Generic Name: Enoxaparin Sodium
Class: Heparins
CAS Number: 9005-49-6
- Spinal/Epidural Hematoma Risk
Epidural or spinal hematomas and neurologic injury, including long-term or permanent paralysis, associated with concurrent use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture.1
Risk increased by use of indwelling epidural catheters for administration of analgesia or by concomitant use of drugs affecting hemostasis (e.g., NSAIAs, platelet inhibitors, other anticoagulants).1
Risk also increased by traumatic or repeated epidural or spinal puncture.1
Monitor frequently for signs and symptoms of neurological impairment and treat urgently if neurologic compromise noted.1
Consider potential benefits versus risks of spinal or epidural anesthesia or spinal puncture in patients receiving or being considered for thromboprophylaxis with anticoagulants.1 (See Hematologic Effects and see Neurologic Effects under Cautions.)
Introduction
Anticoagulant; a low molecular weight heparin.1 2 3 4
Uses for Lovenox
Hip-Replacement Surgery
A low-molecular weight heparin recommended by ACCP for prophylaxis of postoperative deep-vein thrombosis and pulmonary embolism in patients undergoing hip-replacement surgery.1 2 3 5 6 7 20 21 22 27 30 34 35 36 37 38 60 104
Consider extended prophylaxis† in patients undergoing hip-replacement surgery who have ongoing risk factors for venous thromboembolism (e.g., obesity, delayed mobilization, cancer, history of venous thromboembolism).104
Hip-Fracture Surgery
Prevention of postoperative deep-vein thrombosis and pulmonary embolism in patients undergoing hip-fracture surgery†.
Consider extended prophylaxis† in patients undergoing hip-fracture surgery who have ongoing risk factors for venous thromboembolism (e.g., obesity, delayed mobilization, cancer, history of venous thromboembolism).104
Knee-Replacement Surgery
Prophylaxis of deep-vein thrombosis and pulmonary embolism in patients undergoing knee-replacement surgery.1 20 22 30 104
Knee Arthroscopy
A low-molecular weight heparin recommended by ACCP for prophylaxis of venous thromboembolism in high-risk patients undergoing knee arthroscopy† (e.g., those with preexisting thromboembolic risk factors or following a prolonged or complicated procedure); based on limited data.104
General Surgery
Prophylaxis of postoperative venous thromboembolism in patients undergoing general (e.g., abdominal) surgery who are at risk for thromboembolic complications.1 2 3 5 6 7 20 21 22 27 30 34 35 36 37 38 60 104
Early ambulation without specific thromboprophylaxis recommended by ACCP in patients undergoing general surgery who are at low risk for venous thromboembolism (those undergoing minor operations who are <40 years of age and who have no clinical risk factors).30 60 104
Recommended as alternative to fixed low-dose unfractionated heparin in moderate-risk general surgery patients (those undergoing nonmajor surgery who are 40–60 years of age or who have additional risk factors for thromboembolism, patients <40 years of age undergoing major surgery with no additional risk factors, and patients with risk factors who are undergoing minor surgery).23 30 60 104
Recommended as alternative to fixed low-dose unfractionated heparin in patients undergoing general surgery who are at higher risk for thromboembolism (those undergoing major surgery who are ≥40 years of age or who have additional risk factors and patients undergoing nonmajor surgery who are ≥60 years of age or who have additional risk factors).23 30 31 60 104
Recommended as alternative to low-dose unfractionated heparin and in combination with intermittent pneumatic compression or graduated-compression stockings23 30 31 60 in high-risk general surgery patients (those >40 years of age with multiple risk factors such as a history of previous venous thromboembolism, cancer, or a hypercoagulable state)27 90 . Continue therapy with a low molecular weight heparin after hospital discharge in selected high-risk general surgery patients, including those undergoing major cancer surgery.23 31 60 104
Thromboprophylaxis with low-dose unfractionated heparin, low molecular weight heparin, intermittent pneumatic compression, graduated compression stockings, or a combination of these therapies suggested in patients undergoing laparoscopic gynecologic procedures who have additional risk factors for venous thromboembolic events (e.g., malignancy, older age, previous thromboembolism, prior pelvic radiation therapy, use of an abdominal surgical approach).104
