Highlights of prescribing information these highlights do not. Each ml of the sterile solution contains 20 mg of plerixafor. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. Mozobil plerixafor injection, for subcutaneous use. What is the most important information i should know about revlimid. Lenalidomide is a potent, novel thalidomide analog that has demonstrated promising clinical activity in patients with relapsed or refractory multiple myeloma mm. Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. Ninlaro 3 mg capsules contain 3 mg of ixazomib equivalent to 4. Page 3 of 44 full prescribing information 1 indications and usage 1. If you get pregnant while taking lenalidomide or within 4 weeks after the last dose, call your doctor right away. A study showed that adding ninlaro to revlimid lenalidomide and dexamethasone improved median progressionfree survival pfs by nearly 6 months 20. The recommended starting dose of dexamethasone is 40 mg administered on days 1, 8, 15, and 22 of a 28day treatment cycle. It is a lead immunomodulatory drug currently approved by the u.
For the most recent pi, please refer to the tga website at. A phase ii study by the intergroupe francophone du myelome. Revlimid, innlenalidomide european medicines agency europa. Darzalex is a prescription medicine used to treat adults with multiple myeloma. In females of reproductive potential, obtain 2 negative pregnancy.
Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental. Revlimid lenalidomide is a prescription medicine used to treat adults with a condition called myelodysplastic syndromes mds. L or less within the first 4 weeks of therapy, lenalidomide administration is interrupted. Management of side effects of novel therapies for multiple myeloma. See full prescribing information for complete boxed warning. In this study n 45, orr with the triplet of ibrutinib, lenalidomide, and rituximab was 38% and 44% in the overall population and responseevaluable patients, respectively. See important safety information and prescribing information. Lenalidomide len is an oral immunomodulatory medication. Please see indication and important safety information.
In patients taking lysodren, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. This is a multidose vial which contains a total of 32. Ninlaro ixazomib is the first and only oral medication of its kind, a proteasome inhibitor, that you can take at home. Calculate the dose mg, total volume ml of solution required and the darzalex number of darzalex vials needed based on patient actual body weight. The absolute bioavailability of thalidomide from thalomid thalidomide capsules has not yet been characterized in human subjects due to its poor aqueous solubility. Revlimid lenalidomide a treatment option for multiple. It has a role as an angiogenesis inhibitor, an antineoplastic agent and an immunomodulator. Download leaflet view the patient leaflet in pdf format. The most recent prior lenalidomide dose was 25 mg in 625% of the itt population. Dec 30, 2019 not known whether lenalidomide is present in semen. Highlights of prescribing information perforation can occur.
Practical considerations in the use of lenalidomide. Lenalidomide works in several different ways and belongs to several different groups of targeted therapy drugs. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for revlimid lenalidomide. A treatment option for multiple myeloma revlimid lenalidomide. People who have received at least 2 prior treatments, including. Practical guide to management of lenalidomiderelated rash in patients with mds. People who have received prior treatments for their multiple myeloma may receive. This medicinal product is subject to additional monitoring. Apr 23, 2020 lenalidomide caused thalidomidetype limb defects in monkey offspring. This is a multidose vial which contains a total of 22.
Learn more about revlimid lenalidomide, a treatment option for multiple myeloma. 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. Understanding revlimid lenalidomide will familiarize you with a drug that is approved for treating myeloma in the newly diagnosed, relapsed andor refractory, and maintenance therapy settings. Practical guide to management of lenalidomiderelated rash in. Thalidomide is a known human teratogen that causes severe lifethreatening human birth defects. Administer hydrocortisone, monitor for escalating signs of shock and discontinue.
Revlimid lenalidomide is indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate1risk. Lenalidomide, bortezomib, and dexamethasone rvd regimen for. Highlights of prescribing information these highlights. Kyprolis carfilzomib is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. Kyprolis is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat. View physician videos discussing treatment with ninlaro. Empliciti elotuzumab, when used with pd or rd, is a prescription treatment for certain adults with relapsed or refractory multiple myeloma. Clinical benefit, such as improvement in survival or symptoms, has not been verified. Highlightsof prescribing information kyprolis safely and. Your doctor will talk to you about this treatment and its possible side effects before you agree consent to have treatment. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Revlimid lenalidomide capsules au product information. In studies of both healthy volunteers and subjects with hansens disease, the mean. The ninlaro ixazomib regimen extended pfs by 6 months median.
