Drugplain

Arixtra 2.5 mg/.5mL

fondaparinux sodium · INJECTION, SOLUTION · Mylan Institutional LLC

No Recall HistoryCurrently in Shortage
Plain English

Arixtra is a injection, solution containing fondaparinux sodium at 2.5 mg/.5mL, taken subcutaneous. Manufactured by Mylan Institutional LLC.

Key Facts

Brand Name
Arixtra
Generic Name
fondaparinux sodium
NDC Code (Product)
67457-592
Manufacturer
Mylan Institutional LLC
Strength
2.5 mg/.5mL
Dosage Form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Marketing Status
Application #
NDA021345
Marketing Start
05/19/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

anaemia610 reports
haematoma559 reports
pulmonary embolism444 reports
off label use366 reports
haemorrhage351 reports
haemoglobin decreased339 reports
death296 reports
deep vein thrombosis293 reports
dyspnoea270 reports
thrombocytopenia262 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ARIXTRA is a Factor Xa inhibitor (anticoagulant) indicated for: • Prophylaxis of deep vein thrombosis (DVT) in adult patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. ( 1.1 ) • Treatment of DVT or acute pulmonary embolism (PE) in adult patients when administered in conjunction with warfarin sodium. ( 1.2 , 1.3 ) • Treatment of venous thromboembolism (VTE) in pediatric patients aged 1 year or older weighing at least 10 kg. ( 1.4 ) 1.1 Prophylaxis of Deep Vein Thrombosis in Adult Patients ARIXTRA ® is indicated for the prophylaxis of deep vein thrombosis (DVT) in adults, which may lead to pulmonary embolism (PE): • in patients undergoing hip fracture surgery, including extended prophylaxis; • in patients undergoing hip replacement surgery; • in patients undergoing knee replacement surgery; • in patients undergoing abdominal surgery who are at risk for thromboembolic complications. 1.2 Treatment of Acute Deep Vein Thrombosis in Adult Patients ARIXTRA is indicated for the treatment of acute deep vein thrombosis in adults when administered in conjunction with warfari…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • For subcutaneous use, do not mix with other injections or infusions. ( 2.1 ) • Prophylaxis of deep vein thrombosis in adults: ARIXTRA 2.5 mg subcutaneously once daily after hemostasis has been established. The initial dose should be given no earlier than 6 hours to 8 hours after surgery and continued for 5 days to 9 days. For patients undergoing hip fracture surgery, extended prophylaxis up to 24 additional days is recommended. ( 2.2 , 2.3 ) • Treatment of deep vein thrombosis and pulmonary embolism in adults: ARIXTRA 5 mg (body weight less than 50 kg), 7.5 mg (50 kg to 100 kg), or 10 mg (greater than 100 kg) subcutaneously once daily. Treatment should continue for at least 5 days until INR 2 to 3 is achieved with warfarin sodium. ( 2.4 ) • Treatment of venous thromboembolism in pediatric patients weighing at least 10 kg: ARIXTRA 0.1 mg/kg subcutaneously once daily. ( 2.5 ) 2.1 Important Dosing Information Do not mix other medications or solutions with ARIXTRA. Administer ARIXTRA only subcutaneously. Discard unused portion. Monitor routine complete blood counts (including platelet count), serum creatinine level, and stool occult blood periodically [see…

Contraindications

4 CONTRAINDICATIONS ARIXTRA is contraindicated in the following conditions: • Severe renal impairment (creatinine clearance [CrCl] less than 30 mL/min) [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] . • Active major bleeding. • Bacterial endocarditis. • Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium. • Body weight less than 50 kg (venous thromboembolism [VTE] prophylaxis in adults only) [see Warnings and Precautions (5.4) ] . • History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to ARIXTRA. ARIXTRA is contraindicated in the following conditions: ( 4 ) • Severe renal impairment (creatinine clearance less than 30 mL/min) in prophylaxis or treatment of venous thromboembolism. • Active major bleeding. • Bacterial endocarditis. • Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium. • Body weight less than 50 kg (venous thromboembolism prophylaxis in adults only). • History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reaction…

Drug Interactions

7 DRUG 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 [see Warnings and Precautions (5.2) ] . In an in vitro study in human liver microsomes, inhibition of CYP2A6 hydroxylation of coumarin by fondaparinux (200 micromolar i.e., 350 mg/L) was 17% to 28%. Inhibition of the other isozymes evaluated (CYPs 1A2, 2C9, 2C19, 2D6, 3A4, and 3E1) was 0% to 16%. Since fondaparinux does not markedly inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4) in vitro , fondaparinux sodium is not expected to significantly interact with other drugs i…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Spinal or epidural hematomas [see Warnings and Precautions (5.1) ] • Hemorrhage [see Warnings and Precautions (5.2) ] • Renal impairment and bleeding risk [see Warnings and Precautions (5.3) ] • Body weight less than 50 kg and bleeding risk [see Warnings and Precautions (5.4) ] • Thrombocytopenia [see Warnings and Precautions (5.5) ] The most serious adverse reactions associated with the use of ARIXTRA are bleeding complications. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. Clinical 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 abdo…

Frequently Asked Questions

What is Arixtra used for?

Arixtra contains fondaparinux sodium. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.

Is Arixtra a controlled substance?

Arixtra is not classified as a controlled substance by the DEA.

What is the generic name for Arixtra?

The generic name for Arixtra is fondaparinux sodium. There are 11 other brand versions of fondaparinux sodium.

What is the NDC code for Arixtra 2.5 mg/.5mL?

The NDC (National Drug Code) for Arixtra 2.5 mg/.5mL is 67457-592, listed by Mylan Institutional LLC.

Product NDC

67457-592

Package NDC

67457-592-10

Other Arixtra Dosages

Other Fondaparinux Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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