FAQ

	Country	Contact	Telephone Number
Below are some answers to questions about Gleevec (STI571) that I am most frequently asked. Let me remind you again, that I am not a Doctor and I have no medical training so interpret these remarks with caution. While I have tried to answer the questions accurately, I am not an expert. Contact your trial Doctor for accurate information about Gleevec (STI571) and its side effects. Contact Novartis for the latest information about trials and trial centers. I will update this page, regularly, with new information that I receive. Please notify me of any error, so that I may confirm this with the proper source and correct it promptly. This page last checked for accuracy on: Jerry Mayfield (Webmaster)
When will Gleevec (STI571) be approved for prescription sale in the U.S.A. and other Countries? What will Gleevec (STI571) cost? Will my insurance company pay for Gleevec (STI571)? What are the side effects of Gleevec (STI571)? How do I get Gleevec (STI571)? What are the results of the Gleevec (STI571) trials to date? I live outside of the U.S.A. What other Countries are participating in the Gleevec (STI571) trials? Is Gleevec (STI571) available in any Country other than the United States for purchase legally or illegally? Is Gleevec (STI571) used for any type of cancer other than CML? Do you (Jerry Mayfield) have any special influence which might help me get Gleevec (STI571)? Why can't everyone who needs Gleevec (STI571) get it? Can a citizen of one Country participate in Gleevec (STI571) trials in another country? How much does it cost to participate in a Gleevec (STI571) trial? How is Gleevec (STI571) administered and what is the dose amount? Will Gleevec (STI571) cure my cancer? How long will I have to take Gleevec (STI571)? Are there any foods, drugs, vitamins, herbal, homeopathic remedies etc. which I should avoid while taking Gleevec (STI571)? My Question is not answered here. How do I get additional information about Gleevec?

Question:	When will Gleevec (STI571) be approved for prescription sale in the U.S.A. and other Countries?
Answer:	Gleevec was approved by the United States Food and Drug Administration (FDA) for prescription sale in the United States on May 10, 2001. Other countries have different approval processes. To date, Gleevec (Glivec) has been approved for prescription use in the following countries: Argentina, Australia, Bulgaria, Canada, Chile, Columbia, Dominican Republic, Ecuador, El Salvador, Guatemala, Israel, Indonesia, Japan, Jordan, Kuwait, Malta, Mexico, Nicaragua, Palestine, Peru, Romania, Russia, South Korea, Switzerland, Syria, United States, Uruguay, Venezuela. Top

Question:	What will Gleevec (STI571) cost?
Answer:	Novartis has spent "over 100 million dollars" to bring Gleevec to market. There a relatively small number of patients World wide who will need the drug. Novartis says that the drug will cost $2,000 to $2,400 American dollars per month for the average patient (depending on dose). This cost is on par with the cost of Interferon which has been the standard treatment for CML for the past decade. Novartis has set up a very generous Gleevec assistance program to help those patients who do not have insurance coverage and can not afford the drug. Call 1-877-Gleevec (1-877-453-3832) for information. Top

Question:	Will my insurance company pay for Gleevec (STI571)?
Answer:	I can only make a general statement about insurance coverage for Gleevec because each Insurance Company, HMO, etc. has different criteria to determine coverage. Generally, if your Insurance Company pays for prescription drugs and the drug is approved by the F.D.A. for treatment of your disease, they will pay for the drug less any "co-pays" which are included in your policy. Also, Insurance Companies usually cover drugs which are not specifically approved by the F.D.A for your disease but are generally recognized as effective treatments for your disease. One example is Interferon which has never been specifically approved for the treatment of CML but is widely recognized to benefit many patients so Insurance Companies usually cover it. You need to check with your Insurance Company for specific coverage criteria. Novartis has a program to assist patients who do not have drug coverage. Contact Novartis at 1-877-Gleevec (1-877-453-3832) for information. Top

