Caspofungin Tevagen 50 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before you use Caspofungin

3. How to use Caspofungin Tevagen

4. Possible side effects

5. How to store Caspofungin Tevagen

6. Contents of the pack and other information

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

What Caspofungin Tevagen is

Caspofungin powder for concentrate for solution for infusion contains a medicine called caspofungin. This belongs to a group of medicines known as antifungals.

What Caspofungin Tevagen is used for

Caspofungin 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 if you have fever and low white blood cell count that have 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 Tevagen works

Caspofungin Tevagen makes fungal cells fragile and prevents the fungus from growing properly. This stops the infection from spreading and allows the body’s natural defenses the opportunity to completely eliminate the infection.

2. What you need to know before starting to use Caspofungin Tevagen

Do not use Caspofungin Tevagen

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

If you are not sure, consult your doctor, pharmacist, or nurse before starting to use this medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Caspofungin powder for concentrate for solution for infusion 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 you are not sure), consult your doctor, pharmacist, or nurse before starting to use caspofungin.

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

Use of Caspofungin Tevagen 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. Also, 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 you are not sure), 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 Tevagen contains sodium

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

3. How to use Caspofungin Tevagen

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

Caspofungin will be given to you:

• 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 adequate. 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 adult dose.

If you use more Caspofungin Tevagen 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 received too much caspofungin, inform your doctor or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 will experience them.

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

• Rash, itching, feeling of warmth, swelling of the face, lips or throat, or breathing difficulties: you may be experiencing a histamine-type reaction to the medicine.
• Difficulty breathing with wheezing or worsening of an existing rash: you may be having 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 potassium levels in the blood.
• 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, skin redness, or increased 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, imbalance in body salts, high blood sugar levels, low blood calcium levels, increased blood calcium levels, low magnesium levels in the blood, increased levels of acids in the blood.
• Disorientation, feeling nervous, inability to sleep.
• Dizziness, decreased sensation or sensitivity (especially in the skin), restlessness, drowsiness, altered taste, tingling or numbness.
• Blurred vision, increased tear production, 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 flushes, high blood pressure, low blood pressure, redness along a vein that is very sensitive to touch.
• Tightening of the muscle bands around the airways leading to wheezing or coughing, rapid breathing rate, 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, bloating, constipation, difficulty swallowing, dry mouth, indigestion, gas, gastric discomfort, swelling due to fluid accumulation around the abdomen.
• Decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a drug or chemical compound, liver disorder.
• Abnormal skin tissue, generalized itching, hives, rash with variable appearance, abnormal skin, red spots 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, 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 medications you are taking that suppress the immune system.
• Chest discomfort, chest pain, sensation of body temperature change, feeling generally unwell, general pain, facial swelling, swelling of ankles, hands or feet, swelling, tenderness upon palpation, feeling of fatigue.

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.
• Rapid 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Tevagen

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

Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.

Unopened vial: store in a refrigerator between 2°C and 8°C.

Stability data have shown that the concentrate for infusion solution can be stored for up to 24 hours when the vial is kept at a temperature of 25°C or lower, and at 5 ± 3°C when reconstituted with water for injections. From a microbiological standpoint, unless the method of opening/reconstitution/dilution prevents the risk of microbiological contamination, the product should be used immediately.

This is because it contains no components to inhibit bacterial growth. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

Stability data for the diluted solution for patient infusion have shown that the product may be used within 48 hours between 2°C and 8°C and at room temperature (25°C) when 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 in Ringer's lactate solution.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times 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, validated aseptic conditions.

Only a trained healthcare professional who has read the complete instructions should prepare the medicine (see below “Instructions for reconstituting and diluting Caspofungin Tevagen”).

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Caspofungin Tevagen

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

• The active substance is caspofungin. Each vial contains 50 mg of caspofungin (as acetate). After reconstitution in 10.5 ml, each ml of concentrate contains 5.2 mg of caspofungin.
• The other components are sucrose, mannitol, glacial acetic acid and sodium hydroxide.

