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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.
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)
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 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.