Always talk with your doctor before you take any medication while pregnant. Lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats see data. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. Side effect rates for revlimid lenalidomide 0 reports these are side effects of revlimid lenalidomide reported to the fda by people taking it, and by doctors and pharmacists. Lenalidomide approved as firstline therapy in multiple myeloma. Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma. It is approved to treat people who have certain bone marrow diseases, specifically multiple myeloma and myelodysplastic syndromes. See full prescribing information for complete boxed warning embryofetal toxicity pomalyst is contraindicated in pregnancy.
Or o dexamethasone and pomalidomide after disease progression following at least two prior therapies, including an immunomodulatory agent i. Lenalidomide is chemically closely related to its parent compound, thalidomide bartlett et al 2004. Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. Romidepsin istodax is a type of drug called an hdac inhibitor. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. Gently swirl andor invert the vial slowly for about 1 minute, or until complete dissolution. It is also used as maintenance treatment in patients with multiple. The recommended starting dose of revlimid is 25 mg once daily on days 121 of repeated 28day cycles. Identification of the substancemixture and of the companyundertaking product name. Your story matters citation hideshima, teru, noopur raje, paul g.
Revlimid is a thalidomide analogue indicated for the treatment of. It interacts with dna genetic material in cells in ways that can stop tumors from growing. To attach a pdf underlay autocad 2018 autodesk knowledge. Lenalidomide is used to treat anemia low red blood cells in patients with a certain type of myelodysplastic syndrome. Lenalidomide is very similar to thalidomide, a drug which has caused severe possibly fatal birth defects when used during pregnancy. Important reminder at the end of this policy for important regulatory and legal information. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Highlights of prescribing information these highlights. Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. The indications below including fdaapproved indications and compendial uses are considered covered benefits provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
Lenalidomideinduced tyrosine phosphorylation of cd28 on t cells is followed by a downstream activation of nf. In the attach pdf underlay dialog box, select one page, or use shift or ctrl to select multiple pages. Food and drug administration, center for drug evaluation and research. These agents are often given in combination with the synthetic corticosteroid dexamethasone, as well as other cytotoxic agents. Revlimid should not be used to treat people who have chronic lymphocytic leukemia cll unless. Pdf costeffectiveness of lenalidomide plus dexamethasone. Apr 23, 2020 lenalidomide caused thalidomidetype limb defects in monkey offspring. If lenalidomide is taken during pregnancy, it may also cause. Pomalyst may be given in combination with dexamethasone see clinical studies 14. Lenalidomide maintenance therapy for multiple myeloma. See important reminder at the end of this policy for important regulatory and legal information.
Embryofetal toxicity lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. Treatment with a cyclophosphamideadriamycindexamethasone cad regimen was. For mm it is used after at least one other treatment and generally together with dexamethasone. Nphthalimido glutarimide, is an immunomodulatory agent. The overall incidence of aes reported in published pivotal trials employing pibased regimens is shown in table s2b. For evidence, tools, and resources related to covid19, visit our covid19 evidence portal. However, the structural alterations between those compounds have as consequence pronounced differences in biological effects, the most striking, perhaps, being that lenalidomide is nonteratogenic in the new zealand rabbit preclinical model. Highlightsof prescribing information kyprolis safely and. Histologic transformation of mzl to nongerminal center diffuse large bcell lymphoma after multiple lines of chemoimmunotherapy for indolent or transformed disease. Cadth is committed to supporting canadas health care decisionmakers through this challenging and uncertain time. Use during pregnancy may cause birth defects or loss of the unborn baby. Notably, dexamethasone antagonized these immunostimulatory effects of lenalidomide.
Costeffectiveness of lenalidomide plus dexamethasone vs. Mechanism of action lenalidomide is an analogue of thalidomide with immunomodulatory, antiangio. It has been extensively studied for the treatment of multiple myeloma and. Pregnancy must be excluded before start of treatment. Lenalidomide investigated as a drug and reproductive effector. Import the data from a pdf file click insert tabimport panelpdf import. It is a thalidomide analogue, with improved potency and reduced toxicity compared with thalidomide. Pdf lenalidomide maintenance therapy in patients with. The recommended starting dose of pomalyst is 4 mg once daily orally on days 121 of repeated 28day cycles until disease progression.
Coronary artery disease angina, previous mci or interventions for cad. Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. See full prescribing information for complete boxed warning. Highlights of prescribing information these highlights do not include all the information needed to use pomalyst safely and effectively. Description lenalidomide revlimid is an immunomodulatory agent with antiangiogenic and antineoplastic. Revlimid lenalidomide now fda approved as firstline. Your doctor may give you a medicine to help prevent this.
Lenalidomide revlimid is an immunomodulatory drug with multiple mechanisms of action against multiple myeloma. Only select registry of toxic effects of chemical substances rtecs data is presented here. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs. Mar, 2020 detailed lenalidomide dosage information for adults. The empirical formula for thalidomide is ch10n2o4 and the gram molecular weight is 258. If lenalidomide is used during pregnancy, it may cause birth defects or embryofetal death. Revlimid lenalidomide is a prescription medicine, used to treat adults with multiple myeloma mm in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation a type of stem cell transplant that uses your own stem cells.
