Lovenox

• Generic Name: enoxaparin sodium injection
• Brand Name: Lovenox
• Drug Class: Anticoagulants, Cardiovascular

Lovenox (Enoxaparin Sodium Injection) side effects drug center

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• Health Resources
  Blood Clots (in the Leg) Deep Vein Thrombosis (DVT, Blood Clot in the Legs) Phlebitis (Thrombophlebitis) Pulmonary Embolism (Blood Clot in the Lung) Total Hip Replacement
• Drug Comparison
  Lovenox vs. Arixtra Lovenox vs. Aspirin Lovenox vs. Coumadin Lovenox vs. Eliquis Lovenox vs. Fragmin Lovenox vs. Xarelto Plavix vs. Lovenox

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

 

Lovenox Side Effects Center

What Is Lovenox?

Lovenox (enoxaparin sodium) Injection is an anticoagulant (blood thinner) 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.

What Are Side Effects of Lovenox?

Common side effects of Lovenox include:

• nausea,
• diarrhea,
• fever,
• swelling in your hands or feet, or
• injection site reactions (swelling, pain, bruising, or redness).

Dosage for Lovenox

Dose of Lovenox depends on the condition of the patient and the type of surgery being performed.

What Drugs, Substances, or Supplements Interact with Lovenox?

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.

Lovenox During Pregnancy and Breastfeeding

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.

Additional Information

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.

 

Lovenox Consumer Information

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

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

• unusual bleeding, or any bleeding that will not stop;
• easy bruising, purple or red spots under your skin;
• nosebleeds, bleeding gums;
• abnormal vaginal bleeding, blood in your urine or stools;
• coughing up blood or vomit that looks like coffee grounds;
• signs of bleeding in the brain--sudden weakness (especially on one side of the body), sudden severe headache, problems with speech or vision; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• nausea, diarrhea;
• anemia;
• confusion; or
• pain, bruising, redness, or irritation 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)

 

Lovenox Professional Information

SIDE EFFECTS

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

• Spinal/epidural hematomas [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Increased Risk of Hemorrhage [see WARNINGS AND PRECAUTIONS]
• Thrombocytopenia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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 Lovenox. 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. Lovenox 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 subcutaneously once daily to 30 mg subcutaneously 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 Lovenox doses were a 30 mg intravenous bolus followed by 1 mg/kg every 12 hours subcutaneously.

Hemorrhage

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 Surgery*

Indications	Dosing Regimen
	Lovenox 40 mg daily subcutaneously	Heparin 5000 U q8h subcutaneously
Abdominal Surgery	n=555	n=560
	23 (4%)	16 (3%)
Colorectal Surgery	n=673	n=674
	28 (4%)	21 (3%)
* Bleeding 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 Surgery*

Indications	Dosing Regimen
	Lovenox 40 mg daily subcutaneously	Lovenox 30 mg q12h subcutaneously	Heparin 15,000 U/24h subcutaneously
Hip Replacement Surgery without Extended Prophylaxis†		n=786 31 (4%)	n=541 32 (6%)
Hip Replacement Surgery with Extended Prophylaxis
Peri-operative Period‡	n=288 4 (2%)
Extended Prophylaxis Period§	n=221 0 (0%)
Knee Replacement Surgery without Extended Prophylaxis†		n=294 3 (1%)	n=225 3 (1%)
* Bleeding 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. † Lovenox 30 mg every 12 hours subcutaneously initiated 12 to 24 hours after surgery and continued for up to 14 days after surgery ‡ Lovenox 40 mg subcutaneously once a day initiated up to 12 hours prior to surgery and continued for up to 7 days after surgery § Lovenox 40 mg subcutaneously 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 postoperative 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 Illness*

Indication	Dosing Regimen
	Lovenox† 20 mg daily subcutaneously	Lovenox† 40 mg daily subcutaneously	Placebo†
Medical Patients During Acute Illness	n=351	n=360	n=362
	1 (<1%)	3 (<1%)	2 (<1%)
* Bleeding 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. † The 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*

Indication	Dosing Regimen†
	Lovenox 1.5 mg/kg daily subcutaneously	Lovenox 1 mg/kg q12h subcutaneously	Heparin aPTT Adjusted Intravenous Therapy
Treatment of DVT and PE	n=298	n=559	n=554
	5 (2%)	9 (2%)	9 (2%)
* Bleeding 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. † All 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
	Lovenox* 1 mg/kg q12h subcutaneously	Heparin* aPTT Adjusted Intravenous Therapy
Unstable Angina and Non-Q- Wave MI†,‡	n=1578	n=1529
	17 (1%)	18 (1%)
* The rates represent major bleeding on study medication up to 12 hours after dose. † Aspirin therapy was administered concurrently (100 to 325 mg per day). ‡ Bleeding 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
	Lovenox* Initial 30 mg intravenous bolus followed by 1 mg/kg q12h subcutaneously	Heparin* aPTT Adjusted Intravenous Therapy
Acute ST-Segment Elevation Myocardial Infarction	n=10176	n=10151
	n (%)	n (%)
Major bleeding (including ICH)†	211 (2.1)	138 (1.4)
Intracranial hemorrhages (ICH)	84 (0.8)	66 (0.7)
* The rates represent major bleeding (including ICH) up to 30 days † Bleedings 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.

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

Local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous 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 daily subcutaneously n=1228 %		Heparin 5000 U q8h subcutaneously 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	Dosing Regimen
	Lovenox 40 mg daily subcutaneously				Lovenox 30 mg q12h subcutaneously n=1080 %		Heparin 15,000 U/24h subcutaneously n=766 %		Placebo q12h subcutaneously n=115 %
	Peri-operative Period n=288* %		Extended Prophylaxis Period n=131† %
	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
* Data represent Lovenox 40 mg subcutaneously 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. † Data represent Lovenox 40 mg subcutaneously 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 daily subcutaneously n=360 %	Placebo daily subcutaneously 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 daily subcutaneously n=298 %		Lovenox 1 mg/kg q12h subcutaneously n=559 %		Heparin aPTT Adjusted Intravenous 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 ecchymosis and hematomas, were more frequently reported in patients treated with subcutaneous Lovenox than in patients treated with intravenous 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 subcutaneously n=1578 n (%)	Heparin aPTT Adjusted Intravenous 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, thrombocytopenia occurred at a rate of 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, 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)

&Copy; Lovenox Patient Information is supplied by Cerner Multum, Inc. and Lovenox Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.