Cancidas 50 mg powder for concentrate for solution for infusion
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
Cancidas 50mg powder for concentrate for solution for infusion
Cancidas 70mg powder for concentrate for solution for infusion
caspofungin
Read the entire leaflet carefully before you or your child start using 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, consult your doctor, pharmacist, or nurse.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Cancidas is and what it is used for
- What you need to know before using Cancidas
- How to use Cancidas
- Possible side effects
- How to store Cancidas
- Contents of the pack and other information
1. What Cancidas is and what it is used for
What is Cancidas
Cancidas contains a medicine called caspofungin. It belongs to a group of medicines known as antifungals.
What Cancidas is used for
Cancidas 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.
- suspected fungal infections if 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 Cancidas works
Cancidas 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 using Cancidas
Do not use Cancidas
- 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 starting to use Cancidas 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 Cancidas.
Cancidas may also cause serious skin reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Cancidas
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This includes over-the-counter medications, including herbal medicines. This is because Cancidas may affect how other medicines work. Likewise, other medicines may affect how Cancidas works.
Tell 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 Cancidas.
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.
- Cancidas has not been studied in pregnant women. It should only be used during pregnancy if the potential benefit justifies the potential risk to the unborn baby.
- Women receiving Cancidas must not breast-feed.
Driving and using machines
There is no information suggesting that Cancidas affects the ability to drive or operate machinery.
Cancidas contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial; essentially "sodium-free".
3. How to use Cancidas
Cancidas will always be prepared and administered by a healthcare professional.
Cancidas 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 Cancidas 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 in adults.
If you are given more Cancidas than you should
Your doctor will decide how much Cancidas you need and for how long each day. If you are concerned that you may have been given too much Cancidas, inform your doctor or nurse immediately.
If you have any 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 experiences 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 your face, lips or throat, or breathing difficulties: you may be having a histamine 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 further 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
- Vein inflammation
- 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 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, imbalance of body salts, high blood sugar level, low blood calcium level, high blood calcium level, low magnesium levels in the blood, increased level 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, shortness of breath causing awakening, low oxygen 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, flatulence, 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 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, injection site symptoms (redness, hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from the catheter into tissue), vein inflammation 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, feeling generally unwell, general pain, facial swelling, swelling of ankles, hands or feet, swelling, tenderness on palpation, feeling tired.
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
- 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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cancidas
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 on the vial (the first two digits indicate the month; the following four digits indicate the year). The expiry date refers to the last day of that month.
Store in a refrigerator (between 2 °C and 8 °C).
Once Cancidas has been prepared, it should be used immediately. This is because it does not contain any component to prevent bacterial growth. Only a trained healthcare professional who has read the complete instructions should prepare the medicine (see below “Instructions for reconstituting and diluting Cancidas”).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cancidas
- The active substance is caspofungin.
Cancidas 50 mg powder for concentrate for solution for infusion
Each vial of Cancidas contains 50 mg of caspofungin.
Cancidas 70 mg powder for concentrate for solution for infusion
Each vial of Cancidas contains 70 mg of caspofungin.
- The other components are sucrose, mannitol (E-421), glacial acetic acid, and sodium hydroxide (see section 2, "What you need to know before you start using Cancidas").
Nature of the product and pack contents
Cancidas is a compact, sterile, white to off-white powder.
Each pack contains one vial of powder.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem Netherlands | Manufacturing Responsible Person Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem Netherlands or FAREVA Mirabel Route de Marsat-Riom 63963 Clermont-Ferrand Cedex 9 France |
You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:
Belgium/Belgium/Belgium MSD Belgium Tel/Tel: +32(0)27766211 | Lithuania UAB Merck Sharp & Dohme Tel. +370 5 2780 247 |
| Luxembourg/Luxembourg MSD Belgium Tel/Tel: +32(0)27766211 |
Czech Republic Merck Sharp & Dohme s.r.o. Tel.: +420 277 050 000 | Hungary MSD Pharma Hungary Kft. Tel.: +36 1 888 5300 |
Denmark MSD Danmark ApS Tlf.: +45 4482 4000 | Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) |
Germany MSD Sharp & Dohme GmbH Tel.: +49 (0) 89 20 300 4500 | Netherlands Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) |
Estonia Merck Sharp & Dohme OÜ Tel: +372 614 4200 | Norway MSD (Norge) AS Tlf: +47 32 20 73 00 |
Greece MSD Α.Φ.Ε.Ε. Tel: +30 210 98 97 300 | Austria Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 |
Spain Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 | Poland MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 |
France MSD France Tel: +33 (0)1 80 46 40 40 | Portugal Merck Sharp & Dohme, Lda Tel.: +351 21 4465700 |
Croatia Merck Sharp & Dohme d.o.o. Tel: +385 1 6611 333 | Romania Merck Sharp & Dohme Romania S.R.L. Tel.: +40 21 529 29 00 |
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 | Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 520 4201 |
Iceland Vistor ehf. Tel: +354 535 7000 | Slovakia Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 |
Italy MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) | Finland MSD Finland Oy Tel: +358 (0)9 804 650 |
Cyprus Merck Sharp & Dohme Cyprus Limited Tel: 800 00 673 (+357 22866700) | Sweden Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 |
Latvia SIA Merck Sharp & Dohme Latvia Tel.: +371 67025300 |
Date of the most recent review of this summary:
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
This information is intended for healthcare professionals only:
Instructions for reconstituting and diluting CANCIDAS:
Reconstitution of CANCIDAS
DO NOT USE DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose. DO NOT MIX OR CO-ADMINISTER CANCIDAS WITH ANY OTHER MEDICATION, as data on compatibility of CANCIDAS with other substances, additives, or intravenous pharmaceutical preparations are not available. The infusion solution should be inspected visually for solid particles or discoloration.
