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|Dosage & Administration|
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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.
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis: Adverse reactions (≥ 1%) were: upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache. Atopic Dermatitis: Adverse reactions (≥ 1%) are: upper respiratory tract infections, acne, herpes simplex, headache, blood creatine phosphokinase increased, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness. Ulcerative colitis: Adverse reactions (≥ 5%) reported during induction or maintenance are: upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, elevated liver enzymes, and rash.. 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).
What is RINVOQ?
RINVOQ is a drug that may be used to treat certain medical conditions.
Is RINVOQ safe to use during pregnancy?
There is not enough data available to evaluate the potential risk of major birth defects or miscarriage associated with RINVOQ use during pregnancy. However, animal studies have shown that RINVOQ has the potential to harm a developing fetus. Pregnant patients and those of reproductive potential should be advised of this potential risk.
What risks are associated with major birth defects and miscarriage during pregnancy?
The background risks of major birth defects and miscarriage for the indicated populations are unknown. However, all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages are 2-4% and 15-20%, respectively.
What should I do if I become pregnant while taking RINVOQ?
Patients who become pregnant while taking RINVOQ should contact their healthcare provider immediately. Pregnancies should be reported to AbbVie Inc.'s Adverse Event reporting line at 1-888-633-9110 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the risks associated with RINVOQ and lactation?
There are no data on the presence of upadacitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with RINVOQ, and for 6 days (approximately 10 half-lives) after the last dose.
What precautions should females of reproductive potential take before using RINVOQ?
Females of reproductive potential should have their pregnancy status verified before starting treatment with RINVOQ. Female patients of reproductive potential should use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose, based on animal studies that suggest upadacitinib may cause embryo-fetal harm when administered to pregnant women.
Has the safety and effectiveness of RINVOQ been established for pediatric patients?
The safety and effectiveness of RINVOQ have not been established in pediatric patients with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. However, RINVOQ has been established as safe and effective in pediatric patients 12 years of age and older weighing at least 40 kg with atopic dermatitis. Clinical studies have shown that efficacy was consistent between the pediatric patients and adults. The adverse reaction profile in the pediatric patients was similar to the adults.
Is RINVOQ safe for use in geriatric patients?
No significant differences in effectiveness were observed between geriatric and younger patients with rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. However, geriatric patients had a higher rate of overall adverse events, including serious infections, in some cases. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis to determine whether they respond differently from younger adult patients.