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Rheumatoid arthritis (RA) Rheumatoid arthritis (RA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Psoriatic arthritis (PsA) Psoriatic arthritis (PsA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Ulcerative colitis (UC) Ulcerative colitis (UC) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions
Special Populations and ContraindicationsElderly:1
  • No dose adjustment is required in patients aged 65 years and older. There are limited data in patients aged 75 years and older. A higher incidence and severity of adverse events in the elderly (>65 yrs) is an important potential risk.
Hepatic impairment1 Renal impairment1

XELJANZ® (tofacitinib) contains lactose. Patients with hereditary conditions of galactose intolerance e. g. galactosaemia, Lapp lactase deficiency or glucose-galactose malabsorption should not take XELJANZ® (tofacitinib). XELJANZ® (tofacitinib) may have an effect on the glycaemic control of patients with diabetes mellitus.1

Fertility, pregnancy and lactation1Women of childbearing potential/contraception in females1
  • Women of childbearing potential should be advised to use effective contraception during treatment with XELJANZ® (tofacitinib) and for at least 4 weeks after the last dose.
Pregnancy1
  • There are no adequate and well-controlled studies on the use of XELJANZ® (tofacitinib) in pregnant women. XELJANZ® (tofacitinib) has been shown to be teratogenic in rats and rabbits, and to affect parturition and peri/postnatal development. As a precautionary measure, the use of XELJANZ® (tofacitinib) during pregnancy is contraindicated.
Breastfeeding1
  • It is not known whether XELJANZ® (tofacitinib) is secreted in human milk. A risk to the breastfed child cannot be excluded. XELJANZ® (tofacitinib) was secreted in the milk of lactating rats. As a precautionary measure, the use of XELJANZ® (tofacitinib) during breastfeeding is contraindicated.
Fertility1
  • Formal studies of the potential effect on human fertility have not been conducted. XELJANZ® (tofacitinib) impaired female fertility but not male fertility in rats.
ReferencesPfizer Laboratories (Pty) Ltd. XELJANZ® 5mg and 10mg film-coated tablets. Final Approved Package Insert - 27 October 2020.
PP-XEL-ZAF-0083

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