Drug Topics - June 16, 2008 - (Page HSE2)

2 HSE DRUG TOPICS JUNE 16, 2008 www.drugtopics.com > > > Clinical Practice New drug helps palliative patients on opioids take care of business Julio Fernandez, Pharm.D. patients reported laxation within 30 minutes of a dose of methylnaltrexone. The rates of discontinuation due to adverse events during the two studies were comparable between methylnaltrexone-treated patients and the placebo group. The most frequently reported adverse events in the clinical trials were abdominal pain, flatulence, nausea, dizziness, and diarrhea. The manufacturer recommends that patients discontinue therapy if they experience severe or persistent diarrhea during treatment. According to the package insert, the drug should be administered subcutaneously in the abdomen, thighs, or upper arms. Methylnaltrexone is contraindicated in patients with known or suspected gastrointestinal obstruction. “Clinicians should be aware of Relistor’s dosing based on weight. Weight-based dosing presents a unique issue with a palliative care population as a patient’s weight can change dramatically in a short period of time,” explained Runyon. The recommended dose of methylnaltrexone is 8 mg for patients weighing 38-<62 kg (84-<136 lb) or 12 mg for patients weighing 62-114 kg (136-251 lb). Patients whose weights fall outside of these ranges should be dosed at 0.15 mg/kg. “Additionally, renal dosing is required in patients with severe renal impairment, a condition common among this population,” Runyon noted. The manufacturer recommends a dose reduction by one-half in patients with a creatinine clearance less than 30 mL/min. Methylnaltrexone will be supplied as Tips to remember: Relistor 12mg/0.6 mL single-use vials or as a kit Relistor is not a controlled substance and has no known risk containing seven trays. Each tray contains of abuse or dependency. one 12mg/0.6mL single-use vial, one 1mL syringe with a retractable (27 gauge) Instruct patients that the usual schedule is one dose every needle, and two alcohol swabs. The other day, as needed, but no more frequently than one dose in a manufacturer states that the methylnal24-hour period. trexone vial should not be used more than one time even if there is medication left Many patients can expect to experience a bowel movement over. If medication has been drawn into a within the first 30 minutes. syringe and the patient is unable to use it right away, the manufacturer states that it Patients should discontinue Relistor if they stop taking their should be stored at room temperature for opioid pain medication. no more than 24 hours. rogenics Pharmaceuticals and Wyeth Pharmaceuticals have announced that the Food & Drug Administration has recently approved Relistor (methylnaltrexone bromide) for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. “Relistor has a unique mechanism of action that makes it very different from other agents currently on the market. However, its usefulness is limited to patients who have opioid-induced constipation. Additionally, Relistor has been approved in patients with advanced illness undergoing palliative care, which right now will limit our experience with the drug,” stated Autumn Lyn Runyon, Pharm.D., assistant professor of pharmacy practice at Duquesne University Mylan School of Pharmacy. “Relistor offers an alternative for patients who have not experienced success with the agents we currently have available,” said Runyon. The safety and efficacy of Relistor were studied in two randomized, double-blind, placebo-controlled studies in 287 patients with advanced illness receiving opioids over a four-month period. Prior to treatment with methylnaltrexone, patients had been receiving palliative opioid therapy and had opioid-induced constipation. The results showed that in both studies, approximately 30% of THE AUTHOR is a writer based in New Jersey. P http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - June 16, 2008

Drug Topics - June 16, 2008 Contents Latebreakers Letters Latebreakers in Depth Pharmacists Lose in Final ESRD Rule New Drug Helps Palliative Patients on Opioids Take Care of Business Oral Treatment Reduces Multiple Sclerosis Flare-ups Beware of Inflammatory Masses From Implantable Infusion Systems Safer Therapeutic Options Emerging for Atrial Fibrillation Congressional Committee Chair Calls for Action Against Hospital Infections This Software System Helps Hospitals Manage Anticoagulation Therapy Rx Care Community Practice JP at Large Self-Care Cover Story Long-Term Care Chains and Business Technology Technology Update Continuing Education New Products Advertisers Index Classified Viewpoint

Drug Topics - June 16, 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.