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About Lenalidomide (Form A) API

Product
  • Therapeutic Category抗癌/抗肿瘤

  • API Technology

    High Potent

  • Dose Form

    Oral Solid/Capsules

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    Russia DMF, Brazil DMF, USDMF, EUDMF, Canada DMF, China DMF, Japan DMF

作用机制

Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. 

Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including MM. Immunomodulatory properties of lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. In MM cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.

适应症

REVLIMID is a thalidomide analogue indicated for the treatment of patients with:

  • Multiple myeloma (MM), in combination with dexamethasone
  • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT)
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities
  • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

Limitations of Use:

  • REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials

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 来那度胺(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。

RFQ Form

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FAQs

What are the precautions needs to be taken for Lenalidomide?
  • Check with your doctor right away if you have anxiety, chest pain, fainting, a fast heartbeat, trouble breathing, or pain, redness, or swelling in the arm or leg.

What is main purpose of using the Lenalidomide ?
  • Lenalidomide is used to treat anemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS).

What is the BCS classification for Lenalidomide API ?
  • Lenalidomide belongs to class I and III of BCS classification.

What are the DMFs available for Lenalidomide API?
  • The DMFs are available in the US, Brazil, Europe, Canada and Russia.

How do you store Lenalidomide API?
  • Lenalidomide should be stored at 20 °C - 25 °C (68 °F - 77 °F).

What is the dosage form available for Lenalidomide?
  • Lenalidomide is available in capsule form with 2.5, 5, 10, 15, 20 , 25 mg strengths.

Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.