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| __NOTOC__
| | #REDIRECT [[Fondaparinux#Use in Specific Populations]] |
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| {{Fondaparinux}}
| | [[Category: Cardiovascular Drugs]] |
| {{CMG}}; {{AE}} {{AZ}}
| | [[Category: Drug]] |
| ==Use In Specific Populations==
| | [[Category: Anticoagulants]] |
| ===Pregnancy===
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| '''Pregnancy Category B'''
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| Reproduction studies have been performed in pregnant rats at subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area) and pregnant rabbits at subcutaneous doses up to 10 mg/kg/day (about 65 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to fondaparinux sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ARIXTRA should be used during pregnancy only if clearly needed.
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| ===Nursing Mothers===
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| Fondaparinux sodium was found to be excreted in the milk of lactating rats. However, it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ARIXTRA is administered to a nursing mother.
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| ===Pediatric Use===
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| Safety and effectiveness of ARIXTRA in pediatric patients have not been established. Because risk for bleeding during treatment with ARIXTRA is increased in adults who weigh <50 kg, bleeding may be a particular safety concern for use of ARIXTRA in the pediatric population [see [[Fondaparinux warnings and precautions| Warnings and Precautions (5.3)]]].
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| ===Geriatric Use===
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| In clinical trials the efficacy of ARIXTRA in the elderly (65 years or older) was similar to that seen in patients younger than 65 years; however, serious adverse events increased with age. Exercise caution when using ARIXTRA in elderly patients, paying particular attention to dosing directions and concomitant medications (especially anti-platelet medication). [See [[Fondaparinux warnings and precautions| Warnings and Precautions (5.1)]]].
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| Fondaparinux sodium is substantially excreted by the kidney, and the risk of adverse reactions to ARIXTRA may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, assess renal function prior to ARIXTRA administration. [See [[Fondaparinux contraindications|Contraindications (4)]], [[Fondaparinux warnings and precautions| Warnings and Precautions (5.2)]]], and [[Fondaparinux clinical pharmacology|Clinical Pharmacology (12.4)]].]
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| In the peri-operative hip fracture, hip replacement, or knee replacement surgery clinical trials with patients receiving ARIXTRA 2.5 mg, serious adverse events increased with age for patients receiving ARIXTRA. The incidence of major bleeding in clinical trials of ARIXTRA by age is provided in Table 6.
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| |[[File:Fondaparinuxspecificpop.JPG]]
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| ===Renal Impairment===
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| Patients with impaired renal function are at increased risk of bleeding due to reduced clearance of ARIXTRA[see [[Fondaparinux contraindications|Contraindications (4)]]and [[Fondaparinux warnings and precautions| Warnings and Precautions (5.2)]]].
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| . Assess renal function periodically in patients receiving ARIXTRA. Discontinue ARIXTRA 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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| ===Hepatic Impairment===
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| Following a single, subcutaneous dose of 7.5 mg of ARIXTRA in patients with moderate hepatic impairment (Child-Pugh Category B) compared to subjects with normal liver function, changes from baseline in [[aPTT]], [[PT|PT/INR]], and [[antithrombin III]] were similar in the two groups. However, a higher incidence of hemorrhage was observed in subjects with moderate hepatic impairment than in normal subjects, especially mild [[hematomas ]]at the blood sampling or injection site. The pharmacokinetics of fondaparinux have not been studied in patients with severe hepatic impairment. [See Dosage and Administration (2.4) and [[Fondaparinux clinical pharmacology|Clinical Pharmacology (12.4)]].]<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]] | |