patient information leaflet cancidas 50 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANCIDAS® 50 mg powder for concentrate for solution for infusion

Caspofungin (as acetate)

Read all of this leaflet carefully before you 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. 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

1. 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.

2. 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

CANCIDAS should not be used in patients under 18 years of age.

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 you 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.

3. 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.

4. WHAT 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 1of 1000 and less than 1 of 100 patients treated)
Rare (occurring in at least 1 of 10,000 and less than 1 of 1000 patients treated)
Not known (cannot be estimated from the available data)

Nervous system disorders:

Common: headache

Cardiac disorders:

Common: rapid heart beat

Not known: swelling of the hands, ankles or feet

Vascular disorders:

Common: flushing

Respiratory, thoracic and mediastinal disorders:

Common: shortness of breath

Gastrointestinal disorders:

Common: stomach pain, nausea, vomiting, diarrhoea

Skin and subcutaneous tissue disorders:

Common: rash, itching, sweating

General disorders and administration site conditions:

Very common: fever

Common: pain, chills, vein irritations at the infusion site (including itching, redness, discharge, swelling, burning sensation, or clotting)

Hepato biliary disorders

Rare: impaired liver function

Investigations:

Common: alterations in some laboratory blood tests (including decreased red blood cell count and increased values of some liver and kidney tests)

Uncommon: high calcium.

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 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.

5. 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 the 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.

6. 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).

Medicine: cancidas 50 mg