Cancidas (previously Caspofungin MSD)
caspofungin
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor, nurse or pharmacist.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Cancidas is and what it is used for
What you need to know before you are given Cancidas
How to use Cancidas
Possible side effects
How to store Cancidas
Contents of the pack and other information
Cancidas contains a medicine called caspofungin. This belongs to a group of medicines called anti-fungals.
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 might get this type of infection include those who have just had an operation or those whose immune systems are weak. Fever and chills that do not respond to an antibiotic are
the most common signs of this type of infection.
fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis’) if other anti-fungal treatments have not worked or have caused side effects. This infection is caused by a mould called Aspergillus.
People who might get this type of infection include those having chemotherapy, those who have
had a transplant and those whose immune systems are weak.
suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic. People who are at risk of getting a fungal infection include those who have just had an operation or those whose immune systems are weak.
Cancidas makes fungal cells fragile and stops the fungus from growing properly. This stops the infection from spreading and gives the body’s natural defences a chance to completely get rid of the infection.
if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine.
Talk to your doctor, nurse or pharmacist before you are given Cancidas if:
you are allergic to any other medicines
you have ever had liver problems - you might need a different dose of this medicine
you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your
treatment.
if you have ever had any other medical problem.
If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.
Cancidas may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Please 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 Cancidas can affect the way some other medicines work. Also, some other medicines can affect the way Cancidas works.
Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
cyclosporin or tacrolimus (used to help prevent organ transplant rejection or to suppress your immune system) as your doctor may need to run extra blood tests during your treatment
some HIV medicines such as efavirenz or nevirapine
phenytoin or carbamazepine (used for the treatment of seizures)
dexamethasone (a steroid)
rifampicin (an antibiotic).
If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.
Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.
Cancidas has not been studied in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby.
Women given Cancidas should not breast-feed.
There is no information to suggest that Cancidas affects your ability to drive or operate machinery.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially
‘sodium-free’.
Cancidas will always be prepared and given to you by a healthcare professional. You will be given Cancidas:
once each day
by slow injection into a vein (intravenous infusion)
over about 1 hour.
Your doctor will determine the duration of your treatment and how much Cancidas you will be given each day. Your doctor will monitor how well the medicine works for you. If you weigh more than 80 kg, you may need a different dose.
The dose for children and adolescents may differ from the adult dose.
Your doctor will decide how much Cancidas you need and for how long each day. If you are worried that you may have been given too much Cancidas, tell your doctor or nurse straight away.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
rash, itching, feeling warm, swelling of your face, lips or throat or difficulty breathing - you may be having a histamine reaction to the medicine.
difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.
cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.
rash, skin peeling, mucous membrane sores, hives, large areas of peeling skin.
As with any prescription medicine, some side effects may be serious. Ask your doctor for more information.
Other side effects in adults include:
Decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white blood cells
Decreased blood 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
Diarrhoea, nausea or vomiting
Changes in some laboratory blood tests (including increased values of some liver tests)
Itching, rash, skin redness or sweating more than usual
Joint pain
Chills, fever
Itching at the injection site.
Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)
Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood
Disorientation, feeling nervous, being unable to sleep
Feeling dizzy, decreased feeling or sensitivity (especially in the skin), shaking, feeling sleepy, change in the way things taste, tingling or numbness
Blurred vision, increase in tears, swollen eyelid, yellowing of the whites of the eyes
Sensation of fast or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
Flushing, hot flush, high blood pressure, low blood pressure, redness along a vein which is extremely tender when touched
Tightening of the bands of muscle around the airways resulting in wheezing or coughing, fast breathing rate, shortness of breath that wakes you up, shortage of oxygen in the blood, abnormal
breath sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, throat pain
Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly
Decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a drug or chemical, liver disorder
Abnormal skin tissue, generalised itching, hives, rash of varying appearance, abnormal skin, red often itchy spots on your arms and legs and sometimes on the face and the 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
Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site
Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system
Chest discomfort, chest pain, feeling of body temperature change, generally feeling unwell, general pain, swelling of the face, swelling of the ankles, hands or feet, swelling, tenderness, feeling tired.
Fever
Headache
Fast heart beat
Flushing, low blood pressure
Changes in some laboratory blood tests (increased values of some liver tests)
Itching, rash
Catheter site pain
Chills
Changes in some laboratory blood tests.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 the vial (the first two numbers are the month; the next four numbers are the year). The expiry date refers to the last day of that month.
Store in a refrigerator (2C to 8C).
Once Cancidas has been prepared, it should be used straight away. This is because it does not contain any ingredients to stop the growth of bacteria. Only a trained healthcare professional who has read the
complete directions should prepare the medicine (please see below “Instructions of how to reconstitute
and dilute Cancidas”).