Lenalidomide alone increased t cell production of il2, and nk cell production of interferon. On withdrawal of the drug, one patient recovered normal cognitive function and. Neutropenia of any grade was reported in 51% of patients in both trials. Side effect rates for revlimid lenalidomide 0 reports. How to fill a revlimid lenalidomide prescription 1. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020.
Estimated api price per kg in usd for lenalidomide obtained from the import, export data from major ports of india pharmacompass api reference price for lenalidomide determined using sample data obtained from indian trade importexport. It will also look at the effects of extended treatment on the cancer and the immune system. Lenalidomide plus dexamethasone significantly increased the time to progression compared with dexamethasone alone in multiple myeloma patients who had been treated with at least one prior therapy. To test the longterm effectiveness of lenalidomide therapy for multiple myeloma. If the pdf has multiple pages, choose the page to import by clicking a thumbnail image. This emedtv page takes a look at what else the drug is used for and explains how it works. Hcp obtains revlimid rems formerly known as the revassist program authorization number 5. Lenalidomide revlimid is a type of drug known as an immunomodulatory drug, or imid for short.
Lenalidomide maintenance therapy for multiple myeloma full. Smc has previously accepted lenalidomide for use in patients who have received at least two prior lines of therapy i. The recommended dose of dexamethasone is 40 mg once daily on days 14, 912, and 1720 of each 28day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on days 14 every 28 days. The new indication for lenalidomide as firstline treatment for multiple myeloma was based on the first study, a phase 3, multicenter, randomized, openlabel, 3arm clinical trial that compared the efficacy and safety of lenalidomide plus dexamethasone versus mpt and versus lenalidomide given for 18 cycles in patients with newly diagnosed. Fda halts clinical trial of drug revlimid lenalidomide for chronic lymphocytic leukemia due to safety concerns july 18, 20. The recommended starting dose of lenalidomide is 10 mg daily with water. Lenalidomide also known as cc50, an oral derivative of thalidomide, is an antineoplastic agent exhibiting antitumor activity through a variety of mechanisms, including immune system activation, angiogenesis inhibition, and direct antineoplastic effects. On february 22, the food and drug administration fda approved a new use for the drug lenalidomide revlimid in treating patients with multiple myeloma under the new approval, patients with multiple myeloma can receive lenalidomide as maintenance therapy after receiving an autologous stem cell transplant for the disease, to help keep the cancer from coming back. Thalidomide is a known human teratogen that causes severe lifethreatening human birth defects. Lenalidomideinduced tyrosine phosphorylation of cd28 on t cells is followed by. Lenalidomide revlimid for multiple myeloma manufacturer celgene inc. Patients should not break, chew or open the capsules. Celgene, expanding its use, in combination with lowdose dexamethasone, for the firstline treatment of patients with newly diagnosed multiple myeloma. Includes dosages for multiple myeloma, lymphoma and myelodysplastic disease.
Patients with mds may have very low red blood cell counts and require blood transfusions lenalidomide is also used in combination with dexamethasone to treat multiple myeloma plasma cell cancer. These are side effects of revlimid lenalidomide reported to the fda by people taking it, and by doctors and pharmacists. If you get pregnant while taking lenalidomide or within 4 weeks after the last dose, call your doctor right away. Lenalidomide, sold under the trade name revlimid among others, is a medication used to treat multiple myeloma mm and myelodysplastic syndromes mds. On february 18, 2015, the us food and drug administration fda approved a new indication for lenalidomide revlimid. Embryofetal toxicity and venous and arterial thromboembolism.
Will be used for one of the following indications a or b. New use for lenalidomide in multiple myeloma national. To work with importing pdf data autocad 2021 autodesk. Revlimid lenalidomide is a prescription medicine approved in combination with dexamethasone to treat patients with multiple myeloma a type of cancer of the bone marrow who already have had. Aug 29, 2012 lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Pomalyst pomalidomide capsules, for oral use initial u. Strength amount of sterile water for injection, usp required for reconstitution. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Common side effects include diarrhea, itchiness, join pain, fever, headache, and trouble sleeping. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Researchers want to look at the longterm effect of lenalidomide on immune cells. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease. Multiple myeloma mm, in combination with dexamethasone, in patients who have received at least one prior therapy 1. In addition, it is used to treat mantle cell lymphoma. See actual entry in rtecs for complete information. The toxicity profile of lenalidomide r, although structurally very. Education and counseling checklist for pharmacies revlimid. Lenalidomide caused thalidomidetype limb defects in monkey offspring. Ic50 nm 1 in vitro lenalidomide strongly induces il2 and sil2r production. Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure.
In the eu and usa, lenalidomide monotherapy is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone. Lenalidomide revlimid for multiple myeloma patient advocacy group myeloma canada coi declarations. Inform patients not to break, chew or open the capsules. Healthcare provider hcp instructs female patients to complete initial patient survey 2.
1120 672 1609 339 1338 1093 354 719 565 1156 1214 320 1011 820 171 883 1385 1336 568 1068 409 1166 1151 1585 790 1404 430 802 1194 1051 608 749 391 999 635 89 1013 736 137 214 630 1301 622