the calculated loading dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Laboratorios Lorien into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections. Alternatively, the volume (ml) of reconstituted Caspofungin Laboratorios Lorien may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at ≤25°C, or within 48 hours if refrigerated at 2–8°C.

Preparation of 50 mg/m² infusion for pediatric patients aged > 3 months
(using one 70 mg vial)

1. Determine the appropriate daily maintenance dose for the pediatric patient using the patient’s BSA (calculated as 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 Laboratorios Lorien vial to reach room temperature.
3. Aseptically add 10.5 ml of Water for Injections. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will result in a final caspofungin concentration of 7.2 mg/ml in the vial.
4. Withdraw from the vial the volume (ml) corresponding to the calculated daily maintenance dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Laboratorios Lorien into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections. Alternatively, the volume (ml) of reconstituted Caspofungin Laboratorios Lorien may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride for Injections, or Lactated Ringer's for Injections, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at ≤25°C, or within 48 hours if refrigerated at 2–8°C.

Notes on preparation:
a. The white to off-white powder will dissolve completely. Gently swirl until a clear, colorless to slightly yellow solution is obtained.
b. Visually inspect the reconstituted solution for presence of particles or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or contains precipitates.
c. CASPOFUNGIN LORIEN is formulated to deliver the full labeled dose (70 mg) when 10 ml are withdrawn from the vial.
Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)