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| __NOTOC__
| | #REDIRECT [[Fondaparinux#Warnings]] |
| {{Fondaparinux}}
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| {{CMG}}; {{AE}} {{AZ}}
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| ==Warnings And Precautions==
| | [[Category: Cardiovascular Drugs]] |
| [[image:fonda1.png|850px]] | | [[Category: Drug]] |
| ===Hemorrhage===
| | [[Category: Anticoagulants]] |
| Use ARIXTRA with extreme caution in conditions with increased risk of hemorrhage, such as congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, [[hemorrhagic stroke]], uncontrolled [[arterial hypertension]], [[diabetic retinopathy]], or shortly after brain, spinal, or ophthalmological surgery. Isolated 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 [[Fondaparinux adverse reactions | Adverse Reactions (6.5)]]].
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| Do not administer agents that enhance the risk of hemorrhage with ARIXTRA unless essential for the management of the underlying condition, such as [[vitamin K antagonists]] for the treatment of [[VTE]]. If co-administration is essential, closely monitor patients for signs and symptoms of bleeding.
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| Do not administer the initial dose of ARIXTRA earlier than 6 to 8 hours after surgery. Administration earlier than 6 hours after surgery increases risk of major bleeding [see [[Fondaparinux dosage and administration|Dosage and Administration]] (2) and [[Fondaparinux adverse reactions |Adverse Reactions (6.1)]]].
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| ===Renal Impairment and Bleeding Risk===
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| ARIXTRA increases the risk of bleeding in patients with impaired renal function due to reduced clearance [see[[ Fondaparinux clinical pharmacology|Clinical Pharmacology (12.4)]]].
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| The incidence of major bleeding by renal function status reported in clinical trials of patients receiving ARIXTRA for VTE surgical prophylaxis is provided in Table 1. In these patient populations, the following is recommended:
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| :*Do not use ARIXTRA for VTE prophylaxis and treatment in patients with [[CrCl ]]<30 mL/min [see [[Fondaparinux contraindications| Contraindications]] (4)].
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| :*Use ARIXTRA with caution in patients with [[CrCl]] 30 to 50 mL/min.
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| {|
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| |[[File:Fondaparinux warning bleeding.JPG|600px|thumb]]
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| |}
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| Assess renal function periodically in patients receiving ARIXTRA. Discontinue the drug immediately in patients who develop severe renal impairment while on therapy. After discontinuation of ARIXTRA, its anticoagulant effects may persist for 2 to 4 days in patients with normal renal function (i.e., at least 3 to 5 half-lives). The anticoagulant effects of ARIXTRA may persist even longer in patients with renal impairment [see [[ Fondaparinux clinical pharmacology|Clinical Pharmacology (12.4)]]].
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| ===Bleeding Risk When Body Weight < 50 Kg===
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| ARIXTRA increases the risk for bleeding in patients who weigh less than 50 kg, compared to patients with higher weights.
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| '''In patients who weigh less than 50 kg''':
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| :*Do not administer ARIXTRA as prophylactic therapy for patients undergoing hip fracture, hip replacement, or knee replacement surgery and abdominal surgery [see [[Fondaparinux contraindications| Contraindications]] (4)].
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| :*Use ARIXTRA with caution in the treatment of [[PE ]]and [[DVT]].
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| During the randomized clinical trials of [[VTE ]]prophylaxis in the peri-operative period following hip fracture, hip replacement, or knee replacement surgery and abdominal surgery, major bleeding occurred at a higher rate among patients with a body weight <50 kg compared to those with a body weight >50 kg (5.4% versus 2.1% in patients undergoing hip fracture, hip replacement, or knee replacement surgery; 5.3% versus 3.3% in patients undergoing abdominal surgery).
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| ===Thrombocytopenia===
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| [[Thrombocytopenia ]]can occur with the administration of ARIXTRA. [[Thrombocytopenia ]]of any degree should be monitored closely. Discontinue ARIXTRA if the platelet count falls below 100,000/mm3. Moderate [[thrombocytopenia ]](platelet counts between 100,000/mm3 and 50,000/mm3) occurred at a rate of 3.0% in patients given ARIXTRA 2.5 mg in the peri-operative hip fracture, hip replacement, or knee replacement surgery and abdominal surgery clinical trials. Severe [[thrombocytopenia ]](platelet counts less than 50,000/mm3) occurred at a rate of 0.2% in patients given ARIXTRA 2.5 mg in these clinical trials. During extended prophylaxis, no cases of moderate or severe [[thrombocytopenia ]]were reported.
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| Moderate thrombocytopenia occurred at a rate of 0.5% in patients given the ARIXTRA treatment regimen in the [[DVT ]]and [[PE ]]treatment clinical trials. Severe [[thrombocytopenia ]]occurred at a rate of 0.04% in patients given the ARIXTRA treatment regimen in the DVT and PE treatment clinical trials.
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| Isolated occurrences of thrombocytopenia with thrombosis that manifested similar to [[heparin-induced thrombocytopenia]] have been reported with the use of ARIXTRA in postmarketing experience. [See [[Fondaparinux adverse reactions | Adverse Reactions (6.5)]]].
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| ===Neuraxial Anesthesia and Post-operative Indwelling Epidural Catheter Use===
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| Spinal hematomas or[[ epidural hematomas]], which may result in long-term or permanent paralysis, can occur with the use of anticoagulants and neuraxial (spinal/epidural) [[anesthesia ]]or spinal puncture. The risk of these events may be higher with post-operative use of indwelling epidural catheters or concomitant use of other drugs affecting hemostasis such as [[NSAIDs ]][see[[ Fondaparinux warnings and precautions| Boxed Warning]]]. In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of ARIXTRA by subcutaneous (SC) injection. Monitor patients undergoing these procedures for signs and symptoms of neurologic impairment. Consider the potential risks and benefits before neuraxial intervention in patients anticoagulated or who may be anticoagulated for thromboprophylaxis.
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| ===Monitoring: Laboratory Tests===
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| Routine coagulation tests such as[[ Prothrombin Time]] ([[PT]]) and Activated [[Partial Thromboplastin Time]] ([[aPTT]]) are relatively insensitive measures of the activity of ARIXTRA and international standards of heparin or [[LMWH ]]are not calibrators to measure anti-Factor Xa activity of ARIXTRA. If unexpected changes in coagulation parameters or major bleeding occur during therapy with ARIXTRA, discontinue ARIXTRA. In postmarketing experience, isolated occurrences of aPTT elevations have been reported following administration of ARIXTRA [see [[Fondaparinux adverse reactions | Adverse Reactions (6.5)]]].
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| Periodic routine complete blood counts (including platelet count), serum [[creatinine ]]level, and [[stool occult blood tests|stool occult blood test]] are recommended during the course of treatment with ARIXTRA.
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| The anti-[[Factor Xa]] activity of fondaparinux sodium can be measured by anti-Xa assay using the appropriate calibrator (fondaparinux). The activity of fondaparinux sodium is expressed in milligrams (mg) of the fondaparinux and cannot be compared with activities of heparin or [[low molecular weight heparin|low molecular weight heparins]]. [See[[ Fondaparinux clinical pharmacology|Clinical Pharmacology(12.2, 12.3)]].]
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| ===Latex===
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| The packaging (needle guard) of the prefilled syringe of ARIXTRA contains dry natural [[latex ]]rubber that may cause allergic reactions in latex sensitive individuals.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Drugs]] | |