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2004 ACCP Guidelines

Excerpts of Recommendations for

Prophylaxis and Treatment of DVT

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Prophylaxis of DVT in hospitalized patients

PE is the most common preventable cause of hospital death. Appropriate use of prophylaxis for VTE in patients at risk is the number one strategy to improve patient safety.1

Prophylaxis of DVT in medical patients with severely restricted mobility during acute illness1 · Acutely ill medical patients who are admitted to the

hospital with congestive heart failure or severe respiratory disease, or who are confined to bed and have one or more additional risk factors, including active cancer, previous VTE, sepsis, acute neurologic disease, or inflammatory bowel disease: ACCP recommends prophylaxis with LDUH (Grade 1A) or LMWH (Grade 1A)

· Medical patients with risk factors for VTE, and in whom

there is a contraindication to anticoagulant prophylaxis: ACCP recommends mechanical prophylaxis with GCS or IPC (Grade 1C+)

Abbreviations: ACCP=American College of Chest Physicians; ASCRS=American Society of Colon & Rectal Surgeons; ASRA=American Society of Regional Anesthesia and Pain Medicine; CCU=critical care unit; DVT=deep vein thrombosis; GCS=graduated compression stockings; ICU=intensive care unit; INR=international normalized ratio; IPC=intermittent pneumatic compression; IV=Intravenous; LDUH=low-dose unfractionated heparin; LMWH=low-molecular-weight heparin; PE=pulmonary embolism; RCT=randomized clinical trial; SC=subcutaneous; SCIP=Surgical Care Improvement Project;THR=total hip replacement; TKA=total knee arthroplasty; UFH=unfractionated heparin; VFP=venous foot pump; VKA=vitamin K antagonist; VTE=venous thromboembolism=DVT/PE. 2 View Full Prescribing Information Including Boxed WARNING at: http://products.sanofi-aventis.us/lovenox/lovenox.html

Prophylaxis of DVT in cancer and CCU patients1 · Cancer patients undergoing surgical procedures:

prophylaxis appropriate for their current risk state (Grade 1A). Refer to recommendations in the relevant surgical subsections

· Hospitalized cancer patients who are bedridden with

an acute medical illness: prophylaxis appropriate for their current risk state (Grade 1A). Refer to recommendations dealing with medical patients

· On admission to a critical care unit, assess all patients

for their risk of VTE. Accordingly, most patients should receive thromboprophylaxis (Grade 1A)

· ICU patients at moderate risk for VTE (eg, medically ill

or postoperative patients): recommend using LMWH or LDUH therapy (Grade 1A); patients at higher risk (such as after major trauma or orthopedic surgery): recommend prophylaxis using LMWH therapy (Grade 1A)

"...primary thromboprophylaxis reduces DVT, PE, and fatal PE. ...and is the number one strategy to improve patient safety in hospitals." 1

--The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy

LOVENOX® is indicated for the prophylaxis of DVT, which may lead to PE, in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness

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Prophylaxis of DVT following hip- or kneereplacement surgery1

· Elective THR surgery: routine use of one of the following

anticoagulants: (1) LMWH (at a usual high-risk dose, started 12 hours before surgery or 12 to 24 hours after surgery, or 4 to 6 hours after surgery at half the usual high-risk dose and then increasing to the usual high-risk dose the following day); (2) fondaparinux (2.5 mg started 6 to 8 hours after surgery); or (3) adjusted-dose VKA started preoperatively or the evening after surgery (INR target, 2.5; INR range, 2.0 to 3.0) (all Grade 1A)

· Elective TKA surgery: routine thromboprophylaxis using

either LMWH (at the usual high-risk dose), fondaparinux, or adjusted-dose VKA (target INR, 2.5; INR range, 2.0 to 3.0) (all Grade 1A)

· Recommend against the use of aspirin, dextran, LDUH,

GCS, IPC, or VFP as the only method of thromboprophylaxis in THR patients (Grade 1A)

· The optimal use of IPC is an alternative option to

anticoagulant prophylaxis (Grade 1B, due to the fewer number of trials with smaller sample sizes) inTKA patients

· Recommend against the use of any of the following as sole

methods of thromboprophylaxis inTKA patients: aspirin (Grade 1A), LDUH (Grade 1A), orVFP (Grade 1B)

· Patients undergoingTHR orTKA: thromboprophylaxis

with LMWH (using a high-risk dose), fondaparinux (2.5 mg daily), or a VKA (target INR, 2.5; INR range, 2.0 to 3.0) for at least 10 days (Grade 1A)

