The us package insert has been revised to reflect the new dilution procedure, the details of which are described below. Dailymed dexrazoxane injection, powder, lyophilized, for. Dexrazoxane hydrochloride zinecard, cardioxane is a cardioprotective agent. Administer doxorubicin within 30 minutes of completion of dexrazoxane infusion. Reduce zinecard dosage in patients with moderate to severe renal impairment creatinine clearance values less than 40 mlmin by 50% zinecard to doxorubicin ratio reduced to 5. Dexrazoxane proved to be effective and moderately well tolerated. Celebrex was evaluated for treatment of the signs and symptoms of ra in placebo and activecontrolled clinical trials of up to 24 weeks in duration. Once reconstituted, the resultant solution contains 10 mg dexrazoxane per ml. Dexrazoxane is a cyclic derivative of edetic acid edta that readily penetrates cell membranes.
Dexrazoxane is converted intracellularly to a ringopened chelating agent. Fda approval of dexrazoxane hydrochloride totect, topotarget as was based on two prospective, openlabel, singlearm. Niosh list of antineoplastic and other hazardous drugs in. Dexrazoxane, packaged as zinecard, is in the drug class called the chemoprotectants or cardioprotectants. Zinecard medication page for healthcare professionals to search for scientific information on pfizer medications. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication.
Physical and chemical stability of reconstituted and diluted dexrazoxane infusion solutions article pdf available in journal of oncology pharmacy practice 201 may 20 with 741 reads. The hydrolysis products of dexrazoxane are thought to. This decision allows virtually all children to receive dexrazoxane starting with the first dose of anthracycline at the discretion of the treating provider. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. Dexrazoxane is approved in the us and some european countries for cardioprotection in women with advanced andor. Chemically, dexrazoxane is s4,41methyl1,2ethanediylbis2,6piperazinedione.
Dexrazoxane has been used to protect the heart against the cardiotoxic side effects of chemotherapeutic drugs such as anthracyclines, such as daunorubicin or. Nov 01, 2017 dantrium intravenous is a sterile, nonpyrogenic, lyophilized formulation of dantrolene sodium for injection. Dailymed dexrazoxane hydrochloride dexrazoxane kit. Highlights of prescribing information these highlights do not include all the information needed to use vectibix safely and effectively. Dexrazoxane hydrochloride helps make the side effects happen less often and makes them less severe when they do occur. Dexrazoxane dexra pretreatment reduces dxrinduced insult in the. Celebrex doses of 100 mg twice daily and 200 mg twice daily were similar in effectiveness and both were comparable to naproxen 500 mg twice daily. Nov 09, 2018 dexrazoxane is used to protect the heart and other tissues from harmful side effects caused by certain cancer medications.
Dexrazoxane dex ray zox ane is used to protect against damage caused by certain chemotherapy. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4. For instructions on reconstitution and dilution of the medicinal product before. It is used only in women who have already received high doses of doxorubicin and continue to be treated with it. A 500 mg singleuse vial of dexrazoxane should be reconstituted with 50 ml of sterile. Severe local tissue necrosis will occur if there is extravasation during administration. A 250 mg singleuse vial of dexrazoxane should be reconstituted with 25 ml of sterile water for injection, usp. Important notice zinecard dexrazoxane for injection. Dexrazoxane may add to the toxicity induced by the chemotherapy cycle during. This use is approved for the zinecard brand of dexrazoxane hydrochloride.
The totect brand of dexrazoxane is used in men or women to treat a. Apr 16, 2018 dexrazoxane for injection is available in the following strengths as sterile, pyrogenfree lyophilizates. In some cases, health care professionals may use the trade name zinecard when referring to the generic drug name dexrazoxane. Dexrazoxane has an octanolwater partition coefficient of 0. Daunorubicin hydrochloride injection must be given into a rapidly. There appears to be general agreement about dexrazoxane usefulness when extravasations involve large volumes of anthracycline andor central venous. For more than half a century, the different properties of dexrazoxane have captured the attention of scientists and clinicians. Capsule, mg edl solution for injection, g in ml edl. The iv administration of dexrazoxane is in acidic condition with hcl adjusting the ph. If you have questions about this medicine talk to your doctor, pharmacist, or health care provider. Oct 22, 2015 dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on day 1 of a 21day cycle. Dexrazoxane diminishes doxorubicininduced acute ovarian.
