アブストラクト
Japanese
| Title | 多発性骨髄腫患者におけるダラツムマブ皮下投与時の有害事象に対するジフェンヒドラミンとレボセチリジン前処置の比較 |
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| Subtitle | ノート |
| Authors | 末廣直哉1, 長島彩乃1, 西川はる1, 鈴川真由2, 櫻井洋臣1, 村松博1, 青森達1,2,3, 大谷壽一1,2,3 |
| Authors (kana) | |
| Organization | 1慶應義塾大病院薬剤部, 2慶應義塾大学薬学部, 3慶應義塾大学医学部 |
| Journal | 医療薬学 |
| Volume | 49 |
| Number | 8 |
| Page | 303-309 |
| Year/Month | 2023 / 8 |
| Article | 報告 |
| Publisher | 日本医療薬学会 |
| Abstract | 「緒言」多発性骨髄腫は, 血液細胞のなかのリンパ球の1つであるB細胞より分化した形質細胞が腫瘍化し, 異常に増殖する疾患である. 多発性骨髄腫は, 発症してしまうと完治は困難なため, 継続的に治療を続けていくことが重要である. ダラツムマブ(遺伝子組み換え)(ダラツムマブ)は, ヒト型免疫グロブリンG1κモノクローナル抗体であり, 多発性骨髄腫を含む造血器悪性腫瘍の腫瘍細胞表面に発現するCD38抗原に結合することにより, 抗腫瘍効果を発揮する. 本邦では, ダラツムマブは2017年11月に点滴静注製剤(商品名:ダラザレックス(R)点滴静注)(DARA-IV)として発売され, その後2021年5月に, ダラツムマブとボルヒアルロニダーゼ アルファ(遺伝子組換え)(rHuPH20)を配合した皮下投与製剤(商品名:ダラキューロ(R)皮下注)(DARA-SC)が発売された. |
| Practice | 薬学 |
| Keywords | daratumumab, antihistamine, levocetirizine, infusion reaction, drowsiness |
English
| Title | Comparison of Adverse Events between Diphenhydramine and Levocetirizine Pretreatment in Multiple Myeloma Patients Treated with Subcutaneous Daratumumab |
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| Subtitle | |
| Authors | Naoya Suehiro1, Ayano Nagashima1, Haru Nishikawa1, Mayu Suzukawa2, Hiroomi Sakurai1, Hiroshi Muramatsu1, Toru Aomori1,2,3, Hisakazu Ohtani1,2,3 |
| Authors (kana) | |
| Organization | 1Department of Pharmacy, Keio University Hospital, 2Keio University Faculty of Pharmacy, 3Keio University School of Medicine |
| Journal | Japanese Journal of Pharmaceutical Health Care and Sciences |
| Volume | 49 |
| Number | 8 |
| Page | 303-309 |
| Year/Month | 2023 / 8 |
| Article | Report |
| Publisher | Japanese Society of Pharmaceutical Health Care and Sciences |
| Abstract | Subcutaneous daratumumab DARA-SC is superior to intravenous daratumumab with a significantly shorter treatment time for multiple myeloma. To prevent infusion reaction (IR) during DARA-SC, oral diphenhydramine, a first-generation antihistamine, has been used in the phase III clinical trial and following clinical settings. We recently substituted diphenhydramine with levocetirizine, a second-generation antihistamine, to diminish antihistamine-induced sedation in our regimens for daratumumab. In this study, we aimed to retrospectively compare the prevention of IR and rate adverse events between diphenhydramine and levocetirizine. We retrospectively analyzed the clinical records of patients in whom DARA-SC treatment was introduced for the first time from August 1st, 2021 to July 31, 2022, at Keio University Hospital. For the first period, 7 and 24 patients were treated with diphenhydramine and levocetirizine, respectively. Neither patient experienced IR. Two out of 7 patients experienced drowsiness by diphenhydramine while only one of 24 patients experienced it by levocetirizine (P=0.125). Five and one patients initially treated with diphenhydramine were switched to levocetirizine upon the second and third periods of DARA-SC treatment, respectively. After the switching, their drowsiness was reduced. In conclusion, levocetirizine was considered more beneficial than diphenhydramine to prevent IR with a lower rate of drowsiness. |
| Practice | Pharmaceutical sciences |
| Keywords | daratumumab, antihistamine, levocetirizine, infusion reaction, drowsiness |
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参考文献
- 1) 日本骨髄腫学会, "多発性骨髄腫の診療指針", 第5版, 文光堂, 東京, 2020, pp2-4.
- 2) Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, Chari A, Silbermann R, Costa LJ, Anderson LD Jr, Nathwani N, Shah N, Efebera YA, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Murphy S, Lutska Y, Pei H, Ukropec J, Vermeulen J, de Boer C, Hoehn D, Lin TS, Richardson PG, Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma, N Engl J Med, 2016, 375, 1319-1331.
