[October 04, 2014]

IPRIVASK (Desirudin for Injection) Positive Data for DVT Prevention in Orthopedic Reconstruction Presented at the International Congress for Joint Replacement (ICJR) Transatlantic Meeting

Marathon Pharma, LLC today announced positive results from 2 separate - IPRIVASK® studies presented at the International Congress for Joint Reconstruction (ICJR) Transatlantic Meeting, held in New York City.

Study-1: This Post-Hoc analysis evaluated the safety and efficacy of Iprivask in several high-risk patient subgroups of the pivotal registration multicenter trial comparing desirudin to enoxaparin, in patients undergoing elective total hip replacement (THR) surgery (Eriksson et al, 1997). Results from this analysis demonstrated that patients with various high-risk conditions (e.g. age>65, obesity, cancer, varicose veins, previous VTE) undergoing elective hip replacement, had favorable odds ratio's for venous thromboembolism (VTE) incidence with desirudin compared with enoxaparin.

The lead author of the analysis, Dr. Jerrold Levy of Duke University, stated: "Patients undergoing total hip replacement surgery with additional risk factors for venous thromboembolism (i.e. age, obesity, CVD, etc.) present a challenge for choosing thromboprophylactic therapy. The findings from this post-hoc analysis suggest that desirudin may be the preferred parenteral agent over enoxaparin in high-risk patients undergoing total hip replacement surgery."

Study-2: In this observational study, patients were evaluated for bleeding events and wound outcomes after receiving desirudin administered during the immediate postoperative period after total joint replacement surgery (hip and/or knee), followed by rivaroxaban, for outpatient DVT prophylaxis. According to the lead author, Dr. Maurice Jove of Georgia Knee and Sports Medicine, "Many physicians, today, prefer to initiate their DVT prophylaxis after total joint replacement. This observational study showed that Iprivask, when initiated post-surgically, resulted in low post-operative complications (i.e. hemoglobin drops, wound discharge, etc.) without any thrombotic (DVT) complications. By limiting post-operative complications, patients may respond more successfully to the demands of physical therapy."

About IPRIVASK®: IPRIVASK (desirudin by injection) is the first and only direct thrombin inhibitor (DTI (News - Alert)) approved for deep vein thrombosis (DVT) prophylaxis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery. IPRIVASK® has proven superior to risk reduction in preventing DVT's compared to both Lovenox (enoxaparin) and unfractionated heparin, as demonstrated in separate head-to-head clinical trials. The bleeding profile of IPRIVASK® was comparable t enoxaparin. IPRIVASK® is a recombinant form of hirudin, a naturally occurring highly selective thrombin inhibitor that inhibits both soluble and clot bound thrombin. IPRIVASK® is now available as a single dose lyophilized powder vial with an accompanying sterile prefilled syringe of diluent, which once prepared, is administered by subcutaneous injection. Important Safety Information: IPRIVASK® is contraindicated in patients with known hypersensitivity to natural or recombinant hirudins, and in patients with active bleeding and/or irreversible coagulation disorders. When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as IPRIVASK® may be at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these events may be increased by the use of indwelling spinal catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. Likewise, with such agents, the risk appears to be increased by traumatic or repeated epidural or spinal punctures. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. The physician should consider potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis. Iprivask must be used with caution in patients with renal impairment, particularly in those with moderate and severe renal impairment. Dose reductions by factors of three and nine are recommended for patients with moderate and severe renal impairment respectively. In addition, daily aPTT and serum creatinine monitoring are recommended for patients with moderate or severe renal impairment. Iprivask is not intended for intramuscular injection as local hematoma formation may result. Iprivask, like other anticoagulants, should be used with caution in patients with increased risks of hemorrhage such as those with recent major surgery, organ biopsy or puncture of a non-compressible vessel within the last month; a history of hemorrhagic stroke, intracranial or intraocular bleeding including diabetic (hemorrhagic) retinopathy; recent ischemic stroke, severe uncontrolled hypertension, bacterial endocarditis, a known hemostatic disorder (congenital or acquired, e.g. hemophilia, liver disease) or a history of gastrointestinal or pulmonary bleeding within the past 3 months. Bleeding can occur at any site during therapy with Iprivask. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site. Iprivask cannot be used interchangeably with other hirudins as they differ in manufacturing process and specific biological activity (ATUs). Each of these medicines has its own instructions for use. Antibodies have been reported in patients treated with hirudins. Potential for cross-sensitivity to hirudin products cannot be excluded. Fatal anaphylactoid reactions have been reported during hirudin therapy. Iprivask should be used with caution in patients with hepatic insufficiency/liver injury. Activated partial thromboplastin time (aPTT) should be monitored daily in patients with increased risk of bleeding and/or renal impairment. Serum creatinine should be monitored daily in patients with renal impairment. Peak aPTT should not exceed two times control. Should peak aPTT exceed this level, dose reduction is advised based on the degree of aPTT abnormality. If necessary, therapy with desirudin should be interrupted until aPTT falls to less than two times control, at which time treatment with desirudin can be resumed at a reduced dose. The most common adverse reaction in clinical trials was hemorrhagic events.

Please see Full Prescribing Information for instructions on dosing and administration. How Supplied: IPRIVASK® (desirudin by injection) is supplied as a single dose (15.75 mg) lyophilized powder with an accompanying sterile, non-pyrogenic diluent [0.6mL of Mannitol USP (3%) in Water for Injection].

About Marathon Pharmaceuticals

Marathon Pharmaceuticals, LLC is a biopharmaceutical company that develops new treatments for rare diseases and makes small volume, hard-to-manufacture medications available to people who need them. Marathon is focused on providing medicine to patients who currently have no treatment options. The company manufactures prescription medications and is developing a pipeline of treatments for rare neurological, muscular and movement disorders. Marathon is headquartered in Northbrook, Illinois. For more information visit www.marathonpharma.com

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