Thromboprophylaxis with a low molecular weight heparin recommended as alternative to low-dose unfractionated heparin1 60 104 or intermittent pneumatic compression in patients having major gynecologic surgery for benign disease who do not have additional risk factors for thromboembolism.104 Begin just prior to surgery and continue until hospital discharge or patient is ambulatory.104
Routine prophylaxis with low molecular weight heparin or unfractionated heparin recommended in patients undergoing extensive gynecologic procedures for malignancy and in those with additional risk factors for venous thromboembolic events.104 Alternative regimens include intermittent pneumatic compression continued until hospital discharge, or the combination of low-dose unfractionated heparin or low molecular weight heparin and intermittent pneumatic compression or graduated-compression stockings.104 Continue prophylaxis for 2–4 weeks following hospital discharge in those at particularly high risk for thromboembolism (e.g., previous cancer surgery, ≥60 years of age, history of thromboembolism).104
Thromboprophylaxis with a low molecular weight heparin or low-dose unfractionated heparin recommended in patients undergoing major vascular surgery who have additional risk factors for thromboembolism (e.g., advanced age, limb ischemia, long duration of surgery, intraoperative local trauma).104
Medical Conditions Associated with Thromboembolism
Prophylaxis of venous thromboembolism in medical patients with CHF or severe lung disease or who have severely restricted mobility in conjunction with one or more additional risk factors (e.g., previous venous thromboembolism, sepsis, acute neurologic disease, inflammatory bowel disease).1 2 3 5 6 7 20 21 22 27 30 34 35 36 37 60 104
Deep-Vein Thrombosis and Pulmonary Embolism
Inpatient treatment of acute deep-vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium.1 28 102 106
Outpatient treatment of acute deep-vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.1 28
A low molecular weight heparin recommended by ACCP for treatment of suspected deep-vein thrombosis† while awaiting confirmation of diagnosis, provided no contraindications exist.102 103
A low molecular weight heparin preferred over unfractionated heparin for treatment of deep-vein thrombosis and acute nonmassive pulmonary embolism.102
A low molecular weight heparin recommended by ACCP as alternative to oral anticoagulation (e.g., with warfarin) for long-term treatment of deep-vein thrombosis or acute nonmassive pulmonary embolism† in patients in whom oral anticoagulation is contraindicated or inconvenient.102
ACCP recommends that unfractionated heparin be substituted for low molecular weight heparin in patients with severe renal failure.102
Superficial Thrombophlebitis
A low molecular weight heparin suggested by ACCP as an alternative to unfractionated heparin for treatment of superficial thrombophlebitis†.102
Unstable Angina and Non-ST Segment Elevation MI
Reduction in the risk of acute cardiac ischemic events (combined end point of death, MI, or recurrent angina) in patients with unstable angina or non-ST-segment elevation/non-Q-wave MI (i.e., non-ST-segment elevation acute coronary syndromes) when administered concurrently with aspirin.1 40 41 42 43
Considered by ACCP preferable to unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes who have received a GP IIb/IIIa-receptor inhibitor prior to PCI.111
ST-Segment Elevation Myocardial Infarction
A low molecular weight heparin suggested by the American Heart Association (AHA), American College of Cardiology (ACC), and ACCP as alternative to unfractionated heparin for adjunctive therapy in patients with ST-segment elevation MI† receiving thrombolytic therapy.
Additional study and experience recommended before routine use of low molecular weight heparin instead of unfractionated heparin in patients with ST-segment elevation MI.
Low molecular weight heparin not recommended in place of unfractionated heparin as adjunctive therapy for patients who are >75 years of age or who have renal dysfunction (serum creatinine >2.5 mg/dL in men or >2 mg/dL in women).
Preferred over unfractionated heparin by ACC and AHA in patients with CHF after ST-segment elevation MI who are hospitalized for prolonged periods, nonambulatory, or considered at high risk for deep-vein thrombosis and are not receiving other anticoagulant therapy.
Also recommended by ACC and AHA in patients surviving ST-segment elevation MI with or without acute ischemic stroke who have cardiac sources of embolism (atrial fibrillation, mural thrombus, akinetic segment) after reperfusion; administer until adequate anticoagulation with warfarin achieved.
ACC and AHA suggest as reasonable therapy in patients with ST-segment elevation MI who are not receiving thrombolytic therapy, provided no contraindications to anticoagulation exist.
