Drug Topics - February 2009 - (Page 47)

CONTINUING EDUCATION drug can increase thoughts of suicide and worsen depression. Tetrabenazine should not be used by patients taking monoamine oxidase (MAO) inhibitors or reserpine, or by patients with hepatic impairment. Patients with long QT syndrome or arrhythmias should avoid tetrabenazine. Discontinuation of therapy should be considered for patients experiencing signs and symptoms of tardive dyskinesia. Doses should be reduced if patients experience akathisia or parkinsonism. Drug interactions: The major drug metabolites of tetrabenazine are CYP2D6 substrates. Increases in plasma concentrations will occur when tetrabenazine is given with strong CYP2D6 inhibitors (e.g., paroxetine, ﬂuoxetine, and quinidine). Caution is advised when tetrabenazine is used with other drugs known to prolong the QTc interval. Adverse effects: The most common side effects reported by patients during clinical trials included insomnia, drowsiness, fatigue, restlessness, and nausea. Tetrabenazine has also been shown to cause slight worsening in mood, cognition, rigidity, and functional capacity. Dosage and availability: The recommended starting dose of tetrabenazine is 12.5 mg given orally once daily in the morning. After one week, the dose should be increased to 12.5 mg given twice daily. The dose should then be titrated up slowly at weekly intervals by 12.5 mg until the desired effect is obtained. The maximum recommended single dose is 25 mg. Doses above 100 mg/day are not recommended. Patient counseling: Patients should be instructed to pay close attention to any changes in mood, behaviors, thoughts, and feelings. Explain that if a dose is missed, symptoms may reappear after 12 to 18 hours; however, instruct patients not to double the dose if the time for the next dose is near. C1 ESTERASE INHIBITOR (HUMAN) (Cinryze, Lev). FDA Rating: 1-P,O,I. Human C1 esterase inhibitor is derived from human plasma for intravenous use in routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). The primary function of C1 inhibitor, which is deﬁcient among patients with HAE, is to regulate the activation of the complement and intrinsic coagulation pathway. The net result is a reduction in HAE attacks. CERTOLIZUMAB PEGOL (Cimzia, UCB). FDA rating: 1-S,I. Certolizumab pegol is a member of the tumor-necrosisfactor blocker class, providing another option for treatment of Crohn’s disease when conventional therapy fails. Indication: Certolizumab pegol is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. Pharmacology and pharmacokinetics: Tumor necrosis factor alpha (TNF-alpha) plays a central role in the inﬂammatory process. Certolizumab pegol is a humanized monoclonal antibody Fab’ fragment that binds and neutralizes TNF-alpha. Precautions: Certolizumab pegol may suppress the immune system. Patients should be tested for latent tuberculosis prior to receiving treatment. W W W.D R U GTO P I C S .C O M Availability: Certolizumab pegol is available as a 200-mg powder for reconstitution. Patient counseling: Explain to the patient that certolizumab pegol is used to control active Crohn’s disease and to maintain a response when other conventional therapies have been unsuccessful. Tell the patient that a healthcare professional will administer this medication in an institutional setting. Give the patient the medication guide and be available to answer questions. RILONACEPT (Arcalyst, Regeneron Pharmaceuticals). FDA rating: 1-P,O,I. Rilonacept is an innovative new modality for the treatment of cryopyrin-associated periodic syndromes (CAPS) in adults and children 12 and older. ROMIPLOSTIM (Nplate, Amgen). FDA Rating: 1-P,O,I. Romiplostim is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have had an inadequate response to corticosteroids, immunoglobulins, or splenectomy. Romiplostim should be used only by patients whose degree of thrombocytopenia places them at an increased risk of bleeding. It should not be used as an attempt to normalize platelet counts. Romiplostim is available only through a restricted distribution program called the Nplate NEXUS Program. Additional NMEs/addendum Tapentadol (no trade name yet) is approved for acute pain, but can’t be marketed at the time of this writing because it is awaiting a drug scheduling decision from the DEA. Fospropofol (Lusedra) is a water-soluble prodrug of the sedative/hypnotic/anesthetic drug propofol. It is approved for monitored anesthesia care (MAC) sedation, but is, as of this writing, awaiting a drug scheduling decision from the DEA before marketing. Plerixafor (Mozobil) is reported to increase the number of blood stem cells prior to bone marrow transplantation in patients with non-Hodgkins lymphoma and multiple myeloma. The drug is not available in the United States as of this writing, but has orphan drug status in the United States and the European Union. (These three drugs have been included in the total calculated numbers noted in the tables available with the online version of this CE article as well as in the introductory paragraph.) Late addendum: The FDA approved 2 more NMEs in December. Gadofosveset is a new gadolinium-based contrast agent used in magnetic resonance angiography to detect blockages or other problems in blood vessels in patients with known or suspected aortoiliac disease. Degarelix is a novel gonadotropin-releasing hormone (GnRH) receptor inhibitor indicated for treatment of patients with advanced prostate cancer. Full references are available at www.drugtopics.com. Februar y 2009 DRUG TOPICS 47 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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