Niosh list of antineoplastic and other hazardous drugs cdc. Hycamtin has been associated with reports of interstitial lung disease. Hycamtin topotecan for injection, for intravenous use. Topotecan inhibits topoisomerasei, an enzyme that functions in dna replication to relieve the torsional strain introduced ahead of the moving replication fork. Fda label information for this drug is available at dailymed. Germ cell mutagenicity of topoisomerase i inhibitor topotecan detected in the male mousedominant lethal study. Topotecan hydrochloride safety data sheet section 2. Topotecan inhibits topoisomerasei, an enzyme that functions in dna replication to relieve the. When topotecan hydrochloride hycamtin is not covered topotecan hydrochloride hycamtin is considered not medically necessary and therefore not covered when above criteria are not met. Check the msds or the proper handling section of the. Material safety data sheet of topotecan hydrochloride contains identification of substance and details of the supplier of the safety data sheet. At ph less than or equal to 4, the lactone is exclusively present, whereas the ringopened hydroxyacid form predominates at physiologic ph. Topotecan fda prescribing information, side effects and uses.
When this happens, the dna strand breaks further and cannot be repaired resulting in cell death. Balmus et al 2019 atm orchestrates the dnadamage response to counter toxic nonhomologous endjoining at broken replication forks. Exposure controls personal protection control parameters refer to available public information for specific member state occupational exposure. M of topotecan hydrochloride is selected as the optimal administration concentration in the subsequent experiments. Topotecan manufacturers, topotecan suppliers, topotecan. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. It is a synthetic, watersoluble analog of the natural chemical compound camptothecin. Bioavailability and pharmacokinetics of oral topotecan. Topotecan hydrochloride for injection topotecan 54 hydrochloride product information. It is a water soluble analog of the alkaloid camptothecin that potently inhibits dna topoisomerase i. Material safety data sheet of topotecan hydrochloride. Containers were maintained at 5 degrees c for 7 days or 2324 degrees c for 24 h.
Topotecaninduced neutropenia can lead to neutropenic colitis. Topotecan hydrochloride united states pharmacopeia usp. Sheet provided by the manufacturer that summarizes the chemical properties. Topotecan hydrochloride is approved to be used alone or with other drugs to treat cervical cancer that has not gotten better with.
Topotecan inhibits topoisomerasei by stabilizing the covalent complex of enzyme and strandcleaved dna which is an. Topotecan hydrochloride for injection hycamtin 4 mg mylan. Drug product pharmaceutical bulk, primary packed, finished product, pharmaceutical. Topotecan is a semisynthetic derivative of camptothecin, a cytotoxic, quinolinebased alkaloid extracted from the asian tree camptotheca acuminata. Topotecan hydrochloride for injection topotecan 54. Effect of topotecan on retinocytoma cell apoptosis and expression of livin and pten. Dailymed hycamtin topotecan hydrochloride injection. Biotang inc topotecan, hydrochloride salt, 1g 99% skf. Make sure you know the difference between capsules because one contains 4 times as much topotecan as the other, even though they may look the same in size.
Topotecan hydrochloride induces rapid apoptotic death in human blineage acute lymphoblastic leukemia all cells with ic50 values of 33 nm and 0. It kills cancer cells by interfering with the genetic material dna, which is necessary for their growth and reproduction. Topotecan skf104864 has been reported to have a potent antitumor activity against tumors in murine models. Cervical cancer that has not gotten better with other treatment or has recurred come back. Topotecan capsules are taken by mouth, with or without food. Nov 01, 2019 topotecan hydrochloride can cause severe myelosuppression. Topotecan hydrochloride is approved to be used alone or with other drugs to treat. Product information brochure hy7111 for hycamtin topotecan hcl for injection.
Topotecan injection is a solution containing topotecan hydrochloride. Topotecan hydrochloride supplier cas 1194546 tocris. Topotecan skf104864 has been reported to have a potent antitumor activity against tumors in. Topotecan hclskf104864is an inhibitor of topoisomerase 1 and semisynthetic analogue of camptothecin 1. The ic 50 values of topotecan hydrochloride at 24 h are 2. Topotecan is a yellow to green powder with a solubility in water of 80. Topotecan is not able to discriminate between good cells. Selected citations for topotecan hydrochloride include. Topotecan hydrochloride injection, solution, concentrate hospira, inc. Topotecan is a semisynthetic, water soluble derivative of camptothecin, which is a cytotoxic alkaloid extracted from plants such as camptotheca acuminata. Please contact pfizer canada medical information at 1 800 4636001 with any comments or inquiries. Topotecan hydrochloride monograph for professionals.
Topotecan hydrochloride hycamtin, nsc 609669 cas 1194. Topotecan hydrochloride united states pharmacopeia usp reference standard. The pka values obtained for the quinoline, phenol and benzyldimethylamino groups of topotecan tydrochloride were 0. Topotecan trade name hycamtin is a chemotherapeutic agent that is a topoisomerase inhibitor. Topotecan hydrochloride 1067286752 451672257 cymit. It inhibits the action of topoisomerase i, an enzyme that produces reversible singlestrand breaks in dna during dna replication. You may need to take two different colored capsules at one time.
