Repeated administration of temozolomide to animals produced toxicity to. Oct 25, 2017 the material is a white to light tanlight pink powder with a molecular formula of c 6 h 6 n 6 o 2 and a molecular weight of 194. Temozolomide stability in extemporaneously compounded oral suspensions abstract temozolomide, commercially available in capsules, is an oral alkylating agent used to treat brain tumors. Temozolomide chemical degradation to 5aminoimidazole4carboxamide electrochemical study ilanna c. Repeated administration of temozolomide to animals produced toxicity to the immune system and blood e.
Commission regulation eu no 2015830 of 28 may 2015. Temozolomide dna alkylating agent cellagen technology. Harmful by inhalation, in contact with skin and if swallowed. 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. Temozolomide stability in extemporaneously compounded oral. Temozolomide induces g2m arrest and apoptosis through adduction of a methyl group to. Taking this medicine temozolomide capsules on an empty stomach may help prevent upset stomach. Certain features of will be unavailable due to maintenance from saturday morning, april 25th at 9. The main advantage of temozolomide over dacarbazine lies in its. Pneumocystis pneumonia pcp prophylaxis is required during the concomitant administration of temodar and radiotherapy,and should be continued in patients. Safety data sheet temozolomide acid according to regulation ec no 19072006, annex ii, as amended.
For some types of brain tumors, temozolomide is taken daily for 4249 days. Temozolomide exhibits a mean elimination halflife of 1. Temozolomide vetranal, analytical standard neat form. 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. A simplified overall mechanism of methylation of dna guanine residues at the o 6 positions by temozolomide, mismatch base pairing, and repair by an activesite cysteine residue of mgmt is shown. It is an alkylating agent with a broad spectrum of antitumor activity, including brain tumors in.
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 tmz is a prodrug of 3methyltriazen1ylimidazol4carboxamide. Temozolomide tmz is an oral dna methylating, chemotherapeutic agent. Safety data sheet temozolomide according to regulation ec no 19072006, annex ii, as amended. Almost all glioblastomas are intrinsically resistant to chemotherapeutic temozolomide tmz or develop resistance during treatment. Material safety data sheet according to eec directives 91155eec and 93112ec dplubricant blue 20000201 product name. In laboratory animals, temozolomide is moderately toxic by ingestion, slightly irritating to the skin and eyes, and nonsensitizing.
Temozolomide is a prodrug and converts spontaneously to mtic which is also the known active metabolite of dacarbazine. Temozolomide is an orally administered chemotherapeutic drug that methylates dna in a way that prevents tumor cell proliferation. Supplied as 5mg, 20mg, 100mg, 140mg, 180mg and 250mg capsules pretreatment assessment. No component of this product present at levels greater than or equal to 0. Temozolomide acid, also known as tmza, is a metabolite of temozolomide tmz with demonstrable anticancer activity in vitro. Temozolomide for recurrent high grade gliomas protocol. Identification of the substancemixture and of the companyundertaking 1. Identification and physicochemical characteristics of. Buy dnarna synthesis inhibitor temozolomide tmz nsc362856, ccrg81045 from abmole bioscience.
Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. 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. Dosage in cycle 1 maintenance is 150 mgm2 once daily for 5 days followed by 23 days without treatment. Accidental release measures contain spill and collect, as. Safety data sheet oxytocin injection revision date 02. Learn to walk like a penguin to prevent winter falls. Temozolomide tmz nsc362856, ccrg81045 cas 85622931. Temozolomide, tmz brand names temodar and temodal and temcad is an oral chemotherapy drug. Food reduces the rate and extent of temozolomide absorption. Identification of the substancemixture and of the companyundertaking product information product name. Material safety data sheet of temozolomide tmz abmole. Take temozolomide at around the same time every day. Temozolomide can be called as an oral alkylating agent and antitumour drug, which may show potent activity in the treatment of recurrent gliomas or glioblastoma, a kind of tumour that affects the brain or. Formation of toxic gases is possible during heating or fire.
Temozolomide is a second generation imidazotetrazine anticancer chemotherapeutic that is clinically approved to treat gliobastoma multiforme, anaplastic astrocytoma, and oligodendrocytoma. 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. Identification of temozolomide resistance factors in. No component of this product present at levels greater than or. Temozolomide is an highly orallyavailable, imidazotetrazinebased, monofunctional dna alkylating agent. Temozolomide is a dna methylating agent and drug resistancemodifying agent. Temozolomide is rapidly and completely absorbed after oral administration. Chemical storage and segregation cornell university. Temozolomide is an alkylating agent used in the treatment of brain tumors astrocytoma and glioblastoma multiforme and melanomas, at least before the area of targeted agents and immunotherapy. Temozolomide is a secondgeneration alkylating agent approved by the food and drug administration in 1999 1, 2, 5. Identification of the substancemixture and of the companyundertaking product name. Temozolomide induced mammary carcinomas in both males and females at doses 0. As a cytotoxic alkylating agent, temozolomide is converted at physiologic ph to the shortlived active compound, monomethyl triazeno imidazole carboxamide. Temozolomide chemical degradation to 5aminoimidazole4.
