Quest for the right Drug
בסרמי 250 מק"ג/ 0.5 מ"ל BESREMI 250 MCG/0.5 ML (ROPEGINTERFERON ALFA-2B)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תת-עורי : S.C
צורת מינון:
תמיסה להזרקה : SOLUTION FOR INJECTION
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
Adverse reactions : תופעות לוואי
4.8 Undesirable effects Summary of the safety profile The most common adverse reactions are leukopenia (20.2%), thrombocytopenia (18.5%), arthralgia (13.5%), fatigue (12.4%), increased gamma-glutamyltransferase (11.2%), influenza-like illness (11.2 %), myalgia (10.7%), anaemia (9.6%), increased alanine aminotransferase (8.4%), neutropenia (7.9%), pyrexia (7.9%), increased aspartate aminotransferase (7.3%), pruritus (6.8%), pain in extremity (6.7%), alopecia (6.7%), headache (6.2%), diarrhoea (5.7%), injection site reaction (5.6%), chills (5.1%) and dizziness (5.1%). Serious adverse reactions are depression (1.1%), atrial fibrillation (1.1%) and acute stress disorder (0.6%). Tabulated list of adverse reactions Following treatment-related adverse reactions were reported with ropeginterferon alfa-2b in clinical studies in 178 polycythaemia vera adult patients. Adverse reactions are listed by system organ class and frequency (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), very rare (< 1/10,000) or not known (cannot be estimated from available data). System organ class Frequency Adverse reaction Infections and common respiratory tract infection, influenza, rhinitis, fungal skin infestations infection uncommon oral herpes, herpes zoster, oral candidiasis, sinusitis, oesophageal candidiasis, vulvovaginal mycotic infection, hordeolum, onychomycosis Blood and lymphatic very common leukopenia, thrombocytopenia system disorders common pancytopenia, neutropenia, anaemia Immune system uncommon sarcoidosis disorders very rare idiopathic or thrombotic thrombocytopenic purpura# not known Vogt-Koyanagi-Harada disease#, acute hypersensitivity reactions#** Endocrine disorders common hypothyroidism, hyperthyroidism, thyroiditis uncommon Basedow's disease, diabetes mellitus# Metabolism and common hypertriglyceridaemia, decreased appetite nutrition disorders Psychiatric disorders common depression, aggression#, insomnia, anxiety, mood altered, mood swings, mood disorders uncommon suicide attempt#, suicidal ideation#, confusional state#, acute stress disorder, hallucination, emotional distress, nervousness, nightmare, irritability rare bipolar disorder#, mania# Nervous system common headache, dizziness, hypoesthesia, somnolence, disorders paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#, very rare blindness# not known retinal detachment# Ear and labyrinth uncommon deafness, tinnitus, vertigo disorders Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris# very rare myocardial ischemia# Vascular disorders common microangiopathy uncommon Raynaud's phenomenon, hypertension, haematoma, flushing Respiratory, thoracic common dyspnoea and mediastinal uncommon pneumonitis, cough, epistaxis, throat irritation disorders very rare lung infiltration# not known pulmonary fibrosis#, pneumonia#, pulmonary arterial hypertension#* Gastrointestinal common diarrhoea, nausea, abdominal pain, constipation, disorders abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease# Hepatobiliary very common gamma-glutamyltransferase increased disorders common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly, porphyria non-acute rare hepatic failure# Skin and common pruritus, alopecia, rash, erythema, psoriasis, xeroderma, subcutaneous tissue dermatitis acneiform, hyperkeratosis, hyperhidrosis, dry disorders skin uncommon photosensitivity reaction, skin exfoliation, nail dystrophy not known skin depigmentation# Musculoskeletal and very common arthralgia, myalgia connective tissue common Sjogren's syndrome, arthritis, pain in extremity, disorders musculoskeletal pain, bone pain, muscle spasms uncommon muscular weakness, neck pain, groin pain Renal and urinary uncommon cystitis haemorrhagic, dysuria, micturition urgency, disorders urinary retention Reproductive system uncommon erectile dysfunction, haematospermia and breast disorders General disorders very common influenza like illness, fatigue and administration site conditions common pyrexia, injection site reaction, asthenia, chills, general physical health deterioration, injection site erythema uncommon injection site pain, injection site pruritus, sensitivity to weather change not known: tongue hyperpigmentation# Investigations common antithyroid antibody positive, blood thyroid stimulating hormone increased, body temperature increased, antinuclear antibody positive, blood lactate dehydrogenase increased, weight decreased uncommon platelet