Bortezomib is used to treat people with multiple myeloma a type of cancer of the bone marrow. It is currently approved for the treatment of myeloma in the relapsed setting post transplant or as a second line treatment in patients unsuitable for transplantation. Material safety data sheet of bortezomib contains identification of substance and details of the supplier of the safety data sheet. The following bortezomib msds detailed information are provided by hangzhou holypharm biotech co. Velcade bortezomib dosing, indications, interactions. P280 wear protective gloves protective clothing eye protection face protection. Apr 01, 2011 velcade samples, in the containers in which velcade is marketed, containing 3. Bortezomib cas 179324697 calbiochem msds material safety data sheet or sds, coa and coq, dossiers, brochures and other available documents. An nmr study of the bortezomib degradation under clinical. The aim of this investigation was to assess the stability of bortezomib solution 2. According to regulation ec no 19072006, annex ii, as amended. Bortezomib safety data sheet according to regulation ec no.
In addition, bortezomib appears to increase the sensitivity of cancer cells to traditional anticancer agents e. This chemical, bortezomib cas 179324697, is sparingly soluble in aqueous buffers. For maximum solubility in aqueous buffers, bortezomib should first be dissolved in dmso and then diluted with the aqueous buffer of choice. Pdf analysis of two commercially available bortezomib. Material safety data sheet msds cell signaling technology. The consequence of inhibiting the proteasome is the matter of some speculation. Metabolic alterations play an important role in cancer development and aid in the cellular adaptation to pharmacologically changed environments. Bortezomib velcade in the treatment of multiple myeloma. Contains bortezomib signal word danger precautionary statements eu 28, 12722008 p264 wash face, hands and any exposed skin thoroughly after handling p270 do not eat, drink or smoke when using this product 1. Dailymed bortezomib injection, powder, lyophilized, for. Bortezomib is also used to treat people with mantle cell lymphoma a fastgrowing cancer that begins in the cells of the immune system. Bortezomib ps341 is a reversible and selective proteasome inhibitor, and potently inhibits 20s proteasome ki0.
Velcade bortezomib is an antineoplastic agent for intravenous injection iv or subcutaneous sc use only. The assays were performed with triplicate samples, and the results are. Bortezomib cas 179324697 scbt santa cruz biotechnology. The time to progression among patients receiving bortezomib plus melphalanprednisone bortezomib group was 24. H372 causes damage to organs through prolonged or repeated exposure. During formulation, in which mannitol is used, a bortezomibmannitol adduct is formed during lyophilization, which converts to the monomeric form upon reconstitution. Identification of the substancemixture and of the companyundertaking product name. Bortezomib with chemotherapy for relapsed pediatric acute. Bortezomib, cas 179324697, is a cellpermeable, selective, slowly reversible inhibitor of 20s proteasome. Metabolic changes could therefore play an essential role in the. Samples were placed in a shaking incubator 100 rpm for 24 h at 25c prior to centrifugation at 3000 rpm for 10 min to remove undissolved drug. Details of the supplier of the safety data sheet symbolspictograms hazard statements santa cruz biotechnology, inc. Bortezomib drug substance exists in boronic anhydride trimeric form au pdf ausparausparbortezomib116pi. What bortezomib looks like and contents of the pack bortezomib powder for solution for injection is a white to offwhite cake or powder.
Bortezomib is in a class of medications called antineoplastic agents. Patients on bortezomib should be closely monitored if on cyp3a4inhibitors e. Thalidomide vmpt followed by maintenance with bortezomib and thalidomide for initial treatment of elderly multiple myeloma patients, blood, 2009, 11422. Bortezomib is a potent inhibitor of 26s proteasome, which sensitizes activity in dividing multiple myeloma and leukemic cells, thus inducing apoptosis. The concomitant use of bortezomib with strong cyp3a4inducers rifampicin, carabamazepine, phenytoin, phenobarbital, and st johns wort is not recommended as efficacy may be reduced.
