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

  • Program provides a patient call center 24 hours a day, 7 days a week to answer questions about SPRYCEL and the My SPRYCEL Support Program
  • Participants offered access to a SPRYCEL Care Counselor
  • Co-pay assistance also available for eligible patients

PRINCETON, N.J. & TOKYO--(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 John 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 Linda 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 ¥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.

* SPRYCEL, REYATAZ and COUMADIN are registered trademarks of Bristol-Myers Squibb. All other brands listed are the trademarks of their respective owners.

* My SPRYCEL Support is a registered trademark of Bristol-Myers Squibb.

* Gleevec® is a registered trademark of Novartis AG.



CONTACT:

Bristol-Myers Squibb
Media:
Bristol-Myers Squibb
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Bristol-Myers Squibb
John Elicker, 609-252-4611
[email protected]
or
Otsuka
U.S.:
Otsuka America Pharmaceutical Inc.
David Caruba, 609-524-6798
[email protected]
or
Japan:
Otsuka Pharmaceutical Co., Ltd.
Masamitsu Kitada
[email protected]

KEYWORDS:   United States  Asia Pacific  North America  New Jersey  Japan

INDUSTRY KEYWORDS:   Health  Biotechnology  Oncology  Pharmaceutical  Other Health

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