- 3) Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, Mark TM, Qi M, Schecter J, Amin H, Qin X, Deraedt W, Ahmadi T, Spencer A, Sonneveld P, Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma, N Engl J Med, 2016, 375, 754-766.
- 4) Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis NJ, Belch A, Krishnan A, Vescio RA, Mateos MV, Mazumder A, Orlowski RZ, Sutherland HJ, Blade J, Scott EC, Oriol A, Berdeja J, Gharibo M, Stevens DA, LeBlanc R, Sebag M, Callander N, Jakubowiak A, White D, de la Rubia J, Richardson PG, Lisby S, Feng H, Uhlar CM, Khan I, Ahmadi T, Voorhees PM, Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIU): an open-label, randomized, phase 2 trial, Lancet, 2016, 387, 1551-1560.
- 5) Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ, Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomized, phase 3 trial, Lancet Haematol, 2020, 7, e370-e380
残りの13件を表示する
- 6) 松井頌明, 石原慎之, 望月優里, 玉木宏樹, 西村信弘, 直良浩司, フェキソフェナジンあるいはベポタスチンの前投薬によるリツキシマブ投与時のinfusion reaction発現抑制効果, 医療薬学, 2019, 45, 396-403.
- 7) Kotchetkov R, McLean J, Nay D, Gerard L, Hopkins S, Didiodato G, Premedication with montelukast and rupatadine decreased rituximab infusion time, rate, severity of reactions and use of rescue medications, Int J Cancer, 2020, 147, 1979-1986.
- 8) Durham CG, Thotakura D, Sager L, Foster J, Herrington JD, Cetirizine versus diphenhydramine in the prevention of chemotherapy-related hypersensitivity reactions, J Oncol Pharm Pract, 2019, 25, 1396-1401.
- 9) 岩本大紀, 井出貴之, 三村 享, 土屋広行, 山折 大, 多発性骨髄腫におけるダラツムマブ点滴静注製剤初回投与時のinfusion reaction発現に関する後方視的検討, 日本病院薬剤師会雑誌, 2021, 58, 61-66.
- 10) Usmani SZ, Nahi H, Mateos MV, van de Donk NWCJ, Chari A, Kaufman JL, Moreau P, Oriol A, Plesner T, Benboubker L, Hellemans P, Masterson T, Clemens PL, Luo M, Liu K, San-Miguel J, Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma, Blood, 2019, 134, 668-677.
- 11) Chari A, Rodriguez-Otero P, McCarthy H, Suzuki K, Hungria V, Balari AS, Perrot A, Hulin C, Magen H, Iida S, Maisnar V, Karlin L, Pour L, Parasrampuria DA, Masterson T, Kosh M, Yang S, Delioukina M, Qi M, Carson R, Touzeau C, Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy(PLEIADES): an open-label Phase II study, Br J Haematol, 2021, 192, 869-878.
- 12) Kobayashi H, Tsushima T, Terao T, Abe Y, Miura D, Narita K, Kitadate A, Takeuchi M, Matsue K, Evaluation of the safety and efficacy of daratumumab outside of clinical trials, Int J Hematol, 2019, 109, 665-672.
- 13) Chari A, Lonial S, Mark TM, Krishnan AY, Stockerl-Goldstein KE, Usmani SZ, Londhe A, Etheredge D, Fleming S, Liu B, Ukropec J, Lin TS, Jagannath S, Nooka AK, Results of an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma, Cancer, 2018, 124, 4342-4349.
- 14) 中川雄介, 小倉宏之, 伊勢崎竜也, 安室 修, 小林宏紀, 舟越亮寛, 日本人の再発または難治性多発性骨髄腫におけるDaratumumabの安全性に関する後方視的検討とInfusion Related Reaction発現リスク因子の探索, 医療薬学, 2019, 45, 706-713.
- 15) 遠藤征裕, 齋藤雅隆, 大野謙太郎, 鈴木康之, 斉藤匡昭, 工藤直嗣, 非ホジキンリンパ腫患者の初回治療におけるリツキシマブバイオ後続品投与時のinfusion reactionについての検討とリスク因子解析, 日本病院薬剤師会雑誌, 2021, 57, 511-516.
- 16) Church MK, Church DS, Pharmacology of antihistamines, Indian J Dermatol, 2013, 58, 219-224.
- 17) Potter PC, Levocetirizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitized to house dust mites, Allergy, 2003, 58, 893-899.
- 18) Raphael GD, Angello JT, Wu MM, Druce HM, Efficacy of diphenhydramine vs desloratadine and placebo in patients with moderate-to-severe seasonal allergic rhinitis, Ann Allergy Asthma Immunol, 2006, 96, 606-614.
