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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
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.
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)
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.
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.