The main contents, usage, dosage and precautions of the official instructions of Tofacitinib (Shangjie)

Tofacitinib is an oral small molecule Janus kinase (JAK) inhibitor, which is a targeted immunomodulatory drug and was first developed by Pfizer. According to the official instructions, tofacitinib intervenes in the inflammatory response mediated by multiple cytokines by inhibiting the JAK1 and JAK3 signaling pathways, thereby reducing tissue damage caused by abnormal activation of the immune system. Currently, the drug has been widely used for the long-term control treatment of a variety of autoimmune diseases.

From the perspective of indications, tofacitinib is mainly used for patients with moderately to severely active rheumatoid arthritis, and is especially suitable for people who have poor efficacy or are intolerant to traditional disease-improving anti-rheumatic drugs such as methotrexate. In addition, the official instructions also indicate that it can be used for the induction and maintenance treatment of active psoriatic arthritis and moderately to severely active ulcerative colitis. Among these diseases, tofacitinib can significantly improve joint swelling and pain, intestinal inflammation symptoms and quality of life indicators.

In terms of usage and dosage, tofacitinib needs to be dosed strictly according to the indications. The usual recommended dose for rheumatoid arthritis and psoriatic arthritis is 5 mg twice daily, alone or in combination with nonbiologic disease-modifying antirheumatic drugs. The induction treatment phase of ulcerative colitis usually uses a higher dose, that is, 10 mg twice a day for about 8 weeks. Then when entering the maintenance treatment phase, the dose needs to be reduced to 5 mg twice a day. For patients with moderately or severely impaired renal or hepatic function, the instructions recommend further dose reductions.

The official instructions specifically emphasize the medication precautions for tofacitinib. Due to its suppressive effect on the immune system, patients are at significantly increased risk of infections during treatment, including upper respiratory tract infections, herpes zoster, pneumonia, and opportunistic infections. Therefore, tuberculosis, hepatitis B and other potential infections should be screened before starting medication. If symptoms such as persistent fever, cough or rash occur during medication, timely medical evaluation should be sought.

In terms of safety monitoring, the instructions require regular blood routine, liver function and blood lipid level tests. Tofacitinib may cause changes such as a decrease in white blood cells or neutrophils, an increase in transaminases, and an increase in blood lipid levels. In most cases, these changes are reversible, but if the indicators are abnormally obvious, the medication needs to be suspended or the dose adjusted before evaluating whether to continue treatment. For patients with risk factors for blood clots, doctors are often more cautious in assessing the benefits and risks of medication.

There are also clear restrictions on the use of tofacitinib in special populations. The official instructions do not recommend the use of this drug by pregnant and breastfeeding women because the potential risks to the fetus and infant are not fully understood. Since elderly patients are at higher risk of infection and cardiovascular events, they should start with a low dose and strengthen follow-up. Children and adolescent patients are limited to approved indications and dosage forms, and must be used under the guidance of a specialist.

Overall, the official instructions for tofacitinib cover many aspects such as indication selection, standardized dosage, risk monitoring and adverse reaction management, emphasizing the importance of individualized medication. During long-term use, patients should not only pay attention to its significant efficacy in controlling inflammation and improving symptoms, but also strictly follow the follow-up and testing requirements, and rationally adjust the treatment plan under the guidance of a doctor, so as to maximize the therapeutic value of tofacitinib and ensure the safety of medication.

Keyword tags: tofacitinib, official instructions, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, usage and dosage, JAK inhibitors, infection risk, liver function monitoring.

参考资料：https://medlineplus.gov/druginfo/meds/a613025.html