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Questions about CML

Questions about Glivec® (imantinib) in CML

Questions about CML

What is CML?

Leukaemia is a type of cancer of the blood and the bone marrow (the inner part of bones where blood cells are made). With leukaemia, 2 things happen. First, certain blood cells become abnormal. Second, the body keeps producing large numbers of these abnormal cells.

CML is one type of leukaemia. “Chronic” means that it is a slow-acting cancer that may take years to progress. “Myeloid” means that the type of abnormal blood cell being overproduced is a type of white blood cell called a myeloid cell. So, chronic myeloid leukaemia is a slow-acting cancer that makes the body produce an excess of cancerous myeloid white blood cells.

There are 3 phases of CML: the chronic phase, the accelerated phase, and the blast crisis phase. As patients move through these phases, their disease progresses, and they experience more physical symptoms.

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What causes CML?

When a person is healthy, signals in the body tell it to grow new blood cells. These signals reach the source of blood cells, which are called stem cells. The signals turn stem cells on and off as necessary to produce the number of blood cells the body needs. When a person has CML, a change takes place place in their DNA and makes this signal stay on constantly. Because this signal stays on, the body produces more and more leukaemia cells.

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How is CML treated?

CML is either treated with drug therapy or with a bone marrow transplant (BMT)

BMT

BMT is also known as a stem cell transplant (SCT). This type of therapy involves 2 steps. First, a very high dose of a drug is given to the patient to kill most of the cells in the bone marrow (cancer cells and healthy cells). The second step is to replace all of the stem cells that were destroyed with only healthy cells. These replacement cells are usually taken from someone else (this is known as an allogeneic transplant), and are occasionally taken from the patient (this is known as an autologous transplant). Very few patients are actually candidates for BMT.

Glivec

Glivec is an oral therapy that targets the specific cause of CML. Unlike prior drug therapies used in the treatment of CML, Glivec has been shown to extend survival of patients in all phases of CML in clinical trials1-3.

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Questions about Glivec in CML

How does Glivec work in CML?

Glivec is a unique therapy that specifically targets the cause of CML. As mentioned earlier, with CML there is a constant signal that tells the body to keep producing abnormal white blood cells. Glivec works by blocking, or turning off, that signal so the extra white blood cells are not made.

This is the first time a therapy has targeted the cause of CML. This is a very important difference from other types of therapy. BMT destroys most of the cells in a patient’s bone marrow (cancer cells and healthy cells). Side effects can be severe. Chemotherapy enters the bloodstream and destroys as many cells as possible—again, cancer cells and healthy cells. Patients receiving certain types of chemotherapy also have many side effects and are sometimes forced to stop their treatment.

Glivec, on the other hand, targets the signal that produces leukaemic cells, so most healthy cells are left unharmed. Most patients receiving Glivec do not have major problems with side effects.

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What are the side effects?

In clinical studies, most patients experienced mild or moderate side effects with Glivec therapy. Most patients are not bothered enough by side effects to discontinue Glivec therapy. The most common side effects include nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps, skin rash, and fluid retention.

Some patients experienced bleeding from the GI tract or the tumour while on Glivec therapy (GI bleeds are more common in GIST than CML). While bleeding may have been caused by the tumour-not Glivec-you should notify your physician immediately if you observe any blood in your stools, have pain in your abdomen, feel weak or dizzy, or look pale.

If you experience any of these symptoms during Glivec therapy, contact your physician, particularly if they are severe:

  • nausea
  • vomiting
  • diarrhoea
  • abdominal pain
  • fatigue
  • myalgia
  • muscle cramps
  • skin rash
  • fluid retention

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How does Glivec interact with other drugs?

Like many medications, Glivec can affect, or be affected by, other products you may be taking. When this happens, Glivec or the other drugs may lose their effectiveness or produce more severe side effects. Some drugs that can cause interactions are commonly used over-the-counter medications, such as paracetamol (acetaminophen) or herbal products such as St. John’s Wort. Also, birth control pills (oral contraceptives), blood thinners (especially warfarin), and anticonvulsants might interact with Glivec. In addition, Glivec should not be taken with grapefruit juice. Therefore, it is very important to talk to your physician about all medications and supplements you are currently taking or are planning to take in the future.