· Patients undergoing THR: extended prophylaxis for

up to 28 to 35 days after surgery (Grade 1A); the recommended options forTHR include LMWH (Grade 1A), VKA (Grade 1A), or fondaparinux (Grade 1C+)

Underlying values and preferences: the ACCP has not recommended the use of fondaparinux over LMWH and VKA, or the use of LMWH over VKA, because the ACCP places a relatively low value on the prevention of venographic thrombosis and a relatively high value on minimizing bleeding complications

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Prophylaxis of DVT following abdominal surgery1*

· Higher-risk general surgery patients (those undergoing

nonmajor surgery who are >60 years of age or have additional risk factors, or patients undergoing major surgery who are >40 years of age or have additional risk factors): recommend LDUH (5000 U tid) or LMWH (>3400 U daily) (both Grade 1A)

· High-risk general surgery patients with multiple risk factors:

recommend pharmacologic methods (ie, LDUH tid or LMWH >3400 U daily) combined with the use of GCS and/or IPC (Grade 1C+)

· Selected high-risk general surgery patients, including

those who have undergone major cancer surgery: suggest post-hospital discharge prophylaxis with LMWH (Grade 2A) "...performance of more extensive operative procedures in older and sicker patients, the use of preoperative chemotherapy, and the shorter lengths of stay in the hospital (leading to shorter durations of prophylaxis) may heighten the risk of VTE in contemporary patients undergoing inpatient, general surgery." 1

--The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy

LOVENOX® is indicated for the prophylaxis of DVT, which may lead to PE, in: -- Patients undergoing hip-replacement surgery, during and following hospitalization -- Patients undergoing knee-replacement surgery

LOVENOX® is indicated for the prophylaxis of DVT, which may lead to PE, in patients undergoing abdominal surgery who are at risk for thromboembolic complications

*Abdominal surgery was considered as a part of general surgery recommendations. Approved LOVENOX® dosing is 40 mg SC once a day initiated 2 hours preoperatively.

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Consensus guidelines support DVT/PE prophylaxis

ASRA* safety guidelines for neuraxial anesthesia2 · ASRA consensus guidelines for postoperative LMWH

use in patients receiving neuraxial anesthesia -- Administer the first dose of LMWH no earlier than 24 hours postoperatively after establishment of adequate (surgical) hemostasis -- Indwelling catheters should be removed prior to initiation of LMWH thromboprophylaxis -- A continuous epidural catheter may be left indwelling overnight and removed the following day, with the first LMWH dose administered 2 hours after catheter removal

2000 ASCRS guideline recommendations3 · Colon and rectal surgeons should include a protocol of

VTE prophylaxis in their practices and be vigilant for signs and symptoms of VTE

· In addition to decreasing the risk of DVT, such a protocol

will also decrease the additional potential morbidities of long-term anticoagulation, chronic venous insufficiency, and pulmonary embolism

*Excerpted from the 2nd ASRA Consensus Conference on Neuraxial Anesthesia and Anticoagulation. Excerpted from the 7th ASCRS Practice Parameters for the Prevention of Venous Thromboembolism.

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SCIP measures further underscore the need to reduce DVT/PE risk

SCIP is a national partnership of leading organizations committed to improving the safety of surgical care by reducing postoperative complications4 · Mission

-- A nationwide reduction by 25% in surgical complications by 2010

· Current VTE process measures

-- SCIP VTE 1: Surgery patients with recommended venous thromboembolism prophylaxis ordered -- SCIP VTE 2: Surgery patients who received appropriate venous thromboembolism prophylaxis within 24 hours prior to surgery to 24 hours after surgery

Outcome measures featuring the diagnosis of DVT and PE within 30 days of surgery will be determined in the near future.

