Precautions before starting tofacitinib in persons with rheumatoid arthritis

Table 1 Precautions before tofacitinib starting in rheumatoid arthritis

Serial No.	Precautions[4,5]	Reasons
1	Persons with moderate-severe renal impairment or moderate hepatic impairment are recommended 5 mg once daily	In RA, multiple NSAIDS (non-steroidal anti-inflammatory drugs)/DMARDs themselves can cause liver or kidney injury. Furthermore, tofacitinib is hepatotoxic. It is metabolized in the liver largely through the cytochrome P450 3A4 pathway (cytochrome P 3A4)
2	Screening of infections like latent Tuberculosis, Hepatitis, cytomegalovirus, Epstein Barr Virus (EBV), BK virus	Reactivation of TB, and hepatitis can occur
3	Screening to check immunosuppressive conditions like human immunodeficiency virus (HIV) infection, Diabetes etc.	Reactivation of latent infections can occur
4	Blood investigations to be done: Routine complete hemogram, Liver function and kidney function tests, lipid profile and C-reactive protein	To rule out latent infections, liver, kidney status
	Repeat complete blood count 1 to 2 mo following initiation, and every 12 wk after that
	Lipid profile should be monitored 4 to 8 wk after initiation of treatment
5	Mantoux test, Chest X-ray and at times Interferon gamma release assay may be required.	To rule out latent TB
6	Do not start tofacitinib: If haemoglobin (Hb) levels are below 9 g/dL, absolute lymphocyte count is below 500 cells/mm3, and absolute neutrophil count below 1000 cells/mm3	It may aggravate the infection
	In presence of any infection.
7	In renal transplant recipients	Renal transplant subjects receiving tofacitinib alongside immunosuppressive therapy are at increased risk of EBV associated post-transplant lymphoproliferative disorder
8	Reproductive age group: Women of reproductive potential should be counselled on the risk of possible infertility from tofacitinib	Due to potential side effects of tofacitinib
	Pregnancy: Treatment during pregnancy may increase the potential risk to the fetus
	Lactation: Discontinue breastfeeding as tofacitinib may be excreted in breast milk
10	Screening for malignancy and cardiovascular diseases	FDA (The United States Food and Drug Administration) released an updated boxed warning in September 2021 regarding the increased risk of death, major adverse cardiovascular events, malignancies and thrombosis with Janus kinase inhibitors compared with tumor necrosis factor-alpha inhibitors[4,5]