Enoxaparin Sodium (Page 5 of 16)

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 enoxaparin sodium injection. 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 enoxaparin sodium injection should be interpreted with caution.

Local Reactions

Local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of enoxaparin sodium injection.

Adverse Reactions in Patients Receiving Enoxaparin Sodium Injection for Prophylaxis or Treatment of DVT, PE:

Other adverse reactions that were thought to be possibly or probably related to treatment with enoxaparin sodium injection, 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 enoxaparin sodium injection group, are provided below (see Tables 8 to 11).

Table 8: Adverse Reactions Occurring at ≥2% Incidence in Enoxaparin Sodium Injection-Treated Patients Undergoing Abdominal or Colorectal Surgery
Dosing Regimen
Enoxaparin Sodium Injection 40 mg daily subcutaneously n = 1228 % Heparin 5000 U q8h subcutaneously n = 1234 %
Adverse Reaction 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 Enoxaparin Sodium Injection-Treated Patients Undergoing Hip or Knee Replacement Surgery
Dosing Regimen
Enoxaparin Sodium Injection 40 mg daily subcutaneously Enoxaparin Sodium Injection 30 mg q12h subcutaneously Heparin 15,000 U/24h subcutaneously Placebo q12h subcutaneously
Peri-operative Period n = 288 * % Extended Prophylaxis Period n = 131 % n = 1080 % n = 766 % n = 115 %
Adverse Reaction Severe Total Severe Total Severe Total Severe Total Severe Total
*
Data represent enoxaparin sodium injection 40 mg subcutaneously once a day initiated up to 12 hours prior to surgery in 288 hip replacement surgery patients who received enoxaparin sodium injection peri-operatively in an unblinded fashion in one clinical trial.
Data represent enoxaparin sodium injection 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.

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 Enoxaparin Sodium Injection-Treated Medical Patients with Severely Restricted Mobility during Acute Illness
Dosing Regimen
Adverse Reaction Enoxaparin Sodium Injection 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 Enoxaparin Sodium Injection-Treated Patients Undergoing Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism
Dosing Regimen
Enoxaparin Sodium Injection 1.5 mg/kg daily subcutaneously n = 298 % Enoxaparin Sodium Injection 1 mg/kg q12h subcutaneously n = 559 % Heparin aPTT Adjusted Intravenous Therapy n = 544 %
Adverse Reaction 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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