0.4 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]0.7 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]
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Is there a pregnancy exposure registry for ORENCIA?Yes, there is a pregnancy exposure registry for ORENCIA that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972.
What is the risk associated with ORENCIA use during pregnancy?The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. However, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero (see Clinical Considerations).
What are the clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero?It is unknown if abatacept, the active ingredient in ORENCIA, can cross the placenta into the fetus when a woman is treated with the drug during pregnancy. It is also unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.
Is ORENCIA safe to use during lactation?There is no information regarding the presence of abatacept, the active ingredient in ORENCIA, in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with the drug.
Is ORENCIA safe to use in pediatric patients?ORENCIA is safe and effective for reducing signs and symptoms in pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). Use of ORENCIA for this indication is supported by evidence from clinical studies. The safety and effectiveness of ORENCIA use in pJIA in pediatric patients less than two years of age have not been established.
Can geriatric patients use ORENCIA for Rheumatoid Arthritis?Yes, geriatric patients (patients aged 65 years of age and older) can use ORENCIA for Rheumatoid Arthritis. Clinical studies involving 323 patients aged 65 years and older, including 53 patients aged 75 years and older, showed no overall differences in safety or effectiveness between geriatric patients and younger adults. However, caution should be used when treating geriatric patients due to the higher incidence of infections and malignancies in the geriatric population in general. The frequency of serious infection and malignancy among ORENCIA-treated patients over age 65 was higher than for those under age 65.
Are there differences in response between geriatric patients and younger adult patients using ORENCIA for Rheumatoid Arthritis?Other reported clinical experience has not identified differences in responses between geriatric patients and younger adults when using ORENCIA for Rheumatoid Arthritis. However, greater sensitivity of some geriatric patients cannot be ruled out. Clinical studies of ORENCIA for acute graft versus host disease (aGVHD) did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
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