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In the induction and maintenance studies across all treatment groups, the most common types of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC2
<5% of patients in any of the XELJANZ or placebo treatment groups in the induction and maintenance studies discontinued because of adverse events (excluding patients with worsening UC)2
Pooled, post hoc analysis of studies from the UC clinical trial program are subject to certain limitations. First, unlike ORAL Surveillance, the patient population is not limited to a high-risk population but includes all enrolled patients. Second, endpoints of interest (such as MACE and malignancy for ORAL Surveillance) were not specifically defined and adjudicated. Additionally, ORAL Surveillance was a long-term safety study (vs. shorter term and designed to test efficacy). Resultant incidence rates in ORAL Surveillance differed from rates seen from pooled study data, suggesting the pooled data may be obscuring information about predictors of events given adverse rates may differ from one patient population to another and may change over time
OLE studies may provide useful data, however, conduct of OLE studies where both treatment and dose are known to both investigator and patient is subject to certain biases and limitations
Biases include, but are not limited to, patient selection (patient willingness or ineligibility to enroll, which may be due to a prior serious AE), prior treatment, volunteer, observer, initial dose or study drug, investigator/patient expectation and study duration. Limitations include, but are not limited to, AE frequencies and incidence rates subject to change over time due to patient entry/exit, dose changes influenced by both investigator and patient, dose restrictions in certain countries, the number of patients and exposure for a specific safety event possibly differing depending on the timing of censored events, and the number of observed patients with longer exposure times becoming lower
In the long-term extension study, malignancies (including solid cancers, lymphomas, and NMSC) were observed more often in patients treated with XELJANZ 10 mg BID4
XELJANZ should not be used in patients with severe hepatic impairment3
XELJANZ should not be used during pregnancy or by women attempting to become pregnant. Women of reproductive potential should be advised to use effective contraception both during treatment with XELJANZ and after discontinuing therapy.3
The extended pharmacodynamic effects of XELJANZ should be considered when determining how long to continue effective contraception after discontinuing XELJANZ therapy.3
In a large randomised PASS, increased incidence of thrombosis (including pulmonary embolism [PE], deep vein thrombosis [DVT] and arterial thrombosis) and of all-cause mortality (including sudden cardiovascular [CV] death) have been observed in patients with RA who were 50 years of age or older, particularly in patients who were obese (BMI ≥30), with at least one additional CV risk factor treated with XELJANZ 10 mg BID* compared to XELJANZ 5 mg BID or TNF blockers.Assess patients for thrombotic risk factors before starting treatment and periodically during treatment.
Avoid XELJANZ in elderly patients and in patients who may be at increased risk of thrombosis or in whom other risk factors are identified.
Discontinue XELJANZ and promptly evaluate patients with signs and symptoms of thrombosis, regardless of dose or indication. For the treatment of UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintaintherapeutic response.
Advise your patients to seek medical attention immediately if these signs and symptoms occur.*XELJANZ 10 mg BID is not approved for the treatment of RA in Australia
In a large randomised PASS in RA patients who were 50 years or older with at least one additional cardiovascular risk factor, an increase in non-fatal myocardial infarctions was observed in patients treated with XELJANZ compared to TNF inhibitor.
MACE (including events of myocardial infarction) were more common in patients who were older and patients who were current or past smokers 1,3
Caution should be used in treating elderly patients, patients who are current or past smokers, and patients with other malignancy risk factors. Consider the risks and benefits of continuing XELJANZ treatment in patients who develop a malignancy.3
In a Phase IIIb/IV randomized, open-label, non-inferiority, postauthorization safety, endpoint-driven study among patients 50 years of age or older with moderate to severe RA, with at least one additional CV risk factor and taking MTX without adequate control of symptoms:
The coprimary endpoints were adjudicated MACEa and adjudicated malignancies (excluding NMSC)
For adjudicated MACE and adjudicated malignancies (excluding NMSC), the prespecified noninferiority criterion was not met for the primary comparison of the combined tofacitinib doses to TNFib
See pivotal data in active UC
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▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
XELJANZ should only be used if no suitable treatment alternatives are available in patients:
See PI for details, Section 4.4 Special Warnings and Precautions for Use: Mortality; Major Adverse Cardiovascular Events (including Myocardial Infarction); Thrombosis; Malignancy and Lymphoproliferative Disorder (excluding Nonmelanoma Skin Cancer [NMSC]); Skin Cancer and Use in the Elderly.
Before prescribing, please review full Product Information available here.
PBS Information: Authority required for the treatment of adults with severe active rheumatoid arthritis and for adults with severe psoriatic arthritis and for adults with moderate-to-severe ulcerative colitis. Refer to the PBS Schedule for full authority information. This product is not listed on the PBS for juvenile idiopathic arthritis, juvenile psoriatic arthritis, or ankylosing spondylitis.
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