Tofacitinib

Rheumatoid and Psoriatic Arthritis: Most common side effects of tofacitinib include upper respiratory tract infection, nasopharyngitis, diarrhea, and headache.

Ulcerative Colitis: Most common adverse reactions include nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.

• Use of this medication in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
• Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Xeljanz 5 mg.
• Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infections.
• Risk of infection could be greater with an increasing degree of the lymphopenia and consideration must be given to lymphocyte counts when assessing individual patient risk of infection. Interruption and monitoring criteria for the lymphopenia must be recommended.
• Consultation with a healthcare professional or physician with the expertise in the treatment of tuberculosis must be recommended in order to aid in the decision about whether starting anti-tuberculosis therapy is appropriate for an individual patient.
• Patients should be closely  and precisely monitored for the development of symptoms of tuberculosis, including patients who found negative for the latent tuberculosis infection before initiating therapy.
• Non-melanoma skin cancers (NMSCs) have been reported in patients treated with XELJANZ 5MG. Skin examination should be recommended periodically for patients who are at increased risk for skin cancer.
• Avoid Xeljanz Rheumatoid Arthritis drug in patients that may be at increased risk of thrombosis.
• Tofacitinib 5 mg must be used with a lot of caution in patients who are at increased risk for gastrointestinal perforation.
• Patients presenting with the new onset abdominal signs should be observed promptly for early identification of the gastrointestinal perforation.
• Hypersensitivity has been observed in patients receiving XELJANZ 5MG TABLET. In case if a serious hypersensitivity reaction appears, promptly discontinue or interrupt this drug while evaluating the potential causes of reactions.
• Patients with psoriatic arthritis treatment should be monitored for lymphocyte counts at baseline and every 3 months thereafter. Recommended modifications should be based on the lymphocyte counts.
• Routine monitoring of liver tests should be recommended and prompt investigation of the causes of the liver enzyme elevations is also recommended in order to identify the potential cases of drug-induced liver injury.

Care should be exercised in the handling of AFANAT. AFANAT tablets should not be opened or crushed. Store permitted between 15-30°C (59-86°F).  Keep this medication in the original container and keep the container tightly closed also away from the moisture and light.

• Tofacitinib exposure is enhanced when co-administered with potent inhibitors of CYP3A4 (e.g., ketoconazole) or when the use of one or more concomitant drugs results in moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole).
• Tofacitinib exposure is reduced when co-administered with potent CYP3A4 inducers (e.g., rifampicin). Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the PK (pharmacokinetics) of tofacitinib.
• Co-administration of ketoconazole, a strong CYP3A4 inhibitor, with a single dose of tofacitinib enhanced the AUC and Cmax of tofacitinib by 103 & 16 percent, respectively.
• Co-administration of fluconazole, a moderate inhibitor of CYP3A4 and a strong inhibitor of CYP2C19, enhanced the AUC and Cmax of tofacitinib by 79 and 27 percent, respectively.
• Co-administration of cyclosporin, a moderate inhibitor of CYP3A4, enhanced the AUC of tofacitinib by 73 percent and reduced Cmax of tofacitinib by 17 percent. Combined administration of multiple-dose tofacitinib with this potent immunosuppressive has not been assessed in patients with RA or PsA and is contraindicated.
• Co-administration of tacrolimus, a mild inhibitor of CYP3A4, reduced the AUC of tofacitinib by 21 percent and reduced the Cmax of tofacitinib by 9 percent. The combined use of multiple-dose tofacitinib with this potent immunosuppressive has not been assessed in patients with RA or PsA and is not recommended.
• Co-administration of rifampicin, a strong CYP3A4 inducer, reduced the AUC and Cmax of tofacitinib by 84 & 74 percent, respectively.