It is used to treat cancer of the lymph system and malignant melanoma a type of skin cancer. Ixempra in combination with capecitabine must not be given to patients with ast or alt 2. Dacarbazine alkylates and crosslinks dna during all phases of the cell cycle, resulting in disruption. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide.
Dacarbazine fda prescribing information, side effects. Cytoxan cyclophosphamide for injection, usp cytoxan. Dacarbazine fda orange book approved drug product list. Xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia aml with a fmslike tyrosine kinase 3 flt3 mutation as detected by an fdaapproved test. Creatinine clearance crcl 46 to 60 ml min, reduce dose 20%. Dec 01, 2016 dacarbazine belongs to the group of medicines called alkylating agents.
Dacarbazine interactions bnf content published by nice. Dacarbazine fda prescribing information, side effects and uses. Help drugs pi website grow, register now and become a recognized active member. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Reconstitute drug with sterile water for injection to make a solution containing 10 mgml dacarbazine ph 3. Dacarbazine pharmacokinetics absorption bioavailability. Dacarbazine has been approved by the federal drug administration for use in the treatment of metastatic malignant melanoma and hodgkins lymphoma, as well as other neoplasms. Help drugs pi website grow, register now and become a recognized active member by adding new content. It may also be used to treat other kinds of cancer, as determined by your doctor. Dtlcdome sterile dacarbazine is a colorless to an ivory colored solid which is light sensitive. Emcyt capsules are white and opaque, each containing estramustine phosphate sodium as the disodium salt monohydrate equivalent to 140 mg estramustine phosphate, for oral administration. Emcyt estramustine phosphate sodium capsules description. Dec 31, 2019 dacarbazine for injection, usp is reconstituted and administered intravenously ph 34. Fda label information for this drug is available at dailymed.
Dacarbazine drug information indications, dosage, side. Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means. Dtlcdome is reconstituted and administered intravenously ph 34. Indications and usage koselugo is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 nf1 who have symptomatic, inoperable plexiform neurofibromas pn. Crcl less than or equal to 30 mlmin, reduce dose 30%. The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. Nov 09, 2018 dacarbazine is a cancer medication that interferes with the growth and spread of cancer cells in the body. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Please like drugs pis facebook page for even more updates.
Dacarbazinedticdome generic is an antineoplastic chemotherapy drug, prescribed for melanoma and hodgkins disease. Cytoxan cyclophosphamide for injection, usp cytoxan tablets cyclophosphamide tablets, usp description cytoxan cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide mono hydrate. See 17 for patient counseling information and fdaapproved patient labeling revised. If you are using a combination of medicines, it is important that you receive each one at the proper time. Approved drug products containing dacarbazine listed in the fda orange book.
Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a. Dacarbazine is an anticancer antineoplastic or cytotoxic chemotherapy drug. Desferal deferoxamine mesylate for injection usp prescribing. Doxorubicin and dacarbazine ad regimen for soft tissue sarcomas. Product monograph download pdf, 227kb canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means. The product catalog provides you with a full listing of tevas brand and generic product lines. Dailymed dacarbazine injection, powder, for solution. Doxorubicin and dacarbazine ad regimen for soft tissue. Measles, mumps and rubella vaccine, live is predicted to increase the risk of generalised infection possibly lifethreatening when given with dacarbazine. Hepatotoxic drugs and alcohol should be avoided during chemotherapy dacarbazine may influence the ability to drive or operate machines because of its central nervous side effects or because of nausea and vomiting. Aic is not derived endogenously but from the injected dacarbazine, because the administration of radioactive dacarbazine labeled with 14 c in the imidazole portion of the molecule dacarbazine2 14 c gives rise to. Dacarbazine alkylates and crosslinks dna during all phases of the cell cycle, resulting in disruption of dna function, cell cycle arrest, and apoptosis.
Medlineplus information on dacarbazine a lay language summary of important information about this drug that may include the following. Symptoms of anorexia, nausea, and vomiting are the most frequently noted of all toxic reactions. Temodar is administered to patients with severe renal or hepatic impairment. Dacarbazine is a cellcycle nonspecific antineoplastic alkylating agent used in the treatment of metastatic malignant melanoma. See full prescribing information for complete boxed warning. Full prescribing information 1 indications and usage defitelio is indicated for the treatment of adult and pediatric patients with hepatic venoocclusive disease vod, also known as sinusoidal obstruction syndrome sos, with renal or pulmonary dysfunction following hematopoietic stemcell transplantation hsct. Dacarbazine for injection is reconstituted and administered intravenously ph 34. This medication is classified as an alkylating agent. 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. Dacarbazine, also known as dticdome or dtic, is an anticancer agent best known for its longtime use in treating metastatic malignant melanoma.
For more detail, see how this drug works section below. List of approved drug products containing dacarbazine in the fda orange book on. Nov 05, 2008 dtlcdome sterile dacarbazine is a colorless to an ivory colored solid which is light sensitive. Over 90% of patients are affected with the initial few doses. This chapter contains the descriptions of the drug. Nov 05, 2008 our dticdome dacarbazine side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Dacarbazine dacarbazine dose, indications, adverse. Dacarbazine is sometimes given together with certain other medicines. Side effects of dticdome dacarbazine, warnings, uses. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take them at the right times. This medication slows the growth and spread of cancer cells in the body. Jun 10, 2019 dacarbazine pharmacokinetics absorption bioavailability. Highlights of prescribing information pneumonia pcp pcp. For hodgkins it is often used together with vinblastine, bleomycin, and doxorubicin.
