Ifosfamide 40mg/Ml Solution For Infusion
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Please read this leaflet carefully. This leaflet provides some useful information for you about your medicine. Keep this leaflet, you may need to read it again. If you have any questions or are not sure about anything, please ask your doctor or pharmacist.
In this leaflet:
1. What is IFOSFAMIDE 40 mg/ml and what is it used for?
2. Before using IFOSFAMIDE 40 mg/ml
3. How to use IFOSFAMIDE 40 mg/ml
4. Possible side effects
5. Storing IFOSFAMIDE 40 mg/ml
6. Further Information
1. WHAT IS IFOSFAMIDE 40 mg/ml AND WHAT IS IT USED FOR?
IFOSFAMIDE 40 mg/ml is a clear, colourless solution for infusion.
IFOSFAMIDE is a cytotoxic drug used to treat a wide variety of different cancers. It works by killing cancer cells (this is sometimes called "chemotherapy"). It is often used together with other anti-cancer drugs or radiotherapy.
It is presented in a glass vial containing either 25 ml or 50 ml of IFOSFAMIDE 40 mg/ml solution for infusion.
2. BEFORE USING IFOSFAMIDE 40 MG/ML
DO NOT TAKE IFOSFAMIDE
• If you have ever experienced an allergic reaction (shortness of breath, wheezing, skin rashes, itching or swelling) after taking IFOSFAMIDE or any of the other ingredients before.
• If you are pregnant.
At the moment do you have:
• any very bad infections?
• problems with your bone marrow?
• any problems with your bladder (e.g. cystitis or blood in your urine)?
• any problems with your liver function?
• any problems with your kidney function?
If the answer is yes to any of these questions you must tell your doctor - your treatment may need to be altered.
TAKE SPECIAL CARE WHEN BEING GIVEN IFOSFAMIDE
As IFOSFAMIDE is a very powerful drug your doctor will want to do a number of tests, such as blood or urine tests, before you start your treatment and to monitor your condition during treatment. Careful monitoring of your condition may also be required if you suffer from or are at risk of certain medical conditions. Examples of some of these medical conditions are:
• Blood and Lymphatic system disorders. Blood tests will be done to check that your blood count is high enough (the number of red blood cells, white blood cells and platelets).
• Problems with your immune system such as diabetes, long terms liver or kidney disorders.
• If you suffer from cancer effecting the brain or other symptoms effecting the brain.
• If you have a heart condition.
• You will be given advice on oral hygiene to help reduce inflammation in your mouth.
• You will be given drugs called antiemetics to reduce the frequency and level of nausea and vomiting.
WHAT ABOUT OTHER MEDICINES THAT YOU MAY BE TAKING?
IFOSFAMIDE can interact with certain medicines. The effectiveness of the medicines or the risk of
undesirable effects may change.
• The toxicity of other chemotherapy drugs, allopurinol and hydrochlorothiazide and, radiation therapy may be increased.
• The effectiveness of some vaccines may be reduced or a vaccine induced infection may develop.
• The blood thinning effect of warfarin may increase therefore raising the risk of bleeding.
• Drugs which are toxic to the kidneys such as cisplatin, aminoglycosides, acyclovir and amphotericin may increase the toxic effects of IFOSFAMIDE on the kidneys.
• Drugs which act on the brain such as antiemetics, tranquillisers, narcotics and antihistamines should be used with caution and may need to be discontinued.
• The blood glucose lowering effects of some diabetes treatments (sulphonylureas) may be increased.
• The toxicity of IFOSFAMIDE may be increased if you are taking chlorpromazine, triiodothyreonine or aldehyde dehydrogenase inhibitors.
• The muscle relaxant effect of suxamethonium is increased.
• You need to consult you Doctor before taking bupropion, a drug used to help smoking cessation.
Consumption of alcohol should generally be avoided during treatment with IFOSFAMIDE.
TAKING IFOSFAMIDE WITH FOOD AND DRINK
Avoid eating grapefruit or any food or drinks which have it as an ingredient when being treated with
IFOSFAMIDE. The effectiveness of IFOSFAMIDE may be reduced by a substance in grapefruit.
PREGNANCY AND BREASTFEEDING
• Men or women having must use contraception during therapy and the following six months as IFOSFAMIDE can damage an unborn child.
• You should not breast feed while taking IFOSFAMIDE or for 36 hours after completely stopping this treatment.
DRIVING AND USING MACHINES
• IFOSFAMIDE may induce swelling in the brain and cause nausea and vomiting.
• Do not drive or operate and tools or machines.
