By interfering with their function, bortezomib can kill. Velcade bortezomib dose, indications, adverse effects. H372 causes damage to organs through prolonged or repeated exposure. Solubility studies the solubility of bortezomib in various vehicles was determined. Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. Formulation and evaluation of a selfmicroemulsifying drug. This includes multiple myeloma in those who have and have not previously received treatment. Analysis of two commercially available bortezomib products. The results demonstrated that similarly to the reference. Imdg regulations of dangerous goods transported by boat 6. Samples were tested for description, ph, assay, related substances and particulate matter. W hat bortezomib is and what it is used for bortezomib contains the active substance bortezomib, a socalled proteasome inhibitor.
Identification of the substancemixture and of the companyundertaking product name. Bortezomib is in a class of medications called antineoplastic agents. Material safety data sheet msds cell signaling technology. Handling should only be performed by personnel trained and familiar with borteaomib of potent active pharmaceutical ingredients moderate to severe irritant to the skin and eyes 4. Bortezomib also known as velcade, mg341, ps341 is proteasome inhibitor. In the past, cancer treatment has focused primarily on killing rapidly dividing cells because that is an important feature of cancer cells. Management of diarrhea should include, maintaining adequate fluid intake and prompt treatment with loperamide. 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. 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. Fifty milligrams of the drug were added into conical tubes which contained 1 ml of each vehicle. The concomitant use of bortezomib with strong cyp3a4inducers rifampicin, carabamazepine, phenytoin, phenobarbital, and st johns wort is not recommended as efficacy may be reduced. An nmr study of the bortezomib degradation under clinical. Pdf analysis of two commercially available bortezomib.
Apr 01, 2011 velcade samples, in the containers in which velcade is marketed, containing 3. Velcade bortezomib is an antineoplastic agent for intravenous injection iv or subcutaneous sc use only. 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. Find all the information about bortezomib velcade for cell signaling research. 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. Bortezomib is the first proteasome inhibitor to be approved by the us fda for multiple myeloma, a blood cancer. Metabolic alterations play an important role in cancer development and aid in the cellular adaptation to pharmacologically changed environments.
The assays were performed with triplicate samples, and the results are. In addition, bortezomib appears to increase the sensitivity of cancer cells to traditional anticancer agents e. A reversible inhibitor of the 26s proteasomea barrelshaped multiprotein particle found in the nucleus and cytosol of all eukaryotic cells. Patients with severe diarrhea should be carefully monitored for dehydration and given fluid and. According to regulation ec no 19072006, annex ii, as amended. 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. 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. What bortezomib looks like and contents of the pack bortezomib powder for solution for injection is a white to offwhite cake or powder. Thalidomide vmpt followed by maintenance with bortezomib and thalidomide for initial treatment of elderly multiple myeloma patients, blood, 2009, 11422.
Show this safety data sheet to the doctor in attendance. The consequence of inhibiting the proteasome is the matter of some speculation. During formulation, in which mannitol is used, a bortezomibmannitol adduct is formed during lyophilization, which converts to the monomeric form upon reconstitution. Product and company identification product name bortezomib product number 2204 identified uses for research use only ruo.
Cyclophosphamide bortezomib dexamethasone cyclobordex. Details of the supplier of the safety data sheet symbolspictograms hazard statements santa cruz biotechnology, inc. Velcade bortezomib dosing, indications, interactions. Bortezomib resistance in multiple myeloma is associated. Bortezomib drug substance exists in boronic anhydride trimeric form au pdf ausparausparbortezomib116pi. Disclaimer the sds samples above are collected from the internet by chemblink and displayed here for the tutorial purpose only. Jun 07, 2019 velcade bortezomib for injection is supplied as individually cartoned 10 ml vials containing 3. Bortezomib cas 179324697 scbt santa cruz biotechnology.
Velcade fact sheet last update 11282015 how velcade works. P280 wear protective gloves protective clothing eye protection face protection. Bortezomib is used to treat people with multiple myeloma a type of cancer of the bone marrow. Bortezomib is a novel synthetic dipeptide boronic acid with a high specificity for the 26s proteasome and a firstinclass proteasome inhibitor with antitumor activity. Bortezomib is also used to treat people with mantle cell lymphoma a fastgrowing cancer that begins in the cells of the immune system. Material safety data sheet of bortezomib abmole bioscience. Bortezomib originally codenamed ps341 is the first therapeutic proteasome inhibitor to the tested in humans. Material safety data sheet of bortezomib contains identification of substance and details of the supplier of the safety data sheet. The introduction of bortezomib, a novel firstinclass proteasome inhibitor, has been a major break through in the treatment of multiple myeloma. Samples were stored and handled according to label conditions. Bortezomib resistance in multiple myeloma is associated with. Proteasomes play an important role in controlling cell function and growth. The time to progression among patients receiving bortezomib plus melphalanprednisone bortezomib group was 24.
Metabolic changes could therefore play an essential role in the. Bortezomib, sold under the brand name velcade among others, is an anticancer medication used to treat multiple myeloma and mantle cell lymphoma. 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. Bortezomib, cas 179324697, is a cellpermeable, selective, slowly reversible inhibitor of 20s proteasome.
Dailymed bortezomib injection, powder, lyophilized, for. Ghobrial im, hong f, padmanabhan s, et al, phase ii trial of weekly bortezomib in. Bortezomib safety data sheet according to regulation ec no. Bortezomib is a potent inhibitor of 26s proteasome, which sensitizes activity in dividing multiple myeloma and leukemic cells, thus inducing apoptosis. Bortezomib ps341 proteasome inhibitor medchemexpress. Iata regulations dangerous goods transported by air 5. Bortezomib velcade in the treatment of multiple myeloma. For maximum solubility in aqueous buffers, bortezomib should first be dissolved in dmso and then diluted with the aqueous buffer of choice. Diarrhea is a common side effect in patients receiving bortezomib. 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. Bortezomib ps341 is a reversible and selective proteasome inhibitor, and potently inhibits 20s proteasome ki0.
The aim of this investigation was to assess the stability of bortezomib solution 2. Patients on bortezomib should be closely monitored if on cyp3a4inhibitors e. This chemical, bortezomib cas 179324697, is sparingly soluble in aqueous buffers. Bortezomib hospira, innbortezomib as a mannitol boronic ester. The following bortezomib msds detailed information are provided by hangzhou holypharm biotech co. Velcade bortezomib for injection prescribing information. Bortezomib with chemotherapy for relapsed pediatric acute.