- As with all metformin products, lactic acidosis due to metformin accumulation during treatment with GLUMETZA is a rare but potentially fatal occurrence.
- May also occur in association with a number of pathophysiologic conditions.
- The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age, especially patients ≥80 years of age, and in those patients with congestive heart failure requiring pharmacologic management.
- The risk of lactic acidosis while on GLUMETZA therapy may be significantly decreased by initial and regular monitoring of renal and liver function; using the minimum effective dose; withholding in the presence of any condition associated with hypoxemia, dehydration, or sepsis; avoidance in patients with hepatic disease; cautioning patients against excessive alcohol intake; temporarily discontinuing prior to any intravascular radiocontrast study or surgical procedure.
- Lactic acidosis is a medical emergency requiring immediate discontinuation of GLUMETZA.
- General supportive measures and prompt hemodialysis are recommended to correct the acidosis and remove the accumulated metformin.
Hypoglycemia does not occur in patients receiving GLUMETZA alone but could occur with deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress.In clinical trials, the most common side effects with GLUMETZA monotherapy were diarrhea, nausea, dyspepsia, and upper abdominal pain. In a clinical trial of GLUMETZA combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea. For additional information on the product, please access the prescribing information at www.glumetzaxr.com. About Depomed Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 has completed Phase 3 clinical development and has been licensed to Abbott Products Inc. A New Drug Application for DM-1796 was accepted by the FDA in the second quarter of 2010. Product candidate Serada ® is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA ® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform ® drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Additional information about Depomed may be found on its website, http://www.depomed.com. About Santarus Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on GLUMETZA ® (metformin hydrochloride extended release tablets) and CYCLOSET ® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: ULTESA ™ (budesonide MMX ®) for induction of remission of active ulcerative colitis, rifamycin SV MMX ® for treatment of travelers' diarrhea and RHUCIN ® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema. In addition, Santarus plans to initiate a Phase I clinical study in the first half of 2011 with SAN-300, its anti-VLA-1 antibody, which the company expects to investigate for the treatment of rheumatoid arthritis. More information about Santarus is available on the company's website at www.santarus.com. Statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by either Santarus or Depomed that any of their respective plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus' or Depomed’s businesses, including, without limitation: risks related to the promotion arrangement between Santarus and Depomed (including Santarus' ability to increase market demand and sales of GLUMETZA products; competition from other products, unexpected adverse side effects or inadequate therapeutic efficacy of GLUMETZA products; the ability of Depomed to ensure continued supply of GLUMETZA products in the U.S. market; the scope and validity of patent protection for GLUMETZA products, including the outcome and duration of the ongoing GLUMETZA patent litigation; and the potential for termination of the promotion arrangement); and other risks detailed in Santarus' and Depomed’s prior press releases and public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and neither Santarus nor Depomed undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Acuform ® and Serada ® are trademarks of Depomed, Inc. GLUMETZA ® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. Santarus ® and ULTESA ™ are trademarks of Santarus, Inc. CYCLOSET ® is a registered trademark of VeroScience LLC. MMX ® is a registered trademark of Cosmo Technologies Limited. RHUCIN ® is a registered trademark of Pharming Group NV.