Quest for the right Drug
טרמפיה TREMFYA (GUSELKUMAB)
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 reaction was respiratory tract infections in approximately 14% of patients in the psoriasis and psoriatic arthritis clinical studies. Tabulated list of adverse reactions Table 1 provides a list of adverse reactions from psoriasis and psoriatic arthritis clinical studies as well as from post-marketing experience. The adverse reactions are classified by MedDRA System Organ Class and frequency, using 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), not known (cannot be estimated from the available data). Table 1: List of adverse reactions System Organ Class Frequency Adverse reactions Infections and infestations Very common Respiratory tract infections Uncommon Herpes simplex infections Uncommon Tinea infections Uncommon Gastroenteritis Immune system disorders Uncommon Hypersensitivity Uncommon Anaphylaxis Nervous system disorders Common Headache Gastrointestinal disorders Common Diarrhoea Skin and subcutaneous tissue Uncommon Urticaria disorders Uncommon Rash Musculoskeletal and connective Common Arthralgia tissue disorders General disorders and administration Common Injection site reactions site conditions Investigations Common Transaminases increased Uncommon Neutrophil count decreased Description of selected adverse reactions Transaminases increased In two Phase III psoriatic arthritis clinical studies, through the placebo-controlled period, adverse events of increased transaminases (includes ALT increased, AST increased, hepatic enzyme increased, transaminases increased, liver function test abnormal, hypertransaminasaemia) were reported more frequently in the guselkumab-treated groups (8.6% in the q4w group and 8.3% in the q8w group) than in the placebo group (4.6%). Through 1 year, adverse events of increased transaminases (as above) were reported in 12.9% of patients in the q4w group and 11.7% of patients in the q8w group. Based on laboratory assessments, most transaminase increases (ALT and AST) were ≤ 3 x upper limit of normal (ULN). Transaminase increases from > 3 to ≤ 5 x ULN and > 5 x ULN were low in frequency, occurring more often in the guselkumab q4w group compared with the guselkumab q8w group (Table 2). A similar pattern of frequency by severity and by treatment group was observed through the end of the 2- year Phase III psoriatic arthritis clinical study. Table 2: Frequency of patients with transaminase increases post-baseline in two Phase III psoriatic arthritis clinical studies Through week 24a Through 1 yearb Placebo guselkumab guselkumab guselkumab guselkumab N=370c 100 mg q8w 100 mg q4w 100 mg q8w 100 mg q4w N=373c N=371c N=373 c N=371 c ALT >1 to ≤3 x ULN 30.0% 28.2% 35.0% 33.5% 41.2% >3 to ≤ 5 x ULN 1.4% 1.1% 2.7% 1.6% 4.6% >5 x ULN 0.8% 0.8% 1.1% 1.1% 1.1% AST >1 to ≤3 x ULN 20.0% 18.8% 21.6% 22.8% 27.8% >3 to ≤ 5 x ULN 0.5% 1.6% 1.6% 2.9% 3.8% >5 x ULN 1.1% 0.5% 1.6% 0.5% 1.6% a placebo-controlled period b patients randomised to placebo at baseline and crossed over to guselkumab are not included c number of patients with at least one post-baseline assessment for the specific laboratory test within the time period In the psoriasis clinical studies, through 1 year, the frequency of transaminase increases (ALT and AST) for the guselkumab q8w dose was similar to that observed for the guselkumab q8w dose in the psoriatic arthritis clinical studies. Through 5 years, the incidence of transaminase elevation did not increase by year of guselkumab treatment. Most transaminase increases were ≤ 3 x ULN. In most cases, the increase in transaminases was transient and did not lead to discontinuation of treatment. Neutrophil count decreased In two Phase III psoriatic arthritis clinical studies, through the placebo-controlled period, the adverse event of decreased neutrophil count was reported more frequently in the guselkumab-treated group (0.9%) than in the placebo group (0%). Through 1 year, the adverse event of decreased neutrophil count was reported in 0.9% of patients treated with guselkumab. In most cases, the decrease in blood neutrophil count was mild, transient, not associated with infection and did not lead to discontinuation of treatment. Gastroenteritis In two