Fondaparinux Sodium (Page 5 of 13)

6.2 Local Reactions

Local irritation (injection site bleeding, rash, and pruritus) may occur following subcutaneous injection of fondaparinux sodium.

6.3 Elevations of Serum Aminotransferases

In the peri-operative prophylaxis randomized clinical trials of 7 ± 2 days, asymptomatic increases in aspartate (AST) and alanine (ALT) aminotransferase levels greater than 3 times the upper limit of normal were reported in 1.7% and 2.6% of patients, respectively, during treatment with fondaparinux sodium 2.5 mg once daily versus 3.2% and 3.9% of patients, respectively, during treatment with enoxaparin sodium 30 mg every 12 hours or 40 mg once daily enoxaparin sodium. These elevations are reversible and may be associated with increases in bilirubin. In the extended prophylaxis clinical trial, no significant differences in AST and ALT levels between fondaparinux sodium 2.5 mg and placebo-treated patients were observed.

In the DVT and PE treatment clinical trials, asymptomatic increases in AST and ALT levels greater than 3 times the upper limit of normal of the laboratory reference range were reported in 0.7% and 1.3% of patients, respectively, during treatment with fondaparinux sodium. In comparison, these increases were reported in 4.8% and 12.3% of patients, respectively, in the DVT treatment trial during treatment with enoxaparin sodium 1 mg/kg every 12 hours and in 2.9% and 8.7% of patients, respectively, in the PE treatment trial during treatment with aPTT adjusted heparin.

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 fondaparinux sodium should be interpreted with caution.

6.4 Other Adverse Reactions

Other adverse reactions that occurred during treatment with fondaparinux sodium in clinical trials with patients undergoing hip fracture, hip replacement, or knee replacement surgery are provided in Table 5.

Table 5. Adverse Reactions Across Randomized, Controlled, Hip Fracture Surgery, Hip Replacement Surgery, and Knee Replacement Surgery Studies
*
Enoxaparin sodium dosing regimen: 30 mg every 12 hours or 40 mg once daily.
Not approved for use in patients undergoing hip fracture surgery.
Localized blister coded as bullous eruption.

Adverse Reactions

Peri-Operative Prophylaxis (Day 1 to Day 7 ± 1 post-surgery)

Extended Prophylaxis (Day 8 to Day 28 ± 2 post-surgery)

Fondaparinux Sodium

2.5 mg SC

once daily

Enoxaparin Sodium * ,

Fondaparinux Sodium

2.5 mg SC

once daily

Placebo

SC once daily

N = 3,616

N = 3,956

N = 327

N = 329

Anemia

707 (19.6%)

670 (16.9%)

5 (1.5%)

4 (1.2%)

Insomnia

179 (5.0%)

214 (5.4%)

3 (0.9%)

1 (0.3%)

Wound drainage increased

161 (4.5%)

184 (4.7%)

2 (0.6%)

0 (0.0%)

Hypokalemia

152 (4.2%)

164 (4.1%)

0 (0.0%)

0 (0.0%)

Dizziness

131 (3.6%)

165 (4.2%)

2 (0.6%)

0 (0.0%)

Purpura

128 (3.5%)

137 (3.5%)

0 (0.0%)

0 (0.0%)

Hypotension

126 (3.5%)

125 (3.2%)

1 (0.3%)

0 (0.0%)

Confusion

113 (3.1%)

132 (3.3%)

4 (1.2%)

1 (0.3%)

Bullous eruption

112 (3.1%)

102 (2.6%)

0 (0.0%)

1 (0.3%)

Hematoma

103 (2.8%)

109 (2.8%)

7 (2.1%)

1 (0.3%)

Post-operative hemorrhage

85 (2.4%)

69 (1.7%)

2 (0.6%)

2 (0.6%)

The most common adverse reaction in the abdominal surgery trial was post-operative wound infection (4.9%), and the most common adverse reaction in the VTE treatment trials was epistaxis (1.3%).

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