אורסרדו 86 מ"ג - Orserdu 86 mg
מינונים נוספים | |
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קבוצה פרמקולוגית (ATC4) | L02BA Anti-estrogens |
מרכיב פעיל (ATC5) |
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צורת מתן | פומי - PER OS |
צורת מינון | טבליות מצופות פילם, FILM COATED TABLETS למניעת מינון יתר או הרעלה יש ליטול את התרופה בהתאם למינון המומלץ כפי שמופיע בעלון לצרכן |
התוויה | Orserdu is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. |
התוויות נגד | [ Hypersensitivity to the active substance or to any of the excipients listed in section 12. |
תגובות בין תרופתיות | [ Effect of Other Drugs on ORSERDU Strong and Moderate CYP3A4 Inhibitors Avoid concomitant use of strong or moderate CYP3A inhibitors with ORSERDU. Elacestrant is a CYP3A4 substrate. Concomitant use of a strong or moderate CYP3A4 inhibitor including grapefruit or grapefruit juice increase elacestrant exposure, which may increase the risk of adverse reactions of ORSERDU. Strong and Moderate CYP3A4 Inducers Avoid concomitant use of strong or moderate CYP3A inducers with ORSERDU. Elacestrant is a CYP3A4 substrate. Concomitant use of a strong or moderate CYP3A4 inducer decreases elacestrant exposure [see Clinical Pharmacology (13.3)], which may decrease effectiveness of ORSERDU. Effect of ORSERDU on Other Drugs P-gp Substrates Reduce the dosage of P-gp substrates per their Prescribing Information when minimal concentration changes may lead to serious or life-threatening adverse reactions. Elacestrant is a P-gp inhibitor. Concomitant use of ORSERDU with a P-gp substrate increased the concentrations of P-gp substrate, which may increase the adverse reactions associated with a P-gp substrate. BCRP Substrates Reduce the dosage of BCRP substrates per their Prescribing Information when minimal concentration changes may lead to serious or life-threatening adverse reactions. Elacestrant is a BCRP inhibitor. Concomitant use of ORSERDU with a BCRP substrate increased the plasma concentrations of BCRP substrate, which may increase the adverse reactions associated with a BCRP substrate. |
שימוש בהיריון והנקה | [ Risk Summary Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. There are no available human data on ORSERDU use in pregnant women to inform the drug-associated risk. In an animal reproduction study, oral administration of elacestrant to pregnant rats during organogenesis caused embryo-fetal mortality and structural abnormalities at maternal exposures below the recommended dose based on AUC (see Data). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. |
פרמקודינמיקה | [ Elacestrant exposure-response relationships and the time course of pharmacodynamics have not been fully characterized. Cardiac Electrophysiology ORSERDU does not cause a mean increase in QTc interval > 20 msec at the approved recommended dose. |
פרמקוקינטיקה | [ The steady-state mean (%CV) maximum concentration (Cmax) of elacestrant is 119 ng/mL (43.6%) and the area under the concentration-time curve (AUC0-24h) is 2440 ng*h/mL (44.3%) after administration of the recommended dosage of 345 mg once daily. The Cmax and AUC of elacestrant increase more than proportionally over a dosage range from 43 mg to 862 mg once daily (0.125 to 2.5 times the approved recommended dosage). Steady state is reached by Day 6 and the mean accumulation ratio based on AUC0-24h is 2-fold. |
עלון לרופא והחמרות לעלון |
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עלון לצרכן |
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ערכים בוויקירפואה | ערכים קשורים בוויקירפואה |
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אורסרדו 86 מ"ג במאגר משרד הבריאות |
חיפוש מאמרים | מאמרים ב-PubMed |
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מידע ברשת | RxList WebMD Drugs.com |
שם יצרן | STEMLINE THERAPEUTICS, INC., USA |
שם בעל הרישום | .STEMLINE ISRAEL LTD |
רישיון | רישיון מתאריך: |
תאריך עדכון אחרון | 03/08/2024 |