.08..80.50 :‫תאריך‬
Iclusig 15 and Iclusig 45 ‫שם תכשיר באנגלית ומספר הרישום‬
511-11-14241-05 ,511-11-14241-00 :‫ מ"ג‬51 ‫איקלוסיג‬
511-14-14244-05 ,511-14-14244-00 :‫ מ"ג‬41 ‫איקלוסיג‬
‫ פתח‬,50 ‫ רח' השילוח‬,‫ אריאד פרמצבטיקה (ישראל) בע"מ‬.‫ איי‬.‫ פי‬.‫ אי‬: ‫שם בעל הרישום‬
‫תקווה‬
! ‫טופס זה מיועד לפרוט ההחמרות בלבד‬
‫רופא‬
‫בעלון ללרופא‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
‫ההחמרות המבוקשות‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Vascular occlusion
Arterial and venous thrombosis and
occlusions, including fatal myocardial
infarction, stroke, retinal vascular occlusions
associated in some cases with permanent visual
impairment or vision loss, stenosis of large
arterial vessels of the brain, severe peripheral
vascular disease, and the need for urgent
revascularization procedures have occurred in
Iclusig-treated patients. Patients with and
without cardiovascular risk factors, including
patients age 50 years or younger, experienced
these events. Vascular occlusion adverse
events were more frequent with increasing age
and in patients with prior history of ischaemia,
hypertension, diabetes, or hyperlipidaemia.
Vascular occlusion
Arterial and venous thrombosis and
occlusions, including fatal myocardial
infarction, stroke, stenosis of large arterial
vessels of the brain, severe peripheral
vascular disease, and the need for urgent
revascularization procedures have occurred
in Iclusig-treated patients. Patients with and
without cardiovascular risk factors, including
patients age 50 years or younger, experienced
these events. Vascular occlusion adverse
events were more frequent with increasing
age and in patients with prior history of
ischaemia, hypertension, diabetes, or
hyperlipidaemia.
Monitoring for evidence of thromboembolism
and vascular occlusion should be performed
and if decreased vision or blurred vision
occurs, an ophthalmic examination (including
fundoscopy) should be performed. Iclusig
should be interrupted immediately in case of
vascular occlusion. A benefit -risk
consideration should guide a decision to restart
Iclusig therapy (see sections 4.2 and 4.8).
Monitoring for evidence of
thromboembolism and vascular occlusion
should be performed an. Iclusig should be
interrupted immediately in case of vascular
occlusion. A benefit -risk consideration
should guide a decision to restart Iclusig
therapy (see sections 4.2 and 4.8).
Hypertension
Hypertension may contribute to risk of arterial
thrombotic events. During Iclusig treatment,
blood pressure should be monitored and
managed at each clinic visit and hypertension
should be treated to normal. Iclusig treatment
should be temporarily interrupted if
hypertension is not medically controlled (see
section 4.2).
Hypertension may contribute to risk of
arterial thrombotic events. During Iclusig
treatment, blood pressure should be
monitored and managed at each clinic visit
and hypertension should be treated to normal.
Iclusig treatment should be temporarily
interrupted if hypertension is not medically
controlled (see section 4.2).
‫פרק בעלון‬
4.4 Special
warnings
and
precautions
for use
Treatment-emergent hypertension (including
hypertensive crisis) occurred in Iclusig-treated
patients. Patients may require urgent clinical
intervention for hypertension associated with
confusion, headache, chest pain, or shortness
of breath.
Treatment-emergent hypertension occurred
in Iclusig-treated patients. Patients may
require urgent clinical intervention for
hypertension associated with confusion,
headache, chest pain, or shortness of breath.
Hepatotoxicity
Liver function abnormality
Iclusig may result in elevation in ALT, AST,
bilirubin, and alkaline phosphatase. Hepatic
failure (including fatal outcome) has been
observed. Liver function tests should be
performed prior to treatment initiation and
monitored periodically, as clinically indicated.
Liver function abnormality
Iclusig may result in elevation in ALT, AST,
bilirubin, and alkaline phosphatase. Liver
function tests should be performed prior to
treatment initiation and monitored
periodically, as clinically indicated.