Pfizer oncology together provides financial assistance resources to help patients. Dexrazoxane was designated by the us fda as an orphan drug for prevention of cardiomyopathy for children and adults 0 through 16 years of age treated with anthracyclines. Pfizer oncology together provides financial assistance resources to help patients access their prescribed oncology medicines. Zinecard dexrazoxane for injection is a sterile, pyrogenfree lyophilizate intended for intravenous administration.
Dexrazoxane is a drug used to reduce the undesired side effects of doxorubicin, a chemotherapy medication. Dexrazoxane fda prescribing information, side effects and uses. This is based on results in animals with other known arteriolar irritants. Apr 01, 2019 dexrazoxane, an intracellular chelating agent, is a derivative of edta. May 06, 2019 package insert flucytosine ancobon is a the appropriate approved prescribing information should be consulted. Dexrazoxane injection comes as a powder to be mixed with liquid and injected into a vein by a doctor or nurse in a hospital.
Dexrazoxane is a whitish crystalline powder that melts at 191 to 197c. Zinecard dexrazoxane dose, indications, adverse effects. Indications, dose, contraindications, sideeffects, interactions, cautions, warnings and other safety information for dexrazoxane. The recommended dosage ratio of zinecard to doxorubicin is 10. The pharmacokinetics of dexrazoxane can be adequately described by a twocompartment open model with firstorder elimination. Dexrazoxane side effects, dosage, interactions drugs. Dexrazoxane zinecard, totect is a prescription injectible drug used to prevent zinecard and treat totect specific side effects of some chemotherapy medications. Accidental release measures contain spill and collect, as appropriate.
May be harmful by inhalation, ingestion, or skin absorption. Reduce the dexrazoxane dose if the doxorubicin dose is reduced due to hepatic impairment e. Dexrazoxane is the generic name for the trade name drug zinecard. Zinecarddexrazoxane for injection is available in 250 mg or 500 mg single dose vials. Material may be irritating to the mucous membranes and upper respiratory tract. Dexrazoxane is approved in the us and some european countries for cardioprotection in women with advanced andor metastatic breast cancer receiving doxorubicin. It is a cardioprotective agent for use in conjunction with doxorubicin. Important notice zinecard dexrazoxane for injection pfizer. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. Aug 02, 2017 the zinecard brand of dexrazoxane is used to help prevent chemotherapyrelated heart problems in women who are receiving doxorubicin for metastatic breast cancer. Dexrazoxane for the treatment of chemotherapyrelated side. Dexrazoxane cardioxane, zinecard, a cyclic derivative of edetic acid, is a sitespecific cardioprotective agent that effectively protects against anthracyclineinduced cardiac toxicity. It must never be given by the intramuscular or subcutaneous route. Celebrex was shown to be superior to placebo in these studies, using the acr20 responder index, a composite of clinical, laboratory, and functional measures in ra.
Pregnancy dexrazoxane may cause fetal harm when administered during pregnancy, based on its mechanism of action and data from animal studies. Doxorubicin with upfront dexrazoxane for the treatment of advanced or metastatic soft tissue sarcoma the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Dexrazoxane is used to protect the heart and other tissues from harmful side effects caused by certain cancer medications. Presently, dexrazoxane is licensed in many parts of the world for two different indications. Dexrazoxane, packaged as totect urgent treatment kit orphan drug status, is intended only as rescue therapy for extravasation of anthracycline chemotherapy. Dantrium intravenous is a sterile, nonpyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium intravenous is supplied in 70 ml vials containing 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a ph of approximately 9. May 15, 2018 dosage ratio of dexrazoxane to doxorubicin is 10. Advances in cancer treatment utilizing multiple chemotherapies have dramatically increased cancer survivorship. Totect dexrazoxane for injection page 1 of 12 totect package insert totect 500 mg dexrazoxane for injection each vial of dexrazoxane for injection contains 589 mg dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane description totect dexrazoxane for injection is a sterile, pyrogenfree lyophilizate intended for.