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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 ingredients are sucrose, mannitol (E421), glacial acetic acid and sodium hydroxide (please see section 2 What you need to know before you are given Cancidas).
Cancidas is a sterile, white to off-white compact powder. Each pack contains one vial of powder.
MarketingAuthorisationHolder Manufacturer
Merck Sharp & Dohme B.V. Merck Sharp & Dohme B. V.
Waarderweg 39 Waarderweg 39
2031 BN Haarlem 2031 BN Haarlem
The Netherlands The Netherlands or
FAREVA Mirabel Route de Marsat-Riom
63963 Clermont-Ferrand Cedex 9 France
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
MSD Belgium
Tél/Tel: +32(0)27766211
UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
MSD Belgium
Tél/Tel: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: +36 1 888 5300
MSD Danmark ApS Tlf: +45 44 82 40 00
Merck Sharp & Dohme Cyprus Limited Tel.: 8007 4433 (+ 356 99917558)
MSD Sharp & Dohme GmbH
Tel: 0800 673 673 673 (+49 (0) 89 4561 0)
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 (+31 23 5153153)
Merck Sharp & Dohme OÜ Tel.: +372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε
Τηλ: + 30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00
MSD France
Tél: + 33 (0) 1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333
Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
Vistor hf.
Sími: +354 535 7000
Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com
MSD Finland Oy
Puh/Tel: +358 (0) 9 804 650
Merck Sharp & Dohme Cyprus Limited
Τηλ.: 800 00 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 (0)77 5700488
SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224
Tel: +353 (0)1 2998700
Instructions of how to reconstitute and dilute CANCIDAS:
DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CANCIDAS is not stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER
MEDICINES, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products. Visually inspect the infusion solution for particulate matter or discolouration.
CANCIDAS50mgpowderforconcentrateforsolutionforinfusion
To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injection. The concentrations of the reconstituted vials will be 5.2 mg/ml.
The white to off-white compact lyophilised powder will dissolve completely. Mix gently until a clear solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or discolouration. This reconstituted solution may be stored for up to 24 hours at or below 25°C.
Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer’s solution. The solution for infusion 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 in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses. Do not use if the solution is cloudy or has precipitated.
DOSE* | Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle | 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 at reduced volume | 10 ml | - | 0.47 mg/ml |
35 mg for moderate hepatic impairment (from one 50 mg vial) | 7 ml | 0.14 mg/ml | - |
35 mg for moderate hepatic impairment (from one 50 mg vial) at reduced volume | 7 ml | - | 0.34 mg/ml |
10.5 ml should be used for reconstitution of all vials.
Calculation of Body Surface Area (BSA) for paediatric dosing
Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller2 Formula)
Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
BSA (m2) X 70 mg/m2 = Loading Dose
The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.
Equilibrate the refrigerated vial of CANCIDAS to room temperature.
Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of
5.2 mg/ml.
Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 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 stored refrigerated at 2 to 8°C.
Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.
Equilibrate the refrigerated vial of CANCIDAS to room temperature.
2 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)
Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of
5.2 mg/ml.
Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 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 stored refrigerated at 2 to 8°C.
CANCIDAS70mgpowderforconcentrateforsolutionforinfusion
To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injection. The concentrations of the reconstituted vials will be: 7.2 mg/ml.
The white to off-white compact lyophilised powder will dissolve completely. Mix gently until a clear solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or discolouration. This reconstituted solution may be stored for up to 24 hours at or below 25°C.
Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer’s solution. The solution for infusion 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 in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses. Do not use if the solution is cloudy or has precipitated.
DOSE* | Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle | 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 |
DOSE* | Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle | Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration | Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration |
35 mg for moderate hepatic impairment (from one 70 mg vial) | 5 ml | 0.14 mg/ml | 0.34 mg/ml |
10.5 ml should be used for reconstitution of all vials.
**If 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials.
Calculation of Body Surface Area (BSA) for paediatric dosing
Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula)
Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
BSA (m2) X 70 mg/m2 = Loading Dose
The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.
Equilibrate the refrigerated vial of CANCIDAS to room temperature.
Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of
7.2 mg/ml.
Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 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 stored refrigerated at 2 to 8°C.
Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.
Equilibrate the refrigerated vial of CANCIDAS to room temperature.
Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25°C.b This will give a final caspofungin concentration in the vial of
7.2 mg/ml.
Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers
3 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)
Injection, not to exceed a final concentration of 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 stored refrigerated at 2 to 8°C.
The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained.
Visually inspect the reconstituted solution for particulate matter or discolouration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.
CANCIDAS is formulated to provide the full labelled vial dose (70 mg) when 10 ml is withdrawn from the vial.