count increased, blood uric acid increased, Coombs test positive # Reported as adverse reactions during treatment with other interferon alfa medicinal products. *Class label for interferon medicinal products, see below pulmonary arterial hypertension. **e.g., urticaria, angioedema, bronchoconstriction or anaphylaxis. Description of selected adverse reactions Most common adverse reactions The most common adverse reactions (including number of patients, incidence rate, severity grade, necessity for dose adaptation and outcome) reported during the ropeginterferon alfa-2b clinical development program are summarised in Table 1. Table 1. Most common adverse reactions during ropeginterferon alfa-2b treatment. ADR >10% Medicinal CTCAE Dose Recovered PT N (%) IR Medicinal Product intensity reduced N=178 Product discontinued grade ≥3 interrupted N (%) N (%) N (%) N (%) N (%) Leukopenia 36 21.2 3 (8.3) 5 (13.9) 4 (11.1) n.r. 8 (22.2) (20.2) Thrombo- 33 11.2 4 (12.1) 3 (9.1) 2 (6.1) n.r. 6 (18.2) cytopenia (18.5) Arthralgia 24 5.2 1 (4.2) 4 3 (12.5) 1 (4.2) 15 (62.5) (13.5) (16.7) Fatigue 22 6.6 n.r. 3 (13.6) 1 (4.5) 1 (4.5) 11 (50.0) (12.4) Gamma- 20 7.9 7 (35.0) 3 (15.0) n.r. n.r. 4 (20.0) glutamyl- (11.2) transferase increased Influenza like 20 4.9 n.r. 4 (20.0) 2 (10.0) n.r. 10 (50.0) illness (11.2) Myalgia 19 3.5 n.r. 2 (10.5) 1 (5.3) n.r. 9 (47.4) (10.7) No CTCAE grade 5 (death) adverse reactions reported for these preferred terms; 1 AE grade 4 (life-threating or disabling) reported for Gamma-glutamyltransferase increased. Abbreviations: CTCAE, common terminology criteria for adverse events; n.r., not reported; ADR, adverse drug reaction; PT, preferred term; IR, incidence rate of mean adverse events per 100 patients per year; N, number of patients. N (%) number and percentage of patients with given AE Gastrointestinal disorders Gastrointestinal disorders have been reported with other interferon alfa medicinal products and have been reported in 15.7% of patients with ropeginterferon alfa-2b treatment. The most common gastrointestinal disorders reported in these studies were diarrhoea (5.1%; incidence rate: 2.8 [events/100 patients per year]) and nausea (4.5%; incidence rate: 1.2 events/100 patients per year]). CNS In the clinical development program of ropeginterferon alfa-2b, two cases of serious depression (1.1%; incidence rate: 0.4 events/100 patients per year) occurred. The patients recovered completely after permanent medicinal product discontinuation. One patient who experienced serious acute stress disorder (0.6%; incidence rate: 0.2 events/100 patients per year) with moderate intensity recovered completely after the dose of ropeginterferon alfa-2b was reduced. CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4). Cardiovascular system During ropeginterferon alfa-2b therapy, three cases of atrial fibrillation (1.1%; incidence rate: 0.3 events/100 patients per year) with intensity grade 1 to 3 occurred in two patients. Ropeginterferon alfa-2b treatment was continued, and the patients received appropriate medicinal products to treat these events. Patients recovered from the two events; one event was ongoing at the time of assessment. Respiratory system Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis). Events were reported at various time points typically several months after starting treatment with interferon alfa. Visual system Serious eye disorders have been reported with interferon alfa such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion (see section 4.4). 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. התכשיר יינתן לטיפול בפוליציתמיה ורה ללא הגדלת טחול סימפטומטית בחולים העונים על אחד מאלה:1. חולים בני 60 שנים ומטה הזקוקים לטיפול ציטורדוקטיבי;2. חולים בגיל הפוריות.ב. תחילת מתן הטיפול בתכשיר תיעשה לפי מרשם של רופא מומחה בהמטולוגיה.
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
א. התכשיר יינתן לטיפול בפוליציתמיה ורה ללא הגדלת טחול סימפטומטית בחולים העונים על אחד מאלה: 1. חולים בני 60 שנים ומטה הזקוקים לטיפול ציטורדוקטיבי; 2. חולים בגיל הפוריות. ב. תחילת מתן הטיפול בתכשיר תיעשה לפי מרשם של רופא מומחה בהמטולוגיה. | 01/02/2023 | המטולוגיה | פוליציתמיה ורה, Polycythemia vera |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
01/02/2023
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
רישום
166 66 36574 00
מחיר
0 ₪
מידע נוסף
עלון מידע לצרכן
20.12.21 - עלון לצרכן אנגלית 20.12.21 - עלון לצרכן עברית 20.12.21 - עלון לצרכן ערבית 20.12.21 - עלון לצרכן ערבית 30.08.23 - עלון לצרכן עברית 12.10.23 - עלון לצרכן אנגלית 12.10.23 - עלון לצרכן עברית 12.10.23 - עלון לצרכן ערבית 12.10.23 - עלון לצרכן ערבית 01.11.24 - עלון לצרכן אנגלית 01.11.24 - עלון לצרכן עברית 01.11.24 - עלון לצרכן ערביתלתרופה במאגר משרד הבריאות
בסרמי 250 מק"ג/ 0.5 מ"ל