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Lovenox

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Lovenox

Lovenox Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lovenox (enoxaparin sodium) Injection is used to prevent blood clots that are sometimes called deep vein thrombosis (DVT), which can lead to blood clots in the lungs. A DVT can occur after certain types of surgery, or in people who are bed-ridden due to a prolonged illness. Lovenox is also used to prevent blood vessel complications in people with certain types of angina (chest pain) or heart attacks called non-Q-wave myocardial infarction or ST-segment elevation myocardial infarction. It is an anticoagulant (blood thinner). Common side effects include nausea, diarrhea, swelling in your hands or feet, or mild swelling, pain, bruising, or redness where the medicine was injected.

Dose of Lovenox depends on the condition of the patient and the type of surgery being performed. Lovenox may interact with sulfinpyrazone, salicylates, aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs), or medication used to prevent blood clots. Tell your doctor all medications you use. During pregnancy, Lovenox should only be used if prescribed. It is not known if this medication passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our Lovenox (enoxaparin sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lovenox in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; itching or burning skin; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using enoxaparin and call your doctor at once if you have a serious side effect such as:

  • unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
  • easy bruising, purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • black or bloody stools, coughing up blood or vomit that looks like coffee grounds;
  • numbness, tingling, or muscle weakness (especially in your legs and feet);
  • loss of movement in any part of your body;
  • sudden weakness, severe headache, confusion, or problems with speech, vision, or balance; or
  • trouble breathing.

Less serious side effects may include:

  • nausea, diarrhea;
  • fever;
  • swelling in your hands or feet; or
  • mild pain, irritation, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lovenox (Enoxaparin Sodium Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lovenox FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

The following serious adverse reactions are also discussed in other sections of the labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

During clinical development for the approved indications, 15,918 patients were exposed to enoxaparin sodium. These included 1,228 for prophylaxis of deep vein thrombosis following abdominal surgery in patients at risk for thromboembolic complications, 1,368 for prophylaxis of deep vein thrombosis following hip or knee replacement surgery, 711 for prophylaxis of deep vein thrombosis in medical patients with severely restricted mobility during acute illness, 1,578 for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, 10,176 for treatment of acute ST-elevation myocardial infarction, and 857 for treatment of deep vein thrombosis with or without pulmonary embolism. Enoxaparin sodium doses in the clinical trials for prophylaxis of deep vein thrombosis following abdominal or hip or knee replacement surgery or in medical patients with severely restricted mobility during acute illness ranged from 40 mg SC once daily to 30 mg SC twice daily. In the clinical studies for prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction doses were 1 mg/kg every 12 hours and in the clinical studies for treatment of acute ST-segment elevation myocardial infarction enoxaparin sodium doses were a 30 mg IV bolus followed by 1 mg/kg every 12 hours SC.

Hemorrhage

The incidence of major hemorrhagic complications during Lovenox treatment has been low.

The following rates of major bleeding events have been reported during clinical trials with Lovenox [see Tables 2 to 7].

Table 2 : Major Bleeding Episodes Following Abdominal and Colorectal Surgery1

  Dosing Regimen
Lovenox
40 mg q.d. SC
Heparin
5000 U q8h SC
Abdominal Surgery n = 555
23 (4%)
n = 560
16 (3%)
Colorectal Surgery n = 673
28 (4%)
n = 674
21 (3%)
1Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥ 2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal, intraocular, and intracranial hemorrhages were always considered major.

Table 3 : Major Bleeding Episodes Following Hip or Knee Replacement Surgery1

Indications Dosing Regimen
Lovenox
40 mg q.d. SC
Lovenox
30 mg q12h SC
Heparin
15,000 U/24h SC
Hip Replacement Surgery without Extended Prophylaxis2   n = 786
31 (4%)
n = 541
32 (6%)
Hip Replacement Surgery with Extended Prophylaxis
  Peri-operative Period3 Extended Prophylaxis n = 288
4 (2%)
   
  Period4 n = 221
0 (0%)
   
Knee Replacement Surgery without Extended Prophylaxis2   n = 294
3 (1%)
n = 225
3 (1%)
1Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥ 2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal and intracranial hemorrhages were always considered major. In the knee replacement surgery trials, intraocular hemorrhages were also considered major hemorrhages.
2Lovenox 30 mg every 12 hours SC initiated 12 to 24 hours after surgery and continued for up to 14 days after surgery
3Lovenox 40 mg SC once a day initiated up to 12 hours prior to surgery and continued for up to 7 days after surgery
4Lovenox 40 mg SC once a day for up to 21 days after discharge

NOTE: At no time point were the 40 mg once a day pre-operative and the 30 mg every 12 hours post-operative hip replacement surgery prophylactic regimens compared in clinical trials. Injection site hematomas during the extended prophylaxis period after hip replacement surgery occurred in 9% of the Lovenox patients versus 1.8% of the placebo patients.