For research use only, not for human or veterinary use. Toxicity profile of temozolomide in the treatment of 300. The crystal structures of temozolomide polymorphs, as well as its cocrystals with 4,4bipyridinen,ndioxide have been reported by jagadeesh babu et al. Temozolomide 150mgm 2 orally once a day at bedtime for 5 days cycle 1 temozolomide 200mgm 2 orally once a dayat bedtime for 5 days from cycle 2 if cycle 1 tolerated repeated every 28 days for 6 cycles.
Cellagen technology llc 5940 pacific mesa court, suite 206, ca 92121, usa tel. Other metabolites include temozolomide acid and unidentified hydrophilic substances. Highlights of prescribing information pneumonia pcp pcp. Stability of temozolomide in solutions aimed for oral. It is an alkylating agent with a broad spectrum of antitumor activity, including brain tumors in children. Jul 11, 2014 temozolomide has been used in the treatment of glioma and it has been shown to improve the outcomes. Material may be irritating to the mucous membranes and upper respiratory tract. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Newly diagnosed glioblastoma multiforme gbm concomitantly. Material safety data sheet temozolomide sc203292 hazard alert code key. Pdf on jan 1, 2017, maryam omidi and others published using of cornell measuring tool cornell musculoskeletal discomfort questionnaires for assessment of the musculoskeletal disorders.
These sdss are designed to provide essential information. The purpose of this study was to determine the pharmaceutical acceptability and chemical stability of temozolomide. The majority of patients received temodal, once daily for five days, repeating every 28 days up to the high dose of 200 mgm2day. Sds of temozolomide, safety data sheets, cas 85622931. Temozolomide tmz, is an antineoplastic agent that acts through its degraded biological form. Temozolomide is used together with radiation therapy to treat certain types of brain tumor in adults temozolomide. Us20120283304a1 formulations of temozolomide for parenteral. Temozolomide temodar american journal of neuroradiology. Glioblastoma patients with decreased levels due to methylated mgmt promoter may be more likely to benefit from the combination of radiation therapy and temozolomide hegi 2008. Kanzawa et al 2004 role of autophagy in temozolomide induced cytotoxicity for malignant glioma cells. Product and company identification space synonyms softwood plywood oriented strand board osb hardboard. It is usually taken once a day in the evening at bedtime. Take temozolomide capsules on an empty stomach with a glass of water. Other information text of r phrases mentioned in section 3 r61 may cause harm to the unborn child.
The present invention relates to a parenteral formulation of temozolomide comprising an excipient selected from the group consisting of bulking agents, buffers, ph adjusting agents, with the proviso that the formulation is free of dissolution enhancing agents. Temozolomide should be taken whole and not crushed, cut, or dissolved. Temozolomide is an alkylating agent that alkylatesmethylates guanine residues, resulting in dna damage and cell death. Extreme high moderate low section 1 chemical product and company identification product name temozolomide. Jun 11, 2014 drug resistance is a major issue in the treatment of glioblastoma. If you are unable to swallow temozolomide, talk to your care provider or pharmacist for possible options.
Temozolomide supplier cas 85622931 nsc 362856 ccrg. Increased o6methylguaninedna methyltransferase mgmt activitylevels within tumor tissue is associated with temozolomide resistance. Temozolomide accord is used first with radiotherapy and then on its own. Temozolomide can make you more likely to get infections or may worsen any current infections. Welcome to the winter safety page, where you can find all your winter safety needs. Sigmaaldrich offers a number of temozolomide products. Temozolomide is a triazene analog of dacarbazine with antineoplastic activity. The occupational safety and health administrations osha hazard communication standard 29 cfr 1910.
Absolute neutrophil count greater than or equal to 0. The recommended dose for temozolomide as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Mtic is further hydrolyzed to 5aminoimidazole4carboxamide aic, which is known to be an intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species. Product and company identification space synonyms softwood plywood oriented strand board osb hardboard standard, tempered, perforated, paneling lumber products engineered lumber lvl, woodijoists. Avoid contact with people who have infections that may spread to others such as chickenpox, measles. Material safety data sheet tarcevar tablets 100 mg section 1. Extend your arms to keep your balance, point your feet slightly. Accidental release measures contain spill and collect, as appropriate.
It is an alkylating agent used as a treatment of some brain cancers. It may also help to take this medicine temozolomide capsules at bedtime. Temozolomide remains in your body for several days after it is taken, so some of the drug may be present in urine, stool, sweat, or vomit. Bioequivalence has been established only when temozolomide. Other drugs may be given with this medicine temozolomide. Temozolomide dosing interruption or discontinuation during concomitant radiotherapy and temozolomide. Mtic splits into monomethylhydrazine, probably the active methylating agent, and 5aminoimidazole4carboxamide aic. The purpose of this study was to determine the pharmaceutical acceptability and chemical stability of temozolomide in two extempora. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in table 1. Temodar temozolomide for injection administered via intravenous infusion. Mar 01, 2020 temozolomide is spontaneously hydrolyzed at physiologic ph to the active species, mtic and to temozolomide acid metabolite.