Arixtra Side Effects
Please note - some side effects for Arixtra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Arixtra - for the consumer
Arixtra
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Arixtra:
Seek medical attention right away if any of these SEVERE side effects occur when using Arixtra:Bleeding, irritation, rash, or itching at the injection site; chills; constipation; diarrhea; headache; minor bleeding; nausea; sleeplessness; vomiting.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; confusion; fever; one-sided weakness; slurred speech; swelling; unusual or severe bleeding or bruising; unusual tiredness or fatigue; vision problems.
For the professional
Arixtra
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying possible adverse events and for approximating rates.
The data described below reflect exposure in 8,877 patients randomized to Arixtra Injection in controlled trials of hip fracture, hip replacement, major knee, or abdominal surgeries, and DVT and PE treatment. Patients received Arixtra primarily in 2 large peri-operative dose-response trials (n = 989), 4 active-controlled peri-operative trials with enoxaparin sodium (n = 3,616), and an extended prophylaxis trial (n = 327), an active-controlled trial with dalteparin sodium (n = 1,425), a dose-response trial in DVT treatment (n = 111), an active-controlled trial with enoxaparin sodium in DVT treatment (n = 1,091), and an active-controlled trial with heparin in PE treatment (n = 1,092).
Hemorrhage
During administration of Arixtra, the most common adverse reactions were bleeding complications.
Hip Fracture, Hip Replacement and Knee Replacement Surgery
The rates of major bleeding events reported during the hip fracture, hip replacement, or knee replacement surgery clinical trials with Arixtra 2.5 mg Injection are provided in Tables 8 and 9 below.
Indications |
Peri-Operative Prophylaxis (Day 1 to Day 7 ± 1 post-surgery) |
Extended Prophylaxis (Day 8 to Day 28 ± 2 post-surgery) |
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Fondaparinux Sodium 2.5 mg SC once daily |
Enoxaparin Sodium2, 3 |
Fondaparinux Sodium 2.5 mg SC once daily |
Placebo SC once daily |
|
Hip Fracture |
18/831 (2.2%) |
19/842 (2.3%) |
8/327 (2.4 %)4 |
2/329 (0.6 %) |
Hip Replacement |
67/2,268 (3.0%) |
55/2,597 (2.1%) |
— |
— |
Knee Replacement |
11/517 (2.1%)5 |
1/517 (0.2%) |
— |
— |
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1 Major bleeding was defined as clinically overt bleeding that was (1) fatal, (2) bleeding at critical site (e.g. intracranial, retroperitoneal, intra-ocular, pericardial, spinal, or into adrenal gland), (3) associated with re-operation at operative site, or (4) with a bleeding index (BI) ≥2 calculated as [number of whole blood or packed red blood cell units transfused + [(pre-bleeding)− (post-bleeding)] hemoglobin (g/dL) values]. 2 Enoxaparin sodium dosing regimen: 30 mg every 12 hours or 40 mg once daily. 3 Not approved for use in patients undergoing hip fracture surgery . 4 During noncomparative, unblinded, peri-operative prophylaxis, major bleeding was reported in 22/737 (3.0%) patients. Fifteen (15) of these 22 patients continued to receive Arixtra in extended prophylaxis. After randomization, 4/327 (1.2%) patients experienced major bleeding for the first time. 5 p value versus enoxaparin sodium: <0.01, 95% confidence interval: (1.1%, 3.3%) in group receiving Arixtra versus (0.0%, 1.1%) in enoxaparin sodium group. | ||||
Peri-Operative Prophylaxis (Day 1 to Day 7 ± 1 post-surgery) |
Extended Prophylaxis (Day 8 to Day 28 ± 2 post-surgery) |
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Fondaparinux Sodium 2.5 mg SC once daily |
Enoxaparin Sodium1, 2 |
Fondaparinux Sodium 2.5 mg SC once daily |
Placebo SC once daily |
