Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Genvoya

Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Genvoya 90 mg/90 mg/120 mg/6 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 23

HOS-134063 · Präparat HOS-097520

The safety of Genvoya was evaluated through 48 weeks in HIV-1 infected adolescent patients aged 12 to < 18 years weighing ≥ 35 kg (n = 100), in children aged 7 to < 12 years weighing > 25 kg (n = 52), and in children aged 3 to 9 years and weighing ≥ 14 to < 25 kg (n = 27). The safety profile in paediatric patients who received treatment with Genvoya was similar to that in adults. After 48 weeks of treatment with Genvoya, reductions in BMD of the spine and of the TBLH ≥ 4% have been reported in 2.1% (1/47) and 0.0% of adolescents, in 12.2% (6/49) and 3.9% (2/51) of children aged 7 to < 12 years weighing at least 25 kg, and in 3.7% (1/27) and 0.0% of children aged at least 3 years and weighing at least 14 kg to < 25 kg respectively.

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