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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/08/04 06:56:09」(JST)

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Romiplostim (rINN, USAN) is a fusion protein analog of thrombopoietin, a hormone that regulates platelet production.

Safety Concerns vs. Marketing

The drug was developed by Amgen and is marketed under the trade name Nplate through a restricted usage program called NEXUS.^[1] During development and clinical trials the drug was called AMG531.

Romiplostim is indicated as a potential treatment for chronic idiopathic (immune) thrombocytopenic purpura (ITP).^[2] Romiplostim was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in 2003, as the chronic ITP population in the USA is under 200,000 (the chronic adult ITP population in the USA is thought to be around 60,000, with women outnumbering men by a factor of two).^[3] The wholesale cost of romiplostim if administered weekly is currently estimated at US $55,250 per year.^[4]

On August 22, 2008, the FDA approved romiplostim as a long-term treatment for chronic ITP in adults who have not responded to other treatments, such as corticosteroids, intravenous immunoglobulin, Rho(D) immune globulin or splenectomy.^[1]^[5]

Treatment regimen

Romiplostim treatment is generally administered at weekly intervals via subcutaneous injection. Prior to injection, a complete blood count (CBC) is obtained, as the dosage is dependent on the individual's body weight and platelet count at the time of treatment. The goal of treatment is to maintain the count above 50,000 per cubic millimeter (mm³) of blood, not to achieve a normal count—defined as 150,000–450,000 per mm³ in most healthy individuals. If a count of 200,000 or higher is achieved for two consecutive weeks a reduced dose is administered or treatment is suspended until the count decreases below 200,000. Discontinuation of romiplostim must be approached with great caution, as a rapid decrease in the platelet count may occur, possibly leading to bleeding diathesis.

Clinical efficacy

In well designed, 24-week, Phase III trials, romiplostim was significantly more effective than placebo in achieving the primary endpoint of a protocol-defined durable platelet response in nonsplenectomized or splenectomized adults with chronic immune thrombocytopenic purpura.^[6]

Side-effects

Romiplostim's effect is to stimulate the patient's megakaryocytes to produce platelets at a more rapid than normal rate, thus overwhelming the immune system's ability to destroy them. As doing so involves changes to the bone marrow chemistry, a number of potentially serious side-effects may develop, including death, myalgia, joint and extremity discomfort, insomnia, thrombocytosis, which may lead to potentially fatal clots, and bone marrow fibrosis, the latter which may result in an unsafe decrease in the red blood count.

External links

Nplate

References

^ ^a ^b Waknine, Yael (September 4, 2008). "FDA Approvals: Nplate, Aloxi, Vidaza". Medscape. Retrieved 2008-09-04. Freely available with registration.
^ Kuter DJ, Bussel JB, Lyons RM et al. (February 2008). "Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial". Lancet 371 (9610): 395–403. doi:10.1016/S0140-6736(08)60203-2. PMID 18242413.
^ "Amgen to Discuss Romiplostim BLA". drugs.com. March 12, 2008. Retrieved 2008-11-04.
^ Romiplostim: a novel thrombopoiesis-stimulating agent. Am J Health Syst Pharm. 2009 May 1;66(9):817-24. Perreault S, Burzynski J.
^ "FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP" (Press release). Amgen. August 22, 2008. Retrieved 2008-09-04.
^ Frampton JE, Lyseng-Williamson KA.[1].Drugs 2009;69(3):307-317. doi:10.2165/00003495-200969030-00006.

UpToDate Contents

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1. Immune thrombocytopenia (ITP) in adults: Second-line and subsequent therapies
2. 血小板産生因子の臨床応用 clinical applications of thrombopoietic growth factors
3. 小児における免疫性血小板減少症（ITP）：慢性疾患のマネージメント immune thrombocytopenia itp in children management of chronic disease
4. 骨髄異形成症候群の合併症のマネージメント management of the complications of the myelodysplastic syndromes
5. 組換え造血成長因子の概要 introduction to recombinant hematopoietic growth factors

English Journal

Romiplostim in the management of the thrombocytopenic surgical patient.

Marshall AL1,2, Goodarzi K1, Kuter DJ1.
Transfusion.Transfusion.2015 May 30. doi: 10.1111/trf.13181. [Epub ahead of print]
BACKGROUND: Thrombopoietin receptor agonists increase platelet (PLT) counts and are approved for the treatment of chronic immune thrombocytopenia (ITP). These agents may also be useful for the management of thrombocytopenia in patients requiring surgical procedures.STUDY DESIGN AND METHODS: We condu
PMID 26033367

Management of immune-mediated cytopenias in pregnancy.