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Treatment of DVT with or without PE5

· Patients with objectively confirmed DVT: short-term treatment with LMWH SC, or UFH IV or SC (Grade 1A)* · Patients with acute DVT: initial treatment with LMWH or UFH for at least 5 days (Grade 1C)* · Initiation of VKA together with LMWH or UFH on the first

treatment day and discontinuation of heparin when the INR is stable and >2.0 (Grade 1A)*

· Patients with acute DVT: initial treatment with LMWH SC once or twice daily over UFH as an outpatient if possible (Grade 1C) and as an inpatient if necessary (Grade 1A) · Patients with acute DVT treated with LMWH: recommend

against routine monitoring with anti-factor Xa level measurements (Grade 1A)

· Patients with severe renal failure: UFH IV over LMWH (Grade 2C) · Patients with objectively confirmed nonmassive PE: short-term treatment with LMWH SC or UFH IV (Grade 1A)§ · Patients with acute nonmassive PE: LMWH over UFH (Grade 1A)§ · Patients with acute nonmassive PE: initial treatment with LMWH or UFH for at least 5 days (Grade 1C)§ · Patients with acute nonmassive PE treated with LMWH:

recommend against routine monitoring with anti-factor Xa levels (Grade 1A)§

"...the failure to prevent VTE [DVT/PE]...results in delayed hospital discharge or readmission...and in recurrent thrombosis in the future." 1

--The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy

LOVENOX® is indicated for the inpatient treatment of acute DVT, with or without PE, and for the outpatient treatment of acute DVT without PE, when administered in conjunction with warfarin sodium

*Excerpted from section 1.1 of the summary recommendations. Excerpted from section 1.4 of the summary recommendations. Please see 2004 ACCP evidence-based guidelines for appropriate dosing. § Excerpted from section 4.1 of the summary recommendations.

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Current approach to grades of recommendations6¶

ACCP grades of recommendations for antithrombotic and thrombolytic therapy6

Grade of recommendation Clarity of risk/ benefit Methodological strength of supporting evidence Implications

1A

Clear

RCTs without important limitations

Strong recommendation; can apply to most patients in most circumstances without reservation

1C+

Clear

No RCTs, but strong Strong recommendation; RCT results can be can apply to most patients unequivocally in most circumstances extrapolated, or overwhelming evidence from observational studies Strong recommendation; RCTs with important limitations (inconsistent likely to apply to most results, methodological patients flaws#) Observational studies Intermediate-strength recommendation; may change when stronger evidence is available Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values Weak recommendation; best action may differ depending on circumstances or patients' or societal values Weak recommendation; alternative approaches likely to be better for some patients under some circumstances Very weak recommendations; other alternatives may be equally reasonable

1B

Clear

1C

Clear

2A

Unclear

RCTs without important limitations

2C+

Unclear

No RCTs, but strong RCT results can be unequivocally extrapolated, or overwhelming evidence from observational studies RCTs with important limitations (inconsistent results, methodological flaws) Observational studies

2B

Unclear

2C

Unclear

Since studies in categories B and C are flawed, it is likely that most recommendations in these classes will be level 2. The following considerations will bear on whether the recommendation is Grade 1 or Grade 2: the magnitude and precision of the treatment effect; patients' risk of the target event being prevented; the nature of the benefit and the magnitude of the risk associated with treatment; variability in patient preferences; variability in regional resource availability and health care delivery practices; and cost considerations. Inevitably, weighing these considerations involves subjective judgment. # These situations include RCTs with both lack of blinding and subjective outcomes, where the risk of bias in measurement of outcomes is high, or RCTs with large loss to follow up.

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LOVENOX® dosing guidelines7

For treatment of acute DVT

Inpatient and outpatient treatment of acute DVT7

Patient population Inpatients with acute DVT, with or without PE Dosing 1.5 mg/kg SC once a day (at the same time every day) or 1 mg/kg q12h SC (both in conjunction with warfarin sodium therapy) Outpatients with acute DVT without PE 1 mg/kg q12h SC (in conjunction with warfarin sodium therapy) Duration of therapy · Average: 7 days · Continue for a minimum of 5 days and until INR = 2.0-3.0 ·Well tolerated up to 17 days in controlled clinical trials

· Average: 7 days · Continue for a minimum of 5 days and until INR = 2.0-3.0 ·Well tolerated up to 17 days in controlled clinical trials

Inpatients (with acute DVT with or without PE) or outpatients (with acute DVT without PE) with severe renal impairment

1 mg/kg SC once a day (in conjunction with warfarin sodium therapy)

· Average: 7 days · Continue for a minimum of 5 days and until INR = 2.0-3.0

· In patients with severe renal impairment (creatinine clearance <30 mL/min), LOVENOX® dosage should be adjusted accordingly; does not apply to hemodialysis patients7 · LOVENOX® does not require dose adjustments in mild to moderate renal impairment; all such patients should be observed carefully for signs and symptoms of bleeding7 ­ Mild renal impairment: creatinine clearance 50 to 80 mL/min ­ Moderate renal impairment: creatinine clearance 30 to 50 mL/min · LOVENOX® Injection may be largely neutralized (up to 60%) by the slow IV injection of protamine sulfate (1% solution)7 · No routine coagulation monitoring required7*

