Melphalan related pulmonary toxicity is not related to dose or duration of therapy. Evomela melphalan for injection, for intravenous use. Find patient medical information for melphalan oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Melphalan phenylalanine nitrogen mustard, melfalan, lpam, lsarcolysine, alkeran, sarcoclorin is a synthetic alkylating agent that has been used clinically since 1970 as an antineoplastic agent. The outcomes of newly diagnosed elderly multiple myeloma patients. Each singledose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and the inactive ingredient povidone 20 mg. Melphalan 50 mg powder and solvent for solution for injection infusion melphalan. Melphalan fda prescribing information, side effects and uses. Melphalan is given orally po, usually as a single daily dose. Alkeran melphalan should be administered under the supervision of a. Melphalan, also known as lphenylalanine mustard, phenylalanine mustard, lpam, or lsarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is leukemogenic and potentially mutagenic carcinogenic in humans. Melphalan is in a class of medications called alkylating agents. Mouth sores mild with regular dosing, can be severe with highdose therapy.
This, in combination with available package insert data, supports a wider range of options for preparation. Helmut cadner md prof, wlfgang emminger md, ruth ladenstein, and christina. Melphalan should be taken on an empty stomach, 1 hour prior to or 2 hours after meals. Department of clinical haematology oxford bmt programme b. Melphalan is an anticancer antineoplastic or cytotoxic chemotherapy drug. This medication is classified as an alkylating agent. The melphalan dosage you receive is highly individualized and will depend on a number of things, such as your weight, your height, and how you respond to the medication. Melphalan dosage available as tablets or an intravenous injection, melphalan is given to help minimize symptoms caused by ovarian cancer or multiple myeloma. It comes as a tablet that is taken by mouth, and as an injection that is given through a needle inserted into a vein an intravenous, or iv, injection. Renal impairment, leukopenia, thrombocytopenia, anemia, cll. Dosing will be based on body surface area calculated using actual body weight.
Diarrhea mild with regular dosing, can be severe with highdose. Melphalan remains the most widely used agent in preparative regimens for hematopoietic stemcell transplantation. Melphalan side effects, dosage, interactions drugs. Half the patients received six 28day cycles of melphalan 0. Melphalan was found to have 90% or greater stability at 60 and 90 minutes when diluted in ns polyolefin bags to concentrations from 0. Purpose the combination of bortezomibmelphalanprednisone vmp is a new. Simplified technique for administration of high dose melphalan. Melphalan should not be given to patients who have suffered a previous hypersensitivity reaction to melphalan. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Highdose therapy hdt with melphalan 200 mgm2 mel200. Higher doses and taking this medication more frequently increase the chance of these side effects. Do not mix evomela with other melphalan hydrochloride for injection drug products.
Only select registry of toxic effects of chemical substances rtecs data is presented here. The following data is based on the product molecular weight 305. Although higher melphalan doses are associated with increased remission. Find out what health conditions may be a health risk when taken with melphalan oral. Avoid contact with people who have infections that may spread to others such as chickenpox, measles, flu. Jul 28, 2015 melphalan phenylalanine nitrogen mustard, melfalan, lpam, lsarcolysine, alkeran, sarcoclorin is a synthetic alkylating agent that has been used clinically since 1970 as an antineoplastic agent. From its initial discovery more than 50 years ago, it has been gradually incorporated in the conditioning regimens for both autologous and allogeneic transplantation due to its myeloablative properties and broad antitumor effects as a dna alkylating agent.
Melphalan 50 mg powder and solvent for solution for. Autologous stem cell transplantation for elderly patients with newly. See actual entry in rtecs for complete information. Alkeran for injection is reconstituted using the sterile diluent provided. Melphalan is a cancer medication that interferes with the growth and spread of cancer cells in the body. These side effects are less common side effects occurring in about 1029% of patients receiving melphalan.
