and you'll Alkeran Generic Name: Melphalan Class: Antineoplastic Agents VA Class: AN100 CAS Number: 148-82-3 Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons Warning(s) Experience of Supervising Clinician For administration only by individuals experienced in the administration of chemotherapeutic agents. b c Hematologic Toxicity Risk of severe bone marrow suppression (e.g., thrombocytopenia, leukopenia), resulting in bleeding and infection. b c (See Hematologic Effects under Cautions.) Mutagenicity and Carcinogenicity Known carcinogen. b c (See Mutagenicity and Carcinogenicity under Cautions.) Produces chromosomal aberrations in vitro and in vivo; considered potentially mutagenic in humans. b c (See Mutagenicity and Carcinogenicity under Cautions.) Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, reported. c Introduction Antineoplastic agent; nitrogen mustard derivative; alkylating agent. a b c Slideshow Multiple Myeloma: Has Crowd Control Ever Been As Important? Uses for Alkeran Multiple Myeloma Used alone and as a component of various chemotherapeutic regimens in the palliative treatment of multiple myeloma. a b c As effective as cyclophosphamide; combination of either agent with prednisone is considered treatment of choice. a d Ovarian Cancer Palliative treatment of nonresectable epithelial ovarian cancer. 113 122 b Has been administered intraperitoneally for treatment of advanced ovarian cancer confined to the peritoneal cavity and/or associated with malignant ascites. 101 Breast Cancer Has been used alone or as a component of various chemotherapeutic regimens as an adjunct to surgery in the treatment of breast cancer . 134 135 136 138 139 a Melanoma Has been used alone and in combination regimens in isolated limb perfusion for palliative treatment of locally recurrent or unresectable in-transit metastatic melanoma of the extremities. 144 145 146 148 Amyloidosis Has been used with prednisone in the treatment of amyloidosis . 141 Alkeran Dosage and Administration General Adjust dosage carefully according to clinical and hematologic response, based on weekly blood counts, and tolerance of the patient to obtain optimum therapeutic results with minimum adverse effects. a b Consult specialized references for procedures for proper handling and disposal of antineoplastics. 106 b c Administration Administer orally or by IV infusion. b c Has been administered by regional isolation perfusion (e.g., for melanoma ) 144 145 146 148 149 and intraperitoneally (e.g., for advanced ovarian cancer). 101 Usually administered orally; 113 123 124 125 126 127 b however, can also be administered IV in the palliative treatment of multiple myeloma 106 114 115 116 117 118 120 in patients in whom oral therapy is not feasible. 106 118 120 c Oral Administration Administer orally on an empty stomach. 108 Administer continuously (as single daily doses) or intermittently (e.g., daily for 7 days every 4 6 weeks). a b IV Administration For solution and drug compatibility information, see Compatibility under Stability. Administer IV only by individuals experienced in the administration of the drug. a c Administer diluted solution slowly into a freely running IV infusion via an injection port or into a central venous line. c Avoid extravasation; do not administer by direct injection into a peripheral vein. c (See Local Effects under Cautions.) Handle cautiously (e.g., use protective gloves); c avoid exposure during handling and preparation of IV solution. c If skin or mucosal contact occurs, immediately wash skin or mucosa with soap and water and flush with water. c Reconstitution Reconstitute vial containing 50 mg of melphalan by rapidly adding 10 mL of the diluent provided by the manufacturer with a 20-gauge or larger needle to provide a solution containing 5 mg/mL. 106 118 119 c Shake vigorously until a clear solution is obtained. 