Practical Consideration¹

Serious infections

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens have been reported in patients receiving tofacitinib. 

Tuberculosis

Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during the administration of tofacitinib.

Viral reactivation

Viral reactivation, including cases of herpes virus reactivation (e.g. herpes zoster), was observed in clinical studies with tofacitinib.

Mortality

Patients with RA aged 50 years and older with at least 1 CV risk factor who were treated with Tofacitinib 5 mg BID or Tofacitinib 10 mg BID had a higher rate of all-cause mortality.

Malignancy and lymphoproliferative disorder

Consider the risks and benefits of tofacitinib treatment prior to initiating the therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing tofacitinib in patients who develop a malignancy. NMSCs have been reported in patients treated with tofacitinib. Periodic skin examination is recommended for patients who are at an increased risk of skin cancer.

Thrombosis

Thrombosis, including PE, deep venous thrombosis and arterial thrombosis, has occurred in patients treated with tofacitinib and other JAKis that are used to treat inflammatory conditions.

GI perforations

Events of GI have been reported in clinical studies with tofacitinib, although the role of JAKis in these events is not known.

Hypersensitivity

Reactions such as angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving tofacitinib.

Lymphocyte abnormalities

Treatment with tofacitinib was associated with initial lymphocytosis at 1 month of exposure followed by a gradual decrease of approximately 10% in the mean absolute lymphocyte counts below the baseline during the 12 months of therapy. Lymphocyte counts less than 500 cells/mm³ were associated with an increased incidence of treated and serious infections.

Neutropenia

Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2000 cells/mm³) compared to placebo.

Anaemia

Avoid initiation of tofacitinib treatment in patients with a low haemoglobin level (i.e. less than 9 g/dL).

Liver enzyme elevations

Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation compared to treatment with placebo.

Lipid elevations

Treatment with tofacitinib was associated with dose-dependent increases in lipid parameters including total cholesterol, LDL cholesterol and HDL cholesterol.

Vaccinations

Avoid the use of live vaccines concurrently with tofacitinib.

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CV, cardiovascular; GI, gastrointestinal; HDL, high-density lipoprotein; JAKi, Janus kinase inhibitor; LDL, low-density lipoprotein; NMSC, non-melanoma skin cancer; PE, pulmonary embolism; RA, rheumatoid arthritis; UC, ulcerative colitis.