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

• The active substance is caspofungin. Each vial contains 70 mg of caspofungin (as acetate). After reconstitution in 10.5 ml, each ml of concentrate contains 7.2 mg of caspofungin.
• The other components are sucrose, mannitol, glacial acetic acid and sodium hydroxide.

Appearance of the product and contents of the container

Caspofungin Tevagen is a white to off-white lyophilized powder.

Each pack contains one vial (10 ml) of powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.
C/ Anabel Segura, 11 Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid
Spain

Manufacturer

Pharmathen S.A.
Dervenakion str., Pallini, Attiki
153 51, Greece

Or

Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta

Or

Merckle GmbH
Ludwig-Merckle-Strasse 3, Blaubeuren
Baden-Wuerttemberg
89143 Germany

Or

ELPEN PHARMACEUTICAL CO.
Marathonos Ave. 95, Pikermi Attiki,
19009 Greece

This medicinal product is authorised in EEA Member States under the following names:

Austria Caspofungin ratiopharm GmbH 50 mg Powder for a concentrate for solution for infusion
Caspofungin ratiopharm GmbH 70 mg Powder for a concentrate for solution for infusion

Belgium Caspofungin Teva Generics 50 mg powder for concentrate for solution for infusion / poudre pour solution à diluer pour perfusion / Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Caspofungin Teva Generics 70 mg powder for concentrate for solution for infusion / poudre pour solution à diluer pour perfusion / Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Croatia Kaspofungin Pliva 50 mg prašak za koncentrat za otopinu za infuziju
Kaspofungin Pliva 70 mg prašak za koncentrat za otopinu za infuziju

Denmark Caspofungin Teva B.V.

Estonia Caspofungin Teva Generics

France Caspofungine Teva Sante 50 mg poudre pour solution à diluer pour perfusion
Caspofungine Teva Sante 70 mg poudre pour solution à diluer pour perfusion

Germany Caspofungin-ratiopharm 50 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Caspofungin-ratiopharm 70 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Greece Caspofungin/Teva 50 mg κόνις για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Caspofungin/Teva 70 mg κόνις για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση

Hungary Caspofungin ratiopharm 50 mg por oldatos infúzióhoz való koncentrátumhoz
Caspofungin ratiopharm 70 mg por oldatos infúzióhoz való koncentrátumhoz

Italy Caspofungin Teva Italia

Lithuania Caspofungin Teva Generics 50 mg milteliai infuzinio tirpalo koncentratui
Caspofungin Teva Generics 70 mg milteliai infuzinio tirpalo koncentratui

Netherlands Caspofungine 50 mg Teva, poeder voor concentraat voor oplossing voor infusie
Caspofungine 70 mg Teva, poeder voor concentraat voor oplossing voor infusie

Poland Caspofungin Teva Pharmaceuticals

Portugal Caspofungina Teva

Slovenia Kaspofungin Teva 50 mg prašek za koncentrat za raztopino za infundiranje
Kaspofungin Teva 70 mg prašek za koncentrat za raztopino za infundiranje

Slovakia Caspofungin Teva B.V. 50 mg
Caspofungin Teva B.V. 70 mg

Spain Caspofungina Tevagen 50 & 70 mg polvo para concentrado para solución para perfusión EFG

United Kingdom Caspofungin Teva 50 mg & 70 mg Powder For Concentrate For Solution For Infusion

Date of most recent review of this leaflet: April 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Instructions for reconstitution and dilution of Caspofungin Tevagen:

Reconstitution of Caspofungin Tevagen

DO NOT USE DILUENTS CONTAINING GLUCOSE, as CASPOFUNGIN TEVAGEN is not stable in glucose-containing diluents. DO NOT MIX OR CO-ADMINISTER CASPOFUNGIN TEVAGEN WITH ANY OTHER MEDICATION, as compatibility data with other substances, additives, or intravenous pharmaceutical products are not available. The infusion solution should be inspected visually for particulate matter or discoloration.

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

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of 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 compact, white to off-white lyophilized powder will dissolve completely. Gently mix until a clear solution is obtained. Reconstituted solutions should be inspected visually for particulate matter or discoloration. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C.

