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Arixtra

Last reviewed on RxList: 2/18/2020
Arixtra Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Arixtra?

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. Arixtra should be used with extreme caution in people who have other medical conditions that cause an increased bleeding risk.

What Are Side Effects of Arixtra?

Side effects of Arixtra include:

  • injection site reactions (mild bleeding, rash, itching, pain bruising, redness, and swelling),
  • sleep problems (insomnia),
  • dizziness,
  • nausea,
  • vomiting,
  • skin rash,
  • headache,
  • swelling of the hands/feet, or
  • fever.

Dosage for Arixtra

The recommended dose of Arixtra is 2.5 mg administered by subcutaneous injection.

What Drugs, Substances, or Supplements Interact with Arixtra?

Arixtra may interact with dextran, abciximab, eptifibatide, ticagrelor, tirofiban, alteplase, reteplase, tenecteplase, urokinase, anagrelide, cilostazol, clopidogrel, dipyridamole, eltrombopag, oprelvekin, prasugrel, romiplostim, ticagrelor, ticlopidine, argatroban, bivalirudin, dabigatran, lepirudin, dalteparin, enoxaparin, rivaroxaban, heparin, tinzaparin, warfarin, NSAIDs (nonsteroidal anti-inflammatory drugs), or salicylates such as aspirin and others. Tell your doctor all medications and supplements you use.

Arixtra During Pregnancy and Breastfeeding

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. Consult your doctor before breastfeeding.

Additional Information

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.

QUESTION

Deep vein thrombosis (DVT) occurs in the _______________. See Answer
Arixtra Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Fondaparinux can cause you to bleed more easily. Call your doctor at once if you have signs of bleeding such as:

  • easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);
  • pain, swelling, or drainage from a wound or where a needle was injected in your skin;
  • bleeding from wounds or needle injections, any bleeding that will not stop;
  • headaches, dizziness, weakness, feeling like you might pass out;
  • urine that looks red, pink, or brown; or
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Also call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

Common side effects may include:

  • bleeding, bruising;
  • sleep problems (insomnia);
  • rash, blisters;
  • dizziness, confusion; or
  • minor bleeding, rash, itching, or oozing 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)

SLIDESHOW

Spider & Varicose Veins: Causes, Before and After Treatment Images See Slideshow
Arixtra Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Spinal or epidural hematomas [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]
  • Renal impairment and bleeding risk [see WARNINGS AND PRECAUTIONS]
  • Body weight <50 kg and bleeding risk [see WARNINGS AND PRECAUTIONS]
  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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 in controlled trials of hip fracture, hip replacement, major knee, or abdominal surgeries, and DVT and PE treatment.

Hemorrhage

During administration of ARIXTRA, 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 3 active-controlled peri-operative VTE prophylaxis trials with enoxaparin sodium in hip fracture, hip replacement, or knee replacement surgery (N = 3,616) and in an extended VTE prophylaxis trial (n = 327) with ARIXTRA 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 2.5 mg SC once daily
N = 3,616
Enoxaparin Sodiuma, b
N = 3,956
ARIXTRA 2.5 mg SC once daily
N = 327
Placebo SC once daily
N = 329
Major bleedingc96 (2.7%)75 (1.9%)8 (2.4%)2 (0.6%)
  Hip fracture18/831 (2.2%)19/842 (2.3%)8/327 (2.4%)2/329 (0.6%)
  Hip replacement67/2,268 (3.0%)55/2,597 (2.1%)--
  Knee replacement11/517 (2.1%)1/517 (0.2%)--
Fatal bleeding0 (0.0%)1 (<0.1%)0 (0.0%)0 (0.0%)
Non-fatal bleeding at critical site0 (0.0%)1 (<0.1%)0 (0.0%)0 (0.0%)
Re-operation due to bleeding12 (0.3%)10 (0.3%)2 (0.6%)2 (0.6%)
BI ≥2d84 (2.3%)63 (1.6%)6 (1.8%)0 (0.0%)
Minor bleedinge109 (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 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 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 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
2.5 mg SC once daily
Dalteparin Sodium 5,000 IU SC once daily
N = 1,433N = 1,425
Major bleedinga49 (3.4%)34 (2.4%)
Fatal bleeding2 (0.1%)2 (0.1%)
Non-fatal bleeding at critical site0 (0.0%)0 (0.0%)
Other non-fatal major bleeding
  Surgical site38 (2.7%)26 (1.8%)
  Non-surgical site9 (0.6%)6 (0.4%)
Minor bleedingb31 (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 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 a dose-response trial (n = 111) and 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) with ARIXTRA 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 bleedingb28 (1.2%)13 (1.2%)12 (1.1%)
Fatal bleeding3 (0.1%)0 (0.0%)1 (0.1%)
Non-fatal bleeding at a critical site3 (0.1%)0 (0.0%)2 (0.2%)
Intracranial bleeding3 (0.1%)0 (0.0%)1 (0.1%)
Retro-peritoneal bleeding0 (0.0%)0 (0.0%)1 (0.1%)
Other clinically overt bleedingc22 (1.0%)13 (1.2%)10 (0.9%)
Minor bleedingd70 (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.

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 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 ARIXTRA 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. 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 should be interpreted with caution.

Other Adverse Reactions

Other adverse reactions that occurred during treatment with ARIXTRA 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 ReactionsPeri-Operative Prophylaxis
(Day 1 to Day 7 ± 1 post-surgery)
Extended Prophylaxis
(Day 8 to Day 28 ± 2 post-surgery)
ARIXTRA 2.5 mg SC once dailyEnoxaparin Sodiuma, bARIXTRA 2.5 mg SC once dailyPlacebo SC once daily
N = 3,616N = 3,956N = 327N = 329
Anemia707 (19.6%)670 (16.9%)5 (1.5%)4 (1.2%)
Insomnia179 (5.0%)214 (5.4%)3 (0.9%)1 (0.3%)
Wound drainage increased161 (4.5%)184 (4.7%)2 (0.6%)0 (0.0%)
Hypokalemia152 (4.2%)164 (4.1%)0 (0.0%)0 (0.0%)
Dizziness131 (3.6%)165 (4.2%)2 (0.6%)0 (0.0%)
Purpura128 (3.5%)137 (3.5%)0 (0.0%)0 (0.0%)
Hypotension126 (3.5%)125 (3.2%)1 (0.3%)0 (0.0%)
Confusion113 (3.1%)132 (3.3%)4 (1.2%)1 (0.3%)
Bullous eruptionc112 (3.1%)102 (2.6%)0 (0.0%)1 (0.3%)
Hematoma103 (2.8%)109 (2.8%)7 (2.1%)1 (0.3%)
Post-operative hemorrhage85 (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.

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. 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.

In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of ARIXTRA by subcutaneous (SC) injection [see WARNINGS AND PRECAUTIONS]. Occurrences of thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported in the postmarketing experience and cases of elevated aPTT temporally associated with bleeding events have been reported following administration of ARIXTRA (with or without concomitant administration of other anticoagulants) [see WARNINGS AND PRECAUTIONS].

Serious allergic reactions, including angioedema, anaphylactoid/anaphylactic reactions have been reported with the use of ARIXTRA [see CONTRAINDICATIONS].

Read the entire FDA prescribing information for Arixtra (Fondaparinux Sodium)

Related Resources for Arixtra

Read the Arixtra User Reviews »

© Arixtra Patient Information is supplied by Cerner Multum, Inc. and Arixtra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Deep vein thrombosis (DVT) occurs in the _______________. See Answer

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