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What if I’m pregnant?

If Glivec is used during pregnancy, or if the patient becomes pregnant while receiving Glivec, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential are encouraged to use effective contraception during treatment. Please discuss these issues with your physician or nurse before beginning therapy with Glivec.

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How do I take Glivec? What’s the dosage for CML?

Glivec is a convenient therapy for patients to take. Unlike many drugs that must be administered in the hospital, Glivec is available in tablet form and is taken by mouth once a day. It is recommended that patients take Glivec with a meal and a large glass of water to avoid gastrointestinal upset.

Your physician or nurse will discuss with you the dose that you should be taking. Generally, dosing of Glivec depends on your stage of CML, your age, and your response to therapy.

Adult patients with CML in the chronic phase normally take 400 mg/d. Adult patients with CML in the accelerated or blast crisis phase normally take 600 mg/d.

Dosing for children with CML is based on body surface area. Glivec is supplied as 100 mg and 400 mg tablets, so you may need more than one tablet for each dose. Your physician will specify which dose you should take and how many of each tablet. Talk to your doctor or nurse about how and when to take the correct dose each day.

Depending on your response to treatment, your physician may decide to change the dose of Glivec that you are taking. If your daily dose is changed, be sure to follow your physician's recommendations.

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What if I take more Glivec than I should?

If you think you may have taken more Glivec than you should have, talk to your doctor immediately. You may require medical attention

If vomiting occurs, do not take another dose. Contact your physician.

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What are my responsibilities?

Because Glivec is an oral therapy, you have the important responsibility of ensuring that you take the correct dose every day.

If you experience side effects, you should talk with your physician.

It is very important for you to continue taking Glivec unless your physician has told you to stop. Contact your physician before stopping your therapy. Following your prescribed dosage is crucial in achieving optimal results. If you are feeling discouraged, talk to your physician, your nurse, or a friend or family member about the way you feel. Getting emotional support during your treatment is just as important as getting medical support.

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What if I have additional questions?

If you have additional questions or would like more information, please contact your physician.

You may also choose to access patient support groups, which will allow you to share your experiences with others. Ask your physician for advice on getting additional information.

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Questions about GIST

Questions about Glivec in GIST

What is GIST?

GIST is a rare cancer of the gastrointestinal (GI) tract. Most GISTs develop in the stomach or in the small intestine, and a small percentage develop elsewhere along the GI tract. GIST is difficult to diagnose and to treat because it often does not cause any physical symptoms until already advanced.

When GISTs first develop, the tumours stay in one area, such as the stomach. GISTs that stay in their original location are called localised tumours. However, when GISTs advance, they can spread to other parts of the body. When a GIST spreads, it becomes a metastatic tumour. GISTs often grow quite large before they are discovered, and many often spread to other organs, mainly the liver.

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What causes GIST?

A protein called KIT-when abnormal-is thought to be one of the major causes of GIST. Normal cells have a limited life span. The KIT protein, which is located on the surface of normal cells, sends a signal inside the cells that tells them to grow and multiply only as needed. When KIT becomes abnormal, its signal stays on constantly and cells become cancerous and continue to grow and multiply. Cancerous GIST cells have a survival "advantage" because they grow and multiply faster and live longer than the normal surrounding cells. The longer the cancerous cells live, the more potential they have to become dangerous, and the more likely they are to spread to other parts of the body.

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How is GIST treated?

Until now, patients with GIST have had very few treatment options.

Surgery has been the main treatment for GIST. However, many GISTs — those that have already spread to another part of the body—cannot be surgically removed. Often, even with surgery, parts of the original GIST remain or GIST returns to another site in the body. In these cases, when surgery really only relieves disease symptoms, it is considered palliative.