Bortezomib resistance in multiple myeloma is associated with. By interfering with their function, bortezomib can kill. The results demonstrated that similarly to the reference. Bortezomib hospira, innbortezomib as a mannitol boronic ester. Fifty milligrams of the drug were added into conical tubes which contained 1 ml of each vehicle. Bortezomib is a drug that has been approved by the food and drug administration fda for treating adults with multiple myeloma which is a type of blood cancer. Management of diarrhea should include, maintaining adequate fluid intake and prompt treatment with loperamide. Velcade bortezomib for injection prescribing information. Formulation and evaluation of a selfmicroemulsifying drug.
Velcade bortezomib dose, indications, adverse effects. Show this safety data sheet to the doctor in attendance. How to use bortezomib solution, reconstituted recon soln this medication is given by injection into a vein or under the skin by a health care professional. Bortezomib is a novel synthetic dipeptide boronic acid with a high specificity for the 26s proteasome and a firstinclass proteasome inhibitor with antitumor activity. Samples were tested for description, ph, assay, related substances and particulate matter. Samples were stored and handled according to label conditions. Bortezomib is recommended as an option within its marketing authorisation, in combination with dexamethasone, or with dexamethasone and thalidomide, for the induction treatment of adults with previously untreated multiple myeloma, who are eligible for highdose chemotherapy with haematopoietic stem cell transplantation.
Iata regulations dangerous goods transported by air 5. Jun 07, 2019 velcade bortezomib for injection is supplied as individually cartoned 10 ml vials containing 3. This is a phase iii study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia all that has come back recurred. Bortezomib also known as velcade, mg341, ps341 is proteasome inhibitor. Material safety data sheet of bortezomib abmole bioscience. Imdg regulations of dangerous goods transported by boat 6. This includes multiple myeloma in those who have and have not previously received treatment. Velcade is indicated for the treatment of patients with mantle cell lymphoma. Patients with severe diarrhea should be carefully monitored for dehydration and given fluid and. Bortezomib originally codenamed ps341 is the first therapeutic proteasome inhibitor to the tested in humans.
Aug 29, 2017 the proteasome inhibitor bortezomib btz is successfully applied in the treatment of multiple myeloma, but its efficacy is restricted by the widespread occurrence of resistance. Ghobrial im, hong f, padmanabhan s, et al, phase ii trial of weekly bortezomib in. Diarrhea is a common side effect in patients receiving bortezomib. Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells.
Disclaimer the sds samples above are collected from the internet by chemblink and displayed here for the tutorial purpose only. Subcutaneous injection of bortezomib represents a change in practice, and there is a potential safety concern if a solution of the increased concentration used for subcutaneous administration 2. Analysis of two commercially available bortezomib products. Product and company identification product name bortezomib product number 2204 identified uses for research use only ruo. Bortezomib is the first proteasome inhibitor to be approved by the us fda for multiple myeloma, a blood cancer.
Proteasomes play an important role in controlling cell function and growth. Bortezomib, sold under the brand name velcade among others, is an anticancer medication used to treat multiple myeloma and mantle cell lymphoma. The introduction of bortezomib, a novel firstinclass proteasome inhibitor, has been a major break through in the treatment of multiple myeloma. Bortezomib ps341 proteasome inhibitor medchemexpress. In the past, cancer treatment has focused primarily on killing rapidly dividing cells because that is an important feature of cancer cells. W hat bortezomib is and what it is used for bortezomib contains the active substance bortezomib, a socalled proteasome inhibitor. A reversible inhibitor of the 26s proteasomea barrelshaped multiprotein particle found in the nucleus and cytosol of all eukaryotic cells.
430 864 612 1071 1421 111 1529 748 1498 155 1542 655 446 865 1512 156 421 1555 299 1152 762 494 418 604 748 400 770 1366 758 588 853 175 1294 216 1096 1019 1174 1127 1280 568 38 166 1055 901 207