Following results from an ongoing clinical study, an EU safety review of tofacitinib (Xeljanz▼) in patients with rheumatoid arthritis (RA) aged ≥50 years with ≥1 CV risk factor has been started and new contraindications introduced. Findings show an increased risk for pulmonary embolism (PE) and overall mortality, compared with a TNF inhibitor, when patients were treated with bid 10 mg of tofacitinib (double the recommended dose for RA of 5 mg bid).
A dose of 10 mg bid is recommended for initial treatment (for up to 16 weeks) in ulcerative colitis, until the review has concluded, patients with ulcerative colitis at high risk for PE should not initiate treatment with tofacitinib. Patients already on treatment with 10 mg bid dose of tofacitinib who are at high risk for PE should be switched to alternative treatments.
While an in-depth review of these risks is ongoing,10 mg bid dose of tofacitinib must not be prescribed in patients with one or more of the following risk factors for PE:
- Use of combined hormonal contraceptives or hormone replacement therapy,
- Heart failure,
- Previous venous thromboembolism, either DVT or PE,
- Inherited coagulation disorder,
- Patients undergoing major surgery.
Additionally, other risk factors for PE to be considered when prescribing tofacitinib 10 mg bid are age, obesity (BMI >30 kg/m2), smoking, and immobilisation.
Patients receiving tofacitinib, irrespective of indication, should be monitored for the signs and symptoms of PE and seek immediate medical attention if they experience them.