CANCIDAS 50 mg powder for concentrate for solution for infusion
INSTRUCTIONS FOR USE IN ADULT PATIENTS (50 mg vial)
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 white to off-white lyophilized powder will dissolve completely. Gently mix until a clear solution is obtained. Reconstituted solutions should be inspected visually for 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 CANCIDAS to the patient's infusion solution
Diluents suitable 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 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 contains precipitate.
50 mg VIAL: PREPARATION OF INFUSION SOLUTION IN ADULTS
DOSE* | Volume of reconstituted CANCIDAS to transfer to an intravenous bag or vial | Standard preparation (reconstituted CANCIDAS added to 250 ml), final concentration | Reduced volume infusion (reconstituted CANCIDAS 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 reconstitution of all vials.
DOSING INSTRUCTIONS FOR PEDIATRIC PATIENTS (50 mg vial)
Calculation of Body Surface Area (BSA) for Pediatric Dosing
Prior to 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 50 mg vial)
- 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.
- Allow the refrigerated CANCIDAS vial to reach room temperature.
- 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 5.2 mg/ml in the vial.
- Withdraw from the vial a volume of medication equal to the calculated loading dose (Step 1). Aseptically transfer this volume (ml)c of reconstituted CANCIDAS into an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted CANCIDAS may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or Lactated Ringer's solution, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 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 50 mg vial)
- 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.
- Allow the refrigerated CANCIDAS vial to reach room temperature.
- 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 5.2 mg/ml in the vial.
- 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 CANCIDAS into an IV bag (or vial) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or Lactated Ringer's solution. Alternatively, the volume (ml)c of reconstituted CANCIDAS may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride injection solution, or Lactated Ringer's solution, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25 °C, or within 48 hours if refrigerated between 2 and 8 °C.
Preparation notes:
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CANCIDAS 70mg powder for concentrate for solution for infusion
INSTRUCTIONS FOR USE IN ADULT PATIENTS (70mg vial)
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 white to off-white compact lyophilized powder will dissolve completely. Gently swirl until a clear solution is obtained. Reconstituted solutions should be inspected visually for the presence of particulate matter 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 CANCIDAS to the patient's infusion solution
Diluents for the final infusion solution are: sodium chloride solution for 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, when medically necessary, for daily doses of 50 mg or 35 mg. Do not use if the solution is cloudy or if precipitation has occurred.
70mg VIAL: PREPARATION OF THE INFUSION SOLUTION IN ADULTS
DOSE* | Volume of reconstituted CANCIDAS to transfer to an intravenous bag or vial | Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration | Reduced volume infusion (reconstituted CANCIDAS 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 reconstitution of all vials
**If the 70 mg vial is not available, the 70 mg dose may be prepared from two 50 mg vials
DIRECTIONS FOR USE IN PEDIATRIC PATIENTS (70 mg vial)
Calculation of body surface area (BSA) for pediatric dosing
Prior to preparing the infusion, calculate the patient's body surface area (BSA) using the following formula: (Mosteller formula[2])
Preparation of 70 mg/m² infusion for pediatric patients >3 months (using one 70 mg vial)
- 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.
- Allow the refrigerated CANCIDAS vial to reach room temperature.
- Aseptically add 10.5 ml of Water for Injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25 °C.b The final concentration of caspofungin in the vial will be 7.2 mg/ml.
- Withdraw from the vial a volume of medication equal to the calculated loading dose (Step 1). Aseptically transfer this volume (ml)c of reconstituted CANCIDAS 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 CANCIDAS 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. This infusion solution should 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 50 mg/m² infusion for pediatric patients >3 months (using one 70 mg vial)
- 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.
- Allow the refrigerated CANCIDAS vial to reach room temperature.
- Aseptically add 10.5 ml of Water for Injections.a This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25 °C.b The final concentration of caspofungin in the vial will be 7.2 mg/ml.
- 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 CANCIDAS 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 CANCIDAS 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. This infusion solution should 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:
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[1] Mosteller RD: Simplified Calculation of Body Surface Area*. N Engl J Med* 1987 Oct 22;317(17):1098 (letter)
[2] Mosteller RD: Simplified Calculation of Body Surface Area*. N Engl J Med* 1987 Oct 22;317(17):1098 (letter)