Question:	What are the side effects of Gleevec (STI571)?
Answer:	Gleevec (STI571) has been well tolerated in most patients. Most patients feel good and have very few or no side effects. Below are side effects reported so far. Long term side effects will not be known for some time as Gleevec has only been used in human patients since the Summer of 1998. Fluid retention (electrolyte imbalance, renal problems)...Patients with cardiac (heart) problems who might be adversely effected by fluid retention should be especially cautious, but this needs to be confirmed by the Patient’s doctor. Puffiness around the eyes (most common) Swelling of the ankles Weight Gain (due to fluid retention) Retention of fluid in the waist area. Mild Nausea, Gas and diarrhea...Gleevec (STI571) is a mild stomach irritant. Generally, those patients with pre-existing gastrointestinal problems experience more of these side effects. Some patients experience mild nausea about 1 hour after taking Gleevec (STI571). A few patients experience more severe nausea. Nausea is decreased if Gleevec (STI571) is taken with food. Do not take Gleevec with grapefruit or grapefruit juice as it blocks some enzymes which may interfere with the metabolism of Gleevec (STI571). Some patients have excessive gas and mild diarrhea. Check with your trial Doctor before taking antacids with Gleevec (STI571) as they might interfere with absorption. Muscle and joint aches...Some patients experience muscle cramps, sore muscles and joint aches. Most of the time these symptoms appear in the legs especially around the knees. Some trial Doctors have prescribed "Tonic Water" and "Calcium with Vitamin D" to help with this side effect. Check with your trial Doctor before taking any pain medication (prescription or over-the-counter). Possible skin rash...A few patients have developed a rash while taking Gleevec (STI571). Generally, it resolves with time. Notify your trial Doctor if a rash develops. Low ANC (absolute neutrophil count)...Neutrophils fight bacterial infections. Very low numbers of neutrophils make patients more susceptible to bacterial infections. Notify your trial Doctor if your ANC drops below 1000/uL. Low Platelets...Platelets assist in blood clotting. Low platelets increase the risk of bleeding. Notify your trial Doctor if your platelets fall below 50,000/uL or if you notice unusual bruising or bleeding. Low Hemoglobin...some patients have low hemoglobin levels. Check with your trial Doctor if your hemoglobin level falls below 10.0 g/dL. Liver toxicity...About 3% of patients experience elevated liver enzymes. This effect is reversible. Your trial Doctor will order a short break from the drug while your liver returns to normal function. One patient died of liver failure after taking Gleevec (STI571). This patient had been taking high doses of Tylenol (acetaminophen) for an extended period of time. It is believed that this patient had a reaction similar to the (sometimes fatal) reaction that some heavy alcohol drinkers have experienced when taking Tylenol (acetaminophen). Do not take Tylenol (acetaminophen) without approval from your trial Doctor. Do not consume alcoholic beverages while taking Gleevec (STI571). Report any abnormal elevation in liver enzymes to your trial Doctor immediately. Gastrointestinal bleeding...about 1% of patients have reported blood in their stool. Report any black tarry or bloody stools to your trial Doctor. Fatigue...Some patients report fatigue while taking Gleevec. Top

Question:	How do I get Gleevec (STI571)?
Answer:	Gleevec (Glivec) has been approved for prescription use in the following countries: Argentina, Australia, Bulgaria, Canada, Chile, Columbia, Dominican Republic, Ecuador, El Salvador, Guatemala, Israel, Indonesia, Japan, Jordan, Kuwait, Malta, Mexico, Nicaragua, Palestine, Peru, Romania, Russia, South Korea, Switzerland, Syria, United States, Uruguay, Venezuela. In other countries Gleevec (STI571) is only available at designated Trial Centers. In these countries patients must meet the entry criteria of one of the trial protocols and be accepted into a trial to get the drug. Click here for Gleevec Trials information from the National Institutes of Health. For the most recent up-to-date information on trials, contact Novartis in the U.S. at: Novartis Oncology Clinical Trials Hot-Line 1-877-Gleevec (1-877-453-3832) Monday through Friday, between 9 AM and 8 PM Eastern Time, or call anytime to leave a message. Click here for Trials Contacts in other parts of the world. Top

Question:	What are the results of the Gleevec (STI571) trials to date?
Answer:	Trials are ongoing and data is still immature. To date, over 90% of patients who started in chronic phase have achieved hematological remission (normal blood counts). Many patients have cytogenetic remissions (no cancerous cells are found when examining approximately 20 cells from the bone marrow). Some have achieved molecular remission (no cancerous cells can be found by the most sophisticated tests which look at 500,000 to 1,000,000 cells. Of patients who started the trials in the accelerated phase, 65% are in remission at 1 year. Of patients who started the trials in blast phase, 20% to 30% are in remission at 1 year. The most up to date summary of trial results, as of December 15, 2000, can be viewed at Medscape. This summary is by Dr. Moshe Talpaz at M. D. Anderson in Houston, Texas. Medscape requires that you register and get a "User Name" and "Password". Registration is free. Click here to view the summary. Top