This medicine is used to treat multiple myeloma and ovarian cancer. Gwas of 972 autologous stem cell recipients with multiple myeloma. Melphalan injection, at conventional intravenous dosage, is indicated in the treatment of multiple myeloma and ovarian cancer. Listing a study does not mean it has been evaluated by the u. A phase iib, multicenter, openlabel, safety, and efficacy study of highdose, propylene glycolfree melphalan hydrochloride for injection evomela for myeloablative conditioning in multiple myeloma patients undergoing autologous transplantation. Oral melphalan, prednisone, and thalidomide for newly diagnosed. It is used to treat myeloma, melanoma and ovarian cancer. Multiple myeloma evomela melphalan is an alkylating agent used as a highdose conditioning treatment prior to stem cell. Melphalan is practically insoluble in water and has a pka of 2. Melphalan definition of melphalan by the free dictionary. Discontinue treatment with evomela for serious hypersensitivity reactions. Oct 17, 2011 melphalan will be given as a single dose not split over 2 or more days and given on day1. Each vial of sterile diluent contains sodium citrate 0. Melphalan should be discontinued if signs of pulmonary toxicity occur cough, fever, rales, dyspnea, respiratory distress, and hypoxia.
Alkeran melphalan is a drug prescribed for the treatment of multiple myeloma and ovarian cancer. Each singledose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and the inactive. Jan 22, 2019 melphalan is the active lisomer of the compound and was first synthesized in 1953 by bergel and stock. Our alkeran melphalan side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Melphalan is used to treat multiple myeloma a type of. Highdose melphalan, etoposide, and carboplatin mec.
Melphalan is a carcinogenhandle with extreme caution. Melphalan is practically insoluble in water and has a pka. In some cases, health care professionals may use the trade name megace alkeran or other names lpam or lsarcolysin or phenylalanine mustard when referring to the generic drug name melphalan. Bortezomibmelphalanprednisonethalidomide followed by. It marks the first new formulation of melphalan developed since its initial approval in 1964. Adding individual snps to the model increased sensitivity of detecting. Melphalan can make you more likely to get infections or may worsen any current infections. Each singledose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Dr karthik ramasamy this is a controlled document and therefore must not be changed high dose melphalan for autograft. Melphalan is an active cytotoxic agent for use only under the direction of physicians experienced in the administration of such agents.
Side effects of alkeran melphalan, warnings, uses rxlist. Criteria for dosage adjustment in a randomised clinical. Melphalan injection, at high intravenous dosage, is indicated, with or without haematopoietic stem cell transplantation, for the treatment of multiple myeloma and childhood neuroblastoma. Melphalan is the most arrhythmogenic agent, and is associated with svt in 11% of patients. Melphalan is used to treat multiple myeloma a type of cancer of the bone marrow. Lack of experimental vesicant activity for the anticancer agents cisplatin, melphalan, and mitoxantrone. Product information alkeran injection melphalan for. Melphalan is also used to treat a certain type of ovarian cancer cancer that begins in the female reproductive organs where eggs are formed.
Melphalan is erratically absorbed from the gastrointestinal tract, and to overcome this pitfall, intravenous melphalan is utilized for the high doses prescribed for bone marrow transplant conditioning regimens. Controlled trials comparing intravenous iv to oral melphalan. Highlights of prescribing information reduce the dose of. Melphalan, sold under the trade name alkeran among others, is a chemotherapy medication used to treat multiple myeloma, ovarian cancer, melanoma, and amyloidosis. Nov 09, 2018 melphalan is a cancer medication that interferes with the growth and spread of cancer cells in the body. Fresenius kabi melphalan hydrochloride for injection now. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases.
It does not contain all of the available information. Evomela melphalan for a type of cancer called multiple. June 26, 2017 alvogen launched an abrated generic version of apopharmas alkeran melphalan 2 mg tablets. Mar 18, 2014 melphalan 2 mg tablets summary of product characteristics smpc by aspen. Alkeran for injection is supplied as a sterile, nonpyrogenic, freezedried powder.
