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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 reactions are: Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis: Reported during the first 3 months in rheumatoid arthritis placebo-controlled clinical trials and occurring in ≥2% of patients treated with XELJANZ monotherapy or in combination with DMARDs: upper respiratory tract infection, nasopharyngitis, diarrhea, and headache. Ulcerative Colitis: Reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster. Polyarticular Course Juvenile Idiopathic Arthritis: Consistent with common adverse reactions reported in adult rheumatoid arthritis patients.. 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 XELJANZ/XELJANZ XR/XELJANZ Oral Solution?
Yes, there is a pregnancy exposure registry for XELJANZ/XELJANZ XR/XELJANZ Oral Solution that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Patients should be encouraged to enroll in the registry if they become pregnant. To enroll or obtain information from the registry, patients can call the toll-free number 1-877-311-8972.
What is the risk associated with XELJANZ/XELJANZ XR/XELJANZ Oral Solution use during pregnancy?
Available data with XELJANZ/XELJANZ XR/XELJANZ Oral Solution use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal reproduction studies, fetocidal and teratogenic effects were noted when pregnant rats and rabbits received tofacitinib during the period of organogenesis at exposures multiples of 73-times and 6.3-times the maximum recommended dose of 10 mg twice daily, respectively.
Are there any clinical considerations related to XELJANZ/XELJANZ XR/XELJANZ Oral Solution use during pregnancy?
Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis or ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
What is the estimated background risk of major birth defects and miscarriage for the indicated populations?
The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risks in the U.S. general population of major birth defects and miscarriages are 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively.
Is it safe to breastfeed while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution?
No data is available on the presence of tofacitinib in human milk, the effects on a breastfed infant, or the effects on milk production. Tofacitinib is present in the milk of lactating rats. Given the serious adverse reactions seen in patients treated with XELJANZ/XELJANZ XR/XELJANZ Oral Solution, such as increased risk of serious infections, patients should be advised that breastfeeding is not recommended during treatment and for at least 18 hours after the last dose of XELJANZ/XELJANZ Oral Solution or 36 hours after the last dose of XELJANZ XR (approximately 6 elimination half-lives).
Does XELJANZ/XELJANZ XR/XELJANZ Oral Solution affect female fertility?
Based on findings in rats, treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution may result in reduced fertility in females of reproductive potential. It is not known if this effect is reversible.
Is XELJANZ/XELJANZ Oral Solution safe for use in pediatric patients?
The safety and effectiveness of XELJANZ/XELJANZ Oral Solution have been established in patients 2 years to 17 years of age for the treatment of active pcJIA. The safety and efficacy of XELJANZ/XELJANZ Oral Solution in pediatric patients for indications other than pcJIA have not been established. The safety and effectiveness of XELJANZ XR in pediatric patients have not been established.
What is the frequency of serious infection among XELJANZ-treated subjects who are 65 years and older?
The frequency of serious infection among XELJANZ-treated subjects who are 65 years and older was higher than among those under the age of 65.
How should caution be used when treating the elderly with XELJANZ?
As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly with XELJANZ.
Should caution be used when treating patients with diabetes with XELJANZ?
Yes, caution should be used when treating patients with diabetes with XELJANZ as there is a higher incidence of infection in the diabetic population in general.
Is dosage adjustment required in XELJANZ-treated patients with mild renal impairment?
No, dosage adjustment is not required in XELJANZ-treated patients with mild renal impairment.
Is XELJANZ recommended for use in patients with severe hepatic impairment?
No, XELJANZ is not recommended for use in patients with severe hepatic impairment as it has not been studied in this population.
Is dosage adjustment required in XELJANZ-treated patients with mild hepatic impairment?
No, dosage adjustment is not required in XELJANZ-treated patients with mild hepatic impairment.
Has the safety and efficacy of XELJANZ been studied in patients with positive hepatitis B or C virus serology?
No, the safety and efficacy of XELJANZ have not been studied in patients with positive hepatitis B or C virus serology.