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SPRIX is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Important Safety Information About SPRIX

WARNING: LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK

  • Limitations of Use – The total duration of use of SPRIX and other ketorolac formulations should not exceed 5 days.
  • Gastrointestinal (GI) Risk – Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines, which can be fatal. SPRIX is CONTRAINDICATED in patients with peptic ulcer disease or history of GI bleeding.
  • Bleeding Risk – SPRIX inhibits platelet function and is CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding.
  • Cardiovascular (CV) Risk – NSAIDs may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk. SPRIX is CONTRAINDICATED for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
  • Renal Risk – SPRIX is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.

Mild, transient nasal discomfort was the most frequently reported side-effect of SPRIX use. SPRIX is contraindicated in patients with known hypersensitivity or a history of allergic reactions to aspirin, ketorolac, other NSAIDs or EDTA; in patients at risk for GI bleeding; prior to major surgery or during the perioperative period in CABG surgery, in patients with advanced renal disease or volume depletion, patients with certain bleeding risk and during labor and delivery. SPRIX should not be used concurrently with probenecid or pentoxifylline. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX. See the full prescribing information for more details.

ROXRO PHARMA, Inc., 535 Middlefield Rd., Suite 180, Menlo Park, CA 94025 busdev@roxropharma.com (650)322-4554