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:
- 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
| Indications | Dosing Regimen | |
| Lovenox 40 mg q.d. SC | Heparin 5000 U q8h SC | |
| Abdominal Surgery | n = 555 | n = 560 |
| 23 (4%) | 16 (3%) | |
| Colorectal Surgery | n = 673 | n = 674 |
| 28 (4%) | 21 (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, 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 | n = 541 | |
| 31 (4%) | 32 (6%) | ||
| Hip Replacement Surgery with Extended Prophylaxis | |||
| Peri-operative Period3 | n = 288 | ||
| 4 (2%) | |||
| Extended Prophylaxis Period4 | n = 221 | ||
| 0 (0%) | |||
| Knee Replacement Surgery without Extended Prophylaxis2 | n = 294 | n = 225 | |
| 3 (1%) | 3 (1%) | ||
| 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.
2 Lovenox 30 mg every 12 hours SC initiated 12 to 24 hours after surgery and continued for up to 14 days after surgery 3 Lovenox 40 mg SC once a day initiated up to 12 hours prior to surgery and continued for up to 7 days after surgery 4 Lovenox 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 | Lovenox 240 mg q.d. SC | Placebo2 | |
| Medical Patients During | n = 351 | n = 360 | n = 362 |
| Acute Illness | 1 (<1%) | 3 (<1%) | 2 ( < 1%) |
| 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. 2 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 Treatment1
| 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 | n = 559 | n = 554 |
| 5 (2%) | 9 (2%) | 9 (2%) | |
| 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, intraocular, and
intracranial hemorrhages were always considered major. 2 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
| Dosing Regimen | ||
| Lovenox1 1 mg/kg q12h SC | Heparin1 aPTT Adjusted IV Therapy | |
| Indication | ||
| Unstable Angina and | n = 1578 | n = 1529 |
| Non-Q-Wave MI2,3 | 17 (1%) | 18 (1%) |
| 1 The rates represent major bleeding
on study medication up to 12 hours after dose. 2 Aspirin therapy was administered concurrently (100 to 325 mg per day). 3 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 | |
| Lovenox1 Initial 30 mg IV bolus followed by 1 mg/kg q12h SC | Heparin1 aPTT Adjusted IV Therapy | |
| Acute ST-Segment Elevation | n = 10176 | n = 10151 |
| Myocardial Infarction | n (%) | n (%) |
| Major bleeding (including ICH)2 | 211 (2.1) | 138 (1.4) |
| Intracranial hemorrhages (ICH) | 84 (0.8) | 66 (0.7) |
| 1 The rates represent major bleeding
(including ICH) up to 30 days 2 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. 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 | DosingRegimen | |||
| Lovenox 40 mgq.d. SC n =1228 % |
Heparin 5000U 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 | DosingRegimen | |||||||||
| Lovenox 40 mgq.d. SC | Lovenox 30 mgq12h SC | Heparin 15,000U/24h SC | Placebo q12h SC | |||||||
| Peri-operative Period n =2881 % |
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 |
| 1 Data 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. 2 Data 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/kgq.d. SC n =298 % |
Lovenox 1 mg/kg q12h SC n =559 % |
Heparina PTT 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
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.
Read the entire FDA prescribing information for Lovenox (Enoxaparin Sodium Injection) »
Additional Lovenox Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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