Gemzar 1g

What is in your medicine?

Your medicine is called Gemzar 1 g powder for solution for infusion. Its active ingredient is gemcitabine hydrochloride. Gemzar also contains the inactive ingredients mannitol and sodium acetate. Hydrochloric acid or sodium hydroxide (or both) may have been used during manufacture to adjust acidity.

Your medicine came from a glass bottle supplied to the hospital containing 1 gram of gemcitabine hydrochloride powder.

A hospital pharmacist, nurse or doctor will have dissolved the Gemzar powder in sterile sodium chloride solution. This liquid is then passed from a bag or pump through a tube and needle into one of your veins. This is called an 'intravenous infusion'.

Gemzar is a 'cytotoxic' drug. Cytotoxic drugs kill cells which are dividing, including cancer cells.

Gemzar 1 g vials are made by Vianex S.A., Pallini Attikis, 15351 Greece or Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France and released onto the market by Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France. The marketing authorisation holder is Eli Lilly and Company Limited, Basingstoke, RG21 6XA, England.

Why Gemzar?

Gemzar is used to treat patients who have bladder cancer, lung cancer (of the 'non-small cell' type), or cancer of the pancreas or breast. If your doctor gives you this medicine for anything else, ask him or her any questions you have about it.

Before you are treated with Gemzar

Your doctor will make sure it is safe for you to have Gemzar. Children should not have Gemzar.

If you answer YES to any of the following questions, or you are not sure, tell your doctor, nurse or pharmacist.

• Have you ever had an allergic reaction to Gemzar? (An allergic reaction may include rash, itching, swelling or breathing difficulties.)
• Are you pregnant or could you be?
• Are you breast-feeding?
• Do you have, or have you ever had, kidney trouble or liver trouble? (liver trouble may include hepatitis, alcoholism or cancer of the liver).

These are some of the things your doctor will have thought about:

If you have a long infusion injection or a lot of injections (more than once a week) it may cause side effects.

Gemzar and most other cytotoxic drugs may affect the cells in your bone marrow. These cells divide very quickly to make new blood cells. Your doctor or nurse will take samples of your blood when you are treated with Gemzar. The hospital's laboratory will count the number of each different type of blood cell (platelets, white cells and red cells). Your doctor may decide to change the dose or put off treating you if your blood cell counts are too low. Your blood cell counts soon improve as your bone marrow makes new cells.

The laboratory will also check that your liver and kidneys are working normally because these remove Gemzar from the body. If they are not getting rid of it quickly enough your doctor may decide to stop giving you Gemzar.

Do not drive or use dangerous machinery if you feel tired.

How Gemzar is used to treat you

Usual dose

• 1,000 - 1,250 milligrams for every square metre of your body's surface area.

Your nurse will measure your height and weight and work out the surface area of your body from these measurements. Your doctor will use this body surface area to work out the right dose for you.

The doctor or nurse will then inject the right amount of Gemzar solution into a vein over 30 minutes to one hour. The length and timing of your injections will depend on what you are being treated for. You will have 'treatment cycles' of weekly injections followed by a break.

• For lung or bladder cancer this will mean weekly injections for two or three weeks followed by a two-week break before you are next treated with Gemzar. You may be given another drug called cisplatin while you are being treated with Gemzar.
• For pancreas cancer you will have weekly injections for seven weeks followed by a two-week break before you are next treated with Gemzar. You will then have weekly injections for three weeks followed by a two-week break.
• For breast cancer you will have weekly injections for two weeks followed by a two-week break before you are next treated with Gemzar. You will also be given another drug called paclitaxel while you are being treated with Gemzar.

The picture shows an example of two 'treatment cycles', each with three injections and a break.

• You may get more than two 'treatment cycles'.
• Gemzar must only go into a vein.
• If you are being treated as an out-patient it is important that you go to the clinic for all your appointments.

While you are being treated

Gemzar may cause some side effects.

• Very common side effects (occurring in more than 1 in 10 patients) include: low blood cell counts (these may cause symptoms such as fever, a sore throat, rash, nose bleeds or bruising); shortness of breath; feeling or being sick; losing some of your hair (usually mild with minimal hair loss); skin rashes (some may be itchy, but they are usually mild - more serious allergic reactions are very rare); kidney test changes (you may get protein or blood in your urine - but kidney failure is rare); fluid retention (swelling in your hands, feet, legs); a flu-like condition which doesn't last long (fever, headache, pains and so on); changes in your liver test results.
• Common side effects (occurring in more than 1 in 100 and less than 1 in 10 patients) include: feeling tired or sleepy; feeling feverish or shivery; diarrhoea; constipation; sore mouth, lips or tongue, mouth ulcers; fever.
• Uncommon side effects (occurring in less than 1 in 100 and more than 1 in 1,000 patients) include: wheezing.
• Rare side effects (occurring in less than 1 in 1,000 patients) include: more serious effects on your breathing; skin rashes/ulcers; redness, swelling or itching around the area of the injection; kidney failure; liver enzyme test changes (you may get increased levels of certain liver enzymes); low blood pressure (feeling faint).
• Very rare side effects (occurring in less than 1 in 10,000 patients) include: severe peeling or inflammation of the skin; serious allergic reactions (the symptoms of an allergic reaction may include rash, changes in blood pressure, swelling and increased fluid in tissues, an increased heart rate, difficulty with breathing and collapse); liver failure; increase in blood platelets; heart failure, fast or irregular heart beat, heart attack; problems with blood flow to the limbs (this can be felt as numbness, tingling, coldness or loss of sensation). If this is particularly bad or lasts for a long time, permanent damage to the tissues can result. If you experience any of these symptoms, tell your Doctor or Nurse without delay.

Your doctor should be able to give you something to treat any sickness or rash.

• If you have these or any other side effects, tell your doctor. He or she has more information about Gemzar and will tell you what to do.

How your medicine is stored

The hospital pharmacy should keep the bottles of Gemzar at room temperature (15-25°C).They should not use a bottle after the 'Use before' date.

When Gemzar has been dissolved, the hospital should use it within 6 hours. The Gemzar solution should be kept at room temperature during that time. It should not be kept in a fridge.

Therapeutic indications

Non-Small Cell Lung Cancer:

Gemcitabine, in combination with cisplatin, is indicated as a first-line treatment of patients with locally advanced (inoperable Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.

Gemcitabine is indicated for the palliative treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.

Pancreatic Cancer:

Gemcitabine is indicated for the treatment of adult patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine is indicated for patients with 5-FU refractory pancreatic cancer.

Bladder Cancer:

Gemcitabine is indicated for treatment of advanced bladder cancer (muscle invasive Stage IV tumours with or without metastases) in combination with cisplatin therapy.

Breast Cancer:

Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.