Common side effects include diarrhea, itchiness, joint pain, fever, headache, and trouble sleeping.[6] Severe side effects include
low blood platelets,
low white blood cells, and
blood clots.[6] Use during pregnancy may harm the fetus.[6] The dose may need to be adjusted in people with
kidney problems.[6] It has a chemical structure similar to
thalidomide but has a different mechanism of action.[7][6] How it works is not entirely clear as of 2019.[6]
Lenalidomide is effective at inducing a complete or "very good partial" response and improves
progression-free survival. Adverse events more common in people receiving lenalidomide for myeloma include
neutropenia,
deep vein thrombosis,
infections, and an increased risk of other
hematological malignancies.[13] The risk of second primary hematological malignancies does not outweigh the benefit of using lenalidomide in relapsed or refractory multiple myeloma.[14] It may be more difficult to mobilize
stem cells for
autograft in people who have received lenalidomide.[10]
In 2006, lenalidomide received US
Food and Drug Administration (FDA) approval for use in combination with
dexamethasone in people with multiple myeloma who have received at least one prior therapy.[15] In 2017, the FDA approved lenalidomide as standalone
maintenance therapy (without dexamethasone) for people with multiple myeloma following autologous stem cell transplant.[16]
In 2009, The
National Institute for Health and Clinical Excellence issued a final appraisal determination approving lenalidomide in combination with dexamethasone as an option to treat people with multiple myeloma who have received two or more prior therapies in England and Wales.[17]
The use of lenalidomide combined with other drugs was evaluated. It was seen that the drug combinations of lenalidomide plus
dexamethasone and continuous
bortezomib plus lenalidomide plus dexamethasone probably result in an increase of the overall survival.[18]
Myelodysplastic syndromes
Lenalidomide was approved by the FDA in December 2005, for people with low- or intermediate-1-risk
myelodysplastic syndromes who have
chromosome 5q deletion syndrome (5q- syndrome) with or without additional
cytogenetic abnormalities.[19][20][21] It was approved on 17 June 2013 by the
European Medicines Agency for use in patients with low- or intermediate-1-risk myelodysplastic syndromes who have 5q- deletion syndrome but no other cytogenetic abnormalities and are dependent on
red blood celltransfusions, for whom other treatment options have been found to be insufficient or inadequate.[22]
Mantle cell lymphoma
Lenalidomide is approved by FDA as a
specialty drug requiring a
specialty pharmacy distribution for
mantle cell lymphoma in people whose disease has relapsed or progressed after at least two prior therapies, one of which must have included the medicine
bortezomib.[7]
AL amyloidosis
Although not specifically approved by the FDA for use in treating
AL amyloidosis, lenalidomide is sometimes used in the treatment of that condition, often in combination with
dexamethasone.[23]
Lenalidomide is related to
thalidomide, which is known to be
teratogenic. Tests in monkeys suggest that lenalidomide is likewise teratogenic.[25] It cannot be prescribed for women who are pregnant or who may become pregnant during therapy.[1] For this reason, the drug is only available in the United States through a
restricted distribution system in conjunction with a
risk evaluation and mitigation strategy. Females who may become pregnant must use at least two forms of reliable
contraception during treatment and for at least four weeks after discontinuing treatment with lenalidomide.[7][26]
Venous thromboembolism
Lenalidomide, like its parent compound thalidomide, may cause
venous thromboembolism, a potentially serious complication with their use. High rates of venous thromboembolism have been found in patients with multiple myeloma who received thalidomide or lenalidomide in conjunction with
dexamethasone,
melphalan, or
doxorubicin.[27]
Stevens-Johnson syndrome
This section needs to be updated. Please help update this article to reflect recent events or newly available information.(April 2020)
In March 2008, the US
Food and Drug Administration (FDA) included lenalidomide on a list of twenty prescription drugs under investigation for potential safety problems. The drug was investigated for possibly increasing the risk of developing
Stevens–Johnson syndrome, a life-threatening skin condition.[28]
FDA ongoing safety review
This section needs to be updated. Please help update this article to reflect recent events or newly available information.(April 2020)
In 2011, the FDA initiated an ongoing review of clinical trials that found an increased risk of developing cancers such as
acute myelogenous leukemia and
B-cell lymphoma,[29] though it did not advise patients to discontinue treatment with lenalidomide.[30]
Mechanism of action
Lenalidomide has been used to successfully treat both inflammatory disorders and cancers in the past ten years.[when?] There are multiple
mechanisms of action, and they can be simplified by organizing them as mechanisms of action in vitro and in vivo.[31]
On a molecular level, lenalidomide has been shown to interact with the ubiquitin E3 ligase
cereblon[32] and target this enzyme to degrade the Ikaros transcription factors
IKZF1 and
IKZF3.[33]
Lenalidomide was approved for medical use in the United States in 2005.[6]
Economics
Lenalidomide costs US$163,381 per year for the average person in the United States as of 2012.[needs update][29] Lenalidomide made almost $9.7bn for
Celgene in 2018.[34]
In 2013, the UK
National Institute for Health and Care Excellence (NICE) rejected lenalidomide for "use in the treatment of people with a specific type of the bone marrow disorder
myelodysplastic syndrome (MDS)" in England and Scotland, arguing that Celgene "did not provide enough evidence to justify the £3,780 per month (US$5,746.73) price-tag of lenalidomide for use in the treatment of people with a specific type of the bone marrow disorder myelodysplastic syndrome (MDS)".[35]
^World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization.
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^List AF (August 2005). "Emerging data on IMiDs in the treatment of myelodysplastic syndromes (MDS)". Seminars in Oncology. 32 (4 Suppl 5): S31-5.
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^Rao KV (September 2007). "Lenalidomide in the treatment of multiple myeloma". American Journal of Health-System Pharmacy. 64 (17): 1799–807.
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^Ness S (13 March 2014).
"New Specialty Drugs". Pharmacy Times. March 2014 Mental Health. 80 (3). Archived from
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^Bennett CL, Angelotta C, Yarnold PR, Evens AM, Zonder JA, Raisch DW, et al. (December 2006). "Thalidomide- and lenalidomide-associated thromboembolism among patients with cancer". JAMA. 296 (21): 2558–60.
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10.1001/jama.296.21.2558-c.
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abBadros AZ (May 2012). "Lenalidomide in myeloma--a high-maintenance friend". The New England Journal of Medicine. 366 (19): 1836–8.
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^Vallet S, Palumbo A, Raje N, Boccadoro M, Anderson KC (July 2008). "Thalidomide and lenalidomide: Mechanism-based potential drug combinations". Leukemia & Lymphoma. 49 (7): 1238–45.
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