Brand Name
Arixtra
Generic Name
Fondaparinux
View Brand Information FDA approval date: July 14, 2011
Classification: Factor Xa Inhibitor
Form: Injection
What is Arixtra (Fondaparinux)?
ARIXTRA is a Factor Xa inhibitor indicated for: Prophylaxis of deep vein thrombosis in adult patients undergoing hip fracture surgery , hip replacement surgery, knee replacement surgery, or abdominal surgery.
Approved To Treat
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Brand Information
Arixtra (fondaparinux sodium)
WARNING: SPINAL/EPIDURAL HEMATOMAS
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- use of indwelling epidural catheters
- concomitant use of other drugs that affect hemostasis, such as non-steroidal anti- inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
- a history of traumatic or repeated epidural or spinal puncture
- a history of spinal deformity or spinal surgery
- Optimal timing between the administration of ARIXTRA and neuraxial procedures is not known.
Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.
Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
1DOSAGE FORMS AND STRENGTHS
Injection: Single-dose, prefilled syringes containing clear to practically clear and colorless liquid containing either 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL, or 10 mg/0.8 mL of fondaparinux sodium.
2CONTRAINDICATIONS
ARIXTRA is contraindicated in the following conditions:
- Severe renal impairment (creatinine clearance [CrCl] less than 30 mL/min)
- Active major bleeding.
- Bacterial endocarditis.
- Thrombocytopenia associated with a positive
- Body weight less than 50 kg (venous thromboembolism [VTE] prophylaxis in adults only)
- History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to ARIXTRA.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Spinal or epidural hematomas
- Hemorrhage
- Renal impairment and bleeding risk
- Body weight less than 50 kg and bleeding risk
- Thrombocytopenia
3.1Clinical 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.
3.1.1Clinical Trials Experience in Adults
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.
3.1.2Hemorrhage
During administration of ARIXTRA, the most common adverse reactions were bleeding complications
3.1.2.1Hip 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 5.
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: less than 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 (greater than or equal to 75%) of the major bleeding events occurred during the first 4 days after surgery.
3.1.2.2Abdominal 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 6.
The rates of major bleeding according to the time interval following the first ARIXTRA injection were as follows: less than 6 hours was 3.4% (9/263) and 6 hours to 8 hours was 2.9% (32/1,112).
3.1.2.3Treatment 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 7.
3.1.3Local Reactions
Local irritation (injection site bleeding, rash, and pruritus) has occurred following subcutaneous injection of ARIXTRA.
3.1.4Elevations 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.
3.1.5Other 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 8.
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%).
3.1.6Clinical Trials Experience in Pediatric Patients
Safety data for use of ARIXTRA in the treatment of VTE in pediatric patients aged 1 year or older is available from Study FDPX-IJS-7001. In Study FDPX-IJS-7001 (n = 366), the median duration of treatment with fondaparinux sodium injection, including ARIXTRA, was 85 days (range 1 day to 3,768 days).
The incidence of major bleeding events, defined as per the ISTH criteria, was the primary safety outcome of interest in Study FDPX-IJS-7001. Seven patients (1.9%) had composite major bleeding events: 1 patient (0.3%) had clinically overt bleeding (associated with a decrease in hemoglobin of at least 20 g/L (2 g/dL) in a 24-hour period), 3 patients (0.8%) had bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system, and 3 patients (0.8%) had major bleeding that required surgical intervention in an operating suite. Major bleeding events resulted in the interruption of fondaparinux sodium injection treatment for 4 patients and the discontinuation of fondaparinux sodium injection for 3 patients. All major bleeding events were reported in patients between the ages of greater than or equal to 2 years to less than 18 years.
Eleven patients (3%) had non-major bleeding events: 8 patients (2.2%) had overt bleeding for which a blood product was administered, and which was not directly attributable to the patient’s underlying medical condition and 4 patients (1.1%) had bleeding that required medical or surgical intervention to restore hemostasis other than in an operating room. All non-major bleeding events warranted either interruption or withdrawal of fondaparinux sodium injection treatment except for 1 patient for whom the action taken with fondaparinux was not reported. All non-major bleeding events were reported in patients between the ages of greater than or equal to 2 years to less than 18 years.