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N = 3,616 |
N = 3,956 |
N = 327 |
N = 329 |
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Major bleeding3 |
96 (2.7%) |
75 (1.9%) |
8 (2.4%)4 |
2 (0.6%) |
Fatal bleeding |
0 (0.0%) |
1 (<0.1%) |
0 (0.0%) |
0 (0.0%) |
Non-fatal bleeding at critical site |
0 (0.0%) |
1 (<0.1%) |
0 (0.0%) |
0 (0.0%) |
Re-operation due to bleeding |
12 (0.3%) |
10 (0.3%) |
2 (0.6%) |
2 (0.6%) |
BI ≥25 |
84 (2.3%) |
63 (1.6%) |
6 (1.8%) |
0 (0.0%) |
Minor bleeding6 |
109 (3.0%) |
116 (2.9%) |
5 (1.5%) |
2 (0.6%) |
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1 Enoxaparin sodium dosing regimen: 30 mg every 12 hours or 40 mg once daily. 2 Not approved for use in patients undergoing hip fracture surgery. 3 Major bleeding was defined as clinically overt bleeding that was (1) fatal, (2) bleeding at critical site (e.g. intracranial, retroperitoneal, intra-ocular, pericardial, spinal, or into adrenal gland), (3) associated with re-operation at operative site, or (4) with a bleeding index (BI) ≥2. 4 During non-comparative, unblinded, peri-operative prophylaxis, 2 fatal bleeds were reported (one in a 50 kg patient, one in a severe renal failure patient). 5 BI≥2: Overt bleeding associated only with a bleeding index (BI) ≥2 calculated as [number of whole blood or packed red blood cell units transfused + [(pre-bleeding) − (post-bleeding)] hemoglobin (g/dL) values]. 6 Minor bleeding was defined as clinically overt bleeding that was not major. | ||||
A separate analysis of major bleeding across all randomized, controlled, peri-operative, prophylaxis clinical studies of hip fracture, hip replacement, or knee replacement surgery according to the time of the first injection of Arixtra after surgical closure was performed in patients who received Arixtra only post-operatively. In this analysis, the incidences of major bleeding were as follows: <4 hours was 4.8% (5/104), 4-6 hours was 2.3% (28/1196), 6-8 hours was 1.9% (38/1965). In all studies, the majority (≥75%) of the major bleeding events occurred during the first 4 days after surgery.
Abdominal Surgery
The rates of major bleeding reported during the abdominal surgery clinical trial with Arixtra 2.5 mg are provided in Table 10 below.
Fondaparinux Sodium 2.5 mg SC once daily |
Dalteparin Sodium 5,000 IU SC once daily |
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N = 1,433 |
N = 1,425 |
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Major bleeding |
49 (3.4%) |
34 (2.4%) |
Fatal bleeding |
2 (0.1%) |
2 (0.1%) |
Non-fatal bleeding at critical site |
0 (0.0%) |
0 (0.0%) |
Other non-fatal major bleeding Surgical site Non-surgical site |
38 (2.7%) 9 (0.6%) |
26 (1.8%) 6 (0.4%) |
Minor bleeding2 |
31 (2.2%) |
23 (1.6%) |
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1 Major bleeding was defined as bleeding that was (1) fatal, (2) bleeding at the surgical site leading to intervention, (3) non-surgical bleeding at a critical site (e.g. intracranial, retroperitoneal, intra-ocular, pericardial, spinal, or into adrenal gland), or leading to an intervention, and/or with a bleeding index (BI) ≥2. (BI ≥2 calculated as [number of whole blood or packed red blood cell units transfused + [(pre-bleeding) − (post-bleeding)] hemoglobin (g/dL) values].) 2 Minor bleeding was defined as clinically overt bleeding that was not major. | ||
A separate analysis of major bleeding according to the time of the first injection of Arixtra after surgical closure was performed. In this analysis the incidences of major bleeding were as follows: <6 hours was 3.4% (9/263) and 6-8 hours was 2.9% (32/1112).
Treatment of Deep Vein Thrombosis and Pulmonary Embolism:
The rates of bleeding events reported during the DVT and PE clinical trials with the Arixtra injection treatment regimen are provided in Table 11 below.
