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|Dosage & Administration|
Intravenous: Administer at 0, 2, and 4 weeks, and every 4 weeks thereafter, as a 30-minute infusion (weight based). Subcutaneous: Administer 125 mg by subcutaneous injection once weekly (within a day of the intravenous infusion if infusion given).. Learn more.
intravenous: givethe medication at weeks 0, 2, and 4, and then every 4w thereafter, as a 30-minute infusion based on the patient's weight. Subcutaneous give 125 mg qw (within one day of the intravenous infusion if it was given). Learn more.
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
Adverse reactions reported in clinical trials (≥1%) are: Rheumatoid Arthritis: upper respiratory tract infections (URTIs), nausea, herpes simplex, and herpes zoster. COVID-19: increases of liver enzymes, thrombocytosis, creatine phosphokinase increases, neutropenia, deep vein thrombosis, pulmonary embolism, and urinary tract infection (UTI) Alopecia Areata: URTIs, headache, acne, hyperlipidemia, creatine phosphokinase increase, UTI, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.. Learn more.
Most common adverse events (≥10%) in RA are headache, upper respiratory tract infection, nasopharyngitis, and nausea. Most common adverse reactions (≥10%) in prophylaxis of aGVHD are anemia, hypertension, CMV reactivation/CMV infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, and acute kidney injury. . Learn more.
Mechanism of Actions (MoA)
Is OLUMIANT safe to use during pregnancy?
Based on animal studies, OLUMIANT may cause fetal harm during pregnancy. Available data from clinical trials and postmarketing case reports with OLUMIANT exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no human data on chronic baricitinib exposure throughout pregnancy. Consider the risks and benefits with chronic use of OLUMIANT during pregnancy.
Can OLUMIANT be used during breastfeeding?
No information is available on the presence of OLUMIANT in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in nursing infants, advise women not to breastfeed during treatment with OLUMIANT and for 4 days after the last dose.
Is OLUMIANT safe for use in pediatric patients?
The safety and effectiveness of OLUMIANT in pediatric patients have not been established.
Can OLUMIANT be used in geriatric patients?
No overall differences in safety or effectiveness were observed between geriatric patients (65 years of age and older) and younger subjects in clinical trials. However, greater sensitivity of some older individuals cannot be ruled out. Care should be taken in dose selection and it may be useful to monitor renal function as geriatric patients are more likely to have decreased renal function.
Can OLUMIANT be used in patients with hepatic impairment?
No dose adjustment is necessary in patients with mild or moderate hepatic impairment. OLUMIANT has not been studied in patients with rheumatoid arthritis or alopecia areata and severe hepatic impairment and is therefore not recommended. OLUMIANT should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk.
Can OLUMIANT be used in patients with renal impairment?
Renal function significantly affects baricitinib exposure. The recommended dosage of OLUMIANT in patients with moderate renal impairment (estimated glomerular filtration rate (GFR) between 30 and <60 mL/min/1.73 m2) should be reduced by half the recommended dose. OLUMIANT is not recommended for use in patients with rheumatoid arthritis or alopecia areata and severe renal impairment (estimated GFR of less than 30 mL/min/1.73 m2).
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.