Lovenox (Page 5 of 14)
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].
Adverse Reaction | Dosing Regimen | |||
---|---|---|---|---|
Lovenox40 mg q.d. SCn = 1228% | Heparin5000 U q8h SCn = 1234% | |||
Severe | Total | Severe | Total | |
Hemorrhage | <1 | 7 | <1 | 6 |
Anemia | <1 | 3 | <1 | 3 |
Ecchymosis | 0 | 3 | 0 | 3 |
Adverse Reaction | Dosing Regimen | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Lovenox40 mg q.d. SC | Lovenox30 mg q12h SC | Heparin15,000 U/24h SC | Placeboq12h SC | |||||||
Peri-operative Periodn = 288 *% | Extended Prophylaxis Periodn = 131 †% | 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 |
Adverse Reaction | Dosing Regimen | |
---|---|---|
Lovenox40 mg q.d. SCn = 360% | Placeboq.d. SCn = 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 |
Adverse Reaction | Dosing Regimen | |||||
---|---|---|---|---|---|---|
Lovenox1.5 mg/kg q.d. SCn = 298% | Lovenox1 mg/kg q12h SCn = 559% | Heparin aPTT Adjusted IV Therapyn = 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 |
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