106 118 119 c Must be diluted (immediately after reconstitution) prior to IV infusion. a Dilution Immediately dilute reconstituted solution with 0.9% sodium chloride injection to a concentration not >0.45 mg/mL. 106 118 119 c Rate of Administration Administer by IV infusion over >15 minutes. 106 119 120 c Administration should be completed within 60 minutes of reconstitution. 106 119 c Dosage Available as melphalan and melphalan hydrochloride; dosage expressed in terms of melphalan. 106 b c Consult published protocols for the dosage of melphalan and other chemotherapeutic agents and the method and sequence of administration. a Consider dosage adjustments based on the blood cell nadir and blood counts taken on the day of therapy. 106 113 119 Generally, maintain leukocyte count between 3000 3500/mm 3 . b Therapeutic response may occur gradually over several months. b 3 12 months of repeated courses or continuous therapy may be required to evaluate drug response and obtain maximum benefit from the drug. a b Adults Multiple Myeloma Oral Usual initial and maintenance dosage regimen: 6 mg daily for 2 3 weeks. a b Withhold therapy until leukocyte and platelet counts increase (i.e., up to 4 weeks) and then initiate maintenance therapy of 2 mg daily. a b Adjust dosage, as required, to maintain a degree of bone marrow depression. a b Alternatively, 10 mg daily for 7 10 days. 113 Withhold therapy until platelet and leukocyte counts exceed 100,000/mm 3 and 4000/mm 3 , respectively, and then initiate maintenance therapy of 2 mg daily. 113 Adjust dosage, as required, to between 1 3 mg daily, depending on hematologic response. 113 Alternatively, 0.15 mg/kg daily for 7 days. a b Withhold therapy until platelet and leukocyte counts increase (i.e., 2 6 weeks), and then initiate maintenance therapy of 0.05 mg/kg daily. b Adjust dosage, as required, depending on hematologic response. b Alternatively, 0.25 mg/kg daily for 4 days or 0.2 mg/kg daily for 5 days, with prednisone; administer at 4 6 week-intervals, if granulocyte and platelet counts are normal. b IV Usual dosage: 16 mg/m 2 at 2-week intervals for 4 doses. 106 118 119 120 After satisfactory recovery from toxicity, initiate maintenance therapy of 16 mg/m 2 at 4-week intervals. 106 118 119 120 Ovarian Cancer Oral Usual dosage: 0.2 mg/kg daily for 5 successive days; administer at intervals of 4 5 weeks. 113 b Special Populations Hepatic Impairment No specific dosage recommendations at this time. b c Renal Impairment Oral In patients with moderate to severe renal impairment, consider reducing initial dosage; however, no specific dosage recommendations at this time. b IV In patients with renal impairment (BUN 30 mg/dL), reduce dosage by 50%. 106 118 120 c Geriatric Patients Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy. b c Cautions for Alkeran Contraindications Prior resistance to melphalan therapy. a b c Known hypersensitivity to melphalan or any ingredient in the formulation. a b c Warnings/Precautions Warnings Adequate Patient Evaluation and Monitoring Administer only under constant supervision by clinicians experienced in therapy with cytotoxic agents. a b c Hematologic Effects Risk of dose-limiting myelosuppression, manifested principally by leukopenia and thrombocytopenia; anemia also may occur. a b c d Severe myelosuppression more common with IV melphalan than with oral melphalan. c Leukocyte and platelet nadirs generally occur 2 3 weeks after treatment; recovery usually occurs 4 5 weeks after treatment. a c Irreversible bone marrow depression has been reported. 106 113 119 c Careful hematologic monitoring required. a Perform CBCs (leukocyte count with differential, platelet count, hemoglobin) prior to and at periodic intervals during therapy (i.e., prior to each subsequent course of oral melphalan and prior to each subsequent dose of IV melphalan). 