Overall, 65 patients (18%) had composite minor bleeding events: 64 patients (18%) had overt or macroscopic evidence of bleeding that did not fulfill the criteria for either major bleeding or clinically relevant, non-major bleeding and two patients (0.5%) had non-major menstrual bleeding which resulted in a medical consultation and/or intervention.
3.1.7Other Adverse Reactions
Other adverse reactions that occurred during treatment with fondaparinux sodium injection in pediatric studies included: anemia, thrombocytopenia, allergic reactions, generalized skin associated events, abnormal liver function, hypokalemia, and hypotension.
3.2Postmarketing 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
Serious allergic reactions, including angioedema, anaphylactoid/anaphylactic reactions have been reported with the use of ARIXTRA
Elevations of hepatic transaminases have been reported in pediatric patients with elevations greater than 10x ULN.
4DRUG INTERACTIONS
In clinical studies performed with ARIXTRA, the concomitant use of oral anticoagulants (warfarin sodium), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam), and digoxin did not significantly affect the pharmacokinetics/pharmacodynamics of fondaparinux sodium. In addition, ARIXTRA neither influenced the pharmacodynamics of warfarin sodium, acetylsalicylic acid, piroxicam, and digoxin, nor the pharmacokinetics of digoxin at steady state.
Agents that may enhance the risk of hemorrhage should be discontinued prior to initiation of therapy with ARIXTRA unless these agents are essential. If co-administration is necessary, monitor patients closely for hemorrhage
In an
Since fondaparinux sodium does not bind significantly to plasma proteins other than ATIII, no drug interactions by protein-binding displacement are expected.
5OVERDOSAGE
Overdose of ARIXTRA may lead to hemorrhagic complications. Discontinue treatment and initiate appropriate therapy if bleeding complications associated with overdosage occur. There is no known antidote for ARIXTRA.
Data obtained in patients undergoing chronic intermittent hemodialysis suggest that clearance of ARIXTRA can increase by 20% during hemodialysis.
6DESCRIPTION
ARIXTRA (fondaparinux sodium injection, USP) is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl
The molecular formula of fondaparinux sodium is C
ARIXTRA is supplied as a sterile, preservative-free injectable solution for subcutaneous use.
Each single-dose, prefilled syringe of ARIXTRA, affixed with an automatic needle protection system, contains 2.5 mg of fondaparinux sodium in 0.5 mL, 5 mg of fondaparinux sodium in 0.4 mL, 7.5 mg of fondaparinux sodium in 0.6 mL, or 10 mg of fondaparinux sodium in 0.8 mL of an isotonic solution of sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters. The final drug product is a clear and colorless to slightly yellow liquid with a pH between 5 and 8.
7HOW SUPPLIED/STORAGE AND HANDLING
ARIXTRA (fondaparinux sodium injection, USP) is available in single-dose, prefilled syringes containing clear to practically clear and colorless liquid in the following strengths:
2.5 mg/0.5 mL ARIXTRA in single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod.
NDC 67457-592-10 10 Single Unit Syringes
5 mg/0.4 mL ARIXTRA in single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod.
NDC 67457-593-04 10 Single Unit Syringes
7.5 mg/0.6 mL ARIXTRA in single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod.
NDC 67457-594-06 10 Single Unit Syringes
10 mg/0.8 mL ARIXTRA in single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod.
NDC 67457-595-08 10 Single Unit Syringes
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Discard unused portion.
PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling
8.1Patient Advice
If the patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDS, platelet inhibitors, or other anticoagulants, inform patients to watch for signs and symptoms of spinal or epidural hematomas, such as back pain, tingling, numbness (especially in the lower limbs), muscular weakness, and stool or urine incontinence. If any of these symptoms occur, advise patients to contact his or her physician immediately.