3. HOW TO USE IFOSFAMIDE 40 mg/ml
Before it is given to you IFOSFAMIDE 40 mg/ml will be diluted with 0.9% w/v Sodium Chloride solution.
It will normally be given to you in a large bag of intravenous drip solution directly into a vein. The drip containing your IFOSFAMIDE may need to continue for several hours - sometimes even several days. The drip can go into a vein through a small needle usually in the arm or back of the hand. Some people have special "long lines" put into a large vein under the collar bone, and IFOSFAMIDE can be given into this long line. You will usually have your IFOSFAMIDE treatment every two to four weeks. The amount of IFOSFAMIDE given to you will depend on the type of cancer you have, how big you are (a combination of your height and weight), your general condition and whether you are being given other anti-cancer drugs or having radiotherapy.
4. POSSIBLE SIDE EFFECTS
As IFOSFAMIDE is a very powerful anti-cancer drug, it has some side-effects. The most common side effects are:
• Nausea and Vomiting
Feeling sick and occasionally being sick for about 24 hours after a IFOSFAMIDE injection. However, there are very effective anti-sickness medicines which your doctor will prescribe for you. This means that most patients are not sick.
• Loss of hair
You may just notice this as a little extra loss of hair when you are combing or washing your hair, or you may lose most or all of your hair. The amount of hair which you lose will depend on the dose of IFOSFAMIDE, the thickness of your hair and whether you are also having other anti-cancer drugs. If you are having IFOSFAMIDE in combination with other anti-cancer drugs, you are much more likely to lose your hair than if you are having IFOSFAMIDE alone.
Other side-effects which you may not notice, but for which your doctor will check are:
• Damage to the lining of the bladder
IFOSFAMIDE produces a compound which can damage the lining of the bladder, causing bleeding into your urine. Your doctor knows this and he will give you a medicine called mesna which will protect your bladder. Most people having IFOSFAMIDE with mesna do not develop any problems with their bladder, but your doctor may want to test your urine for the presence of blood. If you notice that you have blood in the urine, then you must tell your doctor.
• Damage to the kidneys
Sometimes IFOSFAMIDE can damage the kidneys so that they do not work properly. This is more likely to happen if you only have one kidney, or if your kidneys are already damaged. Usually there are no symptoms from kidney damage, but your doctor will be able to detect any damage by looking at your test results. Often the damage caused by IFOSFAMIDE to kidneys is only temporary, and they will return to normal after you stop IFOSFAMIDE therapy. Occasionally kidney damage is permanent and can be severe.
• A lowering of the blood count (blood cell numbers)
IFOSFAMIDE works by killing cancer cells, but it will also kill some of your normal cells. The normal cells that are most affected are your bone marrow cells. Bone marrow makes the red blood cells, white blood cells which fight infection and platelets which help your blood to clot. Your doctor will check that the number of red blood cells, white blood cells and platelets is high enough before you start your IFOSFAMIDE treatment. After an injection of IFOSFAMIDE your blood count will drop. This is an unavoidable side-effect of IFOSFAMIDE because it is such a powerful drug. Your blood count will reach its lowest level about 5-10 days after your IFOSFAMIDE injection. Most people recover to a normal blood count within 21-28 days. If you have had a lot of chemotherapy in the past, it may take a little longer to return to normal.
You may not notice anything at all when your blood count drops. Some people feel a bit tired. Because your white blood cell count is low it is important that you should take care not to come into contact with any infectious people, as without white blood cells, you cannot fight infection. Unfortunately, some infections are carried in the air, which you cannot avoid. If you think you have an infection (a high temperature, feeling cold and shivery, or hot and sweaty, or any signs of infection such as a cough, or stinging on passing water) you must contact your doctor immediately. Without your white blood cells, you may need antibiotics to fight infection.
Sometimes, people having IFOSFAMIDE become anaemic (a lack of red blood cells). Usually, no treatment is required, your body will eventually replace the red blood cells. If you are very anaemic, you may need a blood transfusion.
If your platelet count is low, your blood will not clot very well. Most people on IFOSFAMIDE do not have problems with blood clotting, but you may notice that if you cut yourself, for instance, while shaving, that it takes a long time to stop bleeding. Women may notice that their periods are heavier than normal.
If you find that you are getting bruises without knocking yourself, or that you are bleeding from the gums - then you must contact your doctor immediately. You may have to have a special platelet transfusion to replace your platelets.