106 b c Withhold therapy until leukocyte count is >3000/mm 3 and platelet count is >100,000/mm 3 . b Monitor closely for symptoms of bone marrow suppression (e.g., severe infections, bleeding, symptomatic anemia). b c Use with caution in patients with compromised bone marrow reserve (i.e., prior radiation therapy or prior therapy with other cytotoxic agents). b c Positive direct Coombs test results and concurrent hemolytic anemia have been reported. a Mutagenicity and Carcinogenicity Possible leukemia or secondary malignancies; assess risk/benefits of therapy. 106 113 b c d Causes chromatid or chromosome damage in humans. 106 113 b c Fetal/Neonatal Morbidity and Mortality May cause fetal harm; teratogenicity and embryolethality demonstrated in animals. 106 113 b c Avoid pregnancy during therapy. b c If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard. 106 113 b c Fertility Reversible and irreversible testicular suppression reported. b c d Ovarian suppression and amenorrhea reported in premenopausal females. 106 113 b c d Local Effects Extravasation may produce severe local tissue necrosis. c Administration by regional isolation perfusion may cause erythema and/or edema of perfused area, thrombophlebitis, necrotizing fasciitis, and varying degrees of vesiculation and tissue necrosis; amputation sometimes has been necessary. 147 148 Sensitivity Reactions Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, urticaria, pruritus, edema, rashes, tachycardia, bronchospasm, dyspnea, and hypotension reported in 2% of patients receiving IV melphalan and rarely in patients receiving oral melphalan. a b c If hypersensitivity reaction occurs, discontinue immediately and initiate appropriate therapy as indicated (e.g., plasma volume expanders, vasopressors, corticosteroids, antihistamines). 106 b c Cross-Sensitivity Potential for cross-sensitivity (rash) between melphalan and other alkylating agents. a General Precautions Immunization. Avoid administration of live vaccines to immunocompromised patients. b c Pulmonary Toxicity Pulmonary embolism, sometimes fatal, 148 and fibrosis have been reported. 106 113 148 d Specific Populations Pregnancy Category D. b c (See Fetal/Neonatal Morbidity and Mortality and also Fertility, under Cautions.) Lactation Not known whether melphalan is distributed into milk; 106 113 b c discontinue nursing or the drug. 106 113 b c Pediatric Use Safety and efficacy not established. 106 113 Geriatric Use Insufficient experience in patients 65 years of age to determine whether geriatric patients respond differently than younger adults. b c Renal Impairment Increased bone marrow suppression and risk of severe leukopenia in patients with renal impairment receiving IV melphalan; dosage reduction should be considered. c Closely monitor patients with azotemia receiving oral melphalan; oral dosage reductions may be required. 106 118 b (See Renal Impairment under Dosage and Administration.) Common Adverse Effects Bone marrow suppression, mild nausea. b Interactions for Alkeran Specific Drugs Drug Interaction Comments Carmustine Possible reduced threshold for carmustine-induced pulmonary toxicity with IV melphalan 106 119 c Cimetidine Possible reduced serum melphalan concentrations secondary to cimetidine-induced inhibition of GI absorption of melphalan 109 Monitor for decreased melphalan activity 109 Cisplatin Possible decreased clearance of melphalan secondary to cisplatin-induced renal impairment 106 119 c Cyclosporine Possible increased risk of cyclosporine-induced nephrotoxicity 107 112 c Monitor renal function 107 112 c Consider reducing cyclosporine dosage in patients receiving high-dose melphalan 112 Interferon alfa Interferon alfa-induced fever may increase plasma elimination of melphalan 110 111 Nalidixic acid Possible increased incidence of severe hemorrhagic necrotic enterocolitis in pediatric patients 106 119 c Alkeran Pharmacokinetics Absorption Bioavailability Absorption from the GI tract is incomplete and extremely variable. a b Food Food decreases bioavailability by about 35%. 