Caspofungin Dr. Reddy's 70 mg Concentrate For Solution For Infusion

Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.

• 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 is in this leaflet

1. What Caspofungin is and what it is used for
2. What you need to know before you are given Caspofungin
3. How to use Caspofungin
4. Possible side effects
5. How to store Caspofungin
6. Contents of the pack and other information

What Caspofungin is

Caspofungin contains a medicine called caspofungin. This belongs to a group of medicines called antifungals.

What Caspofungin 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 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.

How Caspofungin works

Caspofungin 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.

Do not use Caspofungin

• 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.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you are given Caspofungin 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 Caspofungin.

Caspofungin may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other medicines and Caspofungin

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 Caspofungin can affect the way some other medicines work. Also some other medicines can affect the way Caspofungin 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 Caspofungin.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.

• Caspofungin 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 Caspofungin should not breast-feed.

Driving and using machines

There is no information to suggest that Caspofungin affects your ability to drive or operate machinery.

Children and adolescents

The dose for children and adolescents may differ from the adult dose.

If you have been given more Caspofungin than you should

Your doctor will decide how much Caspofungin you need and for how long each day. If you are worried that you may have been given too much Caspofungin, tell your doctor or nurse straight away.

Tell your doctor or nurse straight away if you notice any of the following side effects – you may need urgent medical treatment:

• 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

Common: may affect up to 1 in 10 people:

• 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.

Uncommon: may affect up to 1 in 100 people:

• 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 in 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 heart beats, rapid heart beat, irregular heart beat, 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.

Side 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
• 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.

Reporting of side effects

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 Yellow Card Scheme, website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

What Caspofungin contains

• The active substance is caspofungin. Each vial of Caspofungin contains 70 mg of caspofungin (as acetate). The concentration of the reconstituted vials is 7.2 mg/ml.
• The other ingredients are sucrose, mannitol, glacial acetic acid and sodium hydroxide (please see section 2. What you need to know before you are given Caspofungin).

What Caspofungin looks like and contents of the pack

Caspofungin is a sterile, white to off-white compact powder in a glass vial with a rubber stopper and a yellow aluminium cap.

Each pack contains one vial of powder.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer