News release - New Sprycel (dasatinib) Support Program Announced

[Guest guest]

Published: Thursday, 14 Oct 2010 | 11:00 AM ET

My SPRYCEL® (dasatinib) Support Program Now Available for Patients

PRINCETON, N.J. & TOKYO, Oct 14, 2010 (BUSINESS WIRE) -- Bristol-Myers Squibb

Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. today announced the

launch of My SPRYCEL® (dasatinib) Support, a useful resource to assist adult

patients with chronic myeloid leukemia (CML) who are taking SPRYCEL. SPRYCEL is

a prescription medicine used to treat adults who have CML and are not

benefitting from, or cannot tolerate, prior treatment including Gleevec®*

(imatinib mesylate). The program helps patients learn more about SPRYCEL and how

to be involved in treatment decisions with a healthcare provider.

" In addition to empowering patients to take an active role in managing their

health, programs like My SPRYCEL Support aid in the safe and appropriate use of

medicines, " said A. Manfredi, MD, Georgia Cancer Specialists. " This type of

patient-centric program may also support appropriate medication management,

which is especially important in a chronic disease like CML. " My SPRYCEL Support

also grants patients access to a SPRYCEL Care Counselor 24 hours a day, seven

days a week. SPRYCEL Care Counselors are registered nurses with the background

and training to help understand, and respond to, questions about SPRYCEL;

discuss what patients may expect from treatment; describe side effects that may

occur as well as the importance of contacting a healthcare provider immediately

if they do; and offer general health and lifestyle tips.

SPRYCEL Care Counselors are available to provide patients with important

information regarding SPRYCEL, but cannot offer medical advice specific to their

health.

" CML patients often need support and resources throughout the treatment process.

My SPRYCEL Support is a unique and helpful program that offers patients a

variety of tools to keep them informed about their treatment with SPRYCEL and

motivated to stay involved in their care with their healthcare provider. I am

excited that such an interactive program is now available to patients, " said

Shlemon, a SPRYCEL Care Counselor.

My SPRYCEL Support enrollees are provided helpful information, including: a

patient brochure that reviews study data, dosing, how to take SPRYCEL, potential

side effects, and tips on having productive and meaningful discussions with

members of a healthcare team; as well as a daily journal to help track

activities and personal thoughts throughout the treatment process. Patients will

also receive a co-pay assistance brochure that provides eligible patients with

information about co-pay assistance during their treatment with SPRYCEL.

If patients qualify for co-pay assistance, they can receive up to $100 per month

toward their co-pay for a period of 12 months, with a maximum benefit of $1,200.

Patients residing in Massachusetts, or whose prescriptions are covered in full

or in part by any state or federally funded program, including but not limited

to Medicare, Medicaid, Medigap, Veterans Affairs (VA), or Department of Defense

(DOD) programs, are not eligible for the My SPRYCEL (dasatinib) Support Co-pay

Assistance Program. Additional restrictions apply.

Patients interested in learning more about My SPRYCEL Support can call

1-877-526-7334 or visit www.SPRYCEL.com. A Support Kit will arrive in the mail,

and a SPRYCEL Care Counselor will contact the patient to confirm that they have

received the kit and address questions they may have about SPRYCEL and the

program.

About SPRYCEL SPRYCEL® (dasatinib) is a prescription medicine used to treat

adults who have chronic myeloid leukemia (CML) who are no longer benefiting

from, or cannot tolerate, prior treatment including Gleevec®* (imatinib

mesylate). SPRYCEL is also used to treat adults who have Philadelphia chromosome

-- positive acute lymphoblastic leukemia (Ph+ ALL) who are no longer benefitting

from, or cannot tolerate, prior treatment.

The active ingredient of SPRYCEL is dasatinib. Dasatinib reduces the activity of

one or more proteins responsible for the uncontrolled growth of the leukemia

cells of patients with CML or Ph+ ALL.

About Chronic Myeloid Leukemia CML is a slow-growing type of leukemia in which

the body produces an uncontrolled number of abnormal white blood cells. About

22,475 people are living with the disease in the United States. It is estimated

that 4,870 new cases will be diagnosed in 2010. CML occurs when pieces of two

different chromosomes break off and attach to each other. The

Philadelphia-positive (Ph+) chromosome contains an abnormal gene called the

bcr-abl gene. This gene produces the BCR-ABL protein, which causes your body to

make too many abnormal white blood cells.There is no known cause for the genetic

change that causes CML.

IMPORTANT SAFETY INFORMATION ABOUT SPRYCEL® (dasatinib) SPRYCEL is currently

not recommended for patients who have not previously had a trial of Gleevec®

(imatinib mesylate) Women who are pregnant or planning to become pregnant should

not take SPRYCEL Before you take SPRYCEL, tell your healthcare provider about

all of your medical conditions, including if you: are pregnant or planning to

become pregnant. SPRYCEL (dasatinib) may harm an unborn baby. Women should avoid

becoming pregnant while undergoing treatment with SPRYCEL. Tell your healthcare

provider immediately if you become pregnant or plan to become pregnant while

taking SPRYCEL are breast-feeding. It is not known if SPRYCEL can pass into your

breast milk or if it can harm your baby. Do not breast feed if you are taking

SPRYCEL are a sexually active male. Men who take SPRYCEL are advised to use a

condom to avoid pregnancy in their partner have a liver or heart problem are

lactose intolerant Tell your healthcare provider about all the medicines you

take, including prescription and non-prescription medicines, vitamins, antacids,

and herbal supplements.

SPRYCEL is eliminated from your body through the liver. The use of certain other

medicines may alter the levels of SPRYCEL in your bloodstream. Likewise, levels

of other medicines in your bloodstream can be affected by SPRYCEL. Such changes

can increase the side effects, or reduce the activity of the medicines you are

taking, including SPRYCEL.

Medicines that increase the amount of SPRYCEL in your bloodstream are NIZORAL®

(ketoconazole), SPORANOX® (itraconazole), NORVIR® (ritonavir), REYATAZ®

(atazanavir sulfate), CRIXIVAN® (indinavir), VIRACEPT® (nelfinavir),

INVIRASE® (saquinavir), KETEK® (telithromycin), E-MYCIN® (erythromycin),

and BIAXIN® (clarithromycin) Medicines that decrease the amount of SPRYCEL in

your bloodstream are DECADRON® (dexamethasone), DILANTIN® (phenytoin),

TEGRETOL® (carbamazepine), RIMACTANE® (rifampin), and LUMINAL®

(phenobarbital) Medicines whose blood levels might be altered by SPRYCEL are

SANDIMMUNE® (cyclosporine), ALFENTA® (alfentanil), FENTANYL® (fentanyl),

ORAP® (pimozide), RAPAMUNE® (sirolimus), PROGRAF® (tacrolimus), and

ERGOMAR® (ergotamine) SPRYCEL is best absorbed from your stomach into your

bloodstream in the presence of stomach acid. You should avoid taking medicines

that reduce stomach acid such as TAGAMET® (cimetidine), PEPCID®

(famotidine), ZANTAC® (ranitidine), PRILOSEC® (omeprazole), PROTONIX®

(pantoprazole sodium), NEXIUM® (esomeprazole), ACIPHEX® (rabeprazole), or

PREVACID® (lansoprazole) while taking SPRYCEL. Medicines that neutralize

stomach acid, such as MAALOX® (aluminum hydroxide/magnesium hydroxide),

TUMS® (calcium carbonate), or ROLAIDS® (calcium carbonate and magnesia) may

be taken up to 2 hours before or 2 hours after SPRYCEL (dasatinib).

Since SPRYCEL therapy may cause bleeding, tell your healthcare provider if you

are using blood thinners, such as COUMADIN® (warfarin sodium) or aspirin.

Take SPRYCEL exactly as prescribed by your healthcare provider Take SPRYCEL with

or without a meal. Try to take SPRYCEL at the same time each day Swallow SPRYCEL

tablets whole with water. Do not break, cut, or crush the tablets Do not drink

grapefruit juice while taking SPRYCEL Possible Side Effects of SPRYCEL®

(dasatinib) The following information describes the most important side effects

of SPRYCEL.

It is not a comprehensive list of all side effects recorded in clinical trials

with SPRYCEL.

Low Blood Counts: SPRYCEL may cause low red blood cell counts (anemia), low

white blood cell counts (neutropenia), and low platelet counts

(thrombocytopenia). Your healthcare provider will check your blood counts

regularly during treatment with SPRYCEL and may adjust your dose of SPRYCEL or

withhold the drug temporarily in the event your blood counts drop too low.

Notify your healthcare provider immediately if you develop a fever while taking

SPRYCEL. Bleeding: SPRYCEL may cause bleeding. The most serious bleeding events

observed in clinical studies included bleeding into the brain leading to death

in 1% of patients, and bleeding from the gastrointestinal tract. Less severe

events included bleeding from the nose, the gums, bruising of the skin, and

excessive menstrual bleeding. Tell your healthcare provider immediately if you

have any bleeding or bruising while taking SPRYCEL. Fluid Retention: SPRYCEL may

cause fluid to accumulate in your legs and around your eyes. In more severe

cases, fluid may accumulate in the lining of your lungs, the sac around your

heart, or your abdominal cavity. Notify your healthcare provider immediately if

you experience swelling, weight gain, or increasing shortness of breath while

taking SPRYCEL. QT Prolongation: Talk to your healthcare provider if you have QT

prolongation, a condition called congenital long QT syndrome, or if you have a

family history of QT prolongation. You should also tell your healthcare provider

if you are taking a heart rhythm drug or chemotherapy, or are being treated for

low levels of potassium or magnesium in your blood before taking SPRYCEL.

Other common side effects of SPRYCEL therapy include diarrhea, headache,

shortness of breath, skin rash, fatigue, and nausea. Tell your healthcare

provider if you have any side effects.

Please see Patient Information section of the full Prescribing Information

available at www.SPRYCEL.com.

About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative

partners in the commercialization of SPRYCEL (dasatinib) in the United States,

Japan and major European countries. SPRYCEL was discovered and developed by

Bristol-Myers Squibb.

For more information about Bristol-Myers Squibb, visit http://www.bms.com or

follow us on Twitter at http://twitter.com/bmsnews.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company

with the corporate philosophy: 'Otsuka -- people creating new products for

better health worldwide.' Otsuka researches, develops, manufactures and markets

innovative and original products, with a focus on pharmaceutical products for

the treatment of diseases and consumer products for the maintenance of everyday

health. Otsuka is committed to being a corporation that creates global value,

adhering to the high ethical standards required of a company involved in human

health and life, maintaining a dynamic corporate culture, and working in harmony

with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings

Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group comprises

145 companies and employs approximately 39,000 people in 23 countries and

regions worldwide. Otsuka and its consolidated subsidiaries earned JPY 1,084.2

billion (approx. US $11.7 billion) in annual revenues in fiscal 2009. Visit

Otsuka Pharmaceutical Co., Ltd. at www.otsuka-global.com.

SOURCE: Bristol-Myers Squibb Company