Piatek CI1, El-Hemaidi I2, Feinstein DI1, Liebman HA1, Akhtari M3.
Autoimmunity reviews.Autoimmun Rev.2015 May 13. pii: S1568-9972(15)00111-1. doi: 10.1016/j.autrev.2015.05.003. [Epub ahead of print]
Immune-mediated cytopenias are a well-described complication of pregnancy. Appropriate recognition and treatment are important in order to limit maternal and fetal morbidity and mortality. First line treatment options are fairly well-established for these entities. Refractory disease may be difficul
PMID 25981747

Identification of anti-thrombopoietin receptor antibody in prolonged thrombocytopenia after allogeneic hematopoietic stem cell transplantation treated successfully with eltrombopag.

Fujimi A1, Kamihara Y, Hashimoto A, Kanisawa Y, Nakajima C, Hayasaka N, Yamada S, Okuda T, Minami S, Ono K, Iyama S, Kato J.
International journal of hematology.Int J Hematol.2015 May 13. [Epub ahead of print]
A 55-year-old female with stage IVA follicular lymphoma in third complete remission underwent allogeneic peripheral blood stem cell transplantation. Neutrophil engraftment was achieved on day +18; however, platelet counts remained below 10 × 103/µL, necessitating transfusions twice a week for mo
PMID 25964100

Japanese Journal

脾摘を目的としてロミプロスチムを用いた免疫性血小板減少症の3症例

田口淳,板橋めぐみ,小山哲,大草恵理子,磯貝宜広,熱田幸司,新谷恒弘,白石好,石ヶ坪良明
静岡赤十字病院研究報 = Journal of Japanese Red Cross Shizuoka Hospital 32(1), 25-32, 2013-03-00
慢性免疫性血小板減少症の3例に脾摘術前の血小板増加を目的としてトロンボポエチン受容体作動薬ロミプロスチムを投与した．【症例1】33歳女性．挙児希望．投薬減量のため脾摘実施．ロミプロスチム1μg/kg/週より投与開始し、5μg/kg/週まで増量した．手術直前に血小板低下し、グロブリン製剤を併用した．【症例2】67歳女性．無菌性骨壊死のためステロイド減量目的に脾摘実施．ロミプロスチム2μg/kg …
NAID 120005273621

MDSに対する新規治療薬の開発と展望 (特集 MDSをめぐる最近の進歩 : 治癒を目指して)

宮？泰司
血液内科 65(3), 383-387, 2012-09-00
NAID 40019458177

Industrial Info. 慢性ITPに対するトロンボポエチン受容体作動薬 : ロミプロスチムについて

柳田誠,古屋良宏,桑澤宏 [他]
細胞 44(9), 409-413, 2012-08-00
NAID 40019408416

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「ロミプロスチム」

Romiplostim
Systematic (IUPAC) name
	L-methionyl[human immunogloblin heavy constant gamma 1-(227 C-terminal residues)-peptide (Fc fragment)] fusion protein with 41 amino acids peptide, (7-7′:10,10′)-bisdisulfide dimer
Clinical data
AHFS/Drugs.com	Consumer Drug Information
MedlinePlus	a609008
Licence data	US FDA:link
Pregnancy; category	US: C (Risk not ruled out);
Legal status	US: ℞-only;
Routes of; administration	Subcutaneous injection
Pharmacokinetic data
Biological half-life	1 to 34 days
Identifiers
CAS Registry Number	267639-76-9
ATC code	B02BX04
IUPHAR/BPS	6974
UNII	GN5XU2DXKV
ChEMBL	CHEMBL1201832
Chemical data
Formula	C2634H4086N722O790S18
Molecular mass	59 kDa
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　　[★]

英: romiplostim
商: ロミプレート
関: 他に分類されない代謝性医薬品

[Medscape-1] Waknine, Yael (September 4, 2008). "FDA Approvals: Nplate, Aloxi, Vidaza". Medscape. Retrieved 2008-09-04. Freely available with registration.

[pmid18242413-2] Kuter DJ, Bussel JB, Lyons RM et al. (February 2008). "Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial". Lancet 371 (9610): 395–403. doi:10.1016/S0140-6736(08)60203-2. PMID 18242413.

[3] "Amgen to Discuss Romiplostim BLA". drugs.com. March 12, 2008. Retrieved 2008-11-04.

[4] Romiplostim: a novel thrombopoiesis-stimulating agent. Am J Health Syst Pharm. 2009 May 1;66(9):817-24. Perreault S, Burzynski J.

[5] "FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP" (Press release). Amgen. August 22, 2008. Retrieved 2008-09-04.

[romi-6] Frampton JE, Lyseng-Williamson KA.[1].Drugs 2009;69(3):307-317. doi:10.2165/00003495-200969030-00006.

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romiplostim