Kyprolis is a sterile, white to offwhite lyophilized powder and is available as a singledose 10 mg, 30 mg or 60 mg vial. Prepare the solution for infusion using aseptic technique as follows. Fdaapproved package insert for lenalidomide and have been summarized in table 3. For additional information regarding lenalidomide and dexamethasone, refer to their prescribing.
Carfilzomib is a crystalline substance with a molecular weight of 719. Learn more about revlimid, a treatment option for multiple myeloma. Empliciti is a prescription medicine used with other medications to treat the following types of adult patients with multiple myeloma. However, the capsules are 90% bioavailable relative to an oral peg solution. Learn about ninlaro, including efficacy, safety, dosing, and patient support. Newly approved agents for the treatment of myelodysplastic. Lenalidomide is effective at inducing a complete or very good partial response and improves progressionfree survival. Ninlaro is taken along with 2 other medications, lenalidomide and dexamethasone, in 4week cycles. This dosing calendar is a snapshot of the ninlaro regimen for a 28day cycle. Pomalyst is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. See full prescribing information for afinitorafinitor disperz.
Ninlaro ixazomib capsules, for oral use hepatotoxicity. Use during pregnancy may cause birth defects or loss of the unborn baby. It is a more potent molecular analog of thalidomide, which inhibits tumor angiogenesis, tumorsecreted cytokines, and tumor proliferation through induction of apoptosis. It is an angiogenesis inhibitor, a cancer growth inhibitor and an immune system modulator. Within the past decade, three agents have been approved by the fda for the treatment of mds. Despite advances in treatment, complete remission rates and overall survival remain relatively low. Kyprolis is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. Practical guide to management of lenalidomiderelated rash. Dose delays and modifications for dexamethasone, pomalidomide and lenalidomide should be performed as recommended in their prescribing information.
Realworld analysis of celgene global drug safety database. Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to. Revlimid lenalidomide is indicated for the treatment of patients with transfusion. 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. May 20, 2010 within the past decade, three agents have been approved by the fda for the treatment of mds. If lenalidomide is used during pregnancy, it may cause birth defects or embryofetal death. Before you begin taking revlimid, you must read and agree. The ongoing phase 2 portion with 20 mg lenalidomide will provide a more robust efficacy assessment at this dose. Ibrutinib plus lenalidomide and rituximab has promising. The nccn compendium is a derivative work of the nccn guidelines. Secondline and subsequent therapy and outcomes for follicular lymphoma in the united states. Pregnancy must be excluded before start of treatment. Lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats see data.
Ninlaro ixazomib healthcare professional information. Frontline transplantation program with lenalidomide, bortezomib, and dexamethasone combination as induction and consolidation followed by lenalidomide maintenance in patients with multiple myeloma. For dose adjustments due to toxicity with rituximab, refer to the product prescribing. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. The recommended starting dose of lenalidomide is 25 mg administered daily on days 1 through 21 of a 28day treatment cycle. Lenalidomide caused thalidomidetype limb defects in monkey offspring. Revlimid is for the type of mds with a chromosome problem where part of chromosome 5 is missing. Lenalidomide is a dicarboximide that consists of 1oxoisoindoline bearing an amino substituent at position 4 and a 2,6dioxopiperidin3yl group at position 2. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells autologous stem cell transplant and in people who have received at. Relapsed refractory multiple myeloma treatment pomalyst.
Carfilzomib is practically insoluble in water and very slightly soluble in acidic conditions. Medication guide revlimid rev limid lenalidomide capsules. This leaflet is part iii of a threepart product monograph. Consensus statements developed by the international myeloma foundations nurse leadership board. Kyprolis carfilzomib for relapsed multiple myeloma treatment. Afinitor everolimus tablets, for oral use afinitor disperz everolimus tablets for oral suspension. Highlights of prescribing information these highlights do not include all the information needed to use afinitorafinitor disperz safely and effectively.
Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with granulocytecolony stimulating factor gcsf to mobilize hematopoietic stem cells hscs to the peripheral blood for collection and subsequent autologous transplantation in patients with nonhodgkins lymphoma and multiple myeloma. Check that the darzalex solution is colorless to yellow. Light pink gelatin capsule imprinted with takeda on the cap and 2. Kyprolis is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma. In patients with a baseline platelet count of 100,000. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell. Oct 04, 2019 carfilzomib is a crystalline substance with a molecular weight of 719.
416 44 1465 307 416 1290 250 413 1330 364 1455 378 1296 43 1003 284 241 684 608 1409 1213 361 471 826 995 749 428 1504 1342 851 181 1467 1105 1082 798 353 664 895 116 1197 354 639 1158 960