How does it work?

Gemzar infusion contains the active ingredient gemcitabine, which is a type of chemotherapy medicine for cancer known as a 'cytotoxic antimetabolite'.

Cancers form when cells within the body multiply abnormally and uncontrollably. These cells spread, destroying nearby tissues. Gemcitabine works by stopping the cancer cells from multiplying. It does this by being incorporated into the cells' genetic material, DNA and RNA. Both DNA and RNA are needed for cells to grow, repair themselves and multiply. Gemcitabine causes problems with the production of DNA and RNA in the cancer cells, and this causes the cells to grow in an unbalanced way, resulting in the death of the cells.

Unfortunately, gemcitabine can also affect normal, healthy cells, particularly those that multiply quickly, such as blood cells and hair cells. The most important side effect is on the bone marrow where blood cells are made. Gemcitabine can decrease the production of blood cells, leaving people susceptible to infection. Regular blood tests are therefore needed to monitor the levels of blood cells.

In most chemotherapy regimens, doses are administered in courses at various intervals to allow normal cells to recover from the adverse effects of the anticancer medicines between doses. However, during this period, cancer cells will also recover and start to replicate again. Successful treatment depends on the administration of the next course of therapy before the cancer has regrown to its previous size, with the aimed net effect to decrease the amount of cancer with each successive course of chemotherapy.

Gemcitabine is given by a drip into a vein (intravenous infusion) over 30 to 60 mintues.

What is it used for?

• Non-small cell lung cancer that is locally advanced, or has spread to other areas of the body (usually used in combination with another chemotherapy medicine called cisplatin)
• Cancer of the pancreas that is locally advanced, or has spread to other areas of the body
• Advanced bladder cancer (used in combination with another chemotherapy medicine called cisplatin)
• Breast cancer that has spread to other areas of the body, in people whose cancer has relapsed following previous chemotherapy (used in combination with another chemotherapy medicine called paclitaxel)

Warning!

• This medicine might make you feel sleepy. You should avoid driving or operating machinary until you know how this medicine affects you and you are sure it won't affect your performance.
• Tell your doctor if you experience any difficulty breathing or shortness of breath during treatment with this medicine.
• Chemotherapy medicines can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• You will also need regular blood tests to monitor your kidney and liver function while you are receiving treatment with this medicine.
• Your ability to become pregnant or father a child may be affected by this medicine. It is important to discuss fertility with your doctor before starting treatment.

Use with caution in

• Decreased production of blood cells by the bone marrow
• Decreased kidney function
• Decreased liver function
• People with cancer that has spread to the liver
• History of liver inflammation (hepatitis)
• History of alcoholism
• History of liver cirrhosis
• People also having radiotherapy.

Not to be used in

• Pregnancy
• Breastfeeding
• The safety and efficacy of this medicine have not been established in children. It is not recommended for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should not be used in pregnancy because it may be harmful to a developing baby. Women who could get pregnant should use effective contraception while having treatment with this medicine and for at least a few months afterwards. Seek medical advice from your doctor.
• This medicine should not be used during breastfeeding because it may be harmful to a nursing infant. Mothers who need treatment with this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Nausea and vomiting
• Abnormal liver function tests
• Presence of protein or blood in the urine
• Shortness of breath
• Allergic skin rash or itching
• Cold or flu-like symptoms
• Retention of fluid in the body that may cause swelling (oedema) of the face or legs
• Mild hair loss
• Sleepiness
• Feeling of weakness
• Mouth ulcers
• Diarrhoea or constipation
• Decrease in the number of white blood cells in the blood (neutropenia)
• Decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of red blood cells in the blood (anaemia)
• Low blood pressure
• Accumulation of fluid in the lungs (pulmonary oedema)
• Inflammation of the lungs
• Abnormal increase in the number of platelets in the blood (thrombocythaemia)
• Problems with blood flow to the limbs (thiscan be felt as numbness, tingling, coldness or loss of sensation - tell your doctor if you experience this)
• Abnormal heart beats (arrhythmias), heart failure or heart attack
• Liver or kidney failure

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines during treatment this one, to ensure that the combination is safe.

Chemotherapy decreases the body's immune response. This means that vaccines may be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. If live vaccines are needed they should be postponed until at least six months after finishing chemotherapy.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain gemcitabine as the active ingredient.