Neurosurgery
A low molecular weight heparin recommended by ACCP as alternative therapy (e.g., instead of intermittent pneumatic compression with or without graduated compression stockings) for thromboprophylaxis in selected patients undergoing intracranial neurologic surgery†.104
Combination of a low molecular weight heparin or low-dose unfractionated heparin with graduated-compression stockings and/or intermittent pneumatic compression recommended in patients with multiple risk factors for venous thromboembolism.104
Elective Spinal Surgery
A low molecular weight heparin recommended by ACCP for prevention of venous thromboembolism in patients undergoing elective spinal surgery† who have additional risk factors (e.g., advanced age, known malignancy, neurologic deficit, previous venous thromboembolic event, anterior surgical approach), as alternative to postoperative low-dose unfractionated heparin or perioperative intermittent pneumatic compression.104
Combine anticoagulant therapy with graduated-compression stockings and/or intermittent pneumatic compression in patients with multiple risk factors for venous thromboembolism.104
Acute Spinal Cord Injury
A low molecular weight heparin recommended by ACCP as first-line therapy for prophylaxis of thromboembolism in patients with acute spinal cord injury†.104 For prevention of thromboembolism in therehabilitation phase of acute spinal cord injury†, continue therapy, or, alternatively, convert to full-dose oral anticoagulation.104
Trauma
A low molecular weight heparin recommended by ACCP as first-line prophylaxis for thromboembolism in patients with major trauma†.60
Initiate prophylaxis as soon as considered safe to do so and continue until hospital discharge, including during inpatient rehabilitation.30 104
Extended prophylaxis after hospital discharge suggested in patients with major mobility impairment.104
Burns
A low molecular weight heparin recommended by ACCP as alternative to low-dose unfractionated heparin in burn patients who have at least one additional risk factor for venous thromboembolism (e.g., advanced age, morbid obesity, extensive or lower extremity burns, concomitant lower extremity trauma, use of a femoral catheter, or prolonged immobility).104 Initiate prophylaxis as soon the risk of bleeding is no longer high, provided no contraindications exist.104
Long-Distance Travel
Single prophylactic dose of a low molecular weight heparin may be considered for thromboprophylaxis prior to travel† as alternative to below-knee graduated-compression stockings in those with risk factors for venous thrombosis (e.g., previous deep-vein thrombosis, coagulation disorder, limited mobility, current or recent cancer, large varicose veins, severe obesity).104 Data insufficient to support routine use in any group of travelers.104
Acute Ischemic Stroke
A low molecular weight heparin recommended by ACCP as first-line thromboprophylaxis in patients with acute ischemic stroke† and impaired mobility who have no contraindications.108
Thromboembolism during Pregnancy
A low molecular weight heparin recommended in selected patients for prevention or treatment of thromboembolism during pregnancy†.63 103
Embolism Associated with Atrial Fibrillation/Flutter
A low molecular weight heparin may be initiated at diagnosis to reduce the incidence of embolism in patients undergoing cardioversion for atrial fibrillation/flutter† of <48 hours' duration, provided no contraindications exist.105
A low molecular weight heparin may be substituted for oral anticoagulant (e.g., warfarin) therapy in patients with atrial fibrillation† who require a series of diagnostic or surgical procedures that necessitate interruption of oral anticoagulation† for >1 week or in selected high-risk patients who require interruption of oral anticoagulant therapy for shorter periods.62
Thromboembolism Associated with Prosthetic Heart Valves
Therapy with a low molecular weight heparin has been recommended in selected patients for prophylaxis of thromboembolism associated with prosthetic heart valves†.59 60 62 63 65 105 107
Systemic Venous Thrombosis in Pediatric Patients
A low molecular weight heparin suggested by ACCP for the treatment and prevention of systemic venous thrombosis in neonates and children†; data insufficient to make strong recommendations.118