108 Distribution Extent Rapidly distributed throughout total body water; a distributes into CSF in low concentrations. 106 113 119 b c Not known whether melphalan crosses the placenta or is distributed into milk. a b c Plasma Protein Binding About 60 90% (30% irreversibly); mainly albumin and to a lesser extent α 1 -acid glycoprotein. 106 113 119 b c Elimination Metabolism Undergoes spontaneous hydrolysis in plasma to monohydroxymelphalan and dihydroxymelphalan. a b c Elimination Route 20 35% of oral dose excreted in urine within 24 hours; 20 50% excreted in feces within 6 days. a Not removed by hemodialysis. 106 113 Half-life Following oral administration, terminal half-life of unchanged drug is 1.5 hours; a terminal half-lives of monohydroxymelphalan and dihydroxymelphalan are 2 3 times longer. a Following IV administration, terminal half-life is about 75 minutes. 106 c Stability Storage Oral Tablets 2 8 C. b Parenteral Powder for Injection 15 30 C; protect unopened vials from light. c Reconstituted and diluted solutions are unstable; following reconstitution, 1% of label strength hydrolyzed every 10 minutes. c Use within 60 minutes of reconstitution. c Following reconstitution, do not refrigerate; refrigeration of reconstituted solution may cause precipitation. c Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility HID 1 Incompatible by standard definition; recommended for dilution with use in shorter periods of time. Incompatible Dextrose 5% in water Ringer s injection, lactated Sodium chloride 0.9% 1 Drug Compatibility Y-Site CompatibilityHID Compatible Acyclovir sodium Amikacin sulfate Aminophylline Ampicillin sodium Aztreonam Bleomycin sulfate Bumetanide Buprenorphine HCl Butorphanol tartrate Calcium gluconate Carboplatin Carmustine Caspofungin acetate Cefazolin sodium Cefotaxime sodium Cefotetan disodium Ceftazidime Ceftriaxone sodium Cefuroxime sodium Cisplatin Clindamycin phosphate Co-trimoxazole Cyclophosphamide Cytarabine Dacarbazine Dactinomycin Daunorubicin HCl Dexamethasone sodium phosphate Diphenhydramine HCl Doxorubicin HCl Doxycycline hyclate Droperidol Enalaprilat Etoposide Famotidine Filgrastim Floxuridine Fluconazole Fludarabine phosphate Fluorouracil Furosemide Gallium nitrate Ganciclovir sodium Gentamicin sulfate Granisetron HCl Haloperidol lactate Heparin sodium Hydrocortisone sodium succinate Hydromorphone HCl Hydroxyzine HCl Idarubicin HCl Ifosfamide Imipenem cilastatin sodium Lorazepam Mannitol Mechlorethamine HCl Meperidine HCl Mesna Methotrexate sodium Methylprednisolone sodium succinate Metoclopramide HCl Metronidazole Mitomycin Mitoxantrone HCl Morphine sulfate Nalbuphine HCl Ondansetron HCl Pentostatin Potassium chloride Prochlorperazine edisylate Promethazine HCl Ranitidine HCl Sodium bicarbonate Streptozocin Teniposide Thiotepa Ticarcillin disodium clavulanate potassium Tobramycin sulfate Vancomycin HCl Vinblastine sulfate Vincristine sulfate Vinorelbine tartrate Zidovudine Incompatible Amphotericin B Chlorpromazine HCl Actions Interferes with DNA replication and transcription of RNA, and ultimately results in the disruption of nucleic acid function. a Active against both resting and rapidly dividing tumor cells. b c Possesses some immunosuppressive activity. a Advice to Patients Risk of bone marrow suppression, hypersensitivity reactions, infertility, pulmonary toxicities, and secondary malignancies. 106 113 b c d Advise patients that oral melphalan should be taken on an empty stomach. 