Quest for the right Drug
קיסימפטה KESIMPTA (OFATUMUMAB)
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 important and frequently reported adverse reactions are upper respiratory tract infections (39.4%), systemic injection-related reactions (20.6%), injection-site reactions (10.9%) and urinary tract infections (11.9%) (see section 4.4 and below subsection “Description of selected adverse reactions” for further details). Tabulated list of adverse reactions Adverse reactions that have been reported in association with the use of ofatumumab in pivotal RMS clinical studies and from post-marketing experience are listed by MedDRA system organ class in Table 1. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: 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) and not known (cannot be estimated from the available data). KES API JUL24 V5 Page 6 of 15 EU SmPC 06/2024 Table 1 Tabulated list of adverse reactions Infections and infestations Very common Upper respiratory tract infections1 Urinary tract infections2 Common Oral herpes Immune system disorders Not known Hypersensitivity reactions3 General disorders and administration site conditions Very common Injection-site reactions (local) Injury, poisoning and procedural complications Very common Injection-related reactions (systemic) Gastrointestinal disorders Common Nausea, vomiting4 Investigations Common Blood immunoglobulin M decreased 1 Grouping of preferred terms (PTs) was considered for ADR frequency determination and includes the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis. 2 Grouping of preferred terms (PTs) was considered for ADR frequency determination and includes the following: urinary tract infection, cystitis, escherichia urinary tract infection, asymptomatic bacteriuria, bacteriuria. 3 Reported during post-marketing experience (see section 4.4). 4 Nausea and vomiting have been reported in association with systemic injection-related reactions (see below and section 4.4) Description of selected adverse reactions Infections In the RMS phase III clinical studies, the overall rate of infections and serious infections in patients treated with ofatumumab was similar to patients who were treated with teriflunomide (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively). Two patients (0.2%) discontinued and 11 patients (1.2%) temporarily interrupted study treatment due to a serious infection. Upper respiratory tract infections In these studies, 39.4% of ofatumumab-treated patients experienced upper respiratory tract infections compared to 37.8% of teriflunomide-treated patients. The infections were predominantly mild to moderate and mostly consisted of nasopharyngitis, upper respiratory tract infection and influenza. Injection-related reactions In the RMS phase III clinical studies, injection-related reactions (systemic) were reported in 20.6% of patients treated with ofatumumab. The incidence of injection-related reactions was highest with the first injection (14.4%), decreasing significantly with subsequent injections (4.4% with second, <3% from third injection). Injection-related reactions were mostly (99.8%) mild to moderate in severity. Two (0.2%) ofatumumab-treated MS patients reported serious injection-related reactions but not life-threatening. The most frequently reported symptoms (≥2%) included fever, headache, KES API JUL24 V5 Page 7 of 15 EU SmPC 06/2024 myalgia, chills and fatigue. Additional reported symptoms included nausea (1.7%) and vomiting (0.6%). Injection-site reactions In the RMS phase III clinical studies, injection-site reactions (local) were reported in 10.9% of patients treated with ofatumumab. Local reactions at the administration site were very common. Injection-site reactions were all mild to moderate in severity and non-serious in nature. The most frequently reported symptoms (≥2%) included erythema, pain, itching and swelling. Laboratory abnormalities Immunoglobulins During the course of the RMS phase III clinical studies, decrease in mean value of immunoglobulin M (IgM) (30.9% decrease after 48 weeks and 38.8% decrease after 96 weeks) was observed and no association with risk of infections, including serious infections, was shown. In 14.3% of patients, treatment with ofatumumab resulted in a decrease in IgM that reached a value below 0.34 g/l. Ofatumumab was associated with a transient decrease of 4.3% in mean immunoglobulin G (IgG) levels after 48 weeks of treatment but an increase of 2.2% after 96 weeks. 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. And to Novartis using the following email address: safetydesk.israel@novartis.com.
שימוש לפי פנקס קופ''ח כללית 1994
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