‫מצ"ב טבלה‬
‫מצ"ב טבלה‬
Undesirable
effects
Current:
Table 3
Adverse reactions observed in CML and Ph+ ALL patients – frequency
reported by incidence of treatment emergent events
System organ class
Infections and infestations
Frequency
Very common
Common
Very common
Blood and lymphatic
system disorders
Common
Very common
Metabolism and nutrition
disorders
Common
Psychiatric disorders
Uncommon
Very common
Very common
Nervous system disorders
Common
Uncommon
Adverse reactions
upper respiratory tract infection
pneumonia, sepsis, folliculitis
anaemia, platelet count decreased,
neutrophil count decreased
pancytopenia, febrile neutropenia, white
blood cell count decreased
decreased appetite
dehydration, fluid retention,
hypocalcaemia, hyperglycaemia,
hyperuricaemia, hypophosphataemia,
hypertriglyceridaemia, hypokalaemia,
weight decreased
tumour lysis syndrome
insomnia
headache, dizziness
cerebrovascular accident, cerebral
infarction, neuropathy peripheral,
lethargy, migraine, hyperaesthesia,
hypoaesthesia, paraesthesia, transient
ischaemic attack
cerebral artery stenosis
System organ class
Frequency
Common
Eye disorders
Uncommon
Common
Cardiac disorders
Uncommon
Very common
Common
Vascular Disorders
Uncommon
Very common
Respiratory, thoracic and
mediastinal disorders
Common
Very common
Gastrointestinal disorders
Common
Uncommon
Very common
Hepatobiliary disorders
Common
Uncommon
Very common
Skin and subcutaneous
tissue disorders
Musculoskeletal and
connective tissue disorders
Reproductive system and
breast disorders
General disorders and
administrative site
conditions
Common
Very common
Common
Common
Very common
Common
Adverse reactions
vision blurred, dry eye, periorbital
oedema, eyelid oedema
retinal vein thrombosis, retinal vein
occlusion, retinal artery occlusion, visual
impairment
cardiac failure, myocardial infarction,
cardiac failure congestive, coronary
artery disease, angina pectoris,
pericardial effusion, atrial fibrillation,
ejection fraction decreased
myocardial ischemia, acute coronary
syndrome, cardiac discomfort, ischemic
cardiomyopathy, arteriospasm coronary,
left ventricular dysfunction, atrial flutter
hypertension
peripheral arterial occlusive disease,
peripheral ischaemia, peripheral artery
stenosis, intermittent claudication, deep
vein thrombosis, hot flush, flushing
poor peripheral circulation, splenic
infarction, embolism venous, venous
thrombosis
dyspnoea, cough
pulmonary embolism, pleural effusion,
epistaxis, dysphonia, pulmonary
hypertension
abdominal pain, diarrhoea, vomiting,
constipation, nausea, lipase increased
pancreatitis, blood amylase increased,
gastrooesophageal reflux disease,
stomatitis, dyspepsia, abdominal
distension, abdominal discomfort, dry
mouth
gastric haemorrhage
alanine aminotransferase increased,
aspartate aminotransferase increased
blood bilirubin increased, blood alkaline
phosphatase increased, gammaglutamyltransferase increased
hepatotoxicity, jaundice
rash, dry skin
rash pruritic, exfoliative rash, erythema,
alopecia, pruritis, skin exfoliation, night
sweats, hyperhidrosis, petechia,
ecchymosis, pain of skin, dermatitis
exfoliative
bone pain, arthralgia, myalgia, pain in
extremity, back pain, muscle spasms
musculoskeletal pain, neck pain,
musculoskeletal chest pain
erectile dysfunction
fatigue, asthenia, oedema peripheral,
pyrexia, pain
chills, influenza like illness, non-cardiac
chest pain, mass, face oedema
Updated:
Table 3
Adverse reactions observed in CML and Ph+ ALL patients – frequency
reported by incidence of treatment emergent events
System organ class
Infections and infestations
Frequency
Very common
Common
Very common
Blood and lymphatic
system disorders
Common
Very common
Metabolism and nutrition
disorders
Common
Psychiatric disorders
Uncommon
Very common
Very common
Nervous system disorders
Common
Uncommon
Common
Eye disorders
Uncommon
Common
Cardiac disorders
Uncommon
Very common
Common
Vascular Disorders
Uncommon
Very common
Respiratory, thoracic and
mediastinal disorders
