Caspofungin Normon 70 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Caspofungin

Read all of this leaflet carefully before you or your child start taking 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 get any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Caspofungin Normon is

Caspofungin Normon contains a medicine called caspofungin. It belongs to a group of medicines known as antifungals.

What Caspofungin Normon is used for

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

• Serious fungal infections in your 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 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 your 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 a transplant, and those with a weakened immune system.

• 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 a weakened immune system.

How Caspofungin Normon works

Caspofungin Normon 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 clear the infection completely.

2. What you need to know before using Caspofungin Normon

Do not use Caspofungin Normon

• 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

Consult 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).

Use of Caspofungin Normon with other medicines

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.

Inform 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 are planning 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 Normon contains sodium

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

3. How to use Caspofungin Normon

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

You will be given caspofungin:

• 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 you will receive each day. Your doctor will monitor whether the medicine's effect is appropriate. If you weigh more than 80 kg, you may require a different dose.

Use in children and adolescents

The dose for children and adolescents may differ from the dose used in adults.

If you use more Caspofungin Normon 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 been given too much caspofungin, inform your doctor or nurse immediately.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken.

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 gets them.

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

• Rash, itching, feeling of warmth, swelling of your 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 experiencing 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 more 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 blood potassium levels.
• 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, redness of the skin, or excessive 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, electrolyte imbalance, high blood sugar, low blood calcium, high blood calcium, low blood magnesium, increased levels of acids in the blood.
• Confusion, feeling nervous, inability to sleep.
• Dizziness, reduced sensation 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 flashes, high blood pressure, low blood pressure, redness along a vein that is very tender to touch.
• Tightness in the muscle bands around the airways, leading to wheezing or coughing, rapid breathing, shortness of breath causing awakening, low oxygen levels in the blood, abnormal breathing sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, sore throat.
• Abdominal pain, upper abdominal pain, abdominal swelling, constipation, difficulty swallowing, dry mouth, indigestion, flatulence, gastric discomfort, swelling due to fluid accumulation around the abdomen.
• Reduced bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a medicine or chemical substance, 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 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, 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 medicines 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.
• Fast 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and vial (after "EXP"). The expiry date refers to the last day of the month indicated.

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

Caspofungin Normon does not contain preservatives. From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage duration and conditions prior to use are the responsibility of the user and should not exceed 24 hours between 2 °C and 8 °C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.

The medicine should only be prepared by a trained healthcare professional who has read the complete instructions (see below “Instructions for reconstituting and diluting Caspofungin Normon”).

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

6. Package contents and other information

Composition of Caspofungina Normon

• The active substance is caspofungin. Each vial of Caspofungina Normon contains 70 mg of caspofungin.
• The other components are sucrose, mannitol, glacial acetic acid, and sodium hydroxide (see section 2. What you need to know before using Caspofungina Normon).

Presentation of the product and package contents

Caspofungina Normon is a sterile, compact, white to off-white powder.

Each package contains one vial of powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Normon Drug Discovery, S.L.
Avda. de la Industria 31, 28108 Alcobendas, Madrid, Spain

Manufacturer:
Laboratorios Farmacéuticos ROVI
C/ Fuerte de El Caney, 2, 28048 Madrid, Spain

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/84503/P_84503.html

This information is intended exclusively for healthcare professionals:

Instructions for reconstituting and diluting Caspofungin Normon:

Reconstitution of Caspofungin Normon

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

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of 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 compact lyophilized powder will dissolve completely. Gently mix until a clear solution is obtained. Reconstituted solutions should be inspected visually 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 Normon to the patient's infusion solution

Diluents for the final infusion solution are: Sodium Chloride Injection Solution or Lactated Ringer's Solution. The infusion solution is prepared by aseptically adding the appropriate amount of the reconstituted concentrate (as shown in the following table) 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 contains precipitate.

PREPARATION OF INFUSION SOLUTION FOR ADULTS

*10.5 ml must be used for 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 patient's body surface area (BSA) using the following formula: (Mosteller formula[1])

Preparation of the 70 mg/m² infusion 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) × 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 Normon 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.b This will result in a final caspofungin concentration of 7.2 mg/ml in the vial.
4. 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 Normon to an IV bag (or vial) containing 250 ml of 0.9% or 0.225% sodium chloride injection solution, or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted Caspofungin Normon may be added to a reduced volume of 0.9% or 0.225% sodium chloride injection solution, or Lactated Ringer's solution, provided that the final concentration does not exceed 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 between 2 and 8 °C.

Preparation of the 50 mg/m² infusion 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) × 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 Normon vial to reach room temperature.
3. 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 7.2 mg/ml in the vial.
4. 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 Normon to an IV bag (or vial) containing 250 ml of 0.9% or 0.225% sodium chloride injection solution, or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted Caspofungin Normon may be added to a reduced volume of 0.9% or 0.225% sodium chloride injection solution, or Lactated Ringer's solution, provided that the final concentration does not exceed 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 between 2 and 8 °C.

Preparation Notes:

• The white to off-white powder will completely dissolve. Gently mix until a clear solution is obtained.

• Visually inspect the reconstituted solution for the presence of solid particles or discoloration during reconstitution and before infusion. Do not use if the solution is cloudy or contains precipitate.

• Caspofungin Normon is formulated to deliver the full vial dose stated in the Summary of Product Characteristics (70 mg) when 10 ml are withdrawn from the vial.

[1] Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17):1098 (letter)