CANCIDAS 50 mg powder for concentrate for solution for infusion
Caspofungin (as acetate)
Read all of this leaflet carefully before you or your child start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What CANCIDAS is and what it is used for
- 2. Before you take CANCIDAS
- 3. How to take CANCIDAS
- 4. Possible side effects
- 5. How to store CANCIDAS
- 6. Further information
What Cancidas Is And What It Is Used For
CANCIDAS is an antifungal medicine that interferes with the production of a component (glucan polysaccharide) of the fungal cell wall that is necessary if the fungus is to continue living and growing. Fungal cells exposed to CANCIDAS have incomplete or defective cell walls, making them fragile and unable to grow.
CANCIDAS may have been prescribed to treat a serious fungal infection called invasive candidiasis. The infection is caused by fungal (yeast) cells called Candida. These yeast cells are normally found in the digestive tract, and do not cause an infection unless they enter the bloodstream (in which case the infection is referred to as candidaemia) or other tissues or organs, such as the lining of the abdomen (peritonitis), the heart, the kidneys, the liver, bones, muscles, joints, spleen, or eyes. Persons at high risk for invasive candidiasis include surgical patients and those whose immune systems are deficient. Fever and chills that do not respond to antibacterial therapy are the most common symptoms of this type of infection.
Alternatively, your doctor may have prescribed CANCIDAS to treat a fungal infection in your nose, nasal sinuses, or lungs because other antifungal treatments have not been working as well as expected or because the other antifungal treatments are causing side effects. This infection is caused by organisms called Aspergillus. Aspergillus fungal infections begin in the respiratory system (in the nose, sinuses, or lungs) because the spores of the fungus are found in the air we breathe every day. This infection is named invasive aspergillosis. It is possible for the fungus to spread to other tissues and organs. In most healthy individuals, the natural ability to fight disease destroys the spores and removes them from the body. Some medical conditions lower the body’s resistance to diseases. Also, certain medicines prescribed for patients who are organ or bone marrow recipients lower the body’s resistance to diseases. These are the patients who are most likely to develop an Aspergillus infection.
Persistent fever due to infection may occur following chemotherapy or medical conditions that lower the body’s resistance to disease by lowering counts of certain white blood cells. If the fever is not reduced by treatment with an antibiotic, your doctor may suspect that you have a fungal infection and prescribe CANCIDAS to treat it.
Before You Take Cancidas
Do not take CANCIDAS
- if you are hypersensitive (allergic) to caspofungin or any of the other ingredients of CANCIDAS.
Take special care with CANCIDAS
- if you have had or now have liver problems. Some patients with liver problems may require a dosage adjustment.
- if you are taking ciclosporin, a medicine to help prevent organ transplant rejection or to treat certain problems with your immune system. Your physician may order additional blood tests during your treatment.
- if you have any allergies.
Tell your doctor about any medical conditions you have or have had.
Children and Adolescents
CANCIDAS has been approved for use in children and adolescents for all the infection types described above. The dose used in paediatric patients may differ from the dose used in adult patients.
Taking other medicines
Your physician will determine if any adjustments should be made to other medicines you may be taking. If you are receiving ciclosporin, your physician may order additional blood tests during your treatment.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. It is particularly important for your doctor to know if you are taking certain anti-HIV medicines (including efavirenz or nevirapine), the antiseizure (epilepsy) medicines phenytoin and carbamazepine, the steroid dexamethasone, the antibiotic rifampicin, and the immunosuppressant tacrolimus.
Pregnancy and breastfeeding
CANCIDAS has not been studied in pregnant women, and should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Women receiving CANCIDAS should not breast-feed.
Ask your doctor for advice before taking any medicine.
Driving and using machines
There is no information to suggest that CANCIDAS affects your ability to drive or operate machinery.
Important information about some of the ingredients of CANCIDAS
CANCIDAS contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How To Take Cancidas
CANCIDAS will always be prepared and given to you by a doctor or another healthcare professional.
CANCIDAS should be administered once daily by slow intravenous infusion over approximately 1 hour.
Your physician will determine the duration of your treatment and how much CANCIDAS you will receive each day. He will monitor your response and condition. The dose will not need to be adjusted according to your age or if you are suffering from renal impairment. If you weigh more than 80 kg, a dose adjustment may be required.
If you take more CANCIDAS than you should
Your doctor will monitor your response and condition to determine what CANCIDAS treatment is needed. However, if you are concerned that you may have been given too much CANCIDAS, contact your doctor or another healthcare professional immediately.
If you miss/forget to take a dose of CANCIDAS
Your doctor will monitor your response and condition to determine what CANCIDAS treatment is needed. However, if you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
If you stop taking CANCIDAS
There are no known withdrawal symptoms.
Possible Side Effects
Like all medicines, CANCIDAS can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported.