Renal Vein Thrombosis
A low molecular weight heparin suggested by ACCP for the treatment of renal vein thrombosis in neonates†; data limited and use of anticoagulant or thrombolytic therapy controversial in such patients.118
Cerebral Venous Sinus Thrombosis
A low molecular weight heparin recommended by ACCP with follow-up oral anticoagulation (e.g., warfarin) in adults with acute cerebral venous sinus thrombosis†, even in the presence of hemorrhagic venous infarcts.65 108
Not recommended by some clinicians for use in adults with large hemorrhagic venous infarcts and associated hematomas.65 108
Neonates without large ischemic infarction or intracranial hemorrhage: Initial therapy with a low molecular weight heparin or unfractionated heparin suggested, then administer low molecular weight heparin for 3 months.118
Neonates with large infarcts or intracranial hemorrhage: Radiographic monitoring suggested; initiate anticoagulation if extension of thrombus detected.118
Children without major intracranial hemorrhage: Low molecular weight heparin or unfractionated heparin followed by low molecular weight heparin or oral anticoagulation (e.g., with warfarin).118
Spontaneous Aortic Thrombosis
Neonates with spontaneous aortic thrombosis† and evidence of renal ischemia: Urgent, aggressive use of thrombolytic or surgical therapy supported by anticoagulation with a low molecular weight heparin or unfractionated heparin suggested by ACCP.118
Lovenox Dosage and Administration
General
Evaluate the possibility of an underlying bleeding disorder before initiation of treatment, unless the need for therapy is urgent.1 Since coagulation parameters are insensitive for monitoring enoxaparin activity, routine monitoring of coagulation parameters is not required.1 (For information on populations that require monitoring, see Pregnancy and also Renal Impairment under Cautions and see Hematologic Effects under Cautions.)
In patients with unstable angina and non-ST-segment elevation/non-Q-wave myocardial infarction, adhere precisely to intervals recommended between doses to minimize the risk of bleeding.1 Keep vascular access sheath in place for 6–8 hours following a dose of enoxaparin.1 Administer the next scheduled dose no sooner than 6–8 hours after sheath removal.1 Observe procedure site for signs of bleeding or hematoma formation.1
Administration
Administer by deep sub-Q injection; do not give IM.1
Patient should be supine during administration.1 17
To avoid loss of drug when using the 30- or 40-mg prefilled syringes, do not expel air from syringe prior to injection.1
When using single-use ampuls or multiple-dose vials, withdraw the dose using a tuberculin or equivalent syringe.1
Inject drug sub-Q into the left and right anterolateral and posterolateral abdominal wall.1
Alternate injection sites frequently.1
To minimize bruising, do not massage injection sites after injection.1
Insert the entire length of the needle into a skin fold created by the thumb and forefinger; hold the skin fold until the needle is withdrawn.1
Do not mix enoxaparin with other injections or infusions.1
Dosage
Available as enoxaparin sodium; dosage expressed in terms of the salt.100
Dosages for enoxaparin sodium and regular (unfractionated) heparin or other low molecular weight heparins cannot be used interchangeably on a unit-for-unit (or mg-for-mg) basis.1
Enoxaparin has an approximate anti-factor Xa activity of 100 units/mg using the World Health Organization (WHO) First International Low Molecular Weight Heparin Reference Standard.1
Adults
Prevention of Venous Thrombosis and Pulmonary Embolism
General Surgery
Sub-Q
In patients undergoing general (e.g., abdominal, gynecologic, urologic) surgery who are at moderate to very high risk for thromboembolic complications (e.g., those with malignancy, history of deep-vein thrombosis or pulmonary embolism, or obesity, or patients >40 years of age or undergoing major surgery under general anesthesia lasting >30 minutes), 40 mg once daily with the initial dose given 2 hours prior to surgery.1 30 39 60
Usual duration of therapy is 7–10 days, although up to 12 days of treatment has been well tolerated in clinical trials.1 71