However, alternative approaches for the management of anthracycline extravasations are available such as topical dmso and cooling. Each 1 ml of precedex contains 118 mcg of dexmedetomidine hcl equivalent to 100 mcg dexmedetomidine base and 9 mg of sodium chloride in water. By continuing to browse this site you are agreeing to our use of cookies. Zinecard dexrazoxane for injection description zinecard dexrazoxane for injection is a sterile, pyrogenfree lyophilizate intended for intravenous administration. Doxorubicin with upfront dexrazoxane for the treatment of. Dexrazoxane cardioxane is indicated for the prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin in patients with advanced or metastatic cancer after previous. Zinecard dexrazoxane pfizer medical information us. Dexrazoxane has been administered as a 15 minute infusion over a dose range of 60 to 900 mgm2 with 60 mgm2 of doxorubicin, and at a fixed dose of 500 mgm2 with 50 mgm2 doxorubicin. What other drugs will affect dexrazoxane totect, zinecard. Department of health and human services, centers for disease control and prevention, national institute for occupa. A reconstituted dexrazoxane solution should be administered intravenously by slow push starting 15 to 30 minutes before intravenous administration of anthracycline. When dexrazoxane injection is used to prevent heart damage caused by doxorubicin, it is given over 15 minutes just before each dose of doxorubicin.
Flucytosine is a fluorinated pyrimidine, nonantibiotic. Cardioxane 500 mg powder for solution for infusion. Female cancer survivors treated with doxorubicin dxr chemotherapy often suffer from an acute impairment of ovarian function, which can persist as longterm, permanent ovarian insufficiency. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Dexrazoxane for injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mgm 2 and who will continue to receive doxorubicin therapy to maintain tumor control. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. The hydrolysis products of dexrazoxane are thought to exert their effects by chelating free or bound intracellular iron in the myocardium, thus preventing the formation of the. Pdf physical and chemical stability of reconstituted and. Daunorubicin hydrochloride injection rx only warnings 1.
Extravasation is what happens when iv fluid, and the drug it contains, leaks outside the vein and gets into the tissue. The package insert states that there is no proven successful management of extravasation after it occurs, although sympathetic block and heparinization are commonly employed during acute management. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for lialda mesalamine. Totect 500 mg dexrazoxane for injection each vial of dexrazoxane for injection contains 589 mg dexrazoxane hydrochloride. Treatment of anthracycline extravasations using dexrazoxane. Dexrazoxane has been administered as a 15 minute infusion over a dose range of 60 to 900 mgm 2 with 60 mgm 2 of doxorubicin, and at a fixed dose of 500 mgm 2 with 50 mgm 2 doxorubicin. Zinecard is given only after you have received enough doxorubicin infusions to amount to a certain total dose. Dexrazoxane hydrochloride national cancer institute. Zinecard dexrazoxane dosage and administration pfizer.
Totect dexrazoxane for injection totect package insert. Zinecard dexrazoxane for injection us package insert fda approved labeling for s006 110 1 2 zinecard 3 dexrazoxane for injection 4 5 6 description 7 8 zinecard dexrazoxane for injection is a sterile, pyrogenfree lyophilizate intended for 9 intravenous administration. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In recent years, concern has been raised about the risk of longterm effects of dexrazoxane, particularly in pediatric patients who had repeated doses to prevent cardiotoxicity. Upfront dexrazoxane for the reduction of anthracyclineinduced cardiotoxicity in adults with preexisting cardiomyopathy and cancer. Dexrazoxane, an intracellular chelating agent, is a derivative of edta.
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