Table 4 : Major Bleeding Episodes in Medical Patients with Severely Restricted Mobility During Acute Illness1

Indications Dosing Regimen
Lovenox2
20 mg q.d. SC
Lovenox2
40 mg q.d. SC
Placebo2
Medical Patients During Acute Illness n = 351
1 ( < 1%)
n = 360
3 ( < 1%)
n = 362
2 ( < 1%)
1Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, (2) if the hemorrhage caused a decrease in hemoglobin of ≥ 2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal and intracranial hemorrhages were always considered major although none were reported during the trial.
2The rates represent major bleeding on study medication up to 24 hours after last dose.

Table 5 : Major Bleeding Episodes in Deep Vein Thrombosis with or without Pulmonary Embolism Treatment 1

  Dosing Regimen2
Lovenox Lovenox Heparin
Indication 1.5 mg/kg q.d. SC 1 mg/kg q12h SC aPTT Adjusted IV Therapy
Treatment of DVT and PE n = 298
5 (2%)
n = 559
9 (2%)
n = 554
9 (2%)
1Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥ 2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal, intraocular, and intracranial hemorrhages were always considered major.
2All patients also received warfarin sodium (dose-adjusted according to PT to achieve an INR of 2.0 to 3.0) commencing within 72 hours of Lovenox or standard heparin therapy and continuing for up to 90 days.

Table 6:  Major Bleeding Episodes in Unstable Angina and Non-Q-Wave Myocardial Infarction

Indication Dosing Regimen
Lovenox1 1 mg/kg q12h SC Heparin1 aPTT Adjusted IV Therapy
Unstable Angina and Non-Q-Wave MI2,3 n = 1578
17 (1%)
n = 1529
18 (1%)
1The rates represent major bleeding on study medication up to 12 hours after dose.
2Aspirin therapy was administered concurrently (100 to 325 mg per day).
3Bleeding complications were considered major: (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease by ≥ 3 g/dL or transfusion of 2 or more units of blood products. Intraocular, retroperitoneal, and intracranial hemorrhages were always considered major.

Table 7 : Major Bleeding Episodes in Acute ST-Segment Elevation Myocardial Infarction

Indication Dosing Regimen
Lovenox1 Initial 30 mg IV bolus followed by 1 mg/kg q12h SC Heparin1 aPTT Adjusted IV Therapy
Acute ST-Segment Elevation Myocardial Infarction n = 10176
n (%)
n = 10151
n (%)
   Major bleeding (including ICH)2 211 (2.1) 138 (1.4)
   Intracranial hemorrhages (ICH) 84 (0.8) 66 (0.7)
1The rates represent major bleeding (including ICH) up to 30 days
2Bleedings were considered major if the hemorrhage caused a significant clinical event associated with a hemoglobin decrease by ≥ 5 g/dL. ICH were always considered major.

Elevations of Serum Aminotransferases

Asymptomatic increases in aspartate (AST [SGOT]) and alanine (ALT [SGPT]) aminotransferase levels greater than three times the upper limit of normal of the laboratory reference range have been reported in up to 6.1% and 5.9% of patients, respectively, during treatment with Lovenox. Similar significant increases in aminotransferase levels have also been observed in patients and healthy volunteers treated with heparin and other low molecular weight heparins. Such elevations are fully reversible and are rarely associated with increases in bilirubin.

Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like Lovenox should be interpreted with caution.

Local Reactions

Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow SC injection of Lovenox.

Adverse Reactions in Patients Receiving Lovenox for Prophylaxis or Treatment of DVT, PE:

Other adverse reactions that were thought to be possibly or probably related to treatment with Lovenox, heparin, or placebo in clinical trials with patients undergoing hip or knee replacement surgery, abdominal or colorectal surgery, or treatment for DVT and that occurred at a rate of at least 2% in the Lovenox group, are provided below [see Tables 8 to 11].

Table 8 : Adverse Reactions Occurring at ≥ 2% Incidence in Lovenox-Treated Patients Undergoing Abdominal or Colorectal Surgery

Adverse Reaction Dosing Regimen
Lovenox
40 mg q.d. SC
n = 1228
%
Heparin
5000 U q8h SC
n = 1234
%
Severe Total Severe Total
Hemorrhage < 1 7 < 1 6
Anemia < 1 3 < 1 3
Ecchymosis 0 3 0 3

Table 9 : Adverse Reactions Occurring at ≥ 2% Incidence in Lovenox-Treated Patients Undergoing Hip or Knee Replacement Surgery

