PATIENT INFORMATION LEAFLET

Cisplatin 50

cisplatin

Powder for Injection

PHARMACIA

What you should know about Cisplatin

Please read this leaflet carefully before receiving your medicine. This leaflet provides some useful information for you about your medicine. If you have any questions about anything, please ask your doctor or pharmacist. The information in this leaflet applies only to Cisplatin.

What is in your medicine?

Each vial contains 50 mg Cisplatin (a yellowish-white powder).

The vial also contains the inactive ingredients sodium chloride and mannitol.

Cisplatin is available as a single vial only.

Cisplatin is one of a group of medicines called cytotoxics, which are used to kill cells in tumours.

What is your medicine for?

Cisplatin is used to treat a wide range of tumours, in particular testicular, metastatic ovarian, cervical, lung and bladder cancer. Cisplatin can be given alone or in combination with other medicines.

Your doctor will be able to explain how Cisplatin might help in your particular condition.

How does your medicine work?

Cisplatin works by killing cells in the tumour.

Before receiving your medicine

If you can answer "YES" to any of the following questions, tell your doctor.

• Have you ever been sensitive to this medicine before?
• Do you have kidney disease?
• Do you have any hearing disorders?
• Are you taking any other medicines, in particular any one of a group of antibiotics known as aminoglycosides, cephaloridine (also an antibiotic) or any diuretics (drugs which gets rid of excess water from the body), for example frusemide?
• Have you received anti-tumour drugs before?
• Are you pregnant, trying to become pregnant now, or likely to want to try to become pregnant in the future?
• Are you breast-feeding?
• Are you taking aspirin or NSAIDS?
• Are you taking Bleomycin and/or Methotrexate?
• Are you taking Phenytoin?
• Are you receiving any drugs to treat gout?

How your medicine will be administered

Your medicine will be administered to you by injection under the direction of specialists.

The powder is dissolved in water to make a solution. This solution is then added to a salt solution, or to a sugar and salt solution, which is then given into the blood stream over a period of 6-8 hours in a drip.

The usual dose when given as a single agent is 50 - 120 mg for each square metre of your body surface area by infusion once every 3 - 4 weeks or 15 - 20 mg for each square metre of your body surface area by infusion daily for 5 days every 3-4 weeks.

When given with other medicines, the usual dose of Cisplatin is 20 mg for each square metre of your body surface area upwards every 3 - 4 weeks.

A lower dose will be given if you suffer with renal disease or decreased bone marrow function (not enough blood cells are being made).

You will receive 1-2 litres of fluid by infusion for 8 - 12 hours before you receive your Cisplatin, to initiate diuresis (increase frequency and volume of urine). Adequate fluid levels will be given to maintain diuresis during the 24 hours after receiving Cisplatin.

What might happen while you are receiving your medicine

Cisplatin can cause the following side-effects:

• Nausea, vomiting and loss of appetite.
• Cisplatin can damage your kidneys e.g. kidney problems resulting in reduced function. Blood tests will be done by your doctor for raised blood levels of urea, creatinine, uric acid and reduced clearance.
• Blood problems such as decreased number of formed white and red blood cells and anaemia which might make you more susceptible to infection and bleeding (blood tests will be done by your doctor).
• Hearing problems including tinnitus (a "ringing" in the ears) and some loss of hearing. The "ringing" in the ears usually disappears after a while.
• Tingling, pins and needles or loss of feeling in the arms and legs.
• Shaking.
• A loss of taste.
• Some loss of vision, blurring of vision, change in colour perception which returns when Cisplatin treatment is stopped.
• Allergic symptoms such as flushing, wheezing, rash and swelling of the face, decreased blood pressure and increased heart rate.
• Convulsions, seizures, and/or slurred speech might happen.
• You may have decreased levels of the mineral magnesium and/or sodium in your blood.
• The drug may cause raised blood levels of uric acid. You may be given a drug called allopurinol to counteract this.
• You may notice that the rate that your heart beats changes.
• Low blood pressure
• Mild hair loss
• Muscle aches
• Changes to your gums
• Cancer patients including those receiving Cisplatin are generally at an increased risk for thromboembolic events, including stroke.
• Inflammation at the site of injection

It is important that your liver is monitored regularly during the course of your treatment. Please discuss this with your doctor.

Caution should be taken when driving and operating machinery.

Cisplatin can affect male fertility. Please contact your doctor for more information.

If you suffer from these or any other unwanted effects during or after treatment with Cisplatin, tell your doctor.

Storing your medicine

Cisplatin should not be used after the expiry date printed on the box and on the vial.

The unopened vials should be stored at room temperature