Fondaparinux Sodium Treatment Regimen |
Enoxaparin Sodium 1 mg/kg SC q 12h |
Heparin aPTT adjusted IV |
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N = 2,294 |
N = 1,101 |
N = 1,092 |
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Major bleeding2 |
28 (1.2%) |
13 (1.2%) |
12 (1.1%) |
Fatal bleeding |
3 (0.1%) |
0 (0.0%) |
1 (0.1%) |
Non-fatal bleeding at a critical site |
3 (0.1%) |
0 (0.0%) |
2 (0.2%) |
Intracranial bleeding |
3 (0.1%) |
0 (0.0%) |
1 (0.1%) |
Retro-peritoneal bleeding |
0 (0.0%) |
0 (0.0%) |
1 (0.1%) |
Clinically overt bleeding with a 2 g/dL fall in hemoglobin and/or leading to transfusion of PRBC or whole blood ≥2 units |
22 (1.0%) |
13 (1.2%) |
10 (0.9%) |
Minor bleeding3 |
70 (3.1%) |
33 (3.0%) |
57 (5.2%) |
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1 Bleeding rates are during the study drug treatment period (approximately 7 days). Patients were also treated with Vitamin K antagonists initiated within 72 hours after the first study drug administration. 2 Major bleeding was defined as clinically overt: - and/or contributing to death − and/or in a critical organ including intracranial, retroperitoneal, intraocular, spinal, pericardial, or adrenal gland − and/or associated with a fall in hemoglobin level ≥2 g/dL − and/or leading to a transfusion≥2 units of packed red blood cells or whole blood. 3 Minor bleeding was defined as clinically overt bleeding that was not major. | |||
Thrombocytopenia
See WARNINGS: Thrombocytopenia.
Local Reactions
Mild local irritation (injection site bleeding, rash, and pruritus) may occur following subcutaneous injection of Arixtra.
Elevations of Serum Aminotransferases
In the peri-operative prophylaxis randomized clinical trials of 7 ± 2 days asymptomatic increases in aspartate (AST [SGOT]) and alanine (ALT [SGPT]) aminotransferase levels greater than 3 times the upper limit of normal of the laboratory reference range have been reported in 1.7% and 2.6% of patients, respectively, during treatment with Arixtra 2.5 mg Injection 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. Such elevations are fully reversible and are rarely associated with increases in bilirubin. In the extended prophylaxis clinical trial no significant differences in aspartate (AST [SGOT]) and alanine (ALT [SGPT]) aminotransferase levels between Arixtra 2.5 mg Injection and placebo treated patients were observed.
In the DVT and PE treatment clinical trials asymptomatic increases in aspartate (AST [SGOT]) and alanine (ALT [SGPT]) aminotransferase levels greater than 3 times the upper limit of normal of the laboratory reference range have been reported in 0.7% and 1.3% of patients, respectively, during treatment with the Arixtra injection treatment regimen. In comparison, these increases have been 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 Arixtra should be interpreted with caution.
Other Adverse Events
Other adverse events that occurred during treatment with Arixtra, or enoxaparin sodium in clinical trials with patients undergoing hip fracture surgery, hip replacement surgery, or knee replacement surgery and that occurred at a rate of at least 2% in either treatment group, are provided in Table 12 below. Other adverse events that occurred during treatment with Arixtra or dalteparin sodium in clinical trials with patients undergoing abdominal surgery and that occurred at a rate of at least 2% in either treatment group are provided in Table 13 below. Other adverse events that occurred during treatment with Arixtra, enoxaparin sodium, or heparin in the DVT and PE treatment clinical trials and that occurred at a rate of at least 2% in any treatment group are provided in Table 14 below.
Adverse Events |
