Bivalirudin use in specific populations: Difference between revisions
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== | ==Use in Specific Populations== | ||
====8.1 Pregnancy==== | |||
<u>Pregnancy Category B</u> | |||
<ref>{{Cite web | last = | first = | title = ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=911cd48f-01ea-4dec-b30c-95e7e0ea9d2a | publisher = | date = | accessdate = 10 March 2014 }}</ref> | Reproductive studies have been performed in rats at subcutaneous doses up to 150 mg/kg/day, (1.6 times the maximum recommended human dose based on body surface area) and rabbits at subcutaneous doses up to 150 mg/kg/day (3.2 times the maximum recommended human dose based on body surface area). These studies revealed no evidence of impaired fertility or harm to the fetus attributable to Angiomax. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. | ||
Angiomax is intended for use with aspirin [see Indications and Usage (1.3)]. Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Angiomax and aspirin should be used together during pregnancy only if clearly needed. | |||
====8.3 Nursing Mothers==== | |||
It is not known whether bivalirudin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Angiomax is administered to a nursing woman. | |||
====8.4 Pediatric Use==== | |||
The safety and effectiveness of Angiomax in pediatric patients have not been established. | |||
====8.5 Geriatric Use==== | |||
In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old. Elderly patients experienced more bleeding events than younger patients. Patients treated with Angiomax experienced fewer bleeding events in each age stratum, compared to heparin. | |||
====8.6 Renal Impairment==== | |||
The disposition of Angiomax was studied in PTCA patients with mild, moderate and severe renal impairment. The clearance of Angiomax was reduced approximately 20% in patients with moderate and severe renal impairment and was reduced approximately 80% in dialysis-dependent patients. [see Clinical Pharmacology (12.3)]. The infusion dose of Angiomax may need to be reduced, and anticoagulant status monitored in patients with renal impairment [see Dosage and Administration (2.2)].<ref>{{Cite web | last = | first = | title = ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=911cd48f-01ea-4dec-b30c-95e7e0ea9d2a | publisher = | date = | accessdate = 10 March 2014 }}</ref> | |||
==References== | ==References== | ||
Revision as of 15:49, 10 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
Use in Specific Populations
8.1 Pregnancy
Pregnancy Category B
Reproductive studies have been performed in rats at subcutaneous doses up to 150 mg/kg/day, (1.6 times the maximum recommended human dose based on body surface area) and rabbits at subcutaneous doses up to 150 mg/kg/day (3.2 times the maximum recommended human dose based on body surface area). These studies revealed no evidence of impaired fertility or harm to the fetus attributable to Angiomax. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Angiomax is intended for use with aspirin [see Indications and Usage (1.3)]. Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Angiomax and aspirin should be used together during pregnancy only if clearly needed.
8.3 Nursing Mothers
It is not known whether bivalirudin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Angiomax is administered to a nursing woman.
8.4 Pediatric Use
The safety and effectiveness of Angiomax in pediatric patients have not been established.
8.5 Geriatric Use
In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old. Elderly patients experienced more bleeding events than younger patients. Patients treated with Angiomax experienced fewer bleeding events in each age stratum, compared to heparin.
8.6 Renal Impairment
The disposition of Angiomax was studied in PTCA patients with mild, moderate and severe renal impairment. The clearance of Angiomax was reduced approximately 20% in patients with moderate and severe renal impairment and was reduced approximately 80% in dialysis-dependent patients. [see Clinical Pharmacology (12.3)]. The infusion dose of Angiomax may need to be reduced, and anticoagulant status monitored in patients with renal impairment [see Dosage and Administration (2.2)].[1]
References
- ↑ "ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]". Retrieved 10 March 2014.
Adapted from the FDA Package Insert.