home > drugs a-z list > lovenox (enoxaparin sodium injection) drug center > lovenox (enoxaparin sodium injection) drug - side effects and drug interactions

Clinical Trials Experience

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

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

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

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

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

Table 5 : Major Bleeding Episodes in Deep Vein Thrombosis with or without Pulmonary Embolism Treatment¹

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

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

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

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

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

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

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 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

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), 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.

Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.

Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Lovenox therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If co-administration is essential, conduct close clinical and laboratory monitoring [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 5/31/2011
This monograph has been modified to include the generic and brand name in many instances.