The use of aspirin and other NSAIDS may enhance the risk of hemorrhage. Advise patients to discontinue use prior to ARIXTRA therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored
If patients must self-administer ARIXTRA or if administered by a caregiver, (e.g., if ARIXTRA is used at home), advise patients of the following:
- Advise patients that ARIXTRA should be given by subcutaneous injection. Instruct patients in the proper technique for administration.
- Instruct patients that if they miss a dose of ARIXTRA, to inject the dose as soon as they remember. Advise patients not to inject two doses at the same time.
- The most important risk with ARIXTRA administration is bleeding. Counsel patients on signs and symptoms of possible bleeding.
- Advise patients that it may take them longer than usual to stop bleeding.
- Advise patients that they may bruise and/or bleed more easily when they are treated with ARIXTRA.
- Advise patients to report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician
- Advise patients to tell their physicians and dentists they are taking ARIXTRA and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken
- Advise patients to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs
Manufactured for:
Manufactured by:
MI:ARXTIJ:R7p
9PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 12/2024
MI:PL:ARXTIJ:R7p
10INSTRUCTIONS FOR USE
ARIXTRA
This Instructions for Use contains information on how to inject ARIXTRA. Before you use ARIXTRA, read and follow the step-by-step instructions. Talk to your or your child’s doctor or pharmacist if you have any questions.
Important Information You Need to Know Before Injecting ARIXTRA
- ARIXTRA is available in different types of syringes. Confirm the syringe looks like the figure below before you continue:
- Your healthcare provider should show you how to prepare and inject ARIXTRA.
- Each ARIXTRA syringe is 1 dose of ARIXTRA.
- Use ARIXTRA exactly as prescribed by your doctor.
- The packaging (needle guard) for ARIXTRA contains dry natural latex rubber.
How should I store ARIXTRA syringes?
- Store ARIXTRA at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep ARIXTRA syringes and all medicines out of the reach of children.
Do not use ARIXTRA if:
- the solution appears discolored (the solution should normally appear clear)
- you see any particles in the solution
- the syringe is damaged
- it is out of date (expired)
How should I give an injection of ARIXTRA?
ARIXTRA is injected into a skinfold of the lower stomach-area (abdomen) as directed by your or your child’s doctor.
This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 12/2024
Manufactured for:
Manufactured by:
MI:IFU1:ARXTIJ:R7p
11INSTRUCTIONS FOR USE
ARIXTRA
This Instructions for Use contains information on how to inject ARIXTRA. Before you use ARIXTRA, read and follow the step-by-step instructions. Talk to your child’s doctor or pharmacist if you have any questions.
Important Information You Need to Know Before Injecting ARIXTRA
- ARIXTRA is available in different types of syringes. Confirm the syringe looks like the figure below before you continue:
- Your healthcare provider should show you how to prepare and inject ARIXTRA. Do not inject your child until you have been shown how to inject ARIXTRA.
- Each ARIXTRA syringe is 1 dose of ARIXTRA.
- Use ARIXTRA exactly as prescribed by your doctor.
How should I store ARIXTRA syringes?
- Store ARIXTRA syringes in a refrigerator between 36°F to 46°F (2°C to 8°C) for up to the beyond use date on the syringe.
- Do not freeze.
- Store syringes in a clean container in the refrigerator.
- Do not store ARIXTRA syringes at room temperature between 68°F to 77°F (20°C to 25°C).
- Take ARIXTRA syringe out of the refrigerator and allow it to reach room temperature. Inject right away after the syringe reaches room temperature.
- Throw away (dispose of) ARIXTRA syringes that has been left at room temperature for longer than 4 hours.
- Keep ARIXTRA syringes and all medicines out of the reach of children.
Do not use ARIXTRA if:
- the solution appears discolored (the solution should normally appear clear)
- you see any particles in the solution
- the syringe is damaged, including:
- past the beyond use date on the syringe labeled by the pharmacy
How should I give an injection of ARIXTRA?
ARIXTRA is injected into a skin fold of the lower stomach-area (abdomen) as directed by your child’s doctor. Do not inject ARIXTRA into muscle.
