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百时美施贵宝称，其白血病治疗药Sprycel可用于治疗前列腺癌。该公司公布了Sprycel在两项II期临床实验中获取的数据，表明这种药物极有潜力用于去势治疗失败的前列腺癌（CRPC）患者。
在一项名为CA180-085的大型临床实验中，检测了3种剂量的Sprycel用于治疗CRPC患者的效果，结果发现他们体内癌细胞和前列腺特异抗原对药物的应答率，骨密度的减少程度与每天采用一次或两次Sprycel治疗的患者相当。
此外，在一项名为CA180-086的附加临床实验中发现，患者对Sprycel+Docetaxel（目前的标准药物）联合疗法的耐受性良好，未发现药物发生相互作用的情况。基于这个喜人的临床实验结果，百时美施贵宝已展开这种联合疗法的III期临床实验。
目前它获准用于那些对之前采用的药物已产生抵抗性或无法耐受的成人慢性白血病患者和Ph阳性急性淋巴细胞白血病患者新的治疗希望。
SPRYCEL® (dasatinib) is a prescription medicine used to treat adults who have:
- chronic myeloid leukemia (CML) who are no longer benefitting from, or cannot tolerate, prior treatment including GLEEVEC® (imatinib mesylate)
- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are no longer benefitting from, or cannot tolerate, prior treatment
IMPORTANT SAFETY INFORMATION ABOUT SPRYCEL
- 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 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.
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. |