Very Common (occurring in at least 1 in 10 patients treated)
Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated)
Uncommon (occurring in at least 1 of 1,000 and less than 1 of 100 patients treated)
Rare (occurring in at least 1 of 10,000 and less than 1 of 1,000 patients treated)
Not known (cannot be estimated from the available data)
Adults 18 years of age or older:
Blood and lymphatic system disorders:
Uncommon: alterations in some laboratory blood tests (including decrease in red blood cell count)
Metabolism and nutrition disorders:
Common: low potassium levels in the blood
Uncommon: increase in amount of body fluid, loss of appetite, imbalance of salt in the body, low magnesium levels in the blood, high sugar level in the blood, low calcium level in the blood, increase in acid level in the blood
Psychiatric disorders:
Uncommon: nervousness, disorientation, inability to sleep
Nervous system disorders:
Common: headache
Uncommon: dizziness, taste disturbance, tingling or numbness, sleepiness, shaking, decreased feeling or sensitivity (especially in the skin)
Eye disorders:
Uncommon: yellowing of the whites of the eyes, blurred vision, swollen eyelid, increase in tears
Cardiac disorders:
Uncommon: sensation of fast or irregular heart beats, rapid heart beat, irregular heart beat, abnormal heart rhythm, heart failure
Vascular disorders:
Common: inflammation of vein
Uncommon: swelling and redness along a vein which is extremely tender when touched, flushing, hot flush, high blood pressure, low blood pressure
Respiratory, thoracic and mediastinal disorders:
Common: shortness of breath
Uncommon: blocked nose, pain in throat area, fast breathing rate, tightening of the bands of muscle around the airways resulting in wheezing or coughing, cough, shortness of breath that awakens the patient during sleep, shortage of oxygen in the body, crackling sounds in the lungs, wheezing
Gastrointestinal disorders:
Common: nausea, vomiting, diarrhoea
Uncommon: belly pain, upper belly pain, dry mouth, indigestion, stomach discomfort, bloating, swelling due to build-up of fluid around the belly, constipation, difficulty swallowing, passing gas
Hepatobiliary disorders:
Common: alterations in some laboratory blood tests (including increased values of some liver tests)
Uncommon: decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, chemical-driven liver damage, liver disorder
Skin and subcutaneous tissue disorders:
Common: rash, itching, excessive sweating, skin redness
Uncommon: red often itchy spots on the limbs and sometimes on the face and the rest of the body, rash of varying appearance, hives, generalised itching, abnormal skin tissue
Musculoskeletal and connective tissue disorders:
Common: joint pain
Uncommon: back pain, pain in limb, bone pain, muscular weakness, muscle pain
Renal and urinary disorders:
Uncommon: loss of kidney function, sudden loss of kidney function
General disorders and administration site conditions:
Common: fever, chills, itching at the injection site
Uncommon: pain, catheter site pain, fatigue, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives), inflammation of vein at injection site, swelling in limbs, tenderness, chest discomfort, chest pain, swelling of the face, feeling of body temperature change, generally feeling unwell, swelling
Investigations:
Common: alterations in some laboratory blood tests (including increased values of some kidney tests)
Children and adolescents (12 months to 17 years of age):
Nervous system disorders:
Common: headache
Cardiac disorders:
Common: rapid heart beat
Vascular disorders:
Common: flushing, low blood pressure
Hepatobiliary disorders:
Common: alterations in some laboratory blood tests (increased values of some liver tests)
Skin and subcutaneous tissue disorders:
Common: rash, itching
General disorders and administration site conditions:
Very common: fever
Common: chills, catheter site pain
Investigations:
Common: alterations in some laboratory blood tests
Possible histamine-mediated symptoms have been reported including reports of rash, swelling of the face and/or lips, itching, sensation of warmth, or trouble breathing.
Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have also been reported rarely during administration of CANCIDAS. Other side effects may also occur rarely, and as with any prescription medicine, some side effects may be serious. Ask your doctor for more information.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Cancidas
Keep out of the reach and sight of children.
Do not use CANCIDAS after the expiry date which is stated on the carton and vial. The first 2 numbers indicate the month; the next 4 numbers indicate the year. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C to 8°C).
Reconstituted CANCIDAS should be used immediately because it does not contain any preservatives to prevent bacterial contamination. Only a trained healthcare professional who has read the complete directions (please see below “Instructions of how to reconstitute and dilute CANCIDAS”) can properly prepare this medicine for use.
Further Information
What CANCIDAS contains
The active substance of CANCIDAS is caspofungin (as acetate).
The other ingredients are: sucrose, mannitol, glacial acetic acid, and sodium hydroxide.
What CANCIDAS looks like and contents of the pack
CANCIDAS is a sterile, white to off-white, freeze-dried compact powder.
Each pack contains one vial containing 50 mg Caspofungin (as acetate).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Product Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
Merck Sharp and Dohme Limited
Tel: +44 (0) 1992 467272
medinfo_uk@merck.com
This leaflet was last approved in March 2010
denotes registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA.
© Merck Sharp & Dohme Limited 2010. All rights reserved.
PIL.CANC.10.UK.3223A (II-039)
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