Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is administered intravenously as a 30minute infusion on two consecutive days, each week for threeweeks followed by a 12day rest period as shown in table2. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. It is a first in class inhibitor of the 20s segment of the proteasome, the cellular component that regulates the degradation of many cell cycle. Bortezomib is a reversible inhibitor of the 26s proteasome, a protein complex that. Severe mucocutaneous reactions, some with fatal outcomes 5. Read all of this leaflet carefully before you start using. Darzalex is given as an intravenous iv infusion after dilution at 16 mgkg of actual body weight.
Highlights of prescribing information closely monitor. Dexamethasone may be modified for various patient populations. A unique feature of bortezomib involves the inhibition of nuclear factor nfkappab activation through. The pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as. In cycles 14, velcade is given twice weekly days 1, 4, 8, 11, 22, 25, 29, and 32. Unopened vials of velcade are stable until the date indicated on the package when stored in the original package protected from light. Kyprolis carfilzomib 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. Indications 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. Velcade bortezomib injection millennium pharmaceuticals, inc. Highlights of prescribing information these highlights do not include all the information needed to use velcade safely and effectively.
Authorization of 6 months may be granted for members prescribed velcade for the treatment of multicentric astlemans disease and velcade will be used with or without rituximab as subsequent therapy for disease that has progressed following treatment of relapsed, refractory, or progressive disease. The following conditions are contraindicated with this drug. Kyprolis carfilzomib is a treatment option for people who have already received 1 or more previous treatments for relapsed multiple myeloma. Empliciti is a prescription medicine used in combination with pomalyst and dexamethasone in adults who have received at least two prior treatments for their multiple myeloma including revlimid and a proteasome inhibitor. Prescribing information and velcade reimbursement assistance program vrap application. Velcade bortezomib velcade fep clinical rationale rationale for inclusion in pa program background velcade targets proteasomes inside cells and blocks or slows down the action of these cells. 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. Refer to the dexamethasone prescribing information for other information on that product.
Fatal infusionrelated reactions within 24 hours of rituxan infusion. Highlights of prescribing information these highlights do not. Xgeva includes the same active ingredient denosumab found in prolia. Us package insert fdampi finalized may, 2003 1 1 millennium pharmaceuticals, inc. Tablets containing sorafenib tosylate 274 mg equivalent to 200 mg of sorafenib. Highlights of prescribing information hypotension can. When reconstituted as directed, velcade may be stored at 25. Learn about treatment with remicade across all uses on the official patient website. When reconstituted as directed, velcade may be stored at 25c 77f. Highlightsof prescribing information kyprolis safely and. Empliciti elotuzumab, when used with pd or rd, is a prescription treatment for certain adults with relapsed or refractory multiple myeloma.
Velcade bortezomib for injection, for subcutaneous or intravenous use initial u. Ninlaro ixazomib capsules, for oral use hepatotoxicity. Thrombocytopenia has been reported with ninlaro with platelet nadirs typically occurring between days 1421 of each 28day cycle and recovery to baseline by the start of the next cycle. There are serious and potentially lifethreatening problems that can occur with velcade, so it is important to be aware of any signs of these complications. Velcade bortezomib is approved for the treatment of adults with multiple myeloma a cancer of the plasma cells. In cycles 59, velcade is administered once weekly days 1, 8, 22 and 29. In cycles 59, velcade is given once weekly days 1, 8, 22, and 29. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis tb and histoplasmosis. Pdf bortezomib velcade is approved by the fda for iv or sc injection. 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 least one prior medicine to treat multiple myeloma. Velcade 1 mg powder for solution for injection is administered via intravenous injection at the. Highlights of prescribing information hypotension can occur.
Proteasomes break down proteins in both healthly and cancerous cells. Since dialysis may reduce bortezomib concentrations, the drug should be administered after. May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Kyprolis carfilzomib for relapsed or refractory multiple. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. This page describes other important safety precautions for velcade, including warnings for people who should not take this drug. Check with your physician if you have any of the following.
See full prescribing information for complete boxed warning. Please refer to the bortezomib prescribing information for more detailed information about bortezomib twiceweekly dosing. Empliciti is also used in combination with the medicines revlimid and dexamethasone in patients who have received 1 to 3 prior treatments for their multiple myeloma. For extended therapy of more than 8 cycles, velcade may be administered on the standard schedule or on a maintenance schedule of once. Highlights of prescribing information adequately rehydrate. Highlights of prescribing information these highlights do not include all the information needed to use pegasyssafely and effectively. Kyprolis is approved for use in combination with dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma. Relapsed refractory multiple myeloma treatment pomalyst. 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. Highlights of prescribing information these highlights do not include all the information needed to use revlimid safely and effectively. Explore how pomalyst with dex works as an immunomodulatory treatment for relapsed refractory multiple myeloma. Revlimid lenalidomide and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma. In cycles14, velcade is administered twice weekly on days1, 4, 8, 11, 22, 25, 29 and 32. What is empliciti elotuzumab empliciti is a prescription medicine used to treat multiple myeloma in combination with the medicines.
Pegasys peginterferon alfa2a injection, for subcutaneous use initial u. Velcade is administered in combination with oral melphalan and oral prednisone for nine 6week treatment cycles as shown in table 1. The nccn compendium is a derivative work of the nccn guidelines. Only your doctor can recommend a course of treatment after checking your health condition. Velcade nsc 681239 1995 velcade nsc 681239 is a boronic acid dipeptide discovered by proscript, inc. Velcade 1mg powder for solution for injection is administered via intravenous injection in combination with oral melphalan and oral prednisone as shown in table2. Reconstituted velcade should be administered within 8 hours of preparation. Farydak is in a class of multiple myeloma medicines that offer a different way to attack myeloma cells. Kyprolis carfilzomib for relapsed multiple myeloma treatment.
Apr 30, 2019 unopened vials of velcade are stable until the date indicated on the package when stored in the original package protected from light. Please see indication and important safety information. Velcade bortezomib, a specific, selective inhibitor of the 26s proteasome, is a novel dipeptide boronic acid that is the first proteasome inhibitor to have progressed to clinical trials. Velcade fda prescribing information, side effects and uses. In patients who dont respond to velcade alone, adding dexa methasone has. Monitor patients and discontinue rituxan infusion for severe reactions 5. Until disease progression or unacceptable toxicity. This solution is readytouse and may be administered directly to the patient without further preparation. Hycamtin for injection,in combination with cisplatin,is indicated for the treatment of patients with stage ivb, recurrent, or persistent cervical cancernot amenable to curative treatment.
Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the other side. Apr 01, 2019 unopened vials of velcade are stable until the date indicated on the package when stored in the original package protected from light. As explained in this emedtv segment, velcade can increase your risk for infections and may not be safe for pregnant women. Authorization of 6 months may be granted for members prescribed velcade for the treatment of multicentric astlemans disease and velcade will be used with or without rituximab as subsequent therapy for disease that has progressed following treatment of relapsed, refractory, or. Administer reconstituted velcade within eight hours of preparation. Velcade is also approved for the treatment of adults with mantle cell lymphoma a cancer of the lymph nodes. Highlights of prescribing information these highlights do. Learn more about revlimid, a treatment option for multiple myeloma. In cycles 14, velcade is administered twice weekly days 1, 4, 8, 11, 22, 25, 29 and 32. Darzalex is a cd38directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma 1. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. Unopened vials of velcade are stable until the date indicated on the package when.
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