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ויקסאוס ליפוזומל VYXEOS LIPOSOMAL (CYTARABINE, DAUNORUBICIN AS HCL)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-ורידי : I.V

צורת מינון:

אבקה להכנת תמיסה מרוכזת לעירוי : POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most frequently occurring adverse reactions (ADRs) were hypersensitivity including rash (66.9%), febrile neutropenia (63.5%), oedema (52.3%), diarrhoea/colitis (49.9%), mucositis (49.9%), fatigue (46.4%), musculoskeletal pain (44.5%), abdominal pain (36.3%), decreased appetite (33.9%), cough (33.9%), headache (32.3%), chills (31.2%), arrhythmia (30.4%), pyrexia (29.6%), sleep disorders (25.1%), and hypotension (23.7%).

The most serious and frequently occurring ADRs were infection (58.7%), cardiotoxicity (18.7%) and haemorrhage (13.1%).


Tabulated list of adverse reactions
ADRs have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical studies.

Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
For classification of ADRs which occur at Grades 3-5, a comprehensive listing is available from the NCI at NCI CTCAE. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved. Death (Grade 5) is used for some of the criteria to denote a fatality.

Table 3:       ADRs reported in clinical studies in patients treated with Vyxeos liposomal (n=375)
System Organ Class          ADRs/Frequency (%)                 Grade 3-5 ADRs/Frequency (%) Infections and infestations Very Common                        Very Common Infection (78.1)                   Infection (58.7)
Blood and lymphatic         Very Common                        Very Common system disorders            Febrile neutropenia (63.5)         Febrile neutropenia (62.4) 
Common                            Common
Thrombocytopenia (4.5)            Thrombocytopenia (3.7)
Neutropenia (3.7)                 Neutropenia (3.5)
Anaemia (3.2)                     Anaemia (2.1)
Immune systems disorders       Very Common                       Common Hypersensitivity (including       Hypersensitivity (including rash) rash) (66.9)                      (9.1)
Metabolism and nutrition       Common                            Common disorders                      Tumour lysis syndrome (7.5)       Tumour lysis syndrome (2.7) Psychiatric disorders          Very Common                       Common Sleep disorders (25.1)            Delirium (2.4)
Anxiety (17.3)
Delirium (15.5)                   Uncommon
Sleep disorders (0.5)
Nervous system disorders       Very Common                       Common Headache (32.3)                   Headache (1.1)
Dizziness (23.2)
Uncommon
Dizziness (0.8)
Eye disorders                 Very Common                    Uncommon Visual impairment (10.4)       Visual impairment (0.3)
Cardiac disorders             Very Common                    Very Common Cardiotoxicity (72)            Cardiotoxicity (18.7)
Arrhythmiaa (30.4)
Chest pain (17.6)              Common
Arrhythmiaa (4.3)
Chest pain (1.9)
Vascular disorders            Very Common                    Very Common Haemorrhage (69.1)             Haemorrhage (13.1)
Hypotension (23.7)
Hypertension (17.3)            Common
Hypertension (6.9)
Hypotension (4.5)
Respiratory, thoracic and     Very Common                    Very Common mediastinal disorders         Dyspnoea (36.5)                Dyspnoea (13.1) Cough (33.9)
Pleural effusion (13.9)        Uncommon
Pleural effusion (0.8)
Gastrointestinal disorders    Very Common                    Common
Nausea (51.7)                  Diarrhoea/colitis (6.1)
Diarrhoea/colitis (49.9)       Abdominal pain (2.9)
Mucositis (49.9)               Mucositis (2.1)
Constipation (42.7)            Decreased appetite (1.6)
Abdominal pain (36.3)          Constipation (1.1)
Decreased appetite (33.9)      Nausea (1.1)
Vomiting (27.7)
Uncommon
Common                         Dyspepsia (0.5)
Dyspepsia (9.6)                Vomiting (0.3)
Skin and subcutaneous         Very Common                    Uncommon tissue disorders              Pruritus (17.3)                Hyperhidrosis (0.3) Hyperhidrosis (10.1)

Common
Night sweats (8.3)
Alopecia (3.2)

Uncommon
Palmar-plantar erythrodysaesthesia syndrome
(0.8)
Musculoskeletal and           Very Common                    Common connective tissue            Musculoskeletal pain (44.5)     Musculoskeletal pain (5.1) disorders
Renal and urinary             Very Common                    Common disorders                     Renal insufficiency (10.4)     Renal insufficiency (6.4) 
General disorders and         Very Common                    Very Common administration site           Oedema (52.3)                  Fatigue (10.4) conditions                    Fatigue (46.4)
Chills (31.2)                  Common
Pyrexia (29.6)                 Pyrexia (3.2)
Oedema (2.7)