108 Importance of close medical supervision of patients receiving melphalan. a b c Importance of informing clinicians if rash, bleeding, fever, persistent cough, nausea, vomiting, amenorrhea, weight loss, or unusual lumps or masses occur. b c Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy. b c Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. b c Importance of informing patients of other important precautionary information. b (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Melphalan Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 2 mg Alkeran (scored) Celgene Melphalan Hydrochloride Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection 50 mg (of melphalan) Alkeran Celgene AHFS DI Essentials. Copyright 2017, Selected Revisions July 10, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References Only references cited for selected revisions after 1984 are available electronically. 84. Einhorn N. Acute leukemia after chemotherapy (melphalan). Cancer . 1978; 41:444-7. [PubMed 272946] 100. McElwain TJ, Powles RL. High-dose intravenous melphalan for plasma-cell leukaemia and myeloma. Lancet . 1983; 2:822-4. [PubMed 6137651] 101. Howell SB, Pfeifle CE, Olshen RA. Intraperitoneal chemotherapy with melphalan. Ann Intern Med . 1984; 101:14-8. [PubMed 6732077] 102. Greene MH, Harris EL, Gershenson DM et al. Melphalan may be a more potent leukemogen than cyclophosphamide. Ann Intern Med . 1986; 105:360-7. [PubMed 3740675] 103. Fisher B, Rockette H, Fisher ER et al. Leukemia in breast cancer patients following adjuvant chemotherapy or postoperative radiation: the NSABP experience. J Clin Oncol . 1985; 3:1640-58. [PubMed 3906049] 104. Ovarian epithelial cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2000 Oct. 105. Wadler S, Yeap B, Vogl S et al. Randomized trial of initial therapy with melphalan versus cisplatin-based combination chemotherapy in patients with advanced ovarian carcinoma: initial and long term results Eastern Cooperative Oncology Group Study E2878. Cancer . 1996; 77:733-42. [PubMed 8616766] 106. Glaxo Wellcome. Alkeran (melphalan hydrochloride) for injection prescribing information. Research Triangle Park, NC; 1998 Aug. 107. Melphalan (Alkeran) interactions: cyclosporine (Sandimmune). In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:411. 108. Melphalan (Alkeran) interactions: food. In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:411. 109. Melphalan (Alkeran) interactions: H 2 receptor antagonists. In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:410. 110. Antineoplastic drug interactions: melphalan (Alkeran). In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:410. 111. Ehrsson H, Eksborg S, Wallin I et al. Oral melphalan pharmacokinetics: influence of interferon-induced fever. Clin Pharmacol Ther . 1990; 47:86-90. [PubMed 2295223] 112. Cyclosporine/melphalan. In: Tatro DS, Olin BR, Hebel SK eds. Drug interaction facts. St. Louis: JB Lippincott Co; 1993(January):237. 113. Glaxo Wellcome. Alkeran (melphalan) 2-mg scored tablets prescribing information. Research Triangle Park, NC; 1999 Aug. 114. Cooper MR, McIntyre OR, Propert KJ et al. Single, sequential, and multiple alkylating agent therapy for multiple myeloma: a CALGB study. J Clin Oncol . 1986; 4:1331-9. [PubMed 3528403] 115. Cornwell GG III, Pajak TF, Kochwa S et al. Vincristine and prednisone prolong the survival of patients receiving intravenous or oral melphalan for multiple myeloma: Cancer and Leukemia Group B experience. J Clin Oncol . 1988; 6:1481-90. [PubMed 3047338] 116. Harley JB, Pajak TF, McIntyre OR et al. Improved survival of increased-risk myeloma patients on combined triple-alkylating-agent therapy: a study of the CALGB. Blood . 1979; 54:13-22. 117. Osterborg A, Ahre A, Björkholm M et al. Oral versus intravenous melphalan and prednisone treatment in multiple myeloma stage II: a randomized study from the Myeloma Group of Central Sweden. Acta Oncol . 