Arixtra
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Arixtra
Arixtra Side Effects Center
Pharmacy Editor: Melissa Conrad Stöppler, MD
Arixtra (fondaparinux) is an inhibitor of the blood clotting Factor X and is used to prevent blood clots, often in people undergoing certain surgical procedures. It is administered by subcutaneous injection. Side effects can include mild bleeding, nausea, vomiting, or skin rash. Other side effects may occur. This drug should be used with extreme caution in people who have other medical conditions that cause an increased bleeding risk.
Animal studies have shown no harm to the fetus from Arixtra. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ARIXTRA (fondaparinux sodium) should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk.
Our Arixtra Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Arixtra in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using fondaparinux and call your doctor at once if you have a serious side effect such as:
- unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
- easy bruising, purple or red pinpoint spots under your skin;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
- black or bloody stools, coughing up blood or vomit that looks like coffee grounds;
- numbness, tingling, or muscle weakness (especially in your legs and feet);
- loss of movement in any part of your body;
- sudden weakness, severe headache, confusion, or problems with speech, vision, or balance; or
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, limp feeling).
Less serious side effects may include:
- sleep problems (insomnia);
- mild skin rash;
- dizziness; or
- minor bleeding, rash, or itching where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Arixtra (Fondaparinux Sodium) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Arixtra Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bleeding/bruising.
This medication may rarely cause serious bleeding. (See also Warning section.) Tell your doctor immediately if any signs of serious bleeding occur, including: shortness of breath, coughing up blood, chest pain, cold/blue fingers or toes, unusual dizziness, fainting, fast/irregular heartbeat, joint/muscle pain, mental/mood changes (e.g., confusion), numbness/tingling, severe stomach/abdominal pain, bloody/black/tarry stool, red/pinkish urine, vomit that looks like coffee grounds.
Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, yellow eyes/skin.
Seek immediate medical attention if any of these rare but very serious side effects occur: vision problems, weakness on one side of the body, slurred speech, seizures, difficulty moving, severe/persistent headache.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Arixtra (Fondaparinux Sodium)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Arixtra FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The most serious adverse reactions reported with ARIXTRA (fondaparinux sodium) are bleeding complications and thrombocytopenia [see WARNINGS AND PRECAUTIONS].
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 below is based on data from 8,877 patients exposed to ARIXTRA (fondaparinux sodium) in controlled trials of hip fracture, hip replacement, major knee, or abdominal surgeries, and DVT and PE treatment. These trials consisted of the following:
- 2 peri-operative dose-response trials (n = 989)
- 4 active-controlled peri-operative VTE prophylaxis trials with enoxaparin sodium (n = 3,616), an extended VTE prophylaxis trial (n = 327), and an active-controlled trial with dalteparin sodium (n = 1,425)
- a dose-response trial (n = 111) and an active-controlled trial with enoxaparin sodium in DVT treatment (n = 1,091)
- an active-controlled trial with heparin in PE treatment (n = 1,092)
Hemorrhage
During administration of ARIXTRA (fondaparinux sodium) , the most common adverse reactions were bleeding complications [see WARNINGS AND PRECAUTIONS].
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 (fondaparinux sodium) 2.5 mg are provided in Table 2.
Table 2: Bleeding Across Randomized, Controlled Hip Fracture,
Hip Replacement, and Knee Replacement Surgery Studies
| Peri-Operative Prophylaxis (Day 1 to Day 7 ± 1 post-surgery) | Extended Prophylaxis (Day 8 to Day 28 ± 2 post-surgery) | |||
| ARIXTRA (fondaparinux sodium) 2.5 mg SC once daily N = 3,616 |
Enoxaparin Sodiuma, b N = 3,956 |
ARIXTRA (fondaparinux sodium) 2.5 mg SC once daily N = 327 |
Placebo SC once daily N = 329 |
|
| Major bleedingc | 96 (2.7%) | 75 (1.9%) | 8 (2.4%) | 2 (0.6%) |
| Hip fracture | 18/831 (2.2%) | 19/842 (2.3%) | 8/327 (2.4%) | 2/329 (0.6%) |
| Hip replacement | 67/2,268 (3.0%) | 55/2,597 (2.1%) | - | - |
| Knee replacement | 11/517 (2.1%) | 1/517 (0.2%) | - | - |
| 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 = 2d | 84 (2.3%) | 63 (1.6%) | 6 (1.8%) | 0 (0.0%) |
| Minor bleedinge | 109 (3.0%) | 116 (2.9%) | 5 (1.5%) | 2 (0.6%) |
| a Enoxaparin sodium dosing regimen:
30 mg every 12 hours or 40 mg once daily. b Not approved for use in patients undergoing hip fracture surgery. c Major bleeding was defined as clinically overt bleeding that was (1) fatal, (2) bleeding at critical site (e.g. intracranial, retroperitoneal, intraocular, pericardial, spinal, or into adrenal gland), (3) associated with re-operation at operative site, or (4) with a bleeding index (BI) ≥ 2. d 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]. e 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 (fondaparinux sodium) after surgical closure was performed in patients who received ARIXTRA (fondaparinux sodium) only post-operatively. In this analysis, the incidences of major bleeding were as follows: < 4 hours was 4.8% (5/104), 4 to 6 hours was 2.3% (28/1,196), 6 to 8 hours was 1.9% (38/1,965). In all studies, the majority ( ≥ 75%) of the major bleeding events occurred during the first 4 days after surgery.