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

Diluents for the final infusion solution are: Sodium Chloride Injection or Lactated Ringer's Injection. The infusion solution is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced-volume infusions of 100 ml may be used when 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 IN ADULTS

DOSE*	Volume of reconstituted Caspofungin Tevagen to transfer to an intravenous bag or vial	Standard preparation (Reconstituted Caspofungin Tevagen added to 250 ml) final concentration	Reduced volume infusion (Reconstituted Caspofungin Tevagen added to 100 ml) final concentration
50 mg	10 ml	0.20 mg/ml	-
50 mg in reduced volume	10 ml	-	0.47 mg/ml
35 mg for moderate hepatic impairment (from a 50 mg vial)	7 ml	0.14 mg/ml	-
35 mg for moderate hepatic impairment (from a 50 mg vial) in reduced volume	7 ml	-	0.34 mg/ml

*10.5 ml must be used for the reconstitution of 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)

Preparation of 70 mg/m² Infusion 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 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 Tevagen 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 or at 5 ± 3°C b. This will result in a final caspofungin concentration of 5.2 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 Tevagen into an IV bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted Caspofungin Tevagen may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Preparation of 50 mg/m² Infusion 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 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 Tevagen 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 or at 5 ± 3°C. This will result in a final caspofungin concentration of 5.2 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 Tevagen into an IV bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted Caspofungin Tevagen may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Preparation notes: a. The white to off-white cake will dissolve completely. Gently swirl until a clear solution is obtained. b. Visually inspect the reconstituted solution for the presence of particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or precipitated. c. Caspofungin Tevagen is formulated to provide the full dose from the vial stated in the product information (50 mg) when 10 ml are withdrawn from the vial.

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

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of the 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 compact, white to off-white lyophilized powder will dissolve completely. Gently mix until a clear solution is obtained. Reconstituted solutions should be inspected visually for particulate matter or discoloration. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C.

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

Diluents suitable for the final infusion solution are: sodium chloride injection or lactated Ringer's solution. The infusion solution is prepared by aseptically 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 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 if precipitation has occurred.

PREPARATION OF THE INFUSION SOLUTION IN ADULTS

DOSE*	Volume of reconstituted Caspofungin Tevagen to transfer to an intravenous bag or vial	Standard preparation (reconstituted Caspofungin Tevagen added to 250 ml) final concentration	Reduced volume infusion (reconstituted Caspofungin Tevagen added to 100 ml) final concentration
70 mg	10 ml	0.28 mg/ml	Not recommended
70 mg (from two 50 mg vials) **	14 ml	0.28 mg/ml	Not recommended
35 mg for moderate hepatic impairment (from one 70 mg vial)	5 ml	0.14 mg/ml	0.34 mg/ml

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

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

50 mg

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Body surface area (BSA) calculation for pediatric dosing

Prior to preparing the infusion, calculate the patient's body surface area (BSA) using the following formula: (Mosteller formula)

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

1. Determine the actual loading dose to be administered to 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.

1. Allow the refrigerated Caspofungin Tevagen vial to reach room temperature.
2. 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 or at 5 ± 3°C^a. This will result in a final caspofungin concentration of 7.2 mg/ml in the vial.
3. 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 Tevagen to an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution. Alternatively, the volume (ml)^c of reconstituted Caspofungin Tevagen may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution, provided the final concentration does not exceed 0.5 mg/ml. The infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

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

1. Determine the actual daily maintenance dose to be administered to 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.

1. Allow the refrigerated Caspofungin Tevagen vial to reach room temperature.
2. 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 or at 5 ± 3°C^b. This will result in a final caspofungin concentration of 7.2 mg/ml in the vial.
3. 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 Tevagen to an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution. Alternatively, the volume (ml)^c of reconstituted Caspofungin Tevagen may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer's solution, provided the final concentration does not exceed 0.5 mg/ml. The infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Preparation notes:

1. The white to off-white cake will dissolve completely. Gently mix until a clear solution is obtained.
2. Visually inspect the reconstituted solution for the presence of particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or if precipitation has occurred.
3. Caspofungin Tevagen 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.