Xeljanz(tofacitinib)
Xeljanz 1 MG/mL Oral Solution
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Xeljanz FAQs
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.
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