MGI PHARMA Brings Aloxi Message Directly to Patients and Caregivers.MINNEAPOLIS -- MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) PHARMA, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . today announced the launch of a campaign targeted at patients with cancer experiencing chemotherapy-induced nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. (CINV CINV Chemotherapy Induced Nausea and Vomiting ). The "Yes to Control" Patient Program features resources for patients and their caregivers to help prevent and manage the nausea and vomiting that can affect patients receiving some types of chemotherapy if steps are not taken to prevent it. Patients can also obtain information regarding CINV and how Aloxi(R) (palonosetron hydrochloride palonosetron hydrochloride Aloxi Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist Therapeutic class: Antiemetic Pregnancy risk category B ) injection can help prevent it.Through advertisements in patient magazines such as Cure, Coping, and MAMM MAMM Multi-Media Asset Management , patients are invited to enroll by going to www.YesCTRL.com or calling 1-866-YES-CTRL (1-866-937-2875). Healthcare providers can also enroll to receive educational resources for their patients. Materials available through the Yes to Control program include: --NO to NAUSEA Brochure -This brochure provides an understanding of CINV and explains how ALOXI can help patients say YES to CONTROL --TAKE CONTROL brochure - This brochure offers a more detailed look at CINV, an overview of treatment options, and a summary of additional resources available --YES to NUTRITION Guide - The guide outlines the importance of diet during chemotherapy and provides insights into how nutrition may alleviate the intensity of nausea and vomiting --YES to CONTROL Patient Diary--This tool allows patients to record daily symptoms to improve communication with their healthcare providers Ultimately MGI PHARMA hopes this educational campaign will help optimize the management of CINV by informing patients and caregivers of new advances in the therapeutic area. About Aloxi(R) Injection Aloxi injection was approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. on July 25, 2003 at a fixed dose of 0.25 mg for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Aloxi injection is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) caused by moderately emetogenic cancer chemotherapy. Aloxi injection is a selective 5-HT3 receptor antagonist with high receptor binding affinity and an extended 40-hour plasma half-life that was developed for the prevention of CINV. Results from phase 3 clinical trials demonstrate that a single IV dose of Aloxi injection is effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy, the most common chemotherapy regimens used in the treatment of cancer. Three multicenter, double blind, phase 3 trials were conducted to demonstrate the efficacy and safety of Aloxi injection compared with that of currently marketed 5-HT3 receptor antagonists for prevention of CINV. Study endpoints in each trial included complete response, defined as the percentage of patients that did not experience vomiting or use rescue medication, during the 0-24, 24-120, and 0-120 hour periods following chemotherapy. Adverse reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. observed in the trials were similar in frequency, intensity, and duration with Aloxi injection and the comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. agents. The most common adverse reactions related to the study drug at a dose of 0.25 mg were headache (9%) and constipation (5%). Aloxi injection is contraindicated in patients known to have hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to the drug or any of its components. The effect of Aloxi injection on ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. parameters was comparable to ondansetron and dolasetron in clinical trials; it should be administered with caution in patients who have or may develop prolongation of cardiac conduction intervals. Please see the Aloxi injection package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific , available at www.mgipharma.com and www.aloxi.com, for important additional details. MGI licensed the U.S. and Canada rights for Aloxi injection from Helsinn Healthcare SA of Lugano, Switzerland. About Chemotherapy-Induced Nausea and Vomiting (CINV) If not prevented, CINV is estimated to afflict the majority of cancer patients undergoing chemotherapy and can result in a delay or even discontinuation of chemotherapy treatment. The advent of 5-HT3 receptor antagonists has revolutionized the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy. About MGI PHARMA, INC. MGI PHARMA is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA has a portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) injection, KADIAN(R) (sustained release morphine sulfate morphine sulfate, n brand names: Duramorph PF, MS Contin, Roxanol; drug class: narcotic analgesic (Controlled Substance Schedule II); action: capsules), Salagen(R) Tablets (pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. ) and Hexalen(R) (altretamine) capsules in the United States. The Company directly markets its products in the U.S. and collaborates with partners in international markets. For more information about MGI PHARMA, please visit www.mgipharma.com. KADIAN(R) is a registered trademark of Alpharma, Inc. This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements are typically preceded by words such as "believes," " expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the Company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission including in Exhibit 99 to its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements to conform them to actual results. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion