The molecular formula is c 10 h 7 cl 2 n 3 ohclh 2 o which corresponds to a molecular weight of 310. Anagrelide hydrochloride is the hydrochloride salt of a synthetic quinazoline derivative, anagrelide hydrochloride reduces platelet production through a decrease in megakaryocyte maturation. Material safety data sheet of anagrelide hydrochloride. Orphan australia is now seeking registration of a different anagrelide product, thromboreductin. Please refer to each products fdaapproved label and indication for further information. Anagrelide is a selective thrombocytopenic agent 1. Anagrelide hcl api manufacturers suppliers drug master.
The anagrelide hydrochloride revision bulletin supersedes the currently official. Anagrelide hydrochloride bl4162a is a drug used for the treatment of essential. Anagrelide hydrochloride, usp is a white to off white powder that is practically insoluble in water and slightly soluble in dimethyl sulfoxide and very slightly soluble in dimethylformamide. Anagrelide is an inhibitor of cyclic amp phosphodiesterase iii pde iii.
Anagrelide agrylinxagrid, shire and thromboreductin, aop orphan pharmaceuticals ag is a drug used for the treatment of essential thrombocytosis also known as essential thrombocythemia, or overproduction of blood platelets. Agrylin anagrelide hydrochloride capsules prescribing information. Anagrelide hydrochloride is fda approved for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to improve associated symptoms including thrombohemorrhagic events a process that involves either a blood clot or bleeding, such as a heart attack or stroke. Anagrelide hydrochloride oral capsule drug information, side. Development and validation of a stabilityindicating rp. Hcl chemical name cas noweight % oral ld50 dermal ld50 inhalation lc50 anagrelide hydrochloride5857951498 1500 mgkg rat 4. Wet activated carbon depletes oxygen from the air and therefore dangerously low levels of oxygen. In some cases, health care professionals may use the trade name agrylin when referring to the generic drug name anagrelide. Ensure that medical personnel are aware of the materials involved and take precautions to protect themselves. However, we make no warranty of merchantability or any other warranty, express or implied, with. Adobe acrobat reader is required to reliably view, print and comment on pdf documents anagrelide hydrochloride product citations see how others have used anagrelide hydrochloride. Anagrelide hcl air ih sample method safebridge consultants.
Australian public assessment report for anagrelide. No changes to the approved product information have been requested as a co nsequence of this study report. Find patient medical information for anagrelide oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Find information about common, infrequent and rare side effects of anagrelide oral. Anagrelide inhibits cyclic amp phosphodiesterase, as well as adp and collageninduced platelet aggregation.
Each anagrelide hydrochloride capsule, for oral administration, contains either 0. It works by inhibiting the maturation of megakaryocytes into platelets. The information given is designed only as a guidance for safe handling, use, processing, storage. Use of concomitant anagrelide and acetylsalicylic acid has been associated with major haemorrhagic events see section 4. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy.
See actual entry in rtecs for complete information. The purpose of this revision is to include a process specific impurity, anagrelide open ring methyl ester, with acceptance criteria of nmt 0. Anagrelide hydrochloride leukemia and lymphoma society. Hydrochloric acid, 37% ww safety data sheet according to federal register vol. Anagrelide hydrochloride is a potent pde3 type iii phosphodiesterase inhibitor. Anagrelide ana hydrochloride is an oral imidazoquinazoline registered as an orphan. At therapeutic doses, it does not influence white cell counts or coagulation parameters.
Learn about the reported side effects, related class drugs, and how these medications will affect your daily lifestyle. The information provided in this material safety data sheet is correct to the best of our knowledge, information and belief at the date of its publication. It also has been used in the treatment of chronic myeloid leukemia. Anagrelide hydrochloride safety data sheet section 2. Anagrelide 6,7dichloro1,5dihydroimidazo2,1bquinazolin23hone, fig. Anagrelide is a potent inotropic agent for dogs with remarkable vasodilatory activity. Anagrelide hydrochloride cas 58579514 scbt santa cruz. Only select registry of toxic effects of chemical substances rtecs data is presented here.
