• New onset or worsening of pre-existing hypertension. Blood pressure should be monitored closely during treatment with VIMOVO (5.2, 7.1, 7.4)

• Congestive heart failure and edema. VIMOVO should be used with caution in patients with fluid retention or heart failure (5.3)

• Renal papillary necrosis and other renal injury with long-term use. Use VIMOVO with caution in the elderly, those with impaired renal function, hypovolemia, salt depletion, heart failure, liver dysfunction, and those taking diuretics, or ACE-inhibitors. Not recommended for patients with moderate or severe renal impairment (2, 5.6, 5.7, 7.1, 7.4, 8.7)

• Anaphylactoid reactions. Do not use VIMOVO in patients with the aspirin triad (5.8)

• Serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal and can occur without warning. Discontinue VIMOVO at first appearance of skin rash or any other sign of hypersensitivity (5.9)

• Long-term PPI therapy is associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine (5.16)

• Symptomatic response to esomeprazole does not preclude the presence of gastric malignancy (5.4)

• Atrophic gastritis has been noted on biopsy with long-term omeprazole therapy (5.4)

• Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia, enterochromaffin-like cell hyperplasia, and increased Chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. (5.18)

• Hypomagnesemia has been reported rarely with prolonged treatment with PPIs (5.19)

• Avoid concomitant use of VIMOVO with St John’s Wort or rifampin due to the potential reduction in esomeprazole levels. (5.20, 7.16)

 
ADVERSE REACTIONS
Most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 
DRUG INTERACTIONS
• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE Inhibitors, diuretics, and beta-blockers (7.1, 7.4, 7.9)

• Concomitant use of NSAIDs increases lithium plasma levels (7.5)

• Concomitant use of VIMOVO with methotrexate may increase the toxicity of methotrexate (7.6)

• Concomitant use of VIMOVO with warfarin may result in increased risk of bleeding complications. Monitor for increases in INR and prothrombin time (7.7)

• Esomeprazole inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin) Patients treated with VIMOVO and digoxin may need to be monitored for increases in digoxin toxicity (7.12)

• As with all NSAIDs caution is advised when cyclosporin is co-administered because of the increased risk of nephrotoxicity. (7.4)

• Tacrolimus: Concomitant administration of esomeprazole, a component of VIMOVO, and tacrolimus may increase the serum levels of tacrolimus. (7.5)

 
USE IN SPECIFIC POPULAT