Extended prophylaxis: ACCP suggests continuation for 2–3 weeks after hospital discharge in patients at high risk for thromboembolism.23 31 60 104
Hip-Replacement Surgery
Sub-Q
Initially, 30 mg every 12 hours for ≥10 days; begin 12–24 hours after surgery provided hemostasis has been established.1
Alternatively, consider 40 mg once daily, with the initial dose given approximately 12 hours prior to surgery.1 2 10 34 71
Extended prophylaxis: Following the initial phase of thromboprophylaxis, continue 40 mg once daily for 28–35 days.1 35 36 104
Knee-Replacement Surgery
Sub-Q
Initially, 30 mg every 12 hours for >10 days; begin 12–24 hours after surgery provided hemostasis has been established.1 104
Long-Distance Travel
Long-distance travelers at increased risk for thromboembolism: single dose of <34 mg prior to departure.104
Medical Conditions Associated with Thromboembolism
Sub-Q
Acute illness with impaired mobility: 40 mg once daily.1 Usual duration of therapy is 6–11 days; well tolerated up to 14 days in clinical trials.1
Thromboembolism During Pregnancy
Sub-Q
Primary prevention in women with inherited causes of thrombophilia (e.g., antithrombin deficiency, heterozygous genetic mutation of both prothrombin G20210A and factor V Leiden, or homozygous genetic mutation for factor V Leiden or prothrombin G20210A): 1 mg/kg every 12 hours suggested.103
Primary prevention in other patients with confirmed thrombophilia: 40 mg once daily, followed by postpartum oral anticoagulation (e.g., with warfarin) suggested.103
Secondary prevention after a single episode of idiopathic venous thromboembolism with no long-term anticoagulation: 40 mg once daily.103
Secondary prevention after a single episode of venous thromboembolism with risk factors (e.g., confirmed thrombophilia, strong family history of thrombosis) and no long-term anticoagulation: 40 mg once or twice daily, followed by postpartum oral anticoagulation.103
Secondary prevention after >2 episodes of venous thromboembolism: 1 mg/kg twice daily throughout pregnancy followed by postpartum resumption of long-term anticoagulation.103
Secondary prevention in women who require long-term anticoagulation: 1 mg/kg twice daily throughout pregnancy.103
Treatment of Deep-Vein Thrombosis with or without Pulmonary Embolism
Sub-Q
Outpatient treatment at home in patients without pulmonary embolism: 1 mg/kg every 12 hours.1 29
Pregnant women: 1 mg/kg every 12 hours for remainder of pregnancy.103
Inpatient (hospital) treatment in patients with or without pulmonary embolism (not candidates for outpatient treatment): 1 mg/kg every 12 hours or 1.5 mg/kg once daily at the same time every day.1
Average duration of therapy is 7 days, although up to 17 days of treatment has been well tolerated in clinical trials.1
Initiate concurrent warfarin sodium therapy when appropriate, usually within 72 hours of enoxaparin injection.1 39 59
Continue enoxaparin for a minimum of 5 days, until a therapeutic oral anticoagulant effect is achieved.1 39 59
Embolism Associated with Atrial Fibrillation
Sub-Q
Patients with atrial fibrillation duration <48 hours undergoing cardioversion who have no contraindications to anticoagulation: 1 mg/kg every 12 hours.102 103 105
ACCP suggests same regimen for anticoagulation in patients undergoing cardioversion for atrial flutter.105
Unstable Angina and Non-ST-Segment Elevation MI
Sub-Q
1 mg/kg every 12 hours in conjunction with aspirin therapy.1 41
Administer for a minimum of 2 days and continue until clinical stabilization.1 41
Usual duration of treatment is 2–8 days, although up to 12.5 days of treatment has been well tolerated in clinical trials.1
In patients with unstable angina or non-ST-segment elevation MI undergoingPCI, further anticoagulation suggested based on time of last dose of enoxaparin sodium.114
Last dose within 8 hours of PCI: No additional anticoagulation suggested during procedure.114
Last dose administered 8–12 hours before PCI: 0.3 mg/kg given by directIV injection suggested at initiation of PCI.114
Last dose administered >12 hours prior to PCI: Conventional anticoagulation with unfractionated heparin suggested during PCI.114 116
ST-Segment Elevation Myocardial Infarction
IV, then Sub-Q
Loading dose: 30 mg by direct IV injection†.
Maintenance dosage: 1 mg/kg sub-Q every 12 hours until hospital discharge.