1990; 29:727-31. [PubMed 2223143] 118. Burroughs Wellcome. General questions and answers on Alkeran (melphalan HCl) for injection (ALK1-2). Research Triangle Park, NC: 1993 Apr 16. 119. Burroughs Wellcome. Formulary information: new Alkeran for injection (melphalan hydrochloride) 50 mg vial. Research Triangle Park, NC: 1993 Feb. 120. Burroughs Wellcome. Use of Alkeran (melphalan HCl) for injection in the treatment of multiple myeloma (ALK4-2). Research Triangle Park, NC: 1993 Apr 15. 121. Burroughs Wellcome, Research Triangle Park, NC: Personal communication. 122. Anon. Drugs of choice for cancer chemotherapy. Med Lett Drugs Ther . 2000; 42:83-92. [PubMed 10994034] 123. Dunbar CE, Nienhuis AW. Multiple myeloma: new approaches to therapy. JAMA . 1993; 269:2412-6. [PubMed 7683062] 124. Österborg A, Björkholm M, Björeman M et al. Natural interferon-α in combination with melphalan/prednisone versus melphalan/prednisone in the treatment of multiple myeloma stages II and III: a randomized study from the myeloma group of central Sweden. Blood . 1993; 81:1428-34. [PubMed 8453092] 125. MacLennan ICM, Chapman C, Dunn J et al. Combined chemotherapy with ABCM versus melphalan for treatment of myelomatosis. Lancet . 1992; 339:200-5. [PubMed 1346171] 126. Gregory WM, Richards MA, Malpas JS. Combined chemotherapy versus melphalan and prednisolone for treatment of myelomatosis. Lancet . 1992; 339:1353-4. [PubMed 1350010] 127. Clarke M, Gray R, Dunn J et al. Combination chemotherapy for myelomatosis. Lancet . 1992; 340:433. [PubMed 1353589] 128. Breast cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 1995 Dec 12. 129. Early Breast Cancer Trialists Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy: 133 randomized trials involving 31,000 recurrences and 24,000 deaths among 75,000 women. Lancet . 1992; 339:1-15,71-85. [PubMed 1345950] 130. Bonadonna G, Brusamolino E, Valagussa P et al. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med . 1976; 294:405-10. [PubMed 1246307] 131. Bonadonna G, Valagussa P, Moliterni A et al. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med . 1995; 332:901-6. [PubMed 7877646] 132. Wood WC, Budman DR, Korzun AH et al. Dose and dose intensity of adjuvant chemotherapy for stage II, node-positive breast carcinoma. N Engl J Med . 1994; 330:1253-9. [PubMed 8080512] 133. Bonadonna G, Zambetti M, Valagussa P. Sequential or alternating doxorubicin and CMF regimens in breast cancer with more than three positive nodes: ten-year results. JAMA . 1995; 273:542-7. [PubMed 7837388] 134. Fisher B, Redmond C, Wickerman DL et al. Doxorubicin-containing regimens for the treatment of stage II breast cancer: the National Surgical Adjuvant Breast and Bowel Project experience. J Clin Oncol . 1989; 7:572-82. [PubMed 2651576] 135. Fisher B, Glass A, Redmond C et al. l-Phenylalanine mustard (l-PAM) in the management of breast cancer: an update of earlier findings and a comparison with those utilizing l-PAM plus fluorouracil (5-FU). Cancer . 1977; 39(Suppl):2883-903. [PubMed 194679] 136. Fisher ER, Redmond C, Fisher B. Pathologic findings from the National Surgical Adjuvant Breast Cancer Project. VIII. Relationship of chemotherapeutic responsiveness to tumor differentiation. Cancer . 1983; 51:181-91. [PubMed 6821810] 137. Fisher B, Redmond C, Brown A et al. Adjuvant chemotherapy with and without tamoxifen in the treatment of primary breast cancer: 5-year results from the National Surgical Adjuvant Breast and Bowel Project Trial. J Clin Oncol . 1986; 4:459-71. [PubMed 2856857] 138. Rivkin SE, Green S, Metch B et al. Adjuvant CMFVP versus melphalan for operable breast cancer with positive axillary nodes: 10-year results of a Southwest Oncology Group Study. J Clin Oncol . 