Common
Adverse reactions
upper respiratory tract infection
pneumonia, sepsis, folliculitis
anaemia, platelet count decreased,
neutrophil count decreased
pancytopenia, febrile neutropenia, white
blood cell count decreased
decreased appetite
dehydration, fluid retention,
hypocalcaemia, hyperglycaemia,
hyperuricaemia, hypophosphataemia,
hypertriglyceridaemia, hypokalaemia,
weight decreased
tumour lysis syndrome
insomnia
headache, dizziness
cerebrovascular accident, cerebral
infarction, neuropathy peripheral,
lethargy, migraine, hyperaesthesia,
hypoaesthesia, paraesthesia, transient
ischaemic attack
cerebral artery stenosis
vision blurred, dry eye, periorbital
oedema, eyelid oedema
retinal vein thrombosis, retinal vein
occlusion, retinal artery occlusion, visual
impairment
cardiac failure, myocardial infarction,
cardiac failure congestive, coronary
artery disease, angina pectoris,
pericardial effusion, atrial fibrillation,
ejection fraction decreased
myocardial ischemia, acute coronary
syndrome, cardiac discomfort, ischemic
cardiomyopathy, arteriospasm coronary,
left ventricular dysfunction, atrial flutter
hypertension
peripheral arterial occlusive disease,
peripheral ischaemia, peripheral artery
stenosis, intermittent claudication, deep
vein thrombosis, hot flush, flushing
poor peripheral circulation, splenic
infarction, embolism venous, venous
thrombosis, hypertensive crisis
dyspnoea, cough
pulmonary embolism, pleural effusion,
epistaxis, dysphonia, pulmonary
hypertension
System organ class
Frequency
Very common
Gastrointestinal disorders
Common
Uncommon
Very common
Hepatobiliary disorders
Common
Uncommon
Very common
Skin and subcutaneous
tissue disorders
Musculoskeletal and
connective tissue disorders
Reproductive system and
breast disorders
General disorders and
administrative site
conditions
Common
Very common
Common
Common
Very common
Common
Adverse reactions
abdominal pain, diarrhoea, vomiting,
constipation, nausea, lipase increased
pancreatitis, blood amylase increased,
gastrooesophageal reflux disease,
stomatitis, dyspepsia, abdominal
distension, abdominal discomfort, dry
mouth
gastric haemorrhage
alanine aminotransferase increased,
aspartate aminotransferase increased
blood bilirubin increased, blood alkaline
phosphatase increased, gammaglutamyltransferase increased
hepatotoxicity, hepatic failure, jaundice
rash, dry skin
rash pruritic, exfoliative rash, erythema,
alopecia, pruritis, skin exfoliation, night
sweats, hyperhidrosis, petechia,
ecchymosis, pain of skin, dermatitis
exfoliative
bone pain, arthralgia, myalgia, pain in
extremity, back pain, muscle spasms
musculoskeletal pain, neck pain,
musculoskeletal chest pain
erectile dysfunction
fatigue, asthenia, oedema peripheral,
pyrexia, pain
chills, influenza like illness, non-cardiac
chest pain, mass, face oedema
‫לצרכן‬
‫בעלון לצרכן‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫על‬
‫ההחרמות המבוקשות‬
‫טקסט חדש‬
:‫תופעות לוואי לא שכיחות‬
‫טקסט נוכחי‬
‫פרק בעלון‬
:‫ תופעות לוואי תופעות לוואי לא שכיחות‬.4
‫הפרעות מטבוליות הנגרמות מתוצרי פירוק של תאי סרטן‬
‫הפרעות מטבוליות הנגרמות מתוצרי פירוק של תאי סרטן‬
,‫ חסימת כלי דם בעיניים‬,‫ היצרות של העורקים במוח‬,‫ חסימת כלי דם מתים‬,‫ היצרות של העורקים במוח‬,‫מתים‬
‫ כאב‬,‫ בעיות בכלי דם בשריר הלב‬,‫ בעיות לב‬,‫ בעיות בכלי דם הפרעות בראייה‬,‫ בעיות לב‬,‫ הפרעות בראייה‬,‫בעיניים‬
‫ בעיות בתפקוד החדר השמאלי של‬,‫ בעיות בתפקוד בצד שמאל של החזה‬,‫ כאב בצד שמאל של החזה‬,‫בשריר הלב‬
‫ עליה פתאומית‬,‫ הפרעות בזרימת הדם‬,‫ הצרות כלי דם‬,‫הלב‬
‫ הפרעות בזרימת‬,‫ הצרות כלי דם‬,‫החדר השמאלי של הלב‬
‫ דימום מהקיבה‬,‫ בעיות בזרימת הדם בטחול‬,‫בלחץ דם‬
‫ דימום מהקיבה‬,‫ בעיות בזרימת הדם בטחול‬,‫הדם‬
‫ צהבת‬,‫ נזק כבדי‬,)‫ דם בקיא‬,‫ צהבת (סימפטומים – כאב בטן‬,‫ נזק כבדי‬,)‫ דם בקיא‬,‫(סימפטומים – כאב בטן‬
)‫(מתבטאת בהצהבת העור והעיניים‬
)‫(מתבטאת בהצהבת העור והעיניים‬
.‫ שבו מסומנות ההחמרות המבוקשות על רקע צהוב‬,‫מצ"ב העלון‬
‫ יש לסמן רק תוכן מהותי ולא שינויים במיקום‬.‫שינויים שאינם בגדר החמרות סומנו (בעלון) בצבע ירוק‬
.‫הטקסט‬