• Changes in mental state
In a few people, IFOSFAMIDE can affect the central nervous system (brain). Usually the effects are mild, such as slight confusion or abnormal sleepiness. Sometimes people on IFOSFAMIDE therapy do not realise that they have been affected but friends and relatives may notice a change in them. These mild effects rarely last for more than two days, and usually go away completely after stopping IFOSFAMIDE. Very rarely a more serious form of these effects can occur with IFOSFAMIDE. These serious forms are called "encephalopathy" and can involve having fits, becoming very confused and sometimes aggressive, and also a loss of consciousness. If any of these effects occurs, your IFOSFAMIDE treatment will be stopped. Most people then return to normal in a few days. Very, very rarely people on IFOSFAMIDE have gone into a coma.
Your doctor will be well aware of these possible problems. Although they sound very frightening, he will not prescribe IFOSFAMIDE unless he thinks that your cancer is more of a risk to you than the possible side-effects.
• Infertility
Men on IFOSFAMIDE often become infertile because their sperm count drops. Usually, they will regain normal fertility (and a normal sperm count) about 3 months to 1 year after finishing treatment.
Sometimes IFOSFAMIDE causes permanent infertility. Although this does not happen very often, your doctor may advise you to bank your sperm before you start IFOSFAMIDE. If you do not regain your fertility, this banked sperm can be used in the future if you want to have children. IFOSFAMIDE has no effect on your libido (your desire to have sex) or on your ability to have sex.
Women on IFOSFAMIDE may also become infertile. This is more likely to happen in women over 30 years of age. You may notice that your periods stop altogether, and you may develop menopausal symptoms e.g. "hot flushes". In younger women, periods may stop temporarily, but re-start again after finishing IFOSFAMIDE. If your periods re-start or if they are not affected at all, you may be able to have children in the future.
• Damage to unborn children
Although both men and women having IFOSFAMIDE may remain fertile during their treatment, women must not get pregnant at this time. This is because IFOSFAMIDE can damage your unborn baby, leading to stillbirth, or a permanently damaged or deformed child. Women on IFOSFAMIDE must take care not to get pregnant during their treatment and for at least 6 months after the end of treatment.
Some doctors recommend not trying to get pregnant for one year after the end of treatment as babies conceived before this have a higher chance of being born prematurely or being of low birthweight.
Men on IFOSFAMIDE should not make their wives or girlfriends pregnant during treatment with IFOSFAMIDE or for at least 6 months after the end of treatment. This is because damaged sperm can also cause damage to an unborn child.
However, both men and women on IFOSFAMIDE can have sex if they want to, if contraception is used.
• Other side effects
IFOSFAMIDE has other side-effects which occur in a small number of patients. Your doctor will check for these. They include fluid retention, allergic reactions, diarrhoea, loss of appetite, constipation, liver disorders, acute inflammation of the pancreas (which results in severe upper abdominal pain), inflammation of the lungs, impaired vision, muscle weakness, numbness or abnormal sensations, skin rashes and mouth problems, such as ulcers and swelling, increased reaction to radiation treatment, inflammation in the vein at the site of treatment and possible effects on the heart.
Although these side-effects can be serious and may sound frightening, your doctor has balanced the risk of these side-effects with the risk to you of your cancer. If you have any questions about these side-effects or if you notice any other side-effects or problems, you should tell your doctor or pharmacist.
• Your medicine will be stored a safe place where children cannot see or reach it. Your medicine could harm them.
• Do not use your medicine after the expiry date on the box or vial, even if there is some medicine left after this date. Ask your doctor to replace it with a new prescription.
• Your medicine will be stored between 2°C and 8°C (in a refrigerator) and kept in its outer container before use. Once it has been diluted ready for use it should not be stored above 25°C and should be used within 24 hours.
• Any unused medicine or waste material from its use must be disposed of in accordance with local requirements.
6. FURTHER INFORMATION
♦ NAME OF MEDICINAL PRODUCT
The name of your medicine is IFOSFAMIDE 40 mg/ml solution for infusion.
♦ WHAT IS IN YOUR MEDICINE
Each vial of contains either 25 ml or 50 ml of IFOSFAMIDE 40 mg / ml solution which equals 1 g or 2 g of the active ingredient IFOSFAMIDE. It also contains the inactive ingredients: Sodium chloride, sodium monohydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.
♦ WHO PRODUCES YOUR MEDICINE
The Marketing Authorisation Holder for is:
Baxter Healthcare Ltd
Caxton Way, Thetford Norfolk, IP24 3SE, UK
Marketing Authorisation number: PL00116/0421
The Manufacturer is:
Baxter Oncology GmbH
Kantstrasse 2
33790 Halle-Kunsebeck, GERMANY
For information about IFOSFAMIDE 40 mg/ml or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: 01635 206345.
This leaflet was prepared in May 2006.
Baxter is a trademark of Baxter International Inc.
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