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טיויקיי 50 מ"ג TIVICAY 50 MG (DOLUTEGRAVIR AS SODIUM)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED TABLETS
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 severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4). The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%) and headache (13%). Tabulated list of adverse reactions The adverse reactions considered at least possibly related to dolutegravir are listed by body system, organ class and absolute frequency. 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), very rare (<1/10,000). Table 4 Adverse Reactions Immune system Uncommon Hypersensitivity (see section 4.4) disorders Uncommon Immune Reconstitution Syndrome (see section 4.4)** Psychiatric disorders Common Insomnia Common Abnormal dreams Common Depression Common Anxiety Uncommon Panic attack Uncommon Suicidal ideation*, suicide attempt* *particularly in patients with a pre-existing history of depression or psychiatric illness. Rare Completed suicide* *particularly in patients with a pre-existing history of depression or psychiatric illness. Nervous system Very common Headache disorders Common Dizziness Gastrointestinal Very common Nausea disorders Very common Diarrhoea Common Vomiting Common Flatulence Common Upper abdominal pain Common Abdominal pain Common Abdominal discomfort Hepatobiliary Common Alanine aminotransferase (ALT) and/or Aspartate disorders aminotransferase (AST) elevations Uncommon Hepatitis Rare Acute hepatic failure, increased bilirubin*** Skin and Common Rash subcutaneous tissue Common Pruritus disorders Musculoskeletal and Uncommon Arthralgia connective tissue Uncommon Myalgia disorders General disorders Common Fatigue and administration site conditions Investigations Common Creatine phosphokinase (CPK) elevations, weight increased **see below under Description of selected adverse reactions. ***in combination with increased transaminases Description of selected adverse reactions Changes in laboratory biochemistries Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 48 weeks. A mean change from baseline of 9.96 mol/L was observed after 48 weeks of treatment. Creatinine increases were comparable by various background regimens. These changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate. Co-infection with Hepatitis B or C In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN). Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co- infection for all treatment groups. Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some subjects with hepatitis B and/or C co- infection at the start of dolutegravir therapy, particularly in those whose anti-hepatitis B therapy was withdrawn (see section 4.4). Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4). Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4). Paediatric population Based on available data from the ongoing P1093 (ING112578) and ODYSSEY (201296) studies in 172 infants, children and adolescents (aged 4 weeks and above, to less than 18 years, and weighing at least 3 kg) who received the recommended doses of film-coated tablets or dispersible tablets once daily, there were no additional types of adverse reactions beyond those observed in the adult population. 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 Additionally, you should also report to GSK Israel (il.safety@gsk.com ).
פרטי מסגרת הכללה בסל
א. התרופה תינתן לטיפול בנשא HIV.ב. מתן התרופה ייעשה לפי מרשם של מנהל מרפאה לטיפול באיידס במוסד רפואי שהמנהל הכיר בו כמרכז AIDS;ג. משטר הטיפול בתרופה יהיה כפוף להנחיות המנהל כפי שיעודכנו מזמן לזמן על פי המידע העדכני בתחום הטיפול במחלה.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
12/01/2014
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
מידע נוסף
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טיויקיי 50 מ"ג
