Drug Topics - February 2009 - (Page 41)

NEW MOLECULAR ENTITIES & BIOLOGICS CE CREDIT: BENDAMUSTINE (Treanda, Cephalon). FDA rating: 1-P,O,I (P = priority review, O = orphan drug, I = injection). Bendamustine is a novel alkylating agent that provides a new chemotherapeutic option for the ﬁrstline treatment of adults with chronic lymphocytic leukemia (CLL). When studied head-to- head with chlorambucil, it proved to be more efﬁcacious, with a safety proﬁle similar to other alkylating agents. Indication: Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukemia. Efﬁcacy relative to ﬁrst-line therapies other than chlorambucil has not been established. Pharmacology and pharmacokinetics: Bendamustine is a bifunctional mechlorethamine derivative whose exact mechanism of action is unknown. Mechlorethamine and its derivatives are alkylating agents. Precautions: Bendamustine should not be administered to patients with a known hypersensitivity to bendamustine or mannitol. Like all alkylating agents, bendamustine may cause myelosuppression. Myelosuppression may be severe enough to warrant treatment delay or dose reduction. Patients are at an increased risk of infection; signs of infection should be dealt with promptly. Reactions of varying degrees of severity, including anaphylaxis, have occurred. Depending on severity, drug discontinuation may be necessary. For milder reactions, pretreatment prior to subsequent infusions may abate future reactions. In patients at high risk for tumor lysis syndrome, precautions should be taken to minimize risk. Skin reactions have occurred; for severe reactions, discontinuation is necessary. Women should be advised to avoid becoming pregnant, because bendamustine belongs to pregnancy category D. Adverse reactions: Hematologic toxicity was the most frequently observed adverse reaction in clinical trials. Neutropenia, thrombocytopenia, anemia, and leukopenia occurred in ≥15 percent of patients. A signiﬁcant proportion of these adverse reactions were classiﬁed as severe. Dosage and availability: The dose of bendamustine is 100 mg/m2 infused intravenously over 30 minutes on days 1 and 2 of a 28-day cycle, for up to 6 cycles. Delay in treatment and/or dose reduction may be necessary, depending upon the severity of hematologic and/or non-hematologic toxicity experienced by the patient during treatment. Bendamustine is available in a 100-mg vial for injection. Patient counseling: Explain to patients that bendamustine is a chemotherapy agent used in the treatment of chronic lymphocytic leukemia. Inform patients that a healthcare professional will administer the medication in an institutional setting. Ask patients if they are pregnant or breast-feeding. Instruct patients to report the following symptoms immediately: facial swelling, difﬁculty breathing, signiﬁcant fatigue, bleeding, fever, other signs of infection, and severe or worsening rash or itching. CLEVIDIPINE (Cleviprex, The Medicines Co.). FDA Rating: 1-S,I. Clevidipine is an injectable short-acting dihydropyridine calcium channel blocker used for the treatment of hypertension. Indications: Clevidipine is indicated for the treatment of hypertension when oral therapy is not possible or desirable. Pharmacology and pharmacokinetics: Clevidipine is a dihydropyridine Ltype calcium channel blocker involved in the mediation of calcium inﬂux during depolarization in arterial smooth muscle cells. Studies have shown that clevidipine reduces mean arterial blood pressure by decreasing systemic vascular resistance without affecting venous capacitance vessels or cardiac ﬁlling pressure. Clevidipine is administered as a continuous intravenous emulsion with a rapid distribution and metabolism, resulting in a very short half-life. A 4 percent to 5 percent reduction in systolic blood pressure is seen within 2 to 4 minutes W W W.D R U GTO P I C S .C O M AMA PRA Category Credit 2.0 EARN CME CREDIT FOR THIS ACTIVITY AT WWW.DRUGTOPICS.COM E DU CATIO NAL O BJ E C TIV E S To provide pharmacists and pharmacy technicians with a working knowledge and understanding of the new molecular entities and biologics approved by the Food and Drug Administration in 2008. After participating in this activity, pharmacists should be able to: List drug names, mechanisms of action, and pharmacological/ pharmacokinetic properties. Summarize contraindications and precautions that may preclude use. Outline potential adverse drug reactions and drug interactions as well as necessary monitoring parameters. Restate route of administration, dosing schedule, and dosing forms. Identify salient points for patient discussion during counseling sessions. Compare to other members of the therapeutic class. Explain the drug’s place in therapy. The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education ACPE # 012-999-09-002-H01-P ACPE # 012-999-09-002-H01-T This lesson is no longer valid for CE credit after 02/28/2011. To obtain immediate CE credit, take the test on-line at www.drugtopics.com. Just click on the “Continuing Education”box on the Drug Topics home page, which will take you to the CE site. Log in, find and click on this lesson, and follow the three simple steps. Test results will be displayed immediately and you can print the certificate showing your earned CE credits. The authors disclose they have no nancial relationship with any manufacturer in this area of medicine. For questions concerning PRINT CEs, call (352) 273-6275. For questions concerning ON-LINE CEs, call (866) 261-3558. Februar y 2009 DRUG TOPICS 41 http://WWW.DRUGTOPICS.COM http://www.drugtopics.com http://WWW.DRUGTOPICS.COM

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Drug Topics - February 2009 Contents Health-System Edition Group Attempts to Resurrect Pain Care Act HSE Business Management HSE Clinical Letters Up Front Up Front in Depth Community Practice Niche Pharmacies Serve Special Populations Special Report Oral Oncology Drugs New Drugs Update 2008 Approvals OTC New Products Viewpoint

Drug Topics - February 2009

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