See the fda package insert see pregnancy safe medications. Neutropenia of any grade was reported in 51% of patients in both trials. The empirical formula for thalidomide is ch10n2o4 and the gram molecular weight is 258. Romidepsin istodax is a type of drug called an hdac inhibitor. Lenalidomide is used to treat anemia low red blood cells in patients with a certain type of myelodysplastic syndrome. If lenalidomide is taken during pregnancy, it may also cause. Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. Strength amount of sterile water for injection, usp required for reconstitution. The overall incidence of aes reported in published pivotal trials employing pibased regimens is shown in table s2b. In females of reproductive potential, obtain 2 negative pr. Or o dexamethasone and pomalidomide after disease progression following at least two prior therapies, including an immunomodulatory agent i.
In addition, it is used to treat mantle cell lymphoma. Revlimid lenalidomide now fda approved as firstline. The recommended starting dose of pomalyst is 4 mg once daily orally on days 121 of repeated 28day cycles until disease progression. On withdrawal of the drug, one patient recovered normal cognitive function and. It will also look at the effects of extended treatment on the cancer and the immune system. Pdf lenalidomide maintenance therapy in patients with. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby.
Healthcare provider hcp instructs female patients to complete initial patient survey 2. How to fill a revlimid lenalidomide prescription 1. Import the data from a pdf file click insert tabimport panelpdf import. Thalidomide is a known human teratogen that causes severe lifethreatening human birth defects. Nphthalimido glutarimide, is an immunomodulatory agent. Will be used for one of the following indications a or b. To attach a pdf underlay autocad 2018 autodesk knowledge. Education and counseling checklist for pharmacies revlimid. Identification of the substancemixture and of the companyundertaking product name. The content on this site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only.
Includes dosages for multiple myeloma, lymphoma and myelodysplastic disease. Treatment with a cyclophosphamideadriamycindexamethasone cad regimen was. It interacts with dna genetic material in cells in ways that can stop tumors from growing. These agents are often given in combination with the synthetic corticosteroid dexamethasone, as well as other cytotoxic agents. Pregnancy must be excluded before start of treatment. Highlights of prescribing information these highlights. Lenalidomide approved as firstline therapy in multiple myeloma.
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. In the attach pdf underlay dialog box, select one page, or use shift or ctrl to select multiple pages. Aug 29, 2012 lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Multiple myeloma mm, in combination with dexamethasone, in patients who have received at least one prior therapy 1. Lenalidomide revlimid is a type of drug known as an immunomodulatory drug, or imid for short. Lenalidomide is very similar to thalidomide, a drug which has caused severe possibly fatal birth defects when used during pregnancy. Common side effects include diarrhea, itchiness, join pain, fever, headache. Lenalidomide investigated as a drug and reproductive effector. In the eu and usa, lenalidomide monotherapy is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone. Embryofetal toxicity lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. Always talk with your doctor before you take any medication while pregnant. Celgene, expanding its use, in combination with lowdose dexamethasone, for the firstline treatment of patients with newly diagnosed multiple myeloma.
To attach a pdf underlay autocad 2019 autodesk knowledge. If the pdf has multiple pages, choose the page to import by clicking a thumbnail image. Lenalidomide is chemically closely related to its parent compound, thalidomide bartlett et al 2004. Smc has previously accepted lenalidomide for use in patients who have received at least two prior lines of therapy i. See important reminder at the end of this policy for important regulatory and legal information. 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. Food and drug administration, center for drug evaluation and research. 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. Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Patients should not break, chew or open the capsules. Lenalidomide revlimid is an immunomodulatory drug with multiple mechanisms of action against multiple myeloma. Revlimid is a thalidomide analogue indicated for the treatment of.
Lenalidomide revlimid for multiple myeloma patient advocacy group myeloma canada coi declarations. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020. If lenalidomide is used during pregnancy, it may cause birth defects or embryofetal death. Highlights of prescribing information these highlights do not include all the information needed to use pomalyst safely and effectively. Pomalyst pomalidomide capsules, for oral use initial u. In the select reference file dialog box, select the pdf file you want to attach. 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. Hcp obtains revlimid rems formerly known as the revassist program authorization number 5. Pdf costeffectiveness of lenalidomide plus dexamethasone. Prevention and management of adverse events of novel agents in. Researchers want to look at the longterm effect of lenalidomide on immune cells. Lenalidomideinduced tyrosine phosphorylation of cd28 on t cells is followed by a downstream activation of nf.