Monitor blood cell counts see warnings and precautions 5. Oct 11, 2019 topotecan hydrochloride for injection is a semisynthetic derivative of camptothecin and is an antitumor drug with topoisomerase iinhibitory activity. Material safety data sheet of topotecan hydrochloride abmole. Dailymed topotecan hydrochloride injection, powder. Topotecan hclskf104864has been reported to have a potent antitumor activity. For research use only, not for human or veterinary. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500mm3 and platelet counts greater than or equal to 100,000mm3. Sep, 2018 topotecan undergoes a reversible phdependent hydrolysis of its pharmacologically active lactone moiety. Topotecan may also be given for 5 consecutive days every 34 weeks, but. Topotecan hydrochloride for injection by accord healthcare inc topotecan belongs to the group of cancerfighting medications known as antineoplastics.
Stability and compatibility of topotecan hydrochloride for. Topotecan is metabolized to an ndemethylated metabolite in vitro. Safe handling of hazardous chemotherapy drugs in limited. Topotecan is a pyranoindolizinoquinoline used as an antineoplastic agent. Policy guidelines ovarian cancer and small cell lung cancer. Ensure that medical personnel are aware of the materials involved and take precautions to protect themselves. Clinically, it is used to treat certain types of cancers. For research use only, not for human or veterinary use. Topotecan hcl can take up two moles of water without impacting the basic crystalline structure, 53 i. The dosage is based on your medical condition, body size. It is a derivative of camptothecin and works by binding to the topoisomerase idna complex and preventing religation of. Biotang inc topotecan, hydrochloride salt, 1g 99% skf104864a. Jan 09, 2015 register now and get a free online msds binder.
Additionally, the topotecan hydrochloride formulation was added to 50 ml pvc infusion bags containing either 5% dextrose injection or 0. Please consult a qualified health professional for more detailed information. Monitor patients for symptoms and discontinue hycamtin if the diagnosis is confirmed. Fecal elimination of total topotecan accounted for 18% 4% while fecal elimination of ndesmethyl topotecan was 1. Ovarian cancer in patients whose disease has not gotten better with other chemotherapy. An oglucuronidation metabolite of topotecan and ndesmethyl topotecan has been identified in the urine.
Topotecan skf104864 is an inhibitor of topoisomerase 1 and semisynthetic analogue of camptothecin 1. If you encounter technical difficulties in viewing our product information please contact. Find here information of topotecan manufacturers, topotecan suppliers and topotecan exporters from india. Antineoplastic pregnancy risk category d fda box warning give under supervision of physician. This medication is given by a health care professional. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. The reference listed drug, hycamtin topotecan hydrochloride for injection, was approved on. Topotecan hydrochloride for injection by accord healthcare. D02168 topotecan hydrochloride usan new drug approvals in europe br08329. Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means.
Topotecan hclskf104864has been reported to have a potent antitumor activity against tumors in murine models. Topotecan is typically given weekly for three consecutive weeks out of a four week cycle on days 1, 8, and 15 of a 28 day cycle. May cause eye, skin, or respiratory system irritation. Topotecan inhibits topoisomerase i activity by stabilizing the topoisomerase idna covalent complexes during s phase of cell cycle, thereby inhibiting religation of topoisomerase imediated singlestrand dna breaks and producing potentially lethal. Exposure controls personal protection control parameters refer to available public information for specific member state occupational exposure limits. Topotecan has the same mechanism of action as irinotecan. Group 3 not classifiable in vitro mammalian cell mutagenicity mouse lymphoma positive version. Product monograph download pdf, 331kb patient information download pdf, 177kb canadian. Topotecan hydrochloride for injection hycamtin 4 mg. Topotecan hydrochloride for injection is a semisynthetic derivative of camptothecin and is an antitumor drug with topoisomerase iinhibitory activity.
Oct 08, 2019 mean values of 51% 3% as total topotecan and 3% 1% as ndesmethyl topotecan were excreted in the urine. Topotecan induces apoptosis in retinocytoma cells and ovarian cancer cells. Topotecan hydrochloride liposomes incorporated into thermosensitive hydrogel for sustained and efficient in situ therapy of h22 tumor in kunming. Citations are publications that use tocris products. The pka values obtained for the quinoline, phenol and benzyldimethylamino groups of topotecan. Synonyms topotecan hcl unii 956s425zcy cas number 1194546 weight average. Material may be irritating to the mucous membranes and upper respiratory tract. May be harmful by inhalation, ingestion, or skin absorption. Topotecan hydrochloride for injection is supplied as a sterile lyophilized, buffered, light yellow to greenish powder available in singledose vials. Material safety data sheet for topotecan hydrochloride hydrate. The molecular formula is c 23 h 23 n 3 o 5 hcl and the molecular weight is 457. Topotecan hydrochloride trade name hycamtin is a potent antineoplastic agent. Topotecan interferes with the function of an enzyme called topoisomerase i used by cells to repair breaks in the dna the machinery or brain that runs each cell strand. Topotecan hydrochloride is the watersoluble hydrochloride salt preparation of topotecan, a potent inhibitor of topoisomerase 1 topo i, producing proapoptotic and antiproliferative effects.
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