* Because routine coagulation tests are relatively insensitive measures of LOVENOX® activity, these tests are unsuitable for monitoring in patients with normal baseline coagulation parameters. Periodic complete blood counts, including platelet count, and stool occult blood tests are recommended during treatment.7

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For prophylaxis of DVT

Prophylaxis of DVT7

Patient population Medical patients with restricted mobility Dosing 40 mg SC once a day Duration of therapy · Usual: 6 to 11 days ·Well tolerated up to 14 days in the controlled clinical trial · Usual: 7 to 10 days ·Well tolerated up to 14 days in clinical trials

Hip-replacement patients

30 mg q12h SC (initiated 12 to 24 hours postop) or 40 mg SC once a day (initiated 12 ± 3 hours preop)

Extended prophylaxis in hip-replacement patients Knee-replacement patients

40 mg SC once a day§

· 3 weeks recommended

30 mg q12h SC (initiated 12 to 24 hours postop) 40 mg SC once a day (initiated 2 hours preop) 30 mg SC once a day

· Usual: 7 to 10 days ·Well tolerated up to 14 days in clinical trials · Usual: 7 to 10 days ·Well tolerated up to 12 days in clinical trials

Abdominal surgery patients

Deep vein thrombosis in abdominal surgery, hipor kneereplacement surgery, and medical patients with severe renal impairment during acute illness

Medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness. Provided hemostasis has been established at the wound site. § Following initial phase of thromboprophylaxis (30 mg q12h or 40 mg once a day).

Please see important safety information on back cover. Please see accompanying full prescribing information, including boxed WARNING, inside pocket.

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Important safety information

LOVENOX® (enoxaparin sodium injection) cannot be used interchangeably with other low-molecular-weight heparins or unfractionated heparin, as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins or heparinoids are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these events is increased by the use of postoperative indwelling epidural catheters or by the concomitant use of drugs affecting hemostasis. Patients should be frequently monitored for signs and symptoms of neurological impairment. (See boxed WARNING.) As with other anticoagulants, use with extreme caution in patients with conditions that increase the risk of hemorrhage. Dosage adjustment is recommended in patients with severe renal impairment. Unless otherwise indicated, agents that may affect hemostasis should be discontinued prior to LOVENOX® therapy. Bleeding can occur at any site during LOVENOX® therapy. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site. (See WARNINGS and PRECAUTIONS.) Thrombocytopenia can occur with LOVENOX®. In patients with a history of heparin-induced thrombocytopenia, LOVENOX® should be used with extreme caution. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, LOVENOX® should be discontinued. Cases of heparininduced thrombocytopenia have been observed in clinical practice. (SeeWARNINGS.) The use of LOVENOX® has not been adequately studied for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves. (See WARNINGS.) LOVENOX® is contraindicated in patients with hypersensitivity to enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding.

References: 1. Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(suppl):338S-400S. 2. Horlocker TT, Wedel DJ, Benzon H, et al. Regional anesthesia in the anticoagulated patient: defining the risks (the Second ASRA Consensus Conference on Neuraxial Anesthesia and Anticoagulation). Reg Anesth Pain Med. 2003;28:172-197. 3. The Standards Task Force, American Society of Colon and Rectal Surgeons. Practice parameters for the prevention of venous thromboembolism. Dis Colon Rectum. 2000;43:1037-1047. 4. Hall MC. CKS602 - Surgical Care Improvement Project (SCIP) Module 2: Preventing adverse intra- and postoperative cardiovascular, thromboembolic and respiratory complications self-study continuing education course. Available at: http://www.fmqai.com. Accessed September 26, 2006. 5. Büller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(suppl):401S-428S. 6. Guyatt G, Schünemann HJ, Cook D, Jaeschke R, Pauker S. Applying the grades of recommendation for antithrombotic and thrombolytic therapy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(suppl):179S-187S. 7. LOVENOX® (enoxaparin sodium injection) Prescribing Information. sanofi-aventis, Bridgewater, NJ.

Please see accompanying full prescribing information, including boxed WARNING, inside pocket. Visit our website, www.LOVENOX.com, for health care professional and patient information.

US.ENO.07.01.179 ©2007 sanofi-aventis U.S. LLC

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