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. If you get pregnant while taking lenalidomide or within 4 weeks after the last dose, call your doctor right away. Histologic transformation of mzl to nongerminal center diffuse large bcell lymphoma after multiple lines of chemoimmunotherapy for indolent or transformed disease. These are side effects of revlimid lenalidomide reported to the fda by people taking it, and by doctors and pharmacists. Use during pregnancy may cause birth defects or loss of the unborn baby. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma.
Lenalidomideinduced tyrosine phosphorylation of cd28 on t cells is followed by. Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. Mechanism of action lenalidomide is an analogue of thalidomide with immunomodulatory, antiangio. Mar, 2020 detailed lenalidomide dosage information for adults. Your story matters citation hideshima, teru, noopur raje, paul g.
Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. 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. New use for lenalidomide in multiple myeloma national. Costeffectiveness of lenalidomide plus dexamethasone vs. Lenalidomide, sold under the trade name revlimid among others, is a medication used to treat multiple myeloma mm and myelodysplastic syndromes mds. The recommended starting dose of revlimid is 25 mg once daily on days 121 of repeated 28day cycles.
Your doctor may give you a medicine to help prevent this. It is approved to treat people who have certain bone marrow diseases, specifically multiple myeloma and myelodysplastic syndromes. Embryofetal toxicity and venous and arterial thromboembolism. Lenalidomide maintenance therapy for multiple myeloma full.
It is a thalidomide analogue, with improved potency and reduced toxicity compared with thalidomide. Lenalidomide caused thalidomidetype limb defects in monkey offspring. To work with importing pdf data autocad 2021 autodesk. Romidepsin, lenalidomide, ptcl, chop, clinical trials t. The toxicity profile of lenalidomide r, although structurally very. 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. Pomalyst may be given in combination with dexamethasone see clinical studies 14. 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. Gently swirl andor invert the vial slowly for about 1 minute, or until complete dissolution. 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. To test the longterm effectiveness of lenalidomide therapy for multiple myeloma.
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. See full prescribing information for complete boxed warning embryofetal toxicity pomalyst is contraindicated in pregnancy. 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. Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. Inform patients not to break, chew or open the capsules.
Apr 23, 2020 lenalidomide caused thalidomidetype limb defects in monkey offspring. Highlightsof prescribing information kyprolis safely and. Only select registry of toxic effects of chemical substances rtecs data is presented here. Lenalidomide is prescribed to slow down the progression of multiple myeloma and myelodysplastic syndrome. See actual entry in rtecs for complete information. Lenalidomide alone increased t cell production of il2, and nk cell production of interferon. Description lenalidomide revlimid is an immunomodulatory agent with antiangiogenic and antineoplastic. For mm it is used after at least one other treatment and generally together with dexamethasone. It has been extensively studied for the treatment of multiple myeloma and. Lenalidomide maintenance therapy for multiple myeloma. Side effect rates for revlimid lenalidomide 0 reports. Lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats see data. Cadth is committed to supporting canadas health care decisionmakers through this challenging and uncertain time. 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.
It is also used as maintenance treatment in patients with multiple. 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. On february 18, 2015, the us food and drug administration fda approved a new indication for lenalidomide revlimid. In the eu and usa, lenalidomide monotherapy is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stemcell. 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. Notably, dexamethasone antagonized these immunostimulatory effects of lenalidomide. See full prescribing information for complete boxed warning. Revlimid should not be used to treat people who have chronic lymphocytic leukemia cll unless. Important reminder at the end of this policy for important regulatory and legal information. 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. Ic50 nm 1 in vitro lenalidomide strongly induces il2 and sil2r production.
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. Coronary artery disease angina, previous mci or interventions for cad. This emedtv page takes a look at what else the drug is used for and explains how it works. Common side effects include diarrhea, itchiness, join pain, fever, headache, and trouble sleeping. The recommended starting dose of lenalidomide is 10 mg daily with water. Lenalidomide revlimid for multiple myeloma manufacturer celgene inc. For evidence, tools, and resources related to covid19, visit our covid19 evidence portal. Fda halts clinical trial of drug revlimid lenalidomide for chronic lymphocytic leukemia due to safety concerns july 18, 20.
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