Question:	I live outside of the U.S.A. What other Countries are participating in the Gleevec (STI571) trials?
Answer:	I do not have a complete list of all the trial centers around the world. Below is a list of Novartis (the makers of Gleevec (STI571)) contacts for Gleevec (STI571) trials information. They can give you information about trials nearest to you. Top
	Australia	Sue Cairns	61-2-9805-3555
	Austria	Gerfrie Nell	43-1-86657
	Belgium	Michael Geelhand	32-2-24-61-611
	Canada	Diane Bluteau	(514) 631-6775
	Denmark	Kim Simonsen	45-39-168-400
	Far East	Drummond Paris	41-65-22-36963
	Finland	Kari Harjula	35-89-61-33-2211
	France	Patrice Berthaud or Annick Roche	33-154-76000
	Germany	Rolf Ihrig	49-911-273-12462
	Greece	Eleni Boutati	30-1-28-11-712
	Ireland	John French	35-31-260-1255
	Israel	Savion Gropper	972-3-922-9244-115
	Italy	Danielle Alberti	39-02-9-654-2817
	Latin America	Enrique Isola	54-11-4703-7000
	New Zealand	Sean Evans	64-9-828-3149
	Norway	Dag Solbu	47-23-05-2000
	Peru	Eduardo Parodi	51-1-494-2673
	Portugal	Pedro Freitas	35-1-21-92-68-600
	Sweden	Per Anderson	46-8-73-23-210
	Switzerland	Joan Gloor	41-31-377-5352
	UK	Val Allsup	44-1276-698-260

Question:	Is Gleevec (STI571) available in any Country other than the United States for purchase legally or illegally?
Answer:	Gleevec is available for prescription sale in Argentina, Australia, Bulgaria, Canada, Chile, Columbia, Dominican Republic, Ecuador, El Salvador, Guatemala, Israel, Indonesia, Japan, Jordan, Kuwait, Malta, Mexico, Nicaragua, Palestine, Peru, Romania, Russia, South Korea, Switzerland, Syria, United States, Uruguay, Venezuela. In other countries Gleevec (STI571) is only available at designated Trial Centers. In these countries patients must meet the entry criteria of one of the trial protocols and be accepted into a trial to get the drug. Top

Question:	Is Gleevec (STI571) used for any type of cancer other than CML?
Answer:	Gleevec (STI571) was originally developed to inhibit a particular enzyme (tyrosine Kinase) which is produced by the Bcr-Abl oncogene and is believed to drive the unregulated production of white blood cells. The Bcr-Abl oncogene is present in 95% of CML (Chronic Myelogenous Leukemia) patients and about 20% of ALL (Acute Lymphoblastic Leukemia) patients. Other forms of leukemia which do not have the Bcr-Abl mutation would not likely benefit from Gleevec although there has been some discussion about trying it in some other leukemias. Further laboratory experiments have shown that Gleevec (STI571) also inhibits a protein called C-Kit and PDGF (Platelet Derived Growth Factor). C-Kit and PDGF may play a role in certain other cancers. Trials are now underway on GIST (Gastro Intestinal Stromal Tumor) and have shown very promising early results. Trials are now starting or are about to begin on several other forms of cancer. The Novartis statement below, references these other cancer trials. Click here for Gleevec Trials information from the National Institutes of Health. Please contact Novartis for the latest trials information. Novartis Oncology Clinical Trials Hot-Line 1-877-Gleevec (1-877-453-3832) Monday through Friday, between 9 AM and 8 PM Eastern Time, or call anytime to leave a message. Patients in other countries should call one of the world wide contacts listed above. Novartis Statement (From their Web Site): Reference other cancer trials. ...In CML, we understand the primary cause of the disease—an acquired abnormality in the DNA (a mutation) of the stem cells in the bone marrow, which causes the bone marrow cells to become malignant. STI571 is targeted to inhibit this mutation. Solid tumors are caused by multiple factors that we don't fully understand. However, as there are some data on cells derived from solid tumors that suggest activity against some known mutations, Novartis plans to start testing this concept in studies in late 2000. These tumor types are very specific, including GIST (gastro-intestinal stromal tumors), SCLC (small cell lung cancer), prostate, STS (soft tissue sarcomas), and gliomas. Information from these studies, which will accrue only a limited number of patients, is expected 1.5 to 2 years after initiation of these trials. Top

Question:	Do you (Jerry Mayfield) have any special influence which might help me get Gleevec (STI571)?
Answer:	No, I do not have any special influence with Novartis, any Doctor or Medical Institution. This is, as it should be. Top