Abdominal Surgery
In a randomized study of patients undergoing abdominal surgery, ARIXTRA (fondaparinux sodium) 2.5 mg once daily (n = 1,433) was compared with dalteparin 5,000 IU once daily (n = 1,425). Bleeding rates are shown in Table 3.
Table 3: Bleeding in the Abdominal Surgery Study
| ARIXTRA (fondaparinux sodium) 2.5 mg SC once daily N = 1,433 |
Dalteparin Sodium 5,000 IU SC once daily N = 1,425 |
|
| Major bleedinga | 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 | 38 (2.7%) | 26 (1.8%) |
| Non-surgical site | 9 (0.6%) | 6 (0.4%) |
| Minor bleedingb | 31 (2.2%) | 23 (1.6%) |
| a 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, intraocular, pericardial, spinal, or into adrenal gland),
or leading to an intervention, and/or with a bleeding index (BI) ≥ 2.
b Minor bleeding was defined as clinically overt bleeding that was not major. |
||
The rates of major bleeding according to the time interval following the first ARIXTRA (fondaparinux sodium) injection were as follows: < 6 hours was 3.4% (9/263) and 6 to 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 (fondaparinux sodium) injection treatment regimen are provided in Table 4.
Table 4: Bleedinga in Deep Vein Thrombosis and
Pulmonary Embolism Treatment Studies
| ARIXTRA N = 2,294 |
Enoxaparin Sodium N = 1,101 |
Heparin aPTT adjusted IV N = 1,092 |
|
| Major bleedingb | 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%) |
| Other clinically overt bleedingc | 22 (1.0%) | 13 (1.2%) | 10 (0.9%) |
| Minor bleedingd | 70 (3.1%) | 33 (3.0%) | 57 (5.2%) |
| a 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. b 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. c Clinically overt bleeding with a 2 g/dL fall in hemoglobin and/or leading to transfusion of PRBC or whole blood ≥ 2 units. d Minor bleeding was defined as clinically overt bleeding that was not major. |
|||
Local Reactions
Local irritation (injection site bleeding, rash, and pruritus) may occur following subcutaneous injection of ARIXTRA (fondaparinux sodium) .
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 ARIXTRA (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 rarely associated with increases in bilirubin. In the extended prophylaxis clinical trial, no significant differences in AST and ALT levels between ARIXTRA (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 ARIXTRA (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 ARIXTRA (fondaparinux sodium) should be interpreted with caution.
Other Adverse Reactions
Other adverse reactions that occurred during treatment with ARIXTRA (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
| Adverse Reactions | Peri-Operative Prophylaxis (Day 1 to Day 7 ± 1 post-surgery) | Extended Prophylaxis (Day 8 to Day 28 ± 2 post-surgery) | ||
| ARIXTRA (fondaparinux sodium) 2.5 mg SC once daily N = 3,616 |
Enoxaparin Sodiuma, b N = 3,956 |
ARIXTRA (fondaparinux sodium) 2.5 mg SC once daily N = 327 |
Placebo SC once daily 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 eruptionc | 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%) |
| a Enoxaparin sodium dosing regimen:
30 mg every 12 hours or 40 mg once daily. b Not approved for use in patients undergoing hip fracture surgery. c Localized blister coded as bullous eruption. |
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Adverse reactions in the abdominal surgery study and in the VTE treatment trials generally occurred at lower rates than in the hip and knee surgery trials described above. 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%).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ARIXTRA (fondaparinux sodium) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Isolated occurrences of thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported in the postmarketing experience and isolated cases of elevated aPTT temporally associated with bleeding events have been reported following administration of ARIXTRA (fondaparinux sodium) (with or without concomitant administration of other anticoagulants) [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Arixtra (Fondaparinux Sodium) »
Additional Arixtra Information
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