Adverse Reaction Lovenox
40 mg q.d. SC
Lovenox
30 mg q12h SC
Heparin
15,000 U/24h SC
Placebo
q12h SC
Peri-operative Period
n = 288 1
%
Extended Prophylaxis Period n = 1312
%
n = 1080
%
n = 766
%
n = 115
%
Severe Total Severe Total Severe Total Severe Total Severe Total
Fever 0 8 0 0 < 1 5 < 1 4 0 3
Hemorrhage < 1 13 0 5 < 1 4 1 4 0 3
Nausea < 1 3 < 1 2 0 2
Anemia 0 16 0 < 2 < 1 2 2 5 < 1 7
Edema < 1 2 < 1 2 0 2
Peripheral edema 0 6 0 0 < 1 3 < 1 4 0 3
1Data represent Lovenox 40 mg SC once a day initiated up to 12 hours prior to surgery in 288 hip replacement surgery patients who received Lovenox peri-operatively in an unblinded fashion in one clinical trial.
2Data represent Lovenox 40 mg SC once a day given in a blinded fashion as extended prophylaxis at the end of the peri-operative period in 131 of the original 288 hip replacement surgery patients for up to 21 days in one clinical trial.

Table 10 : Adverse Reactions Occurring at ≥ 2% Incidence in Lovenox-Treated Medical Patients with Severely Restricted Mobility During Acute Illness

Adverse Reaction Dosing Regimen
Lovenox
40 mg q.d. SC
n = 360
%
Placebo q.d.
SC
n = 362
%
Dyspnea 3.3 5.2
Thrombocytopenia 2.8 2.8
Confusion 2.2 1.1
Diarrhea 2.2 1.7
Nausea 2.5 1.7

Table 11 : Adverse Reactions Occurring at ≥ 2% Incidence in Lovenox-Treated Patients Undergoing Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism

Adverse Reaction Dosing Regimen
Lovenox 1.5 mg/kg q.d. SC
n = 298
%
Lovenox 1 mg/kg q12h SC
n = 559
%
Heparin aPTT Adjusted IV Therapy
n = 544
%
Severe Total Severe Total Severe Total
Injection Site Hemorrhage 0 5 0 3 < 1 < 1
Injection Site Pain 0 2 0 2 0 0
Hematuria 0 2 0 < 1 < 1 2

Adverse Events in Lovenox-Treated Patients with Unstable Angina or Non-Q-Wave Myocardial Infarction:

Non-hemorrhagic clinical events reported to be related to Lovenox therapy occurred at an incidence of ≤ 1%.

Non-major hemorrhagic events, primarily injection site ecchymoses and hematomas, were more frequently reported in patients treated with SC Lovenox than in patients treated with IV heparin.

Serious adverse events with Lovenox or heparin in a clinical trial in patients with unstable angina or non-Q-wave myocardial infarction that occurred at a rate of at least 0.5% in the Lovenox group are provided below [see Table 12].

Table 12 : Serious Adverse Events Occurring at ≥ 0.5% Incidence in Lovenox-Treated Patients with Unstable Angina or Non-Q-Wave Myocardial Infarction

Adverse Event Dosing Regimen
Lovenox 1 mg/kg q12h SC
n = 1578
n (%)
Heparin aPTT Adjusted IV Therapy
n = 1529
n (%)
Atrial fibrillation 11 (0.70) 3 (0.20)
Heart failure 15 (0.95) 11 (0.72)
Lung edema 11 (0.70) 11 (0.72)
Pneumonia 13 (0.82) 9 (0.59)

Adverse Reactions in Lovenox-Treated Patients with Acute ST-Segment Elevation Myocardial Infarction:

In a clinical trial in patients with acute ST-segment elevation myocardial infarction, the only adverse reaction that occurred at a rate of at least 0.5% in the Lovenox group was thrombocytopenia (1.5%).

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Lovenox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been reports of epidural or spinal hematoma formation with concurrent use of Lovenox and spinal/epidural anesthesia or spinal puncture. The majority of patients had a postoperative indwelling epidural catheter placed for analgesia or received additional drugs affecting hemostasis such as NSAIDs. Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis.

Local reactions at the injection site (e.g. nodules, inflammation, oozing), systemic allergic reactions (e.g. pruritus, urticaria, anaphylactic/anaphylactoid reactions including shock), vesiculobullous rash, rare cases of hypersensitivity cutaneous vasculitis, purpura, skin necrosis (occurring at either the injection site or distant from the injection site), thrombocytosis, and thrombocytopenia with thrombosis [see WARNINGS AND PRECAUTIONS] have been reported.

Cases of hyperkalemia have been reported. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia (e.g., renal dysfunction, concomitant potassium-sparing drugs, administration of potassium, hematoma in body tissues).

Very rare cases of hyperlipidemia have also been reported, with one case of hyperlipidemia, with marked hypertriglyceridemia, reported in a diabetic pregnant woman; causality has not been determined.

Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported. Osteoporosis has also been reported following long-term therapy.

Read the entire FDA prescribing information for Lovenox (Enoxaparin Sodium Injection) »

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