Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism finds the status quo "unacceptable."¹




The First Direct Thrombin Inhibitor (DTI) Approved for DVT Prophylaxis

The only DTI to offer convenient subcutaneous administration

• A suitable alternative for patients who cannot use heparin²
• Not contraindicated in patients with thrombocytopenia^2,3
• Single-use vials —10 (w. diluent, supplies)
• 15-mg fixed subcutaneous dose in patients with normal renal function
      -Dose reductions are recommended for patients with moderate or severe renal insufficiency

Significantly more effective than the current standard of care

• Significant reduction in proximal DVT events vs low-dose unfractionated heparin (UFH); p<0.001³
• Significant reduction in major venous thromboembolic events (VTE*) vs low molecular weight heparin (LMWH) enoxaparin; p<0.02³

Comparable risk of bleeding to LMWH and UFH

• No significant differences in bleeding compared with enoxaparin 40 mg QD or UFH 5000 IU TID³
• Low rates of major hemorrhage^✝:<1% IPRIVASK, <1% enoxaparin, and 0% heparin (n=2159)³

Unique profile vs other anticoagulants available for use in the US


Preferred Formulatary Status

• Brigham and Women's Hospital of Boston one of the most recent hospitals adding IPRIVASK^® to formulary²

INDICATION:
IPRIVASK^® is approved for the prevention of deep vein thrombosis which may lead to pulmonary embolism in patients undergoing elective hip replacement surgery.

IMPORTANT SAFETY INFORMATION WARNING:
When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with IPRIVASK^® may be at risk of developing epidural or spinal hematoma which can result in long term or permanent paralysis. The risk may be greater with the use of post-operative indwelling catheters or the concomitant use of additional drugs affecting hemostasis such as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), platelet inhibitors or other anticoagulants. Bleeding risk may also be increased by traumatic or repeated neuraxial puncture.

IPRIVASK^® is contraindicated in patients with active bleeding and/or irreversible coagulation disorders, or with known hypersensitivity to natural or recombinant hirudins.
IPRIVASK^® should be used with caution in patients with increased risk of bleeding and in patients with renal impairment. Bleeding can occur at any site during therapy with IPRIVASK^®. All patients should be carefully monitored for bleeding. Any unexpected fall in hematocrit or blood pressure should lead to discontinuation of IPRIVASK^® and a search for a bleeding site. The potential for cross sensitivity to other hirudin products cannot be excluded. Fatal anaphylactiod reactions have been reported during hirudin therapy. Common (> 2%) side effects for IPRIVASK^® in clinical trials include injection site mass, wound secretion and anemia.

IPRIVASK^® Prescribing Information

References: 1. The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. 2008. U.S. Department of Health and Human Services website. Available at www.surgeongeneral.gov/topics/deepvein/calltoaction/call-to-action-on-dvt-2008.pdf. Accessed November 25, 2009. 2. Data on file. Canyon Pharmaceuticals; Hunt Valley, MD. 3. Iprivask^® Prescribing Information. Canyon Pharmacutucals, Hunt Valley, MD. December 1, 2009. 4. Fanikos J. Clinical use of desirudin, a new subcutaneously administered direct thrombin inhibitor. Pharmacy Pract News 2009; Nov: 54-55. 5. Warkentin TW, Greinacher A, Koster A, Lincoff AM. Treatment and prevention of heparin-induced thrombocytopenia. Chest 2008;133:340s-380s. 6. Tahir R. A review of unfractionated heparin and its monitoring. US Pharmacist. 2007:32(7):HS-26-HS-36. 7. Lovenox Prescribing Information, Sanofi-Aventis U.S. LLC, Bridgewater, NJ, 2009

^*Major venous thromboembolism (VTE) included proximal DVT, pulmonary embolism, or death
^✝Bleeding complications were considered major if the hemorrhage was: (1) overt and produced a fall in hemoglobin of =2g/dL or if it lead to a transfusion of =2 units of whole or packed cells outside the perioperative period; (2) Retroperitoneal, intracranial, intraocular, intraspinal, or occurred in a major prosthetic joint
^‡Thrombin affinity based on Ki values reviewed by Warkentin.⁵