It is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and dimethylformamide. Anagrelide hydrochlorideproduct ingredient for anagrelide. Anagrelide is a drug used for the treatment of essential thrombocytosis et. A simple, rapid, and stabilityindicating reversephase liquid chromatographic assay method was developed for anagrelide hydrochloride ang in the presence of its degradation products generated from forced decomposition studies. Agrylin anagrelide hydrochloride is a plateletreducing agent used to treat thrombocythemia also called thrombocytosis, a blood cell disorder in which too many platelet cells are produced, causing bleeding or bloodclotting problems. Identification of the substancemixture and of the companyundertaking product name. In two clinical interaction studies in healthy subjects, coadministration of singledose anagrelide 1mg and aspirin 900mg or repeatdose anagrelide 1mg once daily and aspirin 75mg once daily showed greater. Inquire about dmf, cgmp, price, availability, samples, sourcing, purity and more. Anagrelide hydrochloride ag is an imidazolequinazoline derivative that inhibits bone marrow megakaryocytopoiesis, and this activity underlies the use of the drug in reducing the high platelet. Development and validation of a stabilityindicating rphplc. Anagrelide hydrochloride for essential thrombocythemia.
Pde anagrelide hydrochloride is an oral imidazoquinazoline agent that has been shown to reduce elevated platelet counts and the risk of thrombosis in patients with thrombocythaemia in various myeloproliferative disorders mpd. Anagrelide is used for treatment of essential thrombocythemia. Pdeanagrelide hydrochloride is an oral imidazoquinazoline agent that has been shown to reduce elevated platelet counts and the risk of thrombosis in patients with thrombocythaemia in various myeloproliferative disorders mpd. Following oral administration, peak plasma concentrations attained within 12 hours. Anagrelide hydrochloride bl4162a is a drug used for the treatment of essential thrombocytosis. If released to soil, anagrelide is expected to have slight mobility based upon an estimated koc of 2400. Usp anagrelide hydrochloride rs into a suitable volu use freshly prepared standard and sample solutions and metric flask, add a small amount of 2n hydrochloric inject within 2 h. Our msds database is an easy to use, do it yourself tool, and best of all. Spotlight on anagrelide hydrochloride for the treatment of.
Anagrelide can be useful in times when hydroxyurea proves ineffective. Anagrelide selectively affects thrombocytes while shows no significant effect on white blood cells, erythrocytes, or coagulation. Based on limited data, there appears to be a trend toward dose linearity between doses of 0. It is considered that enough of the process has been included in the dossier and carried out under gmp such that the fate and purge of impurities can be unders tood. Anagrelide hydrochloride newchem technologies limited, durham, uk was. Anagrelide is used to decrease the number of platelets a type of blood cell that is needed to control bleeding in the blood of patients who have a bone marrow disorder, in which the body makes too many of one or more types of blood cells, such as essential thrombocythemia condition in which the body makes too many platelets or polycythemia vera condition in which the body makes too many. Name anagrelide hydrochloride drug entry anagrelide. Anagrelide capsules, 1 mg are available as white opaque hard.
If this product is combined with other materials, deteriorates or becomes contaminated, it. Anagrelide belongs to the imidazo2,1bquinazolin2one series of compounds. Feb 24, 2020 anagrelide is an inhibitor of cyclic amp phosphodiesterase iii pde iii. Verapamil hydrochloride investigated as a drug, mutagen, and reproductive effector. Uranium phosphide reacts with hydrochloric acid to release spontaneously flammable phosphines.
Anagrelide side effects, dosage, interactions drugs. Mar 17, 2020 agrylin anagrelide hydrochloride is a plateletreducing agent. Anagrelide fda prescribing information, side effects and. Orphan designations pursuant to section 526 of the federal food and cosmetic act as amended by the orphan drug act p. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Anagrelide is a synthetic quinazoline derivative, anagrelide reduces platelet production through a decrease in megakaryocyte maturation. Anagrelide hydrochloride pharmacokinetics absorption bioavailability. Anagrelide hydrochloride bl4162a is a drug used for the treatment of essential thrombocytosistarget. The same mrc trial mentioned above also analyzed the effects of anagrelide on bone marrow fibrosis, a common feature in patients with myelofibrosis.
