HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VIMOVO safely and effectively. See full prescribing information for VIMOVO.
VIMOVO®
(naproxen and esomeprazole magnesium) DELAYED RELEASE TABLETS
Initial U.S. Approval: April 2010
 
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS

See full prescribing information for complete boxed warning

Cardiovascular Risk

• Naproxen, a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (5.1)

• VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)

Gastrointestinal Risk

• NSAIDs, including naproxen, a component of VIMOVO, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events. (5.4)
 
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS 05/2011

Hypomagnesemia (5.19)

Concomitant use of St John’s Wort or Rifampin with VIMOVO (5.20) 06/2011

 
INDICATIONS AND USAGE
Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers (1)

 
DOSAGE AND ADMINISTRATION
One tablet twice daily. Use the lowest effective dose. Should be avoided in moderate/severe renal insufficiency or in severe hepatic insufficiency. Consider dose reduction in mild/moderate hepatic insufficiency (2)

 
DOSAGE FORMS AND STRENGTHS
Delayed release tablets: 375 mg/20 mg or 500 mg/20 mg of naproxen and esomeprazole magnesium (3)

 
CONTRAINDICATIONS
• Known hypersensitivity to any component of VIMOVO or substituted benzimidazoles (4)

• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4, 5.8, 5.9, 5.13)

• Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1)

• Late pregnancy (4, 5.10, 8.1)

 
WARNINGS AND PRECAUTIONS
• Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk (5.1)

• Serious gastrointestinal (GI) adverse events, which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at high risk for GI events, especially the elderly. VIMOVO should be used with caution in these patients (5.4, 8.5)

• Treatment should be withdrawn when active and clinically significant bleeding from any source occurs (5.5)

• Elevated liver enzymes and, rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen (5.11, 8.6, 12.3)

• Should be avoided in patients with sever