Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Biktarvy

Biktarvy 30 mg/120 mg/15 mg film-coated tablets Biktarvy 50 mg/200 mg/25 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14

HOS-139315 · Präparat HOS-098314

Frequency Adverse reaction Blood and lymphatic system disorders Uncommon: anaemia2 Psychiatric disorders Common: depression, abnormal dreams suicidal ideation, suicide attempt (particularly in patients with a pre-existing history Uncommon: of depression or psychiatric illness), anxiety, sleep disorders Nervous system disorders Common: headache, dizziness Gastrointestinal disorders Common: diarrhoea, nausea Uncommon: vomiting, abdominal pain, dyspepsia, flatulence Hepatobiliary disorders Uncommon: hyperbilirubinaemia Skin and subcutaneous tissue disorders Uncommon: angioedema3,4, rash, pruritus, urticaria4 Rare: Stevens-Johnson syndrome5 Musculoskeletal and connective tissue disorders Uncommon: arthralgia General disorders and administration site conditions Common: Fatigue Investigations Common: weight increased 1 With the exception of angioedema, anaemia, urticaria and Stevens-Johnson syndrome (see footnotes 2-5), all adverse reactions were identified from Biktarvy clinical studies. The frequencies were derived from the double-blind phase (Week 144) of Phase 3 Biktarvy clinical studies in treatment-naïve patients (GS-US-380-1489 and GS-US-380-1490). 2 This adverse reaction was not observed in the clinical studies of emtricitabine + tenofovir alafenamide-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals. 3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products. 4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products. 5 This adverse reaction was identified through post-marketing surveillance for Biktarvy. The frequency has been calculated using 3/X, where X represent the cumulative number of subjects exposed to Biktarvy in clinical trials (N=3963).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.