Tofacitinib Citrate Powder CAS 540737-29-9 can be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). The medicine should not be used in combination with biologic DMARDs or strong immunosuppressants, such as azathioprine and cyclosporine.
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precautions for product use
Serious, occasionally fatal, infections caused by bacteria, mycobacteria, invasive fungi, viruses, or other opportunistic pathogens have been reported in patients with rheumatoid arthritis treated with tofacitinib. The most common serious infections reported with tofacitinib include pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Among opportunistic infections, tuberculosis and other mycobacterial infections, cryptococcosis, histoplasmosis, esophageal candidiasis, pneumocystis carinii, polycystic ovary syndrome, cytomegalovirus, BK virus, and listeriosis have been reported with tofacitinib. Some patients present with disseminated infection rather than localized disease and are often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Other serious infections not reported in clinical studies (e.g., coccidioidomycosis) may also occur. Avoid initiating tofacitinib in patients with serious active infections, including localized infections.
All patients should be closely monitored for signs and symptoms of infection during and after treatment with tofacitinib. Tofacitinib should be interrupted if a patient develops a serious infection, opportunistic infection, or sepsis. Patients who develop a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for immunocompromised patients; appropriate antimicrobial therapy should be initiated and patients monitored closely. Caution is also recommended in patients with a history of chronic lung disease or interstitial lung disease, as these patients are more susceptible to developing infections.
Patients should be evaluated and tested for latent or active infection according to applicable guidelines before initiating tofacitinib and during dosing.
Patients should be evaluated and tested for latent or active infection before initiating tofacitinib.
Anti-TB treatment should also be considered before initiating tofacitinib in patients with a history of latent or active TB, in whom an adequate course of treatment cannot be confirmed, and in whom risk factors for TB infection remain despite a negative latent TB test result. Consultation with a TB specialist is recommended to help decide whether initiation of anti-TB treatment is appropriate for an individual patient.
Patients should be closely monitored for signs and symptoms of TB, including those who tested negative for latent TB infection prior to initiating treatment.
Patients with latent tuberculosis should be treated with standard antimycobacterial therapy prior to tofacitinib administration.
Viral Reactivation
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), has been observed in clinical studies with tofacitinib. The effect of tofacitinib on reactivation of chronic viral hepatitis has not been established. Patients who screened positive for hepatitis B or C were excluded from clinical trials. Viral hepatitis screening should be performed according to clinical guidelines prior to initiating tofacitinib treatment. The risk of herpes zoster is increased in patients treated with tofacitinib and appears to be higher in Japanese patients treated with tofacitinib.
product News
Tofacitinib citrate in combination with methotrexate is used for the treatment of active rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitors.
In 2022, The Cumulative Sales Of All Dosage Forms Of Tofacitinib Were Approximately US$3.5 Billion, Of Which The Extended-Release Tablets Were Approximately US$2.5 Billion.
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