艾曲波帕片 ELTROMBOPAG 商品名：PROMACTA，重型再生障碍性贫血新药 美国上市，一次性进口，平价供应
英文名： ELTROMBOPAG
商标名：PROMACTA
中文名：艾曲波帕片
生产商：诺华
上市国家：美国
包装规格[注：以下产品除价格以外，运费另加500元/次]
PROMACTA 75MG TAB 30/EA ELTROMBOPAG NOVARTIS 00078-0687-15 $17,478.03
PROMACTA 50MG TAB 30/EA ELTROMBOPAG NOVARTIS 00078-0686-15 $1,318.68
PROMACTA 25MG TAB 30/EA ELTROMBOPAG NOVARTIS 00078-0685-15 $8,701.94
PROMACTA 12.5MG TAB 30/EA ELTROMBOPAG NOVARTIS 00078-0684-15 $9,097.78
完整资料附件：https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf
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附：部份英文处方资料（供参考）
PROMACTA ® (eltrombopag) tablets, for oral use
PROMACTA ® (eltrombopag) for oral suspension
Initial U.S. Approval: 2008
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C RISK OF HEPATOTOXICITY
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. (5.1)
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. (5.2)
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1.4)10/2017
Dosage and Administration, Administration (2.4)7/2018
Warnings and Precautions, Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia (5.3)10/2017
Mechanism of Action
Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells.
INDICATIONS AND USAGE
PROMACTA is a thrombopoietin receptor agonist indicated for the treatment of:
thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1)
thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2)
patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)
Limitations of Use:
PROMACTA is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4)
Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4)
DOSAGE AND ADMINISTRATION
•Take on an empty stomach (1 hour before or 2 hours after a meal). ( 2.4)
•Chronic ITP: Initiate PROMACTA at 50 mg once daily for most adult and pediatric patients 6 years and older, and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment and some |
