On february 18, 2015, the us food and drug administration fda approved a new indication for lenalidomide revlimid. The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for revlimid lenalidomide skip to. Revlimid lenalidomide was granted approval by the food and drug administration fda as a maintenance therapy for patients with multiple myeloma who have had autologous hematopoietic stem cell transplant autohsct, according to celgene, the manufacturer of the treatment. The safety and effectiveness of using this medication have not been established for children. Highlights of prescribing information these highlights. The iaccess program is designed to ensure that revlimid is always prescribed and taken in the recommended way. The empirical formula for thalidomide is ch10n2o4 and the gram molecular weight is 258. It is not known if lenalidomide passes into breast milk. Because a baby may be seriously harmed if exposed to this medication, breastfeeding mothers should not use this medication. For mm it is used after at least one other treatment and generally together with dexamethasone. Common side effects include diarrhea, itchiness, join pain, fever, headache, and trouble sleeping. Lenalidomide, a thalidomide analogue, caused limb abnormalities. For information, the full indications for revlimid will be as.
We have previously shown in a retrospective analysis that lenalidomide combined with. The hospitalist with held anything to drink even though he was asking for it, nothing to eat, no nutrition and stopped all. Discard any unused product or waste material in accordance with local requirements. Revlimid lenalidomide now fda approved as firstline. If revlimid is taken during pregnancy, it may cause birth defects or death to an unborn baby. Possible side effects of velcade, revlimid, dexamethasone. Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma fl. Education and counseling checklist for pharmacies revlimid. Mm, as maintenance following autologous hematopoietic stem cell transplantation autohsct. 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. Pdf the antiretroviral agent nelfinavir has antimyeloma activity and can. A phase i study of oral lenalidomide in patients with refractory. Pdf nelfinavir and lenalidomidedexamethasone in patients with.
Lenalidomide and dexamethasone in patients with relapsed. Possible side effects of velcade, revlimid, dexamethasone table version date. If your partner is pregnant or able to become pregnant, and she doesnt use effective contraception, you must use condoms, during treatment, during dose interruptions and 1 week after the end of treatment even if you have had a vasectomy. Is revlimid being used in combination with any other therapies. Take revlimid exactly as prescribed and follow all the instructions of the revlimid rems program swallow revlimid capsules whole with water 1 time a day.
Learn more about revlimid lenalidomide, a treatment option for multiple myeloma. Supplemental methods, tables, and figures pdf, 260 kb pdf file. A new lawsuit alleges celgenes efforts to block generic revlimid are illegal. After initiation of revlimid therapy, subsequent revlimid dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section. You can enroll your patients and fill out a prescription form using. The introduction of thalidomide, lenalidomide and bortezomib into standard therapy. How to import adobe pdf files to publisher on a pc. Lenalidomide, sold under the trade name revlimid among others, is a medication used to treat multiple myeloma mm and myelodysplastic syndromes mds. Please see accompanying full prescribing information, including oxed warnings. To avoid foetal exposure, revlimid is available only under a special distribution program called the iaccess program. In particular, as shown in figure 1, lenalidomide has been synthesized from the.
Nphthalimido glutarimide, is an immunomodulatory agent. The us food and drug administration fda first approved lenalidomide for the. Blood samples for pk evaluation were obtained before drug administration as well as at 0. Injection into scar tissue should be avoided as this may result in insufficient exposure to ilaris.
Revlimid lenalidomide is structurally related to thalidomide, which is known to cause severe lifethreatening human birth defects deformed babies and death to an unborn baby if taken during. The recommended starting dose of revlimid is 25 mgday orally on days 121 of repeated 28day. It has been used for the treatment of transfusiondependent anemia due to low or intermediaterisk myelodysplastic syndromes mds associated with a deletion 5q. Lenalidomide has been developed by adding an amino group nh2 at 4th. When you want to reuse the content of a pdf in microsoft publisher but you lack access to the file from which you produced it, you cant import the file directly. Phase 12 study of lenalidomide combined with lowdose. To avoid embryofetal exposure, revlimid is only available under a restricted distribution program called revlimid risk evaluation and mitigation strategy rems. In addition, our data suggest that it is taken for lupus, although it is not approved for this condition. Because of the potential for adverse reactions in breastfed infants from lenalidomide, advise women not to breastfeed during treatment. Revlimid prior authorization form if this is an urgent request, please call upmc health plan pharmacy services.
Angry cancer patient sues celgene over 500% jump in. Patients should not break, chew or open the capsules. A treatment option for multiple myeloma revlimid lenalidomide. Revlimid complete drug information, side effects and. Multiple myeloma mm, in combination with dexamethasone. High blood pressure which may cause headaches, dizziness. October 8, 20 common, some may be serious in 100 people receiving velcade, revlimid, dexamethasone, more than 20 and up to 100 may have. Although prescription hope is not a revlimid coupon, individuals looking for a revlimid coupon can find more savings through prescription hope. Maintenance revlimid gains fda approval for multiple myeloma. Biological activity of lenalidomide and its underlying therapeutic.
Downloading fda package insert for revlimid capsule. Revlimid lenalidomide a treatment option for multiple. Lenalidomide, a critical agent in the treatment of relapsed multiple myeloma, is. The recommended starting dose of revlimid is 25 mg once daily on days 121 of repeated 28day cycles. Lenalidomide approved as firstline therapy in multiple myeloma. An expert panel convened to reach a consensus regarding the optimal use of lenalidomide in combination with dexamethasone lendex in patients. According to its prescribing information, lenalidomide should not be started in. Revlimid lenalidomide dosing, indications, interactions.
Optimizing the use of lenalidomide in relapsed or refractory multiple. If patient starting dose was 10 mg daily, resume at 5 mg less than previous dose. Celgene, expanding its use, in combination with lowdose dexamethasone, for the firstline treatment of patients with newly diagnosed multiple myeloma. Revlimid prior authorization form upmc health plan. Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. Uninsured uninsured if you do not have health insurance or enough coverage to pay for revlimid, the celgene patient assistance program pap may be able to provide you with revlimid at no cost. Report any suspected fetal exposure to lenalidomide to the fda via the medwatch program at 1800fda1088 and also to the manufacturer at 18884235436. 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. See full prescribing information for complete boxed warning. Revlimid is a thalidomide analogue indicated for the treatment of adult patients with. Revlimid is for the type of mds with a chromosome problem where part of chromosome 5 is missing. Revlimid lenalidomide is a prescription medicine used to treat adults with a condition called myelodysplastic syndromes mds. If you created a publication that you want to share with others who dont have publisher, you can save it as a pdf portable document format or xps xml. 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.
Cyclophosphamide is prescribed for breast cancer and multiple myeloma and is mostly mentioned together with these indications. Revlimid is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma see sections 4. Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking revlimid, during any breaks interruptions in your treatment with revlimid, and for up to 4 weeks after stopping. Learn more about revlimid, a treatment option for multiple myeloma. Revlimid should not be used to treat people who have chronic lymphocytic leukemia cll unless. This emedtv article presents an indepth look at this medication, with details on specific uses of the drug, dosing instructions, potential side effects, and more.
Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma mzl. The marketing authorisation holder for this medicinal product is celgene europe limited. Transfusiondependent anemia due to low or intermediate1risk myelodysplastic syndromes mds associated with a deletion 5q. Renal insufficiency is common in patients with relapsed multiple myeloma and can often limit choice of therapy.
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