Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.
The following information applies to XELJANZ use in Rheumatoid Arthritis, Psoriatic Arthritis and Ulcerative Colitis. For additional information relating to prescribing, please refer to the 'Practical considerations for use' pages: Rheumatoid Arthritis (RA) / Psoriatic Arthritis (PsA) / Ulcerative Colitis (UC) or the XELJANZ SmPC.
XELJANZ should only be used in patients over 65 years of age, in patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors, if no suitable treatment alternatives are available.
System organ class |
Common (>1/100 to <1/10) |
---|---|
Infections and infestations |
Pneumonia, influenza, herpes zoster, urinary tract infection, sinusitis, bronchitis, nasopharyngitis, pharyngitis |
Blood and lymphatic system disorders |
Anaemia |
Nervous system disorders |
Headache |
Vascular disorders |
Hypertension |
Respiratory, thoracic and mediastinal disorders |
Cough |
Gastrointestinal disorders |
Abdominal pain, vomiting, diarrhoea, nausea, gastritis, dyspepsia |
Skin and subcutaneous tissue disorders |
Rash |
Musculoskeletal and connective tissue disorders |
Arthralgia |
General disorders and administration site conditions |
Oedema peripheral, pyrexia, fatigue |
Investigations |
Blood creatine phosphokinase increased |
System organ class |
Common (>1/100 to <1/10) |
---|---|
Infections and infestations |
Pneumonia, influenza, herpes zoster, urinary tract infection, sinusitis, bronchitis, nasopharyngitis, pharyngitis |
Blood and lymphatic system disorders |
Anaemia |
Nervous system disorders |
Headache |
Vascular disorders |
Hypertension |
Respiratory, thoracic and mediastinal disorders |
Cough |
Gastrointestinal disorders |
Abdominal pain, vomiting, diarrhoea, nausea, gastritis, dyspepsia |
Skin and subcutaneous tissue disorders |
Rash |
Musculoskeletal and connective tissue disorders |
Arthralgia |
General disorders and administration site conditions |
Oedema peripheral, pyrexia, fatigue |
Investigations |
Blood creatine phosphokinase increased |
The most commonly reported adverse reactions seen in rheumatoid arthritis (RA) patients during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension.
Overall, the safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in patients with RA treated with XELJANZ.
In ulcerative colitis (UC), the most commonly reported adverse reactions in patients receiving XELJANZ 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.
The most common serious adverse reactions in RA clinical trials were serious infections.1
Overall, the safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in patients with RA treated with XELJANZ.1
In the induction and maintenance studies, across XELJANZ and placebo treatment groups, the most common categories of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC.1
Viral reactivation and cases of herpes virus reactivation (e.g. herpes zoster) were observed in clinical studies with XELJANZ. In patients treated with XELJANZ, the incidence of herpes zoster appears to be increased in1:
In the RA clinical trials, 703 of 6,194 patients developed herpes zoster (92% involved one dermatome):
XELJANZ treatment in patients with UC is associated with a dose dependent risk of herpes zoster:
In the OCTAVE clinical trial programme, most herpes zoster events were limited to one or two adjacent dermatomes.3,4
Most cases of herpes zoster in the OCTAVE programme (70%) did not require permanent or temporary discontinuation of XELJANZ or dose reduction.3,4
In a large, randomised post-authorisation safety surveillance study of rheumatoid arthritis patients who were 50 years of age and older and had at least one cardiovascular (CV) risk factor, VTE was observed at an increased and dose-dependent incidence in patients treated with XELJANZ compared to TNF inhibitors. The majority of these events were serious and some resulted in death. The incidence rates (95% CI) for PE for XELJANZ 10 mg twice daily, XELJANZ 5 mg twice daily, and TNF inhibitors were 0.54 (0.32‑0.87), 0.27 (0.12‑0.52), and 0.09 (0.02‑0.26) patients with events per 100 patient-years, respectively. Compared with TNF inhibitors, the hazard ratio (HR) for PE was 5.96 (1.75‑20.33) and 2.99 (0.81‑11.06) for XELJANZ 10 mg twice daily and XELJANZ 5 mg twice daily, respectively (see section 5.1 of XELJANZ Summary of Product Characteristics).1
In a subgroup analysis in patients with VTE risk factors in the above-mentioned study, the risk for PE was further increased1. Compared with TNF inhibitors, the HR for PE was 9.14 (2.11‑39.56) for XELJANZ 10 mg twice daily and 3.92 (0.83‑18.48) for XELJANZ 5 mg twice daily.1
In the ongoing UC extension trial, cases of PE and DVT have been observed in patients using XELJANZ 10 mg twice daily and with underlying VTE risk factor(s).1
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BID=twice daily; TNFi=tumour necrosis factor inhibitor; UC=ulcerative colitis; AEs=adverse events.
XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.
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