Reconstitute with sterile water for injection, ns, or d5w to a concentration of 10 mgml. Dacarbazine has been shown to be mutagenic, teratogenic and carcinogenic in animals. Dilute with 250 ml to 1,000 ml ns, d5w, or a salinedextrose solution. Dacarbazine is an anticancer agent designated chemically. Dacarbazine dacarbazine dose, indications, adverse effects. Since the growth of normal body cells may also be affected by. Medicinal forms there can be variation in the licensing of different medicines containing the same drug. Dacarbazine is used to treat melanoma a type of skin cancer that has spread to other parts of your body. Women of childbearing potential have to use effective contraception during treatment. Each vial contains 100 mg of dacarbazine, or 200 mg of dacarbazine the active ingredient, anhydrous citric acid and mannitol. Each vial contains 200 mg of dacarbazine the active ingredient, citric acid monohydrate and mannitol. Chemically, dacarbazine is 53,3dimethyl1triazeno imidazole4carboxamide with the following structural formula. Ask your pharmacist or doctor for a copy of the manufacturers information for the patient. Therefore dacarbazine medac is contraindicated during pregnancy see section 4.
Besides unchanged dacarbazine, 5aminoimidazole 4 carboxamide aic is a major metabolite of dacarbazine excreted in the urine. Drug name active ingredients strength dosage formroute marketing status rld te code application no. These highlights do not include all the information needed to use lysodren safely and effectively. Please consult a qualified health professional for more detailed information. Desferal deferoxamine mesylate for injection usp vials rx only prescribing information. The vomiting lasts 112 hours and is incompletely and unpredictably palliated with phenobarbital andor prochlorperazine. At therapeutic concentrations dacarbazine is not appreciably bound to human plasma protein. Dacarbazine is also used in combination with other medications to treat hodgkins lymphoma hodgkins disease. Please contact pfizer canada medical information at 1 800 4636001 with any comments or inquiries. Dilantin extended capsules and parenteral dilantin are formulated with the sodium salt of phenytoin. Dacarbazine is used for metastatic malignant melanoma, hodgkins disease, soft tissue sarcomas. Besides unchanged dacarbazine, 5aminoimidazole4carboxamide aic is a major metabolite of dacarbazine excreted in the urine. How dacarbazine works, side effects, interactions and. Dacarbazine dtic, also known as imidazole carboxamide, is a chemotherapy medication used in the treatment of melanoma and hodgkins lymphoma.
Csf concentrations approximately 14% of plasma concentrations. Dtic dome dacarbazine dosing, indications, interactions. Desferal, deferoxamine mesylate usp, is an ironchelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration. Dacarbazine is a component of a commonly used combination for hodgkins disease abvddoxorubicin previously adriamycin, bleomycin, vinblastine, and dacarbazine. Dacarbazine dticdome generic is an antineoplastic chemotherapy drug, prescribed for melanoma and hodgkins disease.
Dacarbazine interferes with the growth of cancer cells, which are eventually destroyed. Since dacarbazine is light sensitive, the solution should be protected from light immediately following preparation. The manufacturer reports no information about dose reduction for renal dysfunction. This is not a complete list of side effects and others may occur. Volume of distribution exceeds total body water content, suggesting localization in a body tissue, probably the liver. If you encounter technical difficulties in viewing our product. Toxicity in hepatic impairment see full prescribing information for complete boxed warning. Find patient medical information for dacarbazine intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Dacarbazine is a cancer medication that interferes with the growth and spread of cancer cells in the body. Dacarbazine was teratogenic in rats at doses 20times the daily human dose on day 12 of gestation.
It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Dacarbazine can be dosed in dogs at 200 mgm 2 as a slow iv bolus given once daily for 5 days, or once as a slow iv infusion over 2 to 8 hours at mgm 2 every 3 weeks. Dacarbazine is a triazene derivative with antineoplastic activity. Dacarbazine is approved to be used alone or with other drugs to treat hodgkin lymphoma in patients whose disease has not gotten better with other chemotherapy melanoma that has metastasized spread to other parts of the body dacarbazine is also being studied in the treatment of other types of cancer. Dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive. Nov 01, 2014 dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. It must be assumed that an increased risk for teratogenic effects exists in humans. Each vial also contains anhydrous citric acid and mannitol. Dacarbazine is used to treat skin cancer malignant melanoma and hodgkins disease. Oct 01, 2019 dacarbazine is subject to renal tubular secretion rather than glomerular filtration.
Dacarbazine is a structural analogue of imidazole carboxamide, a purine precursor. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Dacarbazine 100mg, 200mg, 500mg, mg summary of product. When dacarbazine is used to treat hodgkins lymphoma is may be injected once a day for 5 days in a row every 4 weeks or it may be injected once every 15 days. Consult your healthcare professional before using this drug. Special pediatric considerations are noted when applicable, otherwise adult provisions apply. Dacarbazine side effects, dosage, interactions drugs. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Its chemical name is 2chloro1034methyl1piperazinylpropyl10 h phenothiazine z 2butenedioate 1. Dacarbazine belongs to the group of medicines called alkylating agents.
Dacarbazine by injection national library of medicine. Dacarbazine is subject to renal tubular secretion rather than glomerular filtration. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Nearly 8 in 10 americans over age 55 require prescription lenses. For information on potential signs and symptoms of exposure, see section 2 hazards identification andor section 11 toxicological information. Dacarbazine may cause fetal harm when used during pregnancy, based on its mechanism of action and data from animal studies.
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