About Tofacitinib Citrate API
Therapeutic CategoryImmunosuppressant
API Technology
Synthetic
Dose Form
Oral Solid/Tablets
Dr Reddy's Development Status
Available (Commercial)
Available Regulatory Filing
USDMF, Brazil DMF
作用机制
Tofacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. JAK enzymes transmit cytokine signaling through pairing of JAKs (e.g., JAK1/JAK3, JAK1/JAK2, JAK1/TyK2, JAK2/JAK2). Tofacitinib inhibited the in vitro activities of JAK1/JAK2, JAK1/JAK3, and JAK2/JAK2 combinations with IC50 of 406, 56, and 1377 nM, respectively. However, the relevance of specific JAK combinations to therapeutic effectiveness is not known.
适应症
XELJANZ/XELJANZ XR is a Janus kinase (JAK) inhibitor.
1) Rheumatoid Arthritis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
○ Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
2) Psoriatic Arthritis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
○ Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
3) Ulcerative Colitis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
○ Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Dr. Reddy's的专长
Dr. Reddy's总部位于印度海得拉巴,是全球领先的活性药物成分(API)供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。
Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API(如类固醇,多肽,复杂长链分子和高效API(HPAPI /肿瘤药物))方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准,从而为这一专业知识提供补充。 Dr. Reddy's博士 柠檬酸托法替尼(晶型A) API是研发,知识产权和监管方面广泛专业知识的结果。
帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量,安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化,从而避免短缺并满足需求的突然激增。
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FAQs
Tofacitinib Citrate is used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Monitor for infections, avoid use in patients with active infections, and be cautious in patients with a history of malignancy.
Reduces inflammation, improves joint function, and controls symptoms of autoimmune diseases