Peri-Operative Prophylaxis (Day 1 to Day 7 ± 1 post-surgery) |
Extended Prophylaxis (Day 8 to Day 28 ± 2 post-surgery) |
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Fondaparinux Sodium 2.5 mg SC once daily |
Enoxaparin Sodium1, 2 |
Fondaparinux Sodium 2.5 mg SC once daily |
Placebo SC once daily |
|
N = 3,616 |
N = 3,956 |
N = 327 |
N = 329 |
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Anemia |
707 (19.6%) |
670 (16.9%) |
5 (1.5%) |
4 (1.2%) |
Fever |
491 (13.6%) |
610 (15.4%) |
1 (0.3%) |
4 (1.2%) |
Nausea |
409 (11.3%) |
484 (12.2%) |
1 (0.3%) |
4 (1.2%) |
Edema |
313 (8.7%) |
348 (8.8%) |
3 (0.9%) |
2 (0.6%) |
Constipation |
309 (8.5%) |
416 (10.5%) |
6 (1.8%) |
7 (2.1%) |
Rash |
273 (7.5%) |
329 (8.3%) |
2 (0.6%) |
4 (1.2%) |
Vomiting |
212 (5.9%) |
236 (6.0%) |
2 (0.6%) |
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%) |
Urinary tract infection |
136 (3.8%) |
135 (3.4%) |
13 (4.0%) |
13 (4.0%) |
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 eruption3 |
112 (3.1%) |
102 (2.6%) |
0 (0.0%) |
1 (0.3%) |
Urinary retention |
106 (2.9%) |
117 (3.0%) |
0 (0.0%) |
1 (0.3%) |
Hematoma |
103 (2.8%) |
109 (2.8%) |
7 (2.1%) |
1 (0.3%) |
Diarrhea |
90 (2.5%) |
102 (2.6%) |
6 (1.8%) |
8 (2.4%) |
Dyspepsia |
87 (2.4%) |
102 (2.6%) |
1 (0.3%) |
2 (0.6%) |
Post-operative hemorrhage |
85 (2.4%) |
69 (1.7%) |
2 (0.6%) |
2 (0.6%) |
Headache |
72 (2.0%) |
97 (2.5%) |
0 (0.0%) |
2 (0.6%) |
Pain |
62 (1.7%) |
101 (2.6%) |
0 (0.0%) |
0 (0.0%) |
Surgical site reaction |
29 (0.8%) |
41 (1.0%) |
5 (1.5%) |
8 (2.4%) |
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1Enoxaparin sodium dosing regimen: 30 mg every 12 hours or 40 mg once daily. 2Not approved for use in patients undergoing hip fracture surgery. 3Localized blister coded as bullous eruption. | ||||
Adverse Events |
Fondaparinux Sodium 2.5 mg SC once daily |
Dalteparin Sodium 5000 IU SC once daily |
N = 1,433 |
N = 1,425 |
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Post-operative wound infection |
70 (4.9%) |
69 (4.8%) |
Post-operative haemorrhage |
61 (4.3%) |
42 (2.9%) |
Fever |
53 (3.7%) |
54 (3.8%) |
Surgical site reaction |
46 (3.2%) |
40 (2.8%) |
Anaemia |
35 (2.4%) |
26 (1.8%) |
Hypertension |
35 (2.4%) |
41 (2.9%) |
Pneumonia |
33 (2.3%) |
23 (1.6%) |
Vomiting |
31 (2.2%) |
26 (1.8%) |
Adverse Events |
Fondaparinux Sodium |
Enoxaparin Sodium |
Heparin |
N = 2,294 |
N = 1,101 |
N = 1,092 |
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Constipation |
106 (4.6%) |
32 (2.9%) |
93 (8.5%) |
Headache |
104 (4.5%) |
37 (3.4%) |
65 (6.0%) |
Insomnia |
86 (3.7%) |
19 (1.7%) |
75 (6.9%) |
Fever |
81 (3.5%) |
32 (2.9%) |
47 (4.3%) |
Nausea |
76 (3.3%) |
29 (2.6%) |
53 (4.9%) |
Urinary tract infection |
53 (2.3%) |
20 (1.8%) |
24 (2.2%) |
Coughing |
48 (2.1%) |
7 (0.6%) |
26 (2.4%) |
Diarrhea |
43 (1.9%) |
22 (2.0%) |
27 (2.5%) |
Abdominal pain |
33 (1.4%) |
14 (1.3%) |
28 (2.6%) |
Chest pain |
33 (1.4%) |
8 (0.7%) |
26 (2.4%) |
Leg pain |
31 (1.4%) |
10 (0.9%) |
22 (2.0%) |
Back pain |
30 (1.3%) |
11 (1.0%) |
34 (3.1%) |
Epistaxis |
30 (1.3%) |
12 (1.1%) |
41 (3.8%) |
Prothrombin decreased |
30 (1.3%) |
3 (0.3%) |
34 (3.1%) |
Anemia |
28 (1.2%) |
3 (0.3%) |
23 (2.1%) |
Vomiting |
26 (1.1%) |
14 (1.3%) |
27 (2.5%) |
Hypokalemia |
25 (1.1%) |
2 (0.2%) |
23 (2.1%) |
Bruise |
24 (1.0%) |
24 (2.2%) |
14 (1.3%) |
Anxiety |
18 (0.8%) |
8 (0.7%) |
22 (2.0%) |
Hepatic function abnormal |
10 (0.4%) |
14 (1.3%) |
24 (2.2%) |
Hepatic enzymes increased |
7 (0.3%) |
52 (4.7%) |
30 (2.7%) |
SGPT increased |
7 (0.3%) |
47 (4.3%) |
8 (0.7%) |
SGOT increased |
4 (0.2%) |
31 (2.8%) |
3 (0.3%) |
More resources:
Arixtra - Includes detailed dosage instructions.
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