Drug Topics - November 19, 2007 - (Page 8)

8 DRUG TOPICS NOVEMBER 19, 2007 www.drugtopics.com > > > Latebreakers In Depth Leukemia patients now have more options Jillene Magill-Lewis, R.Ph. W Adverse reactions with nilotinib were usually relatively mild (e.g., rash, itching, headache, nausea, vomiting, fatigue, and constipation). More serious reactions included thrombocytopenia and neutropenia. Nilotinib can also prolong the QT interval, which is a potentially lifethreatening effect. Prolonged QT can trigger torsades de pointes, an arrhythmia that may then progress to atrial fibrillation and, potentially, to sudden death. Sudden deaths have occurred in patients taking nilotinib. On the positive side, some of the more common adverse reactions to imatinib and dasatinib were rarely obAccelerated approval served with nilotinib in clinical studies. Edema in legs, In one phase II study of nilotinib, 31% of patients had ankles, and feet and fluid in the lungs have been assoa complete cytogenetic response. That is, no Ph chromociated with both imatinib and dasatinib, but rarely with some was left in their bone nilotinib. The cramps and weight gain ofmarrow. Another 16% of paten seen with imatinib were also uncomtients had the Ph chromomon with nilotinib. It should be noted some reduced to low levels. that dasatinib also may prolong QT and Whether the two newer has warnings to this effect in the prescribdrugs will eventually be aping information. Imatinib does not. proved as primary therapy for Although some adverse effects of nilotinib, imatinib, and dasatinib can be serious, most of them can be prevented or corrected TIPS TO REMEMBER Tasigna through dose adjustments and proper Tasigna should be dosed as 400 mg twice daily, given about 12 monitoring. Experts believe it is remarkable hours apart. that two effective and fairly well-tolerated No food should be taken for at least two hours before a dose of drugs—imatinib and dasatinib—have beTasigna is given and one hour after. come available for CML. With the recent While patients are taking Tasigna, a complete blood count should approval of nilotinib, the arsenal for treating be performed every two weeks for the first two months, and monthCML patients is even better. Nilotinib “reply thereafter to monitor for myelosuppression. resents an important advance for the small Tasigna may cause QT prolongation. Hypokalemia and hypomagnumber of patients resistant or intolerant to nesemia should be corrected prior to initiating therapy with Tasigna. prior therapy,” said David Epstein, presiPatients taking Tasigna should avoid the use of strong inhibitors dent and CEO of Novartis Oncology. or inducers of CYP3A4. THE AUTHOR hen imatinib (Gleevec, Novartis) became available several years ago, it brought new hope for people with chronic myeloid leukemia (CML). Unfortunately, imatinib does not work for all CML patients. But those patients who can’t take imatinib now have other options. Dasatinib (Sprycel, Bristol-Myers Squibb) was approved by the Food & Drug Administration last year, and nilotinib (Tasigna, Novartis) received accelerated FDA approval last month. Like imatinib, both dasatinib and nilotinib are oral tablets and are targeted therapies: They attack malignant cells while generally leaving normal cells alone. In clinical studies, dasatinib and nilotinib were effective in patients who had already tried imatinib. According to the National Cancer Institute, drug efficacy in CML is usually measured by hematologic or cytogenetic response, or both. A hematologic response is a reduction or elimination of abnormal white blood cells. A cytogenetic response is a reduction or elimination of the Philadelphia (Ph) chromosome of stem cells in the bone marrow. CML is hard to say. Some clinicians are now using dasatinib as initial treatment, said Susannah Koontz, Pharm.D., a clinical practice specialist in pediatric hematology/oncology at the M. D. Anderson Cancer Center in Houston. Nilotinib is still too new for data on the drug as primary treatment to be in yet. In five years, things could change if evidence supports the newer drugs as initial therapy for CML, especially if resistance to imatinib increases. Under such circumstances, said Koontz, “Sometimes a newer drug will overtake an older one.” Adverse reactions is a writer based in the Seattle area. http://www.drugtopics.com

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Drug Topics - November 19, 2007 Contents Latebreakers Letters Leukemia Patients Now Have More Options First-in-Class HIV Drug Boon to Patients at End of Tether 150 Years of American Pharmacy Pharmacy Schools Confront New Pressures From Pariah to Patient ACCP Releases Position Paper on Ethical Interactions New Injectable Antibiotic Welcomed with Open Arms NCCN Updates Head and Neck Cancer Guide Improved Phosphate Binder Approved for Dialysis Patients Considering Combination Concern Ensuring Seamless Care Bill Would Create Center for Comparative Effectiveness Hospital Improves Patient Safety with Automatic Drug Distribution System Infection Rates, Patient Stays Drop with New Drug Device How R.Ph.s Helped Three Hospitals Win Quality and Safety Awards A Pharmacist and Dog in Tow are Alzheimer’s Patients’ Best Friends More PBMs Agreeing to Pricing Transparency New Insulins in the Management of Diabetes New Products Advertisers Index Classified VIEWPOINT: Reflections on Pharmacy School After 30 Years

Drug Topics - November 19, 2007

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