Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens have been reported in patients receiving tofacitinib.
Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during the administration of tofacitinib.
Viral reactivation, including cases of herpes virus reactivation (e.g. herpes zoster), was observed in clinical studies with tofacitinib.
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, 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.
Events of GI have been reported in clinical studies with tofacitinib, although the role of JAKis in these events is not known.
Reactions such as angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving tofacitinib.
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.
Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo.
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.
Treatment with tofacitinib was associated with dose-dependent increases in lipid parameters including total cholesterol, LDL cholesterol and HDL cholesterol.
Avoid the use of live vaccines concurrently with tofacitinib.
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.
Efficacy proven by different studies
These pages are not intended for patients or for members of the general public. The web pages contain promotional content.
If you select 'No', you will be redirected to Pfizer.co.in
For more details on, Who is a Registered Medical Practitioner*, please visit
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 13th September 2019.
Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.
PP-UNP-IND-0012 July 2022