Special Populations
Hepatic Impairment
No dosage recommendations.1 No dosage adjustments necessary in patients with mild (Clcr 50–80 mL/minute) or moderate (Clcr 30–50 mL/minute) renal impairment.1
Renal Impairment
Use with caution in renally impaired patients.1 3 No dosage adjustments necessary in patients with mild (Clcr 50–80 mL/minute) or moderate (Clcr 30–50 mL/minute) renal impairment.1
Venous Thrombosis and Pulmonary Embolism
Prophylaxis in General (e.g., Abdominal) Surgery
Sub-Q
In patients with severe renal impairment (Clcr <30 mL/minute), 30 mg once daily.1
Prophylaxis in Hip or Knee Replacement Surgery
Sub-Q
In patients with severe renal impairment (Clcr <30 mL/minute), 30 mg once daily.1
Prophylaxis in Medical Conditions Associated with Thromboembolism
Sub-Q
In patients with severe renal impairment (Clcr <30 mL/minute), 30 mg once daily.1
Treatment of Deep-Vein Thrombosis with or without Pulmonary Embolism
Sub-Q
In patients with severe renal impairment (Clcr <30 mL/minute), 1 mg/kg once daily, in conjunction with warfarin therapy.1
Unstable Angina and Non-ST Segment Elevation MI
Sub-Q
In patients with severe renal impairment (Clcr <30 mL/minute), 1 mg/kg once daily, in conjunction with aspirin therapy.1
Geriatric Patients
Use with caution.1 3
Low-Weight Patients
Consider adjustment of dosage for low weight (women <45 kg or men <57 kg).1
Cautions for Lovenox
Contraindications
Active major bleeding.1
Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of the drug.1
Known hypersensitivity to enoxaparin sodium, heparin, pork products, or any ingredient in the formulation.1
Warnings/Precautions
Warnings
Neurologic Effects
Epidural or spinal hematomas and neurologic injury, including long-term or permanent paralysis, associated with concurrent use of low molecular weight heparins and neuraxial (spinal/epidural) anesthesia or spinal puncture procedures.1 Frequent monitoring for signs of neurologic impairment recommended.1 (See Boxed Warning.)
Hematologic Effects
Use with extreme caution in patients with an increased risk of hemorrhage.1 Such patients include those with bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration and angiodysplastic GI disease, hemorrhagic stroke, or recent brain, spinal, or ophthalmologic surgery.1 Increased risk for hemorrhage in patients treated concomitantly with platelet inhibitors.1
Use with caution in patients with bleeding diathesis, uncontrolled arterial hypertension, or a history of recent GI ulceration, diabetic retinopathy, or hemorrhage.1
Carefully monitor patients with low body weight or renal impairment for signs and symptoms of bleeding.1
As with other anticoagulants, bleeding may occur at any site during therapy.1 Major (sometimes fatal) hemorrhages, including retroperitoneal and intracranial bleeding, have been reported.1 Search for bleeding site if an unexplained fall in hematocrit or blood pressure occurs.1
If enoxaparin overdosage occurs, protamine sulfate may be administered.1 Because fatal reactions resembling anaphylaxis have been reported with protamine sulfate administration, use only when resuscitation techniques and treatment for anaphylactic shock are readily available.1
If a thromboembolic event occurs despite enoxaparin prophylaxis, discontinue the drug and initiate appropriate therapy.1
Cases of heparin-induced thrombocytopenia with thrombosis reported, including complications such as organ infarction, limb ischemia, or death.1
Use with extreme caution in patients with a history of heparin-induced thrombocytopenia.1 Monitor thrombocytopenia of any degree closely.1 If platelet count falls to <100,000/mm3, discontinue therapy.1 113
Patients with Prosthetic Heart Valves
Valve thrombosis that was potentially fatal and/or required surgical intervention reported during prophylaxis in some patients (including pregnant women) with mechanical prosthetic heart valves.1 68 69 70 71 82 83 85 87 90 Women with mechanical prosthetic heart valves are at higher risk for thromboembolism during pregnancy.1 63 85 If enoxaparin is used, monitor anti-factor Xa concentrations frequently and adjust dosage appropriately to maintain antifactor Xa concentrations at approximately 1–1.2 units/mL.1 83 93 103
General Precautions
Hematologic Effects
Periodic CBCs, including platelet counts, and stool occult blood tests are recommended.1 If abnormal coagulation parameters or bleeding should occur, monitor anti-factor Xa levels.1
If thromboembolic events occur despite prophylaxis, institute appropriate therapy.1
Specific Populations
Pregnancy
Category B.