1989; 7:1229-38. [PubMed 2671283] 139. Fisher B, Redmond C, Brown A et al. Influence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast disease. J Clin Oncol . 1983; 1:227-41. [PubMed 6366135] 140. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul. 141. Kyle RA, Gertz MA, Greipp PR et al. A trial of three regimens for primary amyloidosis: colchicine alone, melphalan and prednisone, and melphalan, prednisone, and colchicine. N Engl J Med . 1997; 336:1202-7. [PubMed 9110907] 142. Falk RH, Comenzo RL, Skinner M. The systemic amyloidoses. N Engl J Med . 1997; 337:898-909. [PubMed 9302305] 143. Skinner M, Anderson JJ, Simms R et al. Treatment of 100 patients with primary amyloidosis: a randomized trial of melphalan, prednisone, and colchicine versus colchicine only. Am J Med . 1996; 100:290-8. [PubMed 8629674] 144. Melanoma. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2000 Aug. 145. Duran Garcia E, Santolaya R, Requena T. Treatment of malignant melanoma. Ann Pharmacother . 1999; 33:730-8. [PubMed 10410188] 146. Houghton A, Coit D, Bloomer W et al. NCCN melanoma practice guidelines. National Comprehensive Cancer Network. Oncology (Huntingt) . 1998; 12:153-77. 147. Koops HS, Vaglini M, Suciu S et al. Prophylactic isolated limb perfusion for localized, high-risk limb melanoma: results of a multicenter randomized phase III trial. European Organization for Research and Treatment of Cancer Malignant Melanoma Cooperative Group Protocol 18832, the World Health Organization Melanoma Program Trial 15, and the North American Perfusion Group Southwest Oncology Group-8593. J Clin Oncol . 1998; 16:2906-12. [PubMed 9738557] 148. Hafstrom L, Rudenstam CM, Blomquist E et al. Regional hyperthermic perfusion with melphalan after surgery for recurrent malignant melanoma of the extremities. Swedish Melanoma Study Group. J Clin Oncol . 1991; 9:2091-4. [PubMed 1960549] 149. Fraker DL, Alexander HR, Andrich M et al. Treatment of patients with melanoma of the extremity using hyperthermic isolated limb perfusion with melphalan, tumor necrosis factor, and interferon gamma: results of a tumor necrosis factor dose-escalation study. J Clin Oncol . 1996; 14:479-89. [PubMed 8636761] a. AHFS drug information 2007. McEvoy GK, ed. Melphalan. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1125-8. b. Glaxo Wellcome. Alkeran (melphalan hydrochloride) tablets prescribing information. Research Triangle Park, NC; 2004 Nov. c. Glaxo Wellcome. Alkeran (melphalan hydrochloride) for injection prescribing information. Research Triangle Park, NC; 2007 Mar. d. Treatment Guidelines from the Medical Letter Drugs of Choice for Cancer. Abramowicz M, ed. New Rochelle, NY: The Medical Letter, Inc.; 2003 Mar: 94. HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2013:732-5. Next Interactions Print this page Add to My Med List More about Alkeran (melphalan) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Generic Availability Drug class: alkylating agents Consumer resources Alkeran I.V. oral/injection ... +5 more Professional resources Alkeran (FDA) Alkeran Tablets (FDA) Melphalan (AHFS Monograph) Other brands: Evomela Related treatment guides Multiple Myeloma Ovarian Cancer} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Alkylating agents Related Drugs Multiple Myeloma dexamethasone , Decadron , Revlimid , cyclophosphamide , Cytoxan , Adriamycin , doxorubicin , Velcade , Doxil , vincristine , lenalidomide , More... Ovarian Cancer Avastin , carboplatin , Taxol , cisplatin , cyclophosphamide , paclitaxel , gemcitabine , Gemzar , Cytoxan , bevacizumab , etoposide , Adriamycin , More... Alkeran Rating No Reviews - Be the first! 4.0 /10 No Reviews - Be the first! 4.0 Rate it! Alkeran Images Alkeran 2 mg (A GX EH3) View larger images} } that you are the
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