Phase III psoriasis clinical studies through the placebo-controlled period, gastroenteritis occurred more frequently in the guselkumab-treated group (1.1%) than in the placebo group (0.7%). Through Week 264, 5.8%of all guselkumab-treated patients reported gastroenteritis. Adverse reactions of gastroenteritis were non-serious and did not lead to discontinuation of guselkumab through Week 264. Gastroenteritis rates observed in psoriatic arthritis clinical studies through the placebo-controlled period were similar to those observed in the psoriasis clinical studies. Injection site reactions In two Phase III psoriasis clinical studies through Week 48, 0.7% of guselkumab injections and 0.3% of placebo injections were associated with injection site reactions. Through Week 264, 0.4% of guselkumab injections were associated with injection site reactions. Injection site reactions were generally mild to moderate in severity; none were serious, and one led to discontinuation of guselkumab. In two Phase III psoriatic arthritis clinical studies through Week 24, the number of subjects that reported 1 or more injection site reactions was low and slightly higher in the guselkumab groups than in the placebo group; 5 (1.3%) subjects in the guselkumab q8w group, 4 (1.1%) subjects in the guselkumab q4w group, and 1 (0.3%) subject in the placebo group. One subject discontinued guselkumab due to an injection site reaction during the placebo-controlled period of the psoriatic arthritis clinical studies. Through 1 year, the proportion of subjects reporting 1 or more injection site reactions was 1.6% and 2.4% in the guselkumab q8w and q4w groups respectively. Overall, the rate of injections associated with injection site reactions observed in psoriatic arthritis clinical studies through the placebo-controlled period was similar to rates observed in the psoriasis clinical studies. Immunogenicity The immunogenicity of guselkumab was evaluated using a sensitive and drug-tolerant immunoassay. In pooled Phase II and Phase III analyses in patients with psoriasis, and psoriatic arthritis, 5% (n=145) of patients treated with guselkumab developed antidrug antibodies in up to 52 weeks of treatment. Of the patients who developed antidrug antibodies, approximately 8% (n=12) had antibodies that were classified as neutralizing, which equates to 0.4% of all patients treated with guselkumab. In pooled Phase III analyses in patients with psoriasis, approximately 15% of patients treated with guselkumab developed antidrug antibodies in up to 264 weeks of treatment. Of the patients who developed antidrug antibodies, approximately 5% had antibodies that were classified as neutralizing, which equates to 0.76% of all patients treated with guselkumab. Antidrug antibodies were not associated with lower efficacy or development of injection-site reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medical 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. החולה סובל מאחד מאלה: 1. מחלה מפושטת מעל ל-50% של שטח גוף או PASI מעל 50; 2. נגעים באזורי גוף רגישים - אזורים אלו יכללו פנים, צוואר, קיפולי עור, כפות ידיים, כפות רגליים, אזור הגניטליה והישבן. ב. החולה קיבל שני טיפולים סיסטמיים לפחות ללא שיפור של 50% לפחות ב-PASI לאחר סיום הטיפול בהשוואה לתחילת הטיפול. בהתייחס לחולה העונה על פסקה (1)(א)(2) החולה קיבל שני טיפולים סיסטמיים לפחות בלא שיפור משמעותי לאחר סיום הטיפול בהשוואה לתחילת הטיפול;ג. התרופה תינתן על פי מרשם של מומחה ברפואת עור ומין.
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
א. החולה סובל מאחד מאלה: 1. מחלה מפושטת מעל ל-50% של שטח גוף או PASI מעל 50; 2. נגעים באזורי גוף רגישים - אזורים אלו יכללו פנים, צוואר, קיפולי עור, כפות ידיים, כפות רגליים, אזור הגניטליה והישבן. ב. החולה קיבל שני טיפולים סיסטמיים לפחות ללא שיפור של 50% לפחות ב-PASI לאחר סיום הטיפול בהשוואה לתחילת הטיפול. בהתייחס לחולה העונה על פסקה (1)(א)(2) החולה קיבל שני טיפולים סיסטמיים לפחות בלא שיפור משמעותי לאחר סיום הטיפול בהשוואה לתחילת הטיפול; ג. התרופה תינתן על פי מרשם של מומחה ברפואת עור ומין. | 30/01/2020 | עור ומין | ADALIMUMAB, IXEKIZUMAB, CERTOLIZUMAB PEGOL, USTEKINUMAB, SECUKINUMAB, GUSELKUMAB, ETANERCEPT, INFLIXIMAB, TILDRAKIZUMAB | Psoriasis |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
30/01/2020
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