No evidence of teratogenicity or fetotoxicity.1 No excess in the incidence of congenital anomalies compared with what would be expected in the general population.1
Maternal and neonatal hemorrhage has occurred.1 Hemorrhage may lead to death of mother and/or fetus.1 Monitor pregnant women carefully for evidence of bleeding or excessive anticoagulation.1 As delivery approaches, consider use of a shorter-acting anticoagulant.1
Increased risk of thromboembolism in pregnant women.1 Greater risk of thromboembolism in women with a history of thromboembolism and certain high-risk pregnancy conditions.1 63 82 83 Such conditions include hereditary or acquired thrombophilias and the presence of a mechanical prosthetic heart valve.1 63 82 83 If used in pregnant women with mechanical prosthetic heart valves, frequently monitor peak and trough anti-Factor Xa levels.1 71 83 93 Adjust dosage to ensure consistent anticoagulation.1 71 83 93
Lactation
Not known whether enoxaparin is distributed into breast milk.1 Use caution in nursing women.1
Pediatric Use
Safety and efficacy in children not established.1 17
Geriatric Use
Increased risk of enoxaparin-associated bleeding with age.1 Pay careful attention to dosing intervals and concomitant medications (especially antiplatelet medications).1 Consider monitoring (i.e., with anti-Factor Xa assay) geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function.1
Renal Impairment
Monitor anti-factor Xa concentrations in patients with appreciable renal impairment.1 (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
Hemorrhage (including at injection site), anemia, ecchymosis, thrombocytopenia, hematuria, fever, nausea, diarrhea, peripheral or unspecified edema, dyspnea, injection site pain, or confusion.1
Interactions for Lovenox
Drugs That Affect Hemostasis
Potential pharmacodynamic effect (increased risk of hemorrhage) with concurrent use of drugs that affect hemostasis (i.e., oral anticoagulants and/or drugs that affect platelet function, including aspirin, salicylate salts, other NSAIAs [including ketorolac tromethamine], dipyridamole, and sulfinpyrazone).1
Discontinue such drugs prior to initiating enoxaparin therapy.1
Monitor carefully if concurrent administration of such drugs and enoxaparin are considered essential.1
Lovenox Pharmacokinetics
Absorption
Bioavailability
Mean absolute bioavailability of 92% when given sub-Q (based on anti-Factor Xa activity).1
Onset
Maximum anti-Factor Xa and anti-thrombin (anti-Factor IIa) activities occur 3–5 hours after administration.1
Duration
Substantial anti-Factor Xa activity persists in plasma for about 12 hours following administration (40 mg once daily).1
Distribution
Extent
About 6 L (based on anti-Factor Xa activity).1
Not known whether enoxaparin is distributed into milk.1
Does not appear to cross placenta.1
Elimination
Elimination Route
Excreted mainly in urine.1
Half-life
4.5 hours (based on anti-Factor Xa activity).1
Special Populations
In patients with severe renal impairment (Clcr <30 mL/minute), the mean apparent clearance of enoxaparin was approximately 30% lower than controls.1
Delayed elimination in patients with renal insufficiency.1
Delayed elimination in geriatric patients.1 3
Stability
Storage
Parenteral
Solution for Injection
25°C (may be exposed to 15–30°C).1
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Solution CompatibilityHID
Compatible |
|---|
Sodium chloride 0.9% |
ActionsActions
Less effect on thrombin than unfractionated heparin at a given level of anti-factor Xa activity.1 2 17
Prolongs some global clotting function tests (i.e., thrombin time, activated partial thromboplastin time [aPTT]) by up to 1.8 times the control value.1 At a recommended dosage in a large clinical trial, the aPTT was ≤45 seconds in most treated patients.1
Advice to Patients
Importance of reporting any unexplained bleeding or bruising to clinicians.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Apprise pregnant women of the potential hazards to the mother and fetus associated with use during pregnancy.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 10 mg/0.1 mL (30, 40, 60, 80, and 100 mg) | Lovenox (preservative-free; available as disposable prefilled syringes) | Aventis |
15 mg/0.1 mL (120 and 150 mg) | Lovenox (preservative-free; available as disposable prefilled syringes) | Aventis | ||
300 mg/3 mL | Lovenox (with benzyl alcohol) | Aventis |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Lovenox 300MG/3ML Solution (SANOFI-AVENTIS U.S.): 3/$259.99 or 9/$739.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions
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