Uncommon
Chills (0.3)
a
Arrhythmia group terms includes atrial fibrillation, bradycardia, and the most commonly reported arrhythmia was tachycardia

Description of selected adverse reactions

Infections
Due to the neutropenia experienced with Vyxeos liposomal, infections of various types were very common ADRs. Pneumonia, sepsis and bacteriaemia were the most frequently seen serious infection ADRs in the clinical studies population. The incidence of infection events was 78.1%; the incidence of non-serious events of infections was 73.1%, the incidence of serious events of infections was 28.5%; the incidence of infections which led to discontinuation is 0.5%. The incidence of fatal infections was 6.9%. The fatal infections experienced were sepsis and pneumonia (see section 4.4).

Haemorrhage
Due to the thrombocytopenia experienced with Vyxeos liposomal a variety of haemorrhagic events were seen in clinical studies. The most common haemorrhagic event was epistaxis, and the majority of these were considered not serious (29.1%). The incidence of haemorrhage events is 69.1%; the incidence of non-serious events of haemorrhage was 67.2 %; the incidence of serious events of haemorrhage is 5.6%; the incidence of haemorrhage which led to discontinuation is 0. The incidence of fatal haemorrhage was 2.1%. Serious or fatal haemorrhagic events, including fatal CNS haemorrhages, associated with severe thrombocytopenia were seen in patients treated with Vyxeos liposomal (see section 4.4).


Cardiotoxicity
Cardiotoxicities were seen in Vyxeos liposomal clinical studies. The most frequently reported serious ADRs were decreased ejection fraction and congestive cardiac failure. Cardiotoxicity is a known risk of anthracycline treatment. The incidence of all cardiotoxicity events was 72.0%; the incidence of non-serious events of cardiotoxicity was 68.5 %; the incidence of serious events of cardiotoxicity was 9.1%; the incidence of cardiotoxicity which led to discontinuation is 0. 5%. Incidence of fatal cardiotoxicity events is 0.5%. Cardiac arrest was reported as a fatal event; the patient experienced thrombocytopenia and neutropenia which contributed to cardiac arrest (see section 4.4).

Hypersensitivity
Hypersensitivity reactions were very common ADRs in Vyxeos liposomal clinical studies. The most frequently reported hypersensitivity ADRs were rash and the majority of these were not serious (38.9%). The incidence of all hypersensitivity events was 66.9%; the incidence of non-serious events of hypersensitivity was 66.4 %, of which 38.9 % were rash; the incidence of serious events of hypersensitivity is 1.1%; the frequency of hypersensitivity which led to discontinuation is 0. The frequency of fatal hypersensitivity events was 0 (see section 4.4).

Paediatric population
The safety profile of Vyxeos liposomal in 38 paediatric patients with relapsed AML in study AAML1421 appeared to be in general similar to that observed in the approved indication in adults with newly treated AML treated with Vyxeos liposomal (see section 4.2). However, adverse events in study AAML 1421 observed in paediatric patients that were different from or more severe than those seen in adults (acknowledging limitations of cross study comparisons) included rash maculo- papular (47.4%), electrocardiogram QT prolongation (28.9%), the early onset of cardiotoxicity (defined as > 10% decrease LVEF to final LVEF < 50% LVEF; 21.0%), severe hypokalaemia (13.2%), hyperglycaemia (7.9%) and ALT increased (7.9%). Hypertension was observed in 18.2% of these paediatric patients.

No paediatric long-term safety data beyond the study duration (26 months) are available. There is, thus, no paediatric safety data to address the long-term cardiotoxicity of Vyxeos liposomal, including long-term cardiotoxicity when used at doses above the maximum life-time cumulative anthracycline dose. There are no data on the effects of Vyxeos liposomal treatment on growth and maturation 
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/

פרטי מסגרת הכללה בסל

א. התרופה תינתן לטיפול במקרים האלה:1. לוקמיה מסוג Therapy related acute myeloid leukemia (t-AML).לעניין זה תוגדר לוקמיה תלוית טיפול כלוקמיה שהופיעה תוך שבע שנים מהטיפול החשוד שגרם להופעת AML.2. לוקמיה מסוג AML with myelodysplasia-related changes ((AML-MRC.ב. מתן התרופה האמורה ייעשה לפי מרשם של מומחה באונקולוגיה או מומחה בהמטולוגיה.
שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/02/2023
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