It is originally identified as a potential inhibitor of platelet aggregation. Anagrelide is a fdaapproved drug for the treatment of essential thrombocythemia. Agrylin anagrelide hydrochloride dose, indications, adverse. Spotlight on anagrelide hydrochloride for the treatment of essential thrombocythemia anita sarma,1 donal p mclornan,1,2 claire n harrison2 1department of haematology, kings college hospital nhs foundation trust, 2department of haematology, guys and st thomas nhs foundation trust, london, uk abstract.
Anagrelide is used to treat a blood cell disorder called thrombocythemia also called. Anagrelide inhibits the maturation of megakaryocytes into platelets, reducing. Anagrelide contains chromophores that may absorb light at wavelengths 290 nm and therefore may be susceptible to direct photolysis by sunlight. Anagrelide hydrochloride oral capsule drug summary. Concomitant use of anagrelide with other pde iii inhibitors such as milrinone, amrinone, enoximone, olprinone and cilostazol is not recommended. Agrylin uses generic names in all descriptions of drugs. Anagrelide hydrochloride monograph for professionals. Anagrelide hydrochloride bl4162a phosphodiesterase pde.
Material safety data sheet of anagrelide hydrochloride abmole. Anagrelide hydrochloride was approved by the fda in 1997 for the. Common side effects are headache, diarrhea, unusual weaknessfatigue, hair loss, nausea. Packaging 10, 50 mg in glass bottle biochemphysiol actions anagrelide is a phosphodiesterase inhibitor with antiplatelet activity ic 50 36 nm for inhibition of phosphodiesteraseiii. Agrylin was initially sponsored in australia by orphan australia but in 2008 sponsorship of the product was transferred to shire australia shire pharmaceuticals markets the product internationally. Material may be irritating to the mucous membranes and upper respiratory tract. If this product is combined with other materials, deteriorates or becomes contaminated, it may pose hazards not mentioned in this msds. It also reduces the risk of problems like intestinal bleeding, stroke, and heart attack caused by having too many platelets. Anagrelide hydrochloride oral capsule drug information. Rubidium acetylene carbides burns with slightly warm hydrochloric acid. Agrylin new zealand data sheet, 02 aug 2019, ccds6.
Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. The prices listed below are wholesaler acquisition costs wac. May be harmful by inhalation, ingestion, or skin absorption. Lithium silicide in contact with hydrogen chloride becomes incandescent. Anagrelide fda prescribing information, side effects and uses. Agrylin is supplied as capsules for oral administration, containing 0. Its chemical name is 6,7dichloro 1,5dihydroimidazo2,1bquinazolin23hone monohydrochloride monohydrate.
Calcium carbide reacts with hydrogen chloride gas with incandescence. Anagrelide hydrochloride, usp is an off white powder that is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and in dimethylformamide. Information for colorado prescribers of prescription drugs. Anagrelide inhibits the maturation of megakaryocytes into platelets, reducing both megakaryocyte hyperproliferation and differentiation. Anagrelide lowers platelets bloodclotting cells in the body, which helps prevent blood clots from forming. Agrylin capsules rx only description active ingredient. Anagrelide is a phosphodiesterase inhibitor with antiplatelet activity. As a drug, anagrelide is antithrombocythemic used for the treatment of overproduction of blood platelets. Material safety data sheet of anagrelide hydrochloride contains identification of substance and details of the supplier of the safety data sheet. Australian public assessment report for anagrelide hydrochloride. Material safety data sheet activated carbon section 7 handling and storage keep in a tightly closed container, stored in a cool, dry, ventilated area.
874 471 917 500 531 70 1256 1256 1193 269 89 288 448 1434 849 258 733 1420 68 827 1189 568 859 806 280 543 1192 814 1023 152 18 1118 1251 724 1027 680 216 373 761 916 958 138 675 584 161 1463 870 1463