This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 12/2024
Manufactured for:
Manufactured by:
MI:IFU2:ARXTIJ:R1p
12PRINCIPAL DISPLAY PANEL – 2.5 mg/0.5 mL
NDC 67457-592-10
Arixtra®
2.5 mg/0.5 mL
For Subcutaneous Injection
Leaflet to each patient.
Rx only
Contains 10 Single-Dose, Prefilled Syringes
Contents: Each single-dose prefilled syringe contains 2.5 mg of fondaparinux sodium, USP in 0.5 mL of an isotonic solution of sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters.
The needle guard of the prefilled syringe of ARIXTRA contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
Recommended Dose: 2.5 mg subcutaneous injection, once daily. See package insert.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Discard unused portion.
Manufactured for:
Made in France
MI:592:10C:R6
Mylan.com
13PRINCIPAL DISPLAY PANEL – 5 mg/0.4 mL
NDC 67457-593-04
Arixtra®
(fondaparinux sodium injection, USP)
5 mg/0.4 mL
For Subcutaneous Injection
PHARMACIST: Dispense the accompanying Patient Information
Rx only
Contains 10 Single-Dose, Prefilled Syringes
Contents: Each single-dose prefilled syringe contains 5 mg of fondaparinux sodium, USP
in 0.4 mL of an isotonic solution of sodium chloride and water for injection. May also
contain sodium hydroxide and/or hydrochloric acid as pH adjusters.
in 0.4 mL of an isotonic solution of sodium chloride and water for injection. May also
contain sodium hydroxide and/or hydrochloric acid as pH adjusters.
The needle guard of the prefilled syringe of ARIXTRA contains dry natural latex rubber that
Recommended Dose: 5 mg subcutaneous injection, once daily. See package insert.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Discard unused portion.
Manufactured for:
Made in France
MI:593:10C:R6
Mylan.com
14PRINCIPAL DISPLAY PANEL – 7.5 mg/0.6 mL
NDC 67457-594-06
Arixtra®
(fondaparinux sodium injection, USP)
7.5 mg/0.6 mL
For Subcutaneous Injection
PHARMACIST: Dispense the accompanying Patient Information
Rx only
Contains 10 Single-Dose, Prefilled Syringes
Affixed with an Automatic Needle Protection System
Contents: Each single-dose prefilled syringe contains 7.5 mg of fondaparinux sodium, USP
in 0.6 mL of an isotonic solution of sodium chloride and water for injection. May also
contain sodium hydroxide and/or hydrochloric acid as pH adjusters.
in 0.6 mL of an isotonic solution of sodium chloride and water for injection. May also
contain sodium hydroxide and/or hydrochloric acid as pH adjusters.
The needle guard of the prefilled syringe of ARIXTRA contains dry natural latex rubber that
Recommended Dose: 7.5 mg subcutaneous injection, once daily. See package insert.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Discard unused portion.
Manufactured for:
Made in France
MI:594:10C:R6
Mylan.com
15PRINCIPAL DISPLAY PANEL – 10 mg/0.8 mL
NDC 67457-595-08
Arixtra®
(fondaparinux sodium injection, USP)
10 mg/0.8 mL
For Subcutaneous Injection
PHARMACIST: Dispense the accompanying Patient Information
Rx only
Contains 10 Single-Dose, Prefilled Syringes
Contents: Each single-dose prefilled syringe contains 10 mg of fondaparinux sodium, USP
in 0.8 mL of an isotonic solution of sodium chloride and water for injection. May also
contain sodium hydroxide and/or hydrochloric acid as pH adjusters.
in 0.8 mL of an isotonic solution of sodium chloride and water for injection. May also
contain sodium hydroxide and/or hydrochloric acid as pH adjusters.
The needle guard of the prefilled syringe of ARIXTRA contains dry natural latex rubber that
Recommended Dose: 10 mg subcutaneous injection, once daily. See package insert.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Discard unused portion.
Manufactured for:
Made in France
MI:595:10C:R6
Mylan.com