Traditional cancer therapies such as chemotherapy and radiation therapy, or radiotherapy, have been ineffective in the treatment of the disease. Because of this, and because many GISTs cannot be removed surgically, developing an effective drug therapy was very important. Glivec, the first effective drug approved for this use, is providing a new treatment option for patients who have no other ways to manage their disease.

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Questions about Glivec in GIST

How does Glivec work in GIST?

Glivec is the only therapy that specifically targets the main cause of GIST. The KIT protein on GIST cells sends out a constant signal that tells the cancerous cells to keep growing and multiplying. Glivec works by blocking, or turning off, the signal from the KIT protein, so the cancerous cells stop growing.

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What are the side effects?

In clinical studies, most patients experienced mild or moderate side effects with Glivec therapy. Most patients are not bothered enough by side effects to discontinue Glivec therapy. The most common side effects include nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps, skin rash, and fluid retention.

Some patients experienced bleeding from the GI tract or the tumour while on Glivec therapy (GI bleeds are more common in GIST than CML). While bleeding may have been caused by the tumour—not Glivec—you should notify your physician immediately if you observe any blood in your stools, have pain in your abdomen, feel weak or dizzy, or look pale.

If you experience any of these symptoms during Glivec therapy, contact your physician, particularly if they are severe

  • nausea
  • vomiting
  • diarrhoea
  • abdominal pain
  • fatigue
  • myalgia
  • muscle cramps
  • skin rash
  • fluid retention

Back to top

How does Glivec interact with other drugs?

Like many medications, Glivec can affect, or be affected by, other products you may be taking. When this happens, Glivec or the other drugs may lose their effectiveness or produce more severe side-effects. Some drugs that can cause interactions are commonly used over-the-counter medications, such as paracetamol (acetaminophen) or herbal products such as St. John’s Wort. Also, birth control pills (oral contraceptives), blood thinners (especially warfarin), and anticonvulsants might interact with Glivec. In addition, Glivec should not be taken with grapefruit juice. Therefore, it is very important to talk to your physician about all medications and supplements you are currently taking or are planning to take in the future.

Back to top

What if I’m pregnant?

If Glivec is used during pregnancy, or if the patient becomes pregnant while receiving Glivec, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential are encouraged to use effective contraception during treatment. Please discuss these issues with your physician or nurse before beginning therapy with Glivec.

Back to top

How do I take Glivec? What’s the dosage for GIST?

Glivec is easy to take. Unlike many drugs that must be administered in the hospital, Glivec is available in tablet form and is usually taken by mouth once a day. You should take Glivec with a meal and a large glass of water to minimise GI upset.

The standard recommended starting dose for most patients is 400 mg/d1. Glivec is supplied as 100-mg and 400-mg tablets. Your physician will specify which dose you should take and how many of each tablet

Depending on your response to treatment, your physician may decide to change the dose of Glivec that you are taking. If your daily dose is changed, be sure to follow your physician’s recommendations.

Back to top

What if I take more Glivec than I should?

If you think you may have taken more Glivec than you should have, talk to your doctor immediately. You may require medical attention.

If vomiting occurs, do not take another dose. Contact your physician.

Back to top

What are my responsibilities?

Because Glivec is an oral therapy, you have the important responsibility of ensuring that you take the correct dose every day.

If you experience side-effects, you should talk with your physician.

It is very important for you to continue taking Glivec unless your physician has told you to stop. Contact your physician before stopping your therapy. Following your prescribed dosage is crucial in achieving optimal results. If you are feeling discouraged, talk to your physician, your nurse, or a friend or family member about the way you feel. Getting emotional support during your treatment is just as important as getting medical support.

Back to top

What if I have additional questions?

If you have additional questions or would like more information, please contact your physician.

You may also choose to access patient support groups, which will allow you to share your experiences with others. Ask your physician for advice on getting additional information.

Gist FAQs

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GIPAP is open in about 80 countries.As of November 30, 2007 the total number of patients reached was 19,378.

Disclaimer: This is an international website for Glivec (imatinib) and is intended for healthcare professionals outside the US. If you are a US resident, please click on the For US Residents link at the top of this page. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.



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