Dispense enclosed patient package insert to each patient. Contaminated work clothing must not be allowed out of the. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in table 1. In vivo it spontaneously degrades and reacts with water to release a methyldiazonium cation which preferentially methylates dna at n7 positions of guanine in guanine rich regions. Interaction of temozolomide with dna and repair processes. Temozolomide investigated as a drug, mutagen, and tumorigen. Temozolomide displays antitumor activity against a board spectrum of tumors, including leukemias, lymphomas and solid tumors ic50 5. Harmful by inhalation, in contact with skin and if swallowed.
See actual entry in rtecs for complete information. If you do not have adobe acrobat reader, you can download the most current. Temozolomide is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Temozolomide supplier cas 85622931 nsc 362856 ccrg. Olaparib in combination with temozolomide demonstrated substantial clinical activity in relapsed small. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Material safety data sheet of temozolomide tmz abmole. Pneumocystis pneumonia pcp prophylaxis is required during the concomitant administration of temodar and radiotherapy,and should be continued in patients. Identification of temozolomide resistance factors in. As a cytotoxic alkylating agent, temozolomide is converted at physiologic ph to the shortlived active compound, monomethyl triazeno imidazole carboxamide.
To order an oelade monograph for temozolomide, just click the add to cart button. Product identifier product name temozolomide product number ft28027. Julaug 2007 hormone replacement therapy view all articles in issue. Temozolomide chemical degradation 5aminoimidazole4carboxamide ph effect carbon electrode redox mechanism abstract the evaluation of the chemical degradation of temozolomide tmz, a potential anticancer drug, to its major metabolite 5aminoimidazole4carboxamide aic, in aqueous solution with different ph values.
Drug resistance is a major issue in the treatment of glioblastoma. Temozolomide stability in extemporaneously compounded oral suspensions abstract temozolomide, commercially available in capsules, is an oral alkylating agent used to treat brain tumors. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for temodar temozolomide skip to. Temozolomide has been well characterised and possesses an acceptable clinical safety profile as demonstrated in 1017 patients with malignant glioma, melanoma, or other advanced cancers. Sds are documents that provide critical information about hazardous chemicals. Temozolomide oel fastrac with ade affygility solutions. Temozolomide is an highly orallyavailable, imidazotetrazinebased, monofunctional dna alkylating agent. Temozolomide tmz is an imidazotetrazine that is converted to a compound capable of alkylating dna, thus interfering with dna replication and leading to cytotoxicity in proliferating cells. Sds of temozolomide, safety data sheets, cas 85622931.
Citations are publications that use tocris products. Newly diagnosed glioblastoma multiforme gbm concomitantly. Temozolomide stability in extemporaneously compounded. Temozolomide tmz is a prodrug of 3methyltriazen1ylimidazol4carboxamide. Only select registry of toxic effects of chemical substances rtecs data is presented here. The majority of patients received temodal, once daily for five days, repeating every 28 days up to the high dose of 200 mgm2day. It is an alkylating agent with a broad spectrum of antitumor activity, including brain tumors in children. Temozolomide side effects, dosage, interactions drugs. Temozolomide dosing interruption or discontinuation during concomitant radiotherapy and temozolomide. Commission regulation eu no 2015830 of 28 may 2015. However, if you would like to open and view a safety data sheet you will need to.
Temozolomide is used together with radiation therapy to treat certain types of brain tumor. Role of autophagy in temozolomideinduced cytotoxicity for malignant glioma cells. They should be swallowed whole with a glass of water. Temozolomide dna alkylating agent cellagen technology. A prodrug for m tic 53methyltriaz1en1yl1 h imidazole4carboxamide, formed by spontaneous hydrolysis of temozolomide in the body, it is used as an oral alkylating agent for the treatment of newly diagnosed malignant glioblastoma multiforme concomitantly with radiotherapy and malignant melanoma. Temozolomide tmz is a cytotoxic agent of the imidazotetrazine class, chemically related to dacarbazine. Repeated administration of temozolomide to animals produced toxicity to the immune system and blood e. M for cytotoxicity against mouse tlx5 lymphoma cells. It is an alkylating agent used as a treatment of some brain cancers.
If capsules are accidentally opened or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes see how suppliedstorage and handling 16. Safety data sheet temozolomide according to regulation ec no 19072006, annex ii, as amended. Temozolomide temodar is an oral alkylating agent approved by the fda for use in the firstline treatment of glioblastoma multiforme as well as for recurrent anaplastic astrocytoma. Buy temozolomided3 cas 208107146, a labeled antineoplastic chemical, from santa cruz. Identification of the substancemixture and of the companyundertaking 1. Absolute neutrophil count greater than or equal to 0.
For research use only, not for human or veterinary use. Temodar temozolomide capsules should not be opened or chewed. Stability of temozolomide in solutions aimed for oral. Safety data sheet temozolomide acid according to regulation ec no 19072006, annex ii, as amended. Extreme high moderate low section 1 chemical product and company identification product name temozolomide statement of hazardous nature considered a hazardous substance according to osha 29 cfr 1910. Temozolomide chemical degradation to 5aminoimidazole4. Phase i trial of aflibercept vegf trap with radiation therapy and concomitant and adjuvant temozolomide in patients with highgrade gliomas. Temozolomide exhibits scheduledependent antineoplastic activity by interfering with dna replication. Prabhu et al 20 targeting the unfolded protein response in glioblastoma cells with the fusion protein egfsuba.
Stevens, in cancer drug design and discovery second edition, 2014. Temozolomide is used together with radiation therapy to treat certain types of brain tumor in adults temozolomide is usually given after other cancer medicines have been tried without success. Temodar market exclusivity period mep, news, international patents, generic entry, and litigation and lawsuits. Sigmaaldrich offers a number of temozolomide products. Its use poses higher risks of lymphopenia and opportunistic infections. Find patient medical information for temozolomide oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Temozolomide is carcinogenic in rats at doses less than the maximum recommended human dose. A formulation for preparing temozolomide 10mgml oral liquid. Temozolomide induced mammary carcinomas in both males and females at doses 0. Material safety data sheet temozolomide sc203292 hazard alert code key. There are sixteen drug master file entries for this compound. Temozolomide promiscuously methylates a range of sites in purine residues of dna, notably at the n 7 position of guanine. If youre wondering about hbel, we have something for you. The purpose of this study was to determine the pharmaceutical acceptability and chemical stability of temozolomide in two extempora.
Temozolomide is an antitumor, antiangiogenic compound that has been shown to work by alkylating dna, typically through addition of a methyl group to guanine in genomic dna. Pharmacist information sheet important dispensing information for every patient, temodar must be dispensed in a separate vial or in its. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Product identifier product name temozolomide acid product number ft63449 cas number 1942306 1. Includes ingredients, method of preparation, discussion, and references for the compounding pharmacist.
The efficacy of this compound is dependent on its ability to methylate the dna, thus triggering apoptosis. Almost all glioblastomas are intrinsically resistant to chemotherapeutic temozolomide tmz or develop resistance during treatment. Temozolomide temodar american journal of neuroradiology. Temozolomide is a triazene analog of dacarbazine with antineoplastic activity. Registrationlogin is required to view the sheets which appear to be all in pdf format. The cytotoxicity of mtic is due primarily to methylation of dna at the o6 and n7 positions of guanine, resulting in inhibition of dna.
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