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אונורג 200 מ"ג ONUREG 200 MG (AZACITIDINE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Posology : מינונים
4.2 Posology and method of administration Onureg treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products. Patients are to be treated with an anti-emetic 30 minutes prior to each dose of Onureg for the first 2 treatment cycles. Anti-emetic prophylaxis may be omitted after 2 cycles, if there has been no nausea and vomiting (see section 4.4). Onureg_API_June2022_clean Posology The recommended dose is 300 mg azacitidine orally once daily. Each repeated cycle consists of a treatment period of 14 days followed by a treatment free period of 14 days (28-day treatment cycle). Onureg treatment should be continued until no more than 15% blasts are observed in peripheral blood or bone marrow or until unacceptable toxicity (see dose schedule modification guidance for disease relapse). Onureg should not be used interchangeably with injectable azacitidine due to differences in the exposure, dose and schedule of treatment. Healthcare professionals are recommended to verify the name of the medicinal product, dose and administration route. Laboratory tests Complete blood counts should be performed prior to initiation of therapy. Complete blood count monitoring is also recommended every other week for the first 2 cycles (56 days), every other week for the next 2 cycles after dose adjustment, and monthly thereafter, prior to the start of subsequent cycles of treatment (see section 4.4). Dose schedule modification for AML disease relapse In the case of disease relapse, with 5% to 15% blasts in peripheral blood or bone marrow, in conjunction with a clinical assessment, an extension of the dosing schedule from 14 to 21 days of repeated 28-day cycles should be considered. Dosing should not exceed 21 days during any 28-day period. Onureg should be discontinued if more than 15% blasts are observed in either the peripheral blood or bone marrow or at the physician’s discretion. Dose adjustment for adverse reactions Dose modification guidelines for haematologic and non-haematologic adverse reactions are recommended based on clinical and laboratory findings (see Table 1). Table 1: Dose adjustments for haematologic and non-haematologic adverse reactions Criteria* Recommended action Grade 4 neutropenia or First occurrence Grade 3 neutropenia with • Interrupt Onureg. Resume the treatment cycle at the same dose fever once neutrophils return to Grade 2 or lower. • Use supportive care such as granulocyte colony stimulating factor (GCSF), as clinically indicated (see section 4.4). Occurrence in 2 consecutive cycles • Interrupt Onureg. Resume the treatment cycle at a reduced dose of 200 mg after neutrophils return to Grade 2 or lower. • If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days. • If the toxicity continues or re-occurs after dose and schedule reduction, discontinue Onureg. • Use supportive care such as GCSF, as clinically indicated (see section 4.4). Grade 4 First occurrence thrombocytopenia or • Interrupt Onureg. Resume the treatment cycle at the same dose Grade 3 once platelets return to Grade 2 or lower. thrombocytopenia with Occurrence in 2 consecutive cycles bleeding • Interrupt Onureg. Resume the treatment cycle at a reduced dose of 200 mg after platelets return to Grade 2 or lower. • If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days. • If the toxicity continues or re-occurs after dose and schedule reduction, discontinue Onureg. Onureg_API_June2022_clean Criteria* Recommended action Grade 3 or higher nausea, • Interrupt Onureg. Resume the treatment cycle at the same dose vomiting or diarrhoea once toxicity has resolved to Grade 1 or lower. • Use supportive care such as anti-emetic therapy and treat diarrhoea at the onset of symptoms (see section 4.4). • If event re-occurs, interrupt dose until resolved to Grade 1 or lower and reduce the dose to 200 mg. • If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days. • If the toxicity continues or re-occurs after dose and schedule reduction, discontinue Onureg. Other Grade 3 or higher • Interrupt Onureg and provide medical support according to local non-haematological events recommendations. Resume the treatment cycle at the same dose once toxicity has resolved to Grade 1 or lower. • If the toxicity re-occurs, interrupt Onureg until resolved to Grade 1 or lower and reduce dose to 200 mg. • If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days. • If the toxicity continues or re-occurs after dose and schedule reduction, discontinue Onureg. * Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.3 (NCI-CTCAE v4.3). Missed or delayed doses If a dose of Onureg is missed, or not taken at the usual time, the dose should be taken as soon as possible on the same day. Then, the next scheduled dose should be taken at the normal time the following day. Two doses should not be taken on the same day. If a dose is vomited, another dose must not be taken on the same day. Instead return to the normal time of dose administration the following day. Special populations Elderly patients No dose adjustments are recommended for patients over 65 years of age (see section 5.2). Renal impairment Onureg can be administered to patients with mild, moderate or severe renal impairment without initial dose adjustment (see section 5.2). Hepatic impairment No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin (BIL) ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN, or BIL 1 to 1.5 × ULN and any AST) (see section 5.2). Patients with moderate (BIL > 1.5 to 3 × ULN) and severe hepatic impairment (BIL > 3 × ULN) should be monitored more frequently for adverse reactions and appropriate dose adjustment should be made (see Table 1). Paediatric population The safety and efficacy of Onureg in children and adolescents below 18 years have not been established. No data are available. Method of administration Onureg is for oral use. Onureg_API_June2022_clean Onureg can be taken with or without food. The tablets should be swallowed whole with a glass of water at about the same time each day. They should not be split, crushed, dissolved or chewed (see section 6.6).
פרטי מסגרת הכללה בסל
א. הטיפול בתרופה יינתן לטיפול מתמשך בלוקמיה מסוג AML בחולים שהשיגו תגובה מלאה או תגובה מלאה עם החלמה לא מלאה של ספירות הדם (incomplete blood count recovery (CRi)) לאחר אינדוקציה כימותרפית אינטנסיבית, שאינם מסוגלים לקבל טיפול קוראטיבי אינטנסיבי. במחלה מסוג AML עם מוטציה מסוג FLT3, במהלך מחלתו יוכל החולה לקבל תרופה אחת מבין השתיים כטיפול אחזקה – Azacitidine, Midostaurinב. מתן התרופה ייעשה לפי מרשם של מומחה באונקולוגיה או רופא מומחה בהמטולוגיה.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
03/02/2022
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