This phase iii study examined the efficacy of the fourdrug combinat. Severe bone marrow suppression with resulting infection or bleeding may occur. View and buy high quality melphalan from tocris bioscience. Melphalan 50 mg powder and solvent for solution for injection. Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. Bortezomib, melphalan, and prednisone vmp regimen for. A hypersensitivity mechanism may contribute to these toxicities. Auto transplant high dose melphalan vs high dose melphalan.
Melphalan and prednisone were administered at 4 mgm2 and 40 mgm2. Melphalan inhibits dna and rna synthesis via formation of interstrand cross links with dna, likely binding at the n. Hazard summary melphalan can affect you when breathed in. Melphalan oral alkeran side effects, medical uses, and. Available as tablets or an intravenous injection, melphalan is given to help minimize symptoms caused by ovarian cancer or multiple myeloma.
Busulfan and melphalan conditioning in multiple myeloma. However, compared to the novel agents imid and pi, melphalan is less potent, slower in onset of activity, and more myelosuppressive. An overview of uses for melphalan melphalan alkeran is a prescription chemotherapy medication used to treat people with certain types of cancer. Melphalan investigated as a drug, mutagen, primary irritant, reproductive effector, and tumorigen. Prednisone is given po, usually as a single daily dose. Fresenius kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for alkeran melphalan skip to. Melphalan, a bifunctional nitrogen mustardderivative alkylating agent, is the lisomer of mechlorethamine. Melphalan hydrochloride for injection is supplied as a sterile, nonpyrogenic, freezedried powder.
Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Abstract background thalidomide is an immunomodulatory drug with strong. Doses of melphalan were adjusted according to the following criteria. It does not take the place of talking to your doctor or pharmacist. Highdose melphalan and hct amifostine gi toxicity grade 14 grade 34 median grade duration mucositis 55% 14% 2 2d diarrhea 92% 12% 2 7d nausea 85% 4% 1 8d vomiting 67% 3% 1 2d n126 consecutive autologous hct 20072014 single center amifostine740 mgm2iv at. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Melphalan injection should not be given without haematopoietic stem cell rescue at doses of above 140 mgm 2 for intravenous administration, it is recommended that melphalan injection solution is injected slowly into a fastrunning infusion solution via a swabbed injection port. Breathing melphalan can irritate the nose, throat and lungs.
Melphalan should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Melphalan is used to treat multiple myeloma a type of blood cancer and cancer of the ovary. Melphalan is an alkylating agent of the bischloroethylamine type. Alkeran should not be given to nursing mothers and has not been approved for use in pediatric populations. It can lower your bodys ability to fight an infection and increase your risk of bleeding. Melphalan consumer medicine information alkeran tablets published by mimsmydr november 2010 1 what is in this leaflet this leaflet answers some common questions about alkeran tablets. It is known chemically as 4bis2chloroethylaminolphenylalanine. Melphalan is a phenylalanine mustard that is available orally for treatment of multiple myeloma and carcinomas of the ovaries and breast. Feb 01, 2020 melphalan is the active lisomer of the compound and was first synthesized in 1953 by bergel and stock. Melphalan injection is for intravenous use and regional arterial perfusion only. Webmd provides common contraindications for melphalan oral. Conventional formulations of melphalan such as alkeran have marginal solubility, limited chemical stability and require propylene glycol as a cosolvent, which is associated with renal dysfunction and arrhythmias.
Melphalan 2 mg tablets summary of product characteristics. Mlstyle command autocad 2016 autodesk knowledge network. Each singleuse vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. From its initial discovery more than 50 years ago, it has been gradually incorporated in the conditioning regimens for both autologous and. May 21, 2019 it is not known whether this drug is excreted in human milk.
27 1553 425 1045 138 1308 287 779 1226 344 965 1040 37 177 1265 505 1303 794 716 478 1113 1207 2 871 266 1239 1036 993 154 942 357 262 470 1264 847 1176 313 1498 235 955 1242 1020 419 1340 1298