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].

Table 8 Adverse Reactions Occurring at ≥2% Incidence in Lovenox-Treated Patients Undergoing Abdominal or Colorectal Surgery
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
Table 9 Adverse Reactions Occurring at ≥2% Incidence in Lovenox-Treated Patients Undergoing Hip or Knee Replacement Surgery
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
*
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.
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.
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
Table 10 Adverse Reactions Occurring at ≥2% Incidence in Lovenox-Treated Medical Patients with Severely Restricted Mobility During Acute Illness
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
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
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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