Question:	Why can't everyone who needs Gleevec (STI571) get it?
Answer:	Gleevec is available for prescription sale in Argentina, Australia, Bulgaria, Canada, Chile, Columbia, Dominican Republic, Ecuador, El Salvador, Guatemala, Israel, Indonesia, Japan, Jordan, Kuwait, Malta, Mexico, Nicaragua, Palestine, Peru, Romania, Russia, South Korea, Switzerland, Syria, United States, Uruguay, Venezuela. Other countries have different approval processes. In other countries, Gleevec (STI571) is in clinical trials and is not approved for prescription purchase. In these countries Gleevec (STI571) is only available at designated Trial Centers and patients must meet the entry criteria of one of the trial protocols to be accepted into a trial and get the drug. Clinical trials are designed to answer specific questions about the safety and efficacy (effectiveness) of a new drug. Due to safety and logistical considerations, drug trials limit the number of patients enrolled. The initial success of Gleevec (STI571), in CML patients, has spawned an unprecedented expansion of the Gleevec (STI571) trials to over 3500 patients world-wide. This early success and requests by many patients to be included in the trials prompted Doctor Daniel Vasella, Chairman and CEO of Novartis, to take personal charge of expanding the trials so that as many patients as possible could get the drug. CML is a relatively rare cancer. About 5000 patients are diagnosed yearly in the U.S.A. compared to the hundreds of thousands of other cancers diagnosed. The small number of new CML cases each year makes it highly unlikely that Novartis will ever recoup their investment which I have heard exceeds 100 million dollars so far. Initially it was estimated that a few hundred kilograms of Gleevec (STI571) per year would be needed and could be produced in the laboratory, as most drugs are, during clinical trials. It usually takes several years to ramp-up production of a drug from the small batches produced in a laboratory to commercial production. Gleevec (STI571) is a complex molecule and is difficult to synthesize, taking over a dozen chemical steps. Doctor Vasella and the many employees at Novartis, accelerated production of Gleevec (STI571) from the few hundred kilograms per year, initially estimated to be needed, to commercial production of over 10 tons a year in the span of less than a year. This ramp-up is unprecedented in drug manufacturing history. It is my opinion that these actions, by Novartis were not done for "profit motive" but out of compassion and the desire to see as many people as possible get this new drug and possibly save their lives. We in the CML community, as well as patients with other forms of cancer who might benefit from Gleevec (STI571), owe a debt of gratitude to Doctor Vasella and the many employees at Novartis who worked tirelessly, around-the- clock, so that we might have another chance at life. Top

Question:	Can a citizen of one Country participate in Gleevec (STI571) trials in another Country?
Answer:	Yes, you do not need to be a citizen in the trial country to participate. Top

Question:	How much does it cost to participate in a Gleevec (STI571) trial?
Answer:	The drug company (Novartis) furnishes Gleevec (STI571) free of charge to trial participants. All other expenses such as lab tests, Doctor fees, travel etc. must be paid by the patient or the patient's insurance company. Check with your insurance company for covered expenses. Top

Question:	How is Gleevec (STI571) administered and what is the dose amount?
Answer:	Gleevec (STI571) is a capsule taken by mouth. Dosages vary according to trial protocols and patient responses. Top

Question:	Will Gleevec (STI571) cure my cancer?
Answer:	It is not yet known whether Gleevec (STI571) will cure any form of cancer. It will take many years to answer that question. Top

Question:	How long will I have to take Gleevec (STI571)?
Answer:	To date, no one has stopped taking Gleevec (STI571) who has had a good response. The plan, I am hearing, is that patients who remain in total remission for two years will have the option to stop taking Gleevec (STI571) and be closely monitored for a return of the disease. Total remission for CML patients would mean...negative PCR tests for the Bcr-Abl oncogene. Top

Question:	Are there any foods, drugs, vitamins, herbal, homeopathic remedies etc. which I should avoid while taking Gleevec (STI571)?
Answer:	Patients should consume a healthy diet and inform their trial Doctors of any drugs, vitamins, herbal, or homeopathic remedies which they are taking. The only food that should be avoided is grapefruit or grapefruit juice as it blocks some enzymes which may interfere with the metabolism of Gleevec (STI571). Do not take Tylenol (acetaminophen) without approval from your trial Doctor. Do not consume alcoholic beverages while taking Gleevec (STI571). Do not take antacids with Gleevec as they might interfere with absorption. Gleevec (STI571) may reduce a patient’s platelets, so aspirin should be avoided as it compounds this problem. Top

Question:	My Question is not answered here. How do I get additional information about Gleevec?
Answer:	In the United States, Contact the Novartis Gleevec Information Line at 1-877-GLEEVEC (